Circumcision Status and Risk of HIV Acquisition During Heterosexual Intercourse for Both Males and Females: A Meta-Analysis

Lei, J., Liu L., Wei Q., et al. PLOS ONE (May 2015), 10(5): e0125436, doi: 10.1371/journal.pone.0125436.

This article reported on a meta-analysis evaluating whether male circumcision was associated with lower HIV acquisition for heterosexual men and women. The analysis included 15 studies: four randomized controlled trials (RCTs), and 11 prospective cohort studies. Ten studies (3 RCTs and 7 cohort studies) assessed HIV transmission from females to males, and five studies (1 RCT and 4 cohort studies) assessed HIV transmission from males to females. The pooled analysis showed that circumcision provided 70 percent protection for men, consistent with an earlier meta-analysis from 2000. Another pooled analysis showed no difference in HIV acquisition between women with circumcised and uncircumcised partners. The studies in women differed in their design and measurement: in two cohort studies the partners’ HIV status was unknown, while three studies enrolled serodiscordant couples (SDCs). The only RCT was stopped due to futility. The authors noted that while the lower rate of HIV among men may benefit women, the meta-analysis showed no evidence of a direct benefit from HIV-positive men to HIV-negative women in SDCs. The analysis provided strong evidence that male circumcision reduces HIV acquisition in males, but there was no protective benefit for female sexual partners of circumcised men. The authors concluded that MMC should be considered as part of broader HIV prevention strategies to benefit both men and women.

Voluntary Medical Male Circumcision: Modeling the Impact and Cost of Expanding Male Circumcision for HIV Prevention in Eastern and Southern Africa

Njeuhmeli, E., Forsythe, S., Reed, J., et al. PLOS Medicine (November 2011), 8(11),

This study used the Male Circumcision Decision- Makers’ Program Planning Tool to predict  the cost and impact of scaling up voluntary male medical circumcision (VMMC) in 13 countries in eastern and southern Africa where VMMC is considered a priority (Botswana, Lesotho, Malawi, Mozambique, Namibia, Rwanda, South Africa, Swaziland, Tanzania, Uganda, Zambia, Zimbabwe, and Nyanza province in Kenya). The calculations were based on epidemiologic and demographic data from each of the countries, and the cost of each procedure, which ranged from USD$65 to $95, was calculated according to World Health Organization supply-side models for optimal volume and efficiency. To attain 80 percent coverage in these countries would require over 20 million circumcisions between 2011 and 2015, and 8.4 million more in the subsequent decade to maintain coverage at that level. Modeling showed that if coverage at this level could be achieved, it would avert more than 3.3 million new HIV infections, with USD$16.5 billion in cost savings on care and treatment.

Will Circumcision Provide Even More Protection from HIV to Women and Men? New Estimates of the Population Impact of Circumcision Interventions

Hallett, T. B., Alsallaq, R. A., Baeten, J. M., et al. Sexually Transmitted Infections (August 2010), 87(2): 85, doi:10.1136/sti.2010.043372.

This article was the first to note circumcision’s protective effect on male-to-female transmission. Using data from various studies in eastern and southern Africa, the authors asserted that circumcision confers a 46 percent reduction in male-to-female HIV transmission. The authors posited that the impact of circumcision on HIV prevention is greater than originally estimated. These projections showed a significant increase in infections averted by male circumcision: overall infections averted increased by 40 percent, which includes a doubling of infections averted among women. The authors also noted that the increased risk during wound healing does not have a statistically significant impact at a population level.

Male Circumcision and Risk of HIV Infection in Women: A Systematic Review and Meta-Analysis

Weiss, H.A., Hankins, C.A., & Dickson, K. The Lancet Infectious Diseases (2009), 9(11), pp. 669-677.

Because male circumcision (MC) reduces the risk of HIV infection among heterosexual men, it also provides long-term, indirect protection to women. In this systematic review and meta-analysis, the authors looked at 19 epidemiological studies covering 11 populations, including one randomized controlled trial and six longitudinal studies, to see what direct effect MC may have on HIV risk in women. The latter seven studies indicated little evidence of a direct protective effect of MC against women becoming infected with HIV. It would require a randomized controlled trial of 10,000 serodiscordant couples to generate more definitive data, a task that is not logistically practicable. The authors concluded that with the scale-up of MC in high-prevalence settings, the maximum benefits for both men and women would be gained by integrating MC with other prevention strategies, and they urged rigorous monitoring for potential adverse effects in women.

Risk Compensation is not Associated with Male Circumcision in Kisumu, Kenya: A Multi-Faceted Assessment of Men Enrolled in a Randomized Controlled Trial

Mattson, C., Campbell, R., Baily, R.C., et al. PLOS ONE (June 2008), 3(6): e2443.

This study assessed whether about 1,000 18–24-year-old men, participants in a randomized, controlled trial in Kisumu, Kenya on male circumcision (MC), adopted risky sexual behaviors after being circumcised. Participants received counseling that research about MC's protective effect against HIV was inconclusive. This study included a comprehensive, 18-point scale that was validated with serologic text results for sexually transmitted infections. Detailed sexual histories were collected at baseline, 6 months, and 12 months after randomization, with individualized HIV risk reduction counseling taking place at this time. The researchers found that sexual risk behaviors decreased one year after being randomized to either MC or control. There was no difference between circumcised and uncircumcised men after one year of follow-up in propensity for sexual risk, or in incidence of gonorrhea, chlamydia, and trichomoniasis. While this study indicated that risk compensation may not be an issue with MC, study participants had risk reduction counseling and the support of a clinical trial—counseling and support that will be difficult to replicate when MC becomes widely available. Furthermore, changes in sexual behavior may take place more than one year after MC.

Male Circumcision for HIV Prevention in Young Men in Kisumu, Kenya: A Randomized Controlled Trial

Bailey, R., Moses, S., Parker, C., et al. The Lancet (February 2007), 369(95620): 643–656.

This two-year trial was halted early because interim findings from the intervention arm were clear: male circumcision (MC) was protective of HIV infection. Nearly 2,800 men aged 18–24 in Kisumu, Kenya were randomized to immediate circumcision or delayed circumcision at 24 months. Researchers provided HIV counseling and testing and genital examination, and asked participants about their sexual activity; collected blood and urine for sexually transmitted infection (STI) testing; and used a comprehensive questionnaire about sexual function and HIV risk behaviors. Men testing positive for HIV were referred for free treatment and support. When the study was halted, MC had a protective effect of 53 percent compared to the control arm, which increased to 60 percent when the analysis was statistically adjusted. Men in both study arms reported a reduction in HIV sexual risk behaviors. Uncircumcised men reported decreasing sexual concurrency over the study period, which remained stable after month six in circumcised men. Circumcised men were more likely to have unprotected sexual intercourse with any partner in the previous 6 months, and less likely to use condoms consistently at 24 months of follow-up. However, researchers attributed this difference to a move to safer sexual behavior in the control group, rather than risk compensation among circumcised men.

Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: The ANRS 1265 Trial

Auvert, B., Taljaard, D., Lagarde, E., et al. PLOS Medicine (October 2005), 2(11): 1112–1122.

This landmark study was the first randomized, controlled trial to confirm the results of observations studies: that male circumcision (MC) reduced the rate of heterosexual HIV transmission. In fact, this protection was evident partway through the trial, which was stopped early. Among 3,274 HIV-negative men aged 18–24 in Orange Farm, South Africa, those who had been circumcised were 60 percent less likely to contract HIV than those who had not been circumcised over an 18-month period. This level of protection was evident when using statistical techniques to control for other factors, such as condom use and non-marital sexual partnerships. Because the trial was stopped early, the long-term protective effects of MC on HIV acquisition are unknown. Furthermore, the men who had been circumcised were more likely to have risky sexual behaviors than uncircumcised men, raising concerns about behavioral disinhibition among circumcised men.

Economics of Antiretroviral Treatment vs. Circumcision for HIV Prevention

Bärnighausen, T., Bloom, D., and Humair, S. Proceedings of the National Academy of Sciences (December 2012), 109(52): 21271–21276. 

This article reported on a model developed and applied to South Africa to compare the health effects and costs of scaling up treatment as prevention (TasP), expanded antiretroviral therapy (ART), and medical male circumcision (MMC) in preventing new HIV infections and averting deaths. The researchers defined TasP (initiating ART at CD4 cell count >350/μL) and ART (initiating ART at CD4 <350/μL) according to the World Health Organization definitions, and included optimistic assumptions about the programmatic effectiveness of TasP. The model showed that high ART coverage plus high MMC coverage provided roughly the same reduction in new HIV infections as TasP and cost some USD$5 billion less from 2009-2020. MMC was more cost-effective than ART in averting new infections, and similar in cost per death averted. TasP was significantly less cost-effective than either MMC or ART. In this model, which included recurrent costs but not start up costs, the most cost-effective approach for reducing HIV-mortality was to scale up MMC and ART together. The authors concluded although TasP has been heralded as a “game changer,” continuing to scale up MMC and ART could have the same impact at significantly lower cost.

Criticisms of African Trials Fail to Withstand Scrutiny: Male Circumcision Does Prevent HIV Infection

Wamai, R., Morris, B., Waskett, J., et al. Journal of Law and Medicine (September 2012), 20(1): 93–123.

This article was a refutation of a 2011 article in the Journal of Law and Medicine that criticized the randomized controlled trials (RCTs) showing that voluntary medical male circumcision (VMMC) reduced the risk of HIV acquisition in heterosexual men. These trials were cited as evidence to inform VMMC policies and programs for HIV prevention. The authors of the 2011 paper, opponents of circumcision, maintained that the VMMC researchers were biased in favor of VMMC and questioned the scientific and ethical basis of the trials. In its defense of VMMC as an HIV reduction strategy, the authors outlined and explained findings from several systematic reviews and meta-analyses, describing in detail the quality and validity of evidence from different types of studies. They also addressed charges of different types of bias, validity, ethical, and legal concerns in the RCTs, as well as seemingly contradictory evidence. The article provided a detailed analysis of the evidence for VMMC as an HIV prevention strategy.

Circumcision Status and Risk of HIV Acquisition During Heterosexual Intercourse for Both Males and Females: A Meta-Analysis

Lei, J., Liu L., Wei Q., et al. PLOS ONE (May 2015), 10(5): e0125436, doi: 10.1371/journal.pone.0125436.

This article reported on a meta-analysis evaluating whether male circumcision was associated with lower HIV acquisition for heterosexual men and women. The analysis included 15 studies: four randomized controlled trials (RCTs), and 11 prospective cohort studies. Ten studies (3 RCTs and 7 cohort studies) assessed HIV transmission from females to males, and five studies (1 RCT and 4 cohort studies) assessed HIV transmission from males to females. The pooled analysis showed that circumcision provided 70 percent protection for men, consistent with an earlier meta-analysis from 2000. Another pooled analysis showed no difference in HIV acquisition between women with circumcised and uncircumcised partners. The studies in women differed in their design and measurement: in two cohort studies the partners’ HIV status was unknown, while three studies enrolled serodiscordant couples (SDCs). The only RCT was stopped due to futility. The authors noted that while the lower rate of HIV among men may benefit women, the meta-analysis showed no evidence of a direct benefit from HIV-positive men to HIV-negative women in SDCs. The analysis provided strong evidence that male circumcision reduces HIV acquisition in males, but there was no protective benefit for female sexual partners of circumcised men. The authors concluded that MMC should be considered as part of broader HIV prevention strategies to benefit both men and women.

The Effectiveness of Male Circumcision for HIV Prevention and Effects on Risk Behaviors in a Post-Trial Follow-Up Study

Gray, R., Kigozi G., Kong, X., et al. AIDS (March 2012), 26(5): 609–615, doi: 10.1097/QAD.0b013e3283504a3f.

This article reported on a post-trial observational study of the effectiveness of medical male circumcision (MMC) for HIV prevention in longer-term follow-up of a clinical trial population over five years in Rakai, Uganda. It also looked at any impact that self-selection or behavioral risk compensation may have on longer-term effectiveness. The initial trial was stopped after it had demonstrated that MMC reduced the risk of HIV acquisition in heterosexual men by approximately 59 percent. Researchers continued to follow the study population, and trial participants who had not been circumcised were offered MMC, with 78.4 percent accepting. There were no sociodemographic differences found between those who chose circumcision and those who declined. The study showed that overall effectiveness was maintained over five years, with rates similar to or higher than in the randomized trial. There was no statistically significant evidence of risk compensation or self-selection. The authors concluded that MMC offers long-term protection from HIV acquisition in men.

The Long-Term Efficacy of Medical Male Circumcision Against HIV Acquisition

Mehta, S., Moses, S., Agot, K., et al. AIDS (November 2013), 27(18): 2899–2907, doi: 10.1097/01.aids.0000432444.30308.2d.

This article reported on a modeling study that accompanied long-term follow-up of the study population in the Kisumu medical male circumcision (MMC) clinical trial that ended in 2006. In this trial, MMC reduced HIV acquisition by 60 percent after approximately two years of follow-up. Men in the control group were offered circumcision, and participants in both arms followed for a total of 72 months. A modeling approach, marginal structural modeling, was used to estimate the efficacy of MMC while controlling for confounding and bias, thereby increasing confidence that any reduction in HIV incidence was due to MMC. MMC's efficacy against HIV acquisition was sustained at 58 percent over six years. These findings were from a long-term cohort that received risk reduction counseling and testing and treatment for sexually transmitted infections every six months, which may limit their generalizability. The authors suggested that the finding of sustained efficacy, consistent with the results from the three randomized efficacy trials, supports the World Health Organization recommendation to scale up MMC to reduce HIV.

Association of the ANRS-12126 Male Circumcision Project with HIV Levels Among Men in a South African Township: Evaluation of Effectiveness Using Cross-Sectional Surveys

Auvert, B., Taljaard, D., Rech, D., et al. PLOS Medicine (September 2013), 10(9): e1001509

This study evaluated the effectiveness of voluntary medical male circumcision (VMMC) in reducing the risk of HIV acquisition at a population level. VMMC was provided free as part of a community-based HIV prevention program in Orange Farm, a South African township that hosted one of the randomized controlled trials of VMMC for HIV prevention. Researchers conducted two cross-sectional surveys among random samples of men aged 15–49. Both surveys included questions, HIV testing and counseling, and circumcision status. The baseline Included 1,998 men, with 3,338 men in the follow-up three years later. The prevalence rate of adult male circumcision increased (from 12% to 53%). The researchers estimated that HIV incidence was reduced by between 57 percent and 61 percent among circumcised men compared with uncircumcised men, and found no association between circumcision status and reported risky sexual behavior. This study was not a randomized trial, so it could not show causality. However, the findings suggested that VMMC roll-out in this community was associated with a significant reduction in HIV incidence. Rapid uptake of VMMC was demonstrated in a setting where circumcision is not the norm. The authors recommended scaling up adult VMMC programs for HIV prevention as an international priority, and additional research to determine any effect on human papillomavirus and herpes simplex virus.

Male Circumcision and Risk of Male-to-Female HIV-1 Transmission: A Multinational Prospective Study in African HIV-1-Serodiscordant Couples

Baeten, J., Donnell, D., Kapiga, S., et al. AIDS (March 2010), 24(5): 737–744.

This prospective observational study assessed the relationship between male circumcision (MC) and male-to-female HIV-1 transmission. This study took place at seven sites in eastern Africa and seven sites in southern Africa as part of a larger randomized controlled trial to test whether acyclovir reduced the risk of HIV-1 transmission among heterosexual HIV-1-serodiscordant couples (SDCs). For this analysis, a total of 1,096 SDCs with an HIV-positive man were followed for an average of 18 months. Thirty-four percent (n=374) of male partners were circumcised, and 64 women became HIV-positive, an incidence rate of 3.8. Viral sequencing confirmed which of these seroconversions was genetically linked to the primary partner. The study showed that male partner circumcision was associated with a non-statistically significant reduction of approximately 40 percent in the risk of HIV-1 acquisition by the female partner. This effect size was essentially the same in various subgroup analyses. The authors saw no increased risk, and possibly decreased risk, of HIV-1 transmission from known HIV-positive male partners to female partners in SDCs. They concluded that MMC (medical male circumcision) programs should involve partners through couples counseling and testing, and provide clear information on risks and possible benefits of MMC.

Women’s Beliefs about Male Circumcision, HIV Prevention, and Sexual Behaviors in Kisumu, Kenya

Riess, T., Achieng, M., Bailey, R. PLOS ONE (May 2014), 9(5): e97748.

This study assessed women’s beliefs about male circumcision (MC) for HIV prevention and the implications for sexual preferences and behavior. The authors conducted in-depth, qualitative interviews with 30 sexually active women in Kisumu, Kenya, the setting of one of the MC clinical trials. The women understood that MC provided partial protection against HIV acquisition for men, and that being circumcised did not mean that men were HIV-negative. Overall, they preferred circumcised men as sex partners. They associated male circumcision with cleanliness, and perceived circumcised men as less likely to have sexually transmitted infections. Some thought that circumcised men took longer to reach ejaculation, which led to greater sexual satisfaction for women. The authors noted that these findings are consistent with other research, and that women’s perceptions should be considered in scale-up and uptake of MC. They suggested incorporating couple counseling into MC programs, emphasizing MC's partial protection, the continued need for safer sex and condom use, and the importance of planning for complete wound healing before having sex.

Effect of Circumcision of HIV-Negative Men on Transmission of Human Papillomavirus to HIV-Negative Women: A Randomized Trial in Rakai, Uganda

Wawer, M., Tobian, A., Kigozi, A., et al. Lancet (January 2011), 377:209–218, doi: 10.1016/S0140-6736(10)61967-8.

This article reported on the human papillomavirus (HPV) results of two medical male circumcision (MMC) trials in Rakai, Uganda. The trials assessed the efficacy of MMC in reducing the prevalence and incidence of HPV infection in female sexual partners of circumcised men as a secondary endpoint. HIV-negative female partners of trial participants were enrolled and followed for 24 months after their partners were circumcised. Self-administered vaginal swabs were used to measure prevalence of HPV genotypes, clearance of previously detected genotypes, and incidence of new infections (newly detected genotypes or ones previously cleared) at 12 and 24 months after MMC. Prevalence and incidence of low-risk and high-risk HPV infections were lower in women with circumcised partners than in women with uncircumcised partners. Over two years MMC reduced prevalence of high-risk HPV by 28 percent; clearance of high-risk HPV infection (except for HPV-16) was also higher in the MMC group. Results were consistent with observational studies showing lower rates of cervical cancer associated with male circumcision. The authors posited that reduced penile high-risk HPV could decrease incidence in females and increase clearance, decreasing re-infection. They concluded that MMC should be seen as effective for reducing prevalence and incidence of HPV in female partners. Because it was partly protective, interventions promoting safer sex should continue.

Male Circumcision Wound Healing in Human Immunodeficiency Virus (HIV)-Negative and HIV-Positive Men in Rakai, Uganda

Kigozi, G., Musoke, R., Kighoma, N., et al. BJU International (January 2014), 113(1): 127–132.

MMC is recommended as an HIV prevention intervention for HIV-negative men to reduce their risk of HIV acquisition. HIV-positive men may seek MMC services, so it was important to determine if MMC is safe for HIV-positive men with low CD4 counts. This study assessed completed wound healing following medical male circumcision (MMC) among HIV-negative and HIV-positive men. The study enrolled 439 men aged 12 and older: 262 HIV-negative and 177 HIV-positive men with CD-4 viral counts below 350 and ≥350 cells/mm. Data on demographic characteristics and behavior were collected at baseline, and blood samples were tested for HIV and CD4 counts. At weekly follow-up visits, participants were asked about behavior and assessed for wound healing. The study found no statistically significant differences in healing by HIV status or CD4 count. The median time to complete healing was four weeks, and all participants were fully healed by six weeks following MMC. At four weeks, 22.7 percent had resumed sexual activity before complete wound healing. The authors noted the importance of reinforcing messages about condom use and complete wound healing before resuming sex. They concluded that including HIV-positive men in MMC services would not adversely affect wound healing, and that HIV-positive men should not be excluded from MMC services.

Changes in Plasma Viral Load and Penile Viral Shedding After Circumcision Among HIV-Positive Men in Kisumu, Kenya

Odoyo-June, E., Rogers, J., Jaoko, W., et al. Journal of Acquired Immune Deficiency Syndromes (December 2013), 64(5): 511–517.

This prospective cohort study, nested within a larger study, assessed whether medical male circumcision (MMC) of HIV-positive men who had never taken antiretroviral therapy (ART) leads to increased viral load and penile viral shedding. Increase in viral load or shedding may affect the transmissibility of HIV to partners. A total of 108 participants were evaluated at baseline and every week for six weeks or until wound healing was complete. Of these, 29 were evaluated for penile viral shedding, and HIV-1 RNA was measured in blood from 19 men and penile lavage samples from 29 men. For the 65 men who had not taken ART, mean CD4 count increased from baseline to two weeks; there was no change in the men (n=37) on ART. The study found no change in viral load. Penile viral shedding rose significantly by week one, but was undetectable by week six. The researchers found no detectable viral shedding after the MMC wound was fully healed in 96.6 percent (28 of 29) study participants. The authors concluded that MMC in men who have never taken ART leads to a temporary rise in penile viral shedding before complete wound healing. Programs should reinforce the importance of abstinence for six weeks after MMC to avoid higher risk of HIV transmission.

Sex With Stitches: Assessing the Resumption of Sexual Activity During the Postcircumcision Wound-Healing Period

Hewett, P., Hallett, T., Mensch, B., et al. AIDS (March 2012), 26(6): 749–756.

This observational study measured sexual behavior during the six-week period of abstinence that is recommended for wound healing following medical male circumcision (MMC). These data were used to model how post-circumcision behavior may influence HIV transmission for men and their female partners and ultimately, affect the program's overall impact. The researchers interviewed 248 men aged 15–29 in Zambia’s MMC program just before MMC and at six weeks after the surgery. One-quarter (24%) resumed sex early, among these, nearly half (46%) had sex in the first three weeks; 82 percent reported unprotected sex; and 37 percent reported sex with multiple partners. Risk behavior was associated with reporting risky sex at baseline. The researchers estimated that the program would lead to an estimated 230 fewer HIV infections in one year, 95 percent among men. Early resumption of sex would lead to 69 extra HIV infections (32 in men and 37 in women). Risky sexual behavior during the recommended wound healing period following MMC was high. The researchers stressed that clients should be given strong messages about the risks of this behavior and the importance of abstinence after MMC. Identifying clients who engage in risky sexual behavior before MMC may be useful. They suggested that women should also be informed that sex before complete wound healing could increase their risk of HIV.

Risk Compensation Following Male Circumcision: Results from a Two-Year Prospective Cohort Study of Recently Circumcised and Uncircumcised Men in Nyanza Province, Kenya

Westercamp, N., Agot, K., Jaoko, W., et al. AIDS and Behavior (September 2014), 18(9): 1764–1775, doi: 10.1007/s10461-014-0846–4.

This article reported on the first program-based longitudinal study of reported HIV risk behaviors before and after voluntary medical male circumcision (VMMC). Diverse stakeholders have expressed concern that risk compensation—increase in risk behavior due to perception that an intervention like MMC reduces risk—could negate VMMC’s effects at individual and population levels. Previous research showed little evidence of risk compensation but was conducted in trial settings with intensive support. Newly circumcised men (1,588) were matched on age and community of residence with uncircumcised controls (1,598) in urban and rural Nyanza Province, Kenya. Participants were asked about their risk behavior using audio computer-assisted self-interview or paper at baseline and every six months for 24 months. No difference was found in specific reported risk behaviors between circumcised and uncircumcised men; all behaviors decreased over time in both groups. Reported condom use increased in both groups, more among circumcised men. Circumcised men reported significant decline in perceived HIV risk but with no differential effect on reported behavior. The authors recommended that models of VMMC impact and cost-effectiveness reflect this evidence, and said that concerns about risk compensation should not pose a barrier to widespread implementation of VMMC for HIV prevention.

The Safety and Acceptance of the PrePex Device for Non-Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Study

Kigozi, G., Musoke, R., Watya, S. et al. PLOS ONE (August 2014), 9(8): e100008, doi: 10.1371/journal.pone.0100008.

This article reported on a two-phase observational study of the safety and acceptability of the PrePex device for medical male circumcision (MMC) in rural Uganda. MMC reduces the risk of HIV acquisition among men, but its impact may be limited by lack of capacity to perform surgical MMC. The PrePex MMC device could facilitate MMC scale-up. In the first phase, 100 men received PrePex to assess safety. In the second phase, 329 men were given the option of PrePex (n=250) or surgical (n=79) MMC. PrePex was contraindicated in a small number of men (n=17). Participants circumcised with PrePex were followed up at seven days to remove the device and assess adverse events (AEs). Four mild AEs occurred, along with five serious AEs, four of which were due to premature non-medical removal of PrePex. Surgery was required to treat the AEs; there were no AEs with surgical circumcision. PrePex participants returned at four weeks to assess wound healing and each week until the wound was fully healed (84.8% at week five and 98.6% by week seven). The authors noted that PrePex was well accepted and offered an alternative to surgical circumcision. Follow-up visits and back-up surgical capacity were important, and should be factored into analyses about the cost and feasibility of implementing MMC using PrePex.

Achieving the HIV Prevention Impact of Voluntary Medical Male Circumcision: Lessons and Challenges for Managing Programs

Sgaier, S.K., Reed, J.B., Thomas, A., et al. PLOS Medicine (May 2014), 11(5): e1001641, doi: 10.1371/journal.pmed.1001641. 

This article provided an introductory overview to the 13 papers in the PLOS Collection "Voluntary Medical Male Circumcision for HIV Prevention: Improving Quality, Efficiency, Cost Effectiveness, and Demand for Services during an Accelerated Scale-up." This complementary set of studies and analyses examined service quality, cost, demand creation, and efficiency related to the implementation and rapid scale-up of voluntary medical male circumcision (VMMC). Drawing on these studies, the authors focused on management strategies to help VMMC programs avert the highest feasible number of HIV infections in 14 target countries in East and Southern Africa. They made recommendations in nine key areas: conducting advocacy, increasing funding, targeting risk groups, boosting efficiency, exploring new technologies, creating demand, using data to inform decisions, improving management capacity of governments, building in sustainability, and ensuring that scale-up is flexible and driven by data generated through monitoring and evaluation. They concluded that the collection of papers added key knowledge derived from program experience to inform a learning culture and realize VMMC’s potential in averting HIV and saving lives.

Systematic Monitoring of Voluntary Medical Male Circumcision Scale-Up: Adoption of Efficiency Elements in Kenya, South Africa, Tanzania, and Zimbabwe

Bertrand, J.T., Rech, D., Omondi Aduda, D., et al. PLOS ONE (May 2014), 9(4): e82518, doi:  10.1371/journal.pone.0082518.

This paper was an overview of the multi-country SYMMACS study, the Systematic Monitoring of the Voluntary Medical Male Circumcision (VMMC) Scale-up, in Kenya, South Africa, Tanzania, and Zimbabwe. SYMMACS is a method of tracking the implementation and adoption of six elements of surgical efficiency for VMMC. These elements are use of: multiple surgical beds, pre-bundled kits, task shifting, task sharing, the forceps-guided surgical method, and electrocautery. This study, conducted in 2011 and 2012 as VMMC expanded rapidly in the four countries, first sampled VMMC sites, then observed providers and surgical procedures. The authors noted that the study was contributing to policy dialogue and change in each country according to the specific findings: overall service delivery in Kenya, adverse events in South Africa, VMMC kits in Tanzania and task shifting in Zimbabwe.

Implications of the Fast-Evolving Scale-Up of Adult Voluntary Medical Male Circumcision for Quality of Services in South Africa

Rech, D., Spyrelis, A., Frade, S., et al. PLOS ONE (May 2014), 9(4): e80577, doi: 10.1371/journal.pone.0080577.

This study assessed the effect of rapid scale-up on service quality in the voluntary medical male circumcision (VMMC) program in South Africa, where the number of VMMC sites expanded from one in 2010 to over 80 by 2012. It compared service quality at 15 VMMC sites operational in 2011 to (1) the same sites in 2012 and (2) 40 representative sites in the expanded program in 2012. Sites were scored on two sets of criteria by a team of trained clinicians during a two-day visit. They used an assessment tool to measure readiness to provide quality services, and observed VMMC procedures to assess the quality of surgical care provided: pre-operative care, surgical technique, and post-operative care. Of 58 criteria measured, only two improved. Concern centered on monitoring adverse events, supervision, postoperative counseling, and aspects of infection control. Expanded sites had more negative outcomes in readiness, while both existing and expanded sites had limitations in providing quality surgical care. Surgical technique generally scored highest across all criteria. This study highlighted the challenges of providing VMMC sites with equipment, supplies, and protocols during rapid expansion. The authors concluded that diluting resources, especially human resources, had negative effects on existing and expanded sites. This study informed the creation of a working group to address these issues.

Quality of Voluntary Medical Male Circumcision Services During Scale-Up: A Comparative Process Evaluation in Kenya, South Africa, Tanzania and Zimbabwe

Jennings, L., Bertrand, J., Rech, D., et al. PLOS ONE (May 2014), 9(4): e79524, doi: 10.1371/journal.pone.0079524.

This study examined data from the Systematic Monitoring of the Voluntary Medical Male Circumcision Scale-Up (SYMMACS) study to determine whether voluntary medical male circumcision (VMMC) can be delivered and sustained at scale according to quality standards. The study assessed the proportion of facilities that met measures for preparedness, and the number of surgical tasks conducted correctly. Data were collected in 2011 and 2012, when VMMC was expanding rapidly in the four countries studied: Kenya, South Africa, Tanzania, and Zimbabwe. Site assessments determined preparedness to deliver quality care, and direct observation of VMMC surgeries established service quality. The results showed that overall, safe, high-quality VMMC could be delivered and sustained at scale. However, the quality of services varied considerably. The preparedness and quality of some services improved as the number of VMMC sites expanded. In other settings, services were expanded even when they were not meeting readiness and quality standards. Overall, surgery scored highest, while other areas, including infection control, pre-operative examinations, and post-operative monitoring and counseling, scored lower. The authors recommended that quality improvement processes be integrated into VMMC scale-up, and underscored that programs should invest in ongoing monitoring of service quality.

Voluntary Medical Male Circumcision Programs Can Address Low HIV Testing and Counseling Usage and ART Enrollment Among Young Men: Lessons from Lesotho

Kikaya, V., Skolnik, L., García, M.C., et al. PLOS ONE (May 2014), 9(4): e83614, doi: 10.1371/journal.pone.0083614.

This study examined the contribution of voluntary medical male circumcision (VMMC) services to HIV diagnosis and treatment at Mafeteng district hospital, the first public facility in Lesotho to provide VMMC. Only 40 percent of men in Lesotho had ever been tested for HIV, limiting the individual and population benefits of antiretroviral therapy (ART); VMMC could draw men into HIV testing and counseling, referral, and care. VMMC clients diagnosed with HIV were traced to determine whether they had attended the referral HIV service, received testing for CD4 counts, and initiated ART. Nearly 3,000 males ages 15–49 were tested for HIV, 65 percent in the VMMC clinic. Among the men who tested positive at the VMMC site, 62.5 percent received immediate CD4 count; 89 percent of them were eligible for treatment and started ART. A lack of reagents meant that 27 clients did not receive CD4 counts, and they did not go or return to the HIV clinic. The authors concluded that VMMC services with referral to HIV care can increase HIV testing, diagnosis, and care among men. The study highlighted weaknesses in the supply chain, and the researchers suggested point-of-care CD4 analyzers for rapid results to optimize men’s continuity of care and ART initiation.

Surgical Efficiencies and Quality in the Performance of Voluntary Medical Male Circumcision Procedures in Kenya, South Africa, Tanzania, and Zimbabwe

Rech, D., Bertrand, J.T., Thomas, N., et al. PLOS ONE (May 2014), 9(4): e84271, doi: 10.1371/journal.pone.0084271.

This analysis examined the association among elements of surgical efficiency in voluntary medical male circumcision (VMMC), the quality of surgical technique, and the time required to conduct VMMC procedures. The primary provider's time with the client (PPTC) and total elapsed operating time (TEOT) were the efficiency outcomes of interest. The analysis drew on cross-sectional data from the Systematic Monitoring of the VMMC Scale-up study in Kenya, South Africa, Tanzania and Zimbabwe in 2011 and 2012. Trained clinicians observed VMMC surgery to assess technique and timed nine specific steps in the procedure. Having a secondary provider perform suturing and electrocautery reduced PPTC. Task-sharing for suturing and/or electrocautery were also significantly related to TEOT in two of the four countries. The overall quality of the surgical technique was not significantly related to either variable, except in South Africa in 2012, where higher surgical quality was associated with lower TEOT. These data confirmed that task-sharing of suturing and use of electrocautery for VMMC increased efficiency and decreased TEOT. Lower elapsed time and provider time with patients did not lead to lower quality of surgical care.

Work Experience, Job-Fulfillment and Burnout among VMMC Providers in Kenya, South Africa, Tanzania and Zimbabwe

Perry, L., Rech, D., Mavhu, W., et al. PLOS ONE (May 2014), 9(4): e84215, doi: 10.1371/journal.pone.0084215.

Human resources are critical to voluntary medical male circumcision (VMMC) scale-up, but the repetitive and intense work required for high-volume VMMC services may lead to burnout among providers. VMMC providers in Kenya, South Africa, Tanzania, and Zimbabwe were interviewed in 2011 (n=357) and 2012 (n=591) as part of the Systematic Monitoring of the Voluntary Medical Male Circumcision Scale-up study. Analysis identified factors associated with provider burnout. In 2012, more than three-quarters (range 78–99%) of providers in all four countries reported that VMMC is a fulfilling job. Kenya had the highest burnout; about two-thirds (67%) of providers stated that they were beginning to experience work fatigue, twice as high as in South Africa (33%) and much higher than Tanzania (15%) and Zimbabwe (17%). The Kenyan providers had worked in VMMC much longer (mean=31 months) than the other countries (mean=10–15 months). A 2011 analysis did not identify any factors significantly associated with burnout. In 2012, older age and number of months working in VMMC were associated with burnout, while a higher total number of VMMCs was associated with a lower likelihood of burnout. Noting the differences by country, the authors suggested further investigation into specific factors that may influence burnout, and recommended that programs reinforce the important role of VMMC providers in the global effort to address HIV.

Provider Attitudes Toward the Voluntary Medical Male Circumcision Scale-Up in Kenya, South Africa, Tanzania and Zimbabwe

Mavhu, W., Frade, S., Yongho, A., et al. PLOS ONE (May 2014), 9(4): e82911, doi: 10.1371/journal.pone.0082911a.

This study examined provider attitudes and adherence to six elements of voluntary medical male circumcision (VMMC) surgical efficiency: multiple surgical beds, pre-bundled kits, task shifting, task sharing, the forceps-guided surgical method, and electrocautery. Data were collected in Kenya, South Africa, Tanzania, and Zimbabwe as part of the Systematic Monitoring of the VMMC Scale-up study. Each country had adopted and emphasized elements in accordance with national policy. Qualitative and quantitative data showed that, overall, provider attitudes toward the efficiency elements in each country reflected those aspects emphasized in their country’s policies. Task-shifting was the only exception; providers in all countries were in favor of task-shifting, which is not included in policies in South Africa or Zimbabwe. Providers generally agreed with and adhered to the elements included in their country’s policies. The authors suggested that this is a positive sign for compliance with national policies and effective VMMC implementation.

Cost Drivers for Voluntary Medical Male Circumcision Using Primary Source Data from Sub-Saharan Africa

Bollinger, L., Adesina, A., Forsythe, S., et al. PLOS ONE (May 2014), 9(4): e84701, doi: 10.1371/journal.pone.0084701.

This modeling study estimated potential gains in efficiency as voluntary medical male circumcision (VMMC) programs scale up. The authors examined the primary cost drivers associated with providing VMMC in sub-Saharan Africa for different dimensions of VMMC service, such as the type of facility and service provider. The analysis used actual cost data from urban and rural facilities in Kenya, Namibia, South Africa, Tanzania, Uganda, and Zambia. The two highest components of costs across all countries were direct personnel (36%) and consumables (28%), with considerable variation by country. Training, capital costs, maintenance and utilities, support staff, and management and supervision accounted for the other costs. The model showed that economies of scale (EOS) declined as VMMC volume increased. According to this analysis, efficiency could be improved. The decline in EOS as VMMC volume increased suggested that programs were still at the phase where adding new sites led to additional start-up costs, rather than savings due to EOS. The authors noted that personnel costs represent a substantial proportion of overall costs, so task sharing would be central to improving efficiency. They also anticipated that consumables would likely become more efficient as prices and distribution costs decline. The authors recommended conducting additional analyses with country-specific data that also include the considerable investment in demand creation for VMMC.

Barriers and Motivators to Voluntary Medical Male Circumcision Uptake among Different Age Groups of Men in Zimbabwe: Results from a Mixed Methods Study

Hatzold, K., Mavhu, W., Jasi, P., et al. PLOS ONE (May 2014), 9(4): e85051, doi: 10.1371/journal.pone.0085051.

This quantitative and qualitative study explored barriers and motivating factors to voluntary medical male circumcision (VMMC) for HIV prevention in Zimbabwe, where uptake of VMMC had been slower than anticipated. The study also assessed which communication channels reached respondents with information on VMMC. Data were collected through a survey (N=2,350, 49.6% men, 50.4% women) and focus group discussions, using purposeful sampling to ensure representative ethnic and age diversity. Most had heard about VMMC for HIV prevention (68% of men; 53% of women); 71 percent of women were supportive of VMMC. Motivating factors cited by men were prevention of HIV and sexually transmitted infections (44%), improved hygiene (26%), enhanced sexual performance (6%), and cervical cancer prevention for the partner (6%). Men cited fear of pain (40%), no risk of HIV (18%), and lack of partner support (6%) as key barriers. Respondents received information on VMMC from radio (71%), TV, newspaper, billboards and posters, and interpersonal communication with community health workers and others. The authors concluded that messages to create demand for VMMC should be tailored to different ages, address men’s fear of pain, and emphasize benefits aside from HIV prevention, such as improved hygiene and sexual appeal. They also recommended greater emphasis on promoting VMMC among women who influence men’s decisions.

Attitudes, Perceptions and Potential Uptake of Male Circumcision Among Older Men in Turkana County, Kenya Using Qualitative Methods

Macintyre, K., Andrinopoulos, K., Moses, N., et al. PLOS ONE (May 2014), 9(4): e83998, doi: 10.1371/journal.pone.0083998.

This qualitative study explored barriers and facilitators to voluntary medical male circumcision (VMMC) services to better understand the low demand for VMMC among men older than 25 years in Turkana, Kenya. This community had no tradition of male circumcision, and high rates of HIV and other sexually transmitted infections. The researchers conducted 20 focus groups and 69 in-depth interviews focusing on the attitudes and perceptions of circumcised and uncircumcised men, and their female partners. Circumcision is not part of Turkana culture, but is common in some neighboring ethnic groups. Study participants cited different types of stigma surrounding VMMC that are not related to HIV. VMMC was associated with younger men, since older men were seen as having little risk of HIV and being “protected” by marriage. Some participants felt that older men accepting circumcision could serve as examples for younger men. Health infrastructure in the area was weak, and respondents expressed concern about service capacity to deliver VMMC. At the same time, VMMC was associated with “modernity,” protection against HIV, and cleanliness. Overall, men and women supported VMMC, but cited numerous barriers. The researchers indicated that strategic and sensitive communication messages and sustained high-quality services could help address these barriers. They emphasized that messages should reinforce VMMC as a medical procedure to reduce HIV risk.

Voluntary Medical Male Circumcision (VMMC) in Tanzania and Zimbabwe: Service Delivery Intensity and Modality and Their Influence on the Age of Clients

Ashengo, T.A., Hatzold, K., Mahler, H., et al. PLOS ONE (May 2014), 9(4): e83642, doi: 10.1371/journal.pone.0083642.

This article described how different delivery modalities and intensity of VMMC services influenced the number and age of clients reached. National and service delivery data from 2009–2012, a period of rapid expansion of VMMC services in Tanzania and Zimbabwe, were supplemented with key informant interviews. Efforts to increase uptake of VMMC included diversified service outlet types (fixed, outreach, or mobile) and campaigns to supplement routine services. In Tanzania, service modality was associated with age: most clients (59%) receiving VMMC during campaigns were young (10–14 years), and most (64%) coming to routine VMMC services were age 15 or older. In Zimbabwe, significantly more VMMCs were done during campaigns (64%) than during routine service delivery (36%). In both countries, service modalities and intensities influenced the profile of clients served. The authors noted that some of this effect may be due to contextual factors. The countries were at different stages of VMMC scale-up. Most men in Tanzania (80% in most regions) are circumcised, generally during adolescence; peer pressure may have played a role. Zimbabwe did not have a tradition of male circumcision, and many campaigns were implemented during school holidays. Given these complex and specific dynamics, the authors recommended that VMMC programs integrate formative research to inform context-specific approaches to service delivery.

Evaluation of Loss-to-Follow-up and Post-Operative Adverse Events in a Voluntary Medical Male Circumcision Program in Nyanza Province, Kenya

Reed, J., Grund, J., Liu, Y., et al. Journal of Acquired Immune Deficiency Syndromes (May 2015), 69(1): e13–23.

This article reported on a study of adverse events (AEs) following voluntary medical male circumcision (VMMC) in Nyanza Province, Kenya. All VMMC clients in Kenya are instructed to return for postoperative follow-up care. Overall rates of AEs are low, but little is known about the clinical status of clients who do not return. A total of 1,699 VMMC clients were recruited immediately after surgery, and 1,600 contributed data to the study. Medical records were reviewed two weeks after surgery to determine which clients had adhered to recommended follow-up (ADFU) and which had been lost to follow-up (LTFU). More than half (56.1%) were LTFU, and 84.9 percent of those received clinical evaluations at home approximately two weeks after surgery. The rate of moderate to severe AEs was 6.8 percent in the LTFU group, approximately twice as high as the 3.3 percent in the ADFU group. The authors recommended including surveillance systems to identify LTFU clients and address AEs in VMMC programs, along with systems to underscore to clients the importance of follow-up care.

Covering the Last Kilometer: Using GIS to Scale-Up Voluntary Medical Male Circumcision Services in Iringa and Njombe Regions, Tanzania

Mahler, H., Searle, S., Plotkin, M., et al. Global Health: Science and Practice (September 2015), 3(3): 503–515.

This article reported on efforts by Tanzania’s Ministry of Health and Social Welfare to use geographic information systems (GIS) to plan where to locate voluntary medical male circumcision (VMMC) outreach campaigns in two districts. These campaigns aimed to reach underserved areas with mobile teams to provide temporary VMMC services in clinics or other settings. Information on key issues such as population, roads and road conditions, staff availability, and health facility infrastructure were combined with demographic and service data in a central database to develop comprehensive, interactive maps. The maps showed where to locate mobile VMMC outreach. Following introduction of GIS, the program met 98 percent of its target of eligible males in the two districts. Many more men were reached in rural and non-health facilities each year after GIS initiation; the proportion of VMMCs in rural areas increased from 48 percent of total VMMCs in year one to 88 percent in year two, and 93 percent by the end of the project. The authors concluded that GIS was effective in informing strategic decisions about where to prioritize VMMC service delivery, particularly for mobile and outreach services. They noted that collaborating on mapping initiatives across different agencies and types of interventions would be efficient, and suggested that donors consider this approach to improve service delivery and share start-up costs.

Voluntary Medical Male Circumcision (VMMC) Demand Creation Toolkit

RTI International and Population Services International.

This practical toolkit provides guidance and tools to quickly and easily create and conduct communication and outreach activities to drive demand for voluntary medical male circumcision (VMMC). The tools are community-specific and meet agreed on standards for quality, content, and sensitivity. Intended users include program managers and planners, demand creation coordinators and other staff in Ministries of Health, non-governmental organizations, and implementing partners responsible for creating VMMC demand. The toolkit addresses three key audiences: men at risk of HIV acquisition; females, including sexual partners, who influence males’ decisions about circumcision; and key influencers in the community and at regional and national levels. The tools include a step-by-step process for demand creation: establishing readiness; designing communications that drive demand; creating and pilot-testing communication products; implementing activities and measuring effectiveness; and evaluating activities in the context of overall program goals. An appendix includes case studies, existing materials, links to templates for developing campaigns, and additional resources.

Male Circumcision Under Local Anaesthesia Course Workbook for Participants: Self-Paced/Individual Learning

World Health Organization, Joint United Nations Programme on HIV/AIDS, Maternal and Child Health Integrated Program) (n.d.).

This workbook is intended for use by health care providers who are being trained to perform male circumcision (MC) under local anesthesia. The innovative, flexible, competency-based course builds on an individualized assessment of knowledge and skills. The self-paced, individualized learning workbook is designed to be completed at the home facility over two to four weeks, and used in conjunction with classroom demonstration and coaching using anatomic models, simulation exercises, and clinic attachment. The course is meant to be flexible and adaptable while maintaining the standards of more formal training. It allows participants to move at their own pace, and enables both participants and trainers to spend less time away from their clinical duties, with less service disruption. The course is designed to build providers' capacity to provide MC-related services including describing the relationship of MC and HIV; linking with other male sexual and reproductive health services; counseling and screening adult and adolescent clients; building competency in one of the surgical methods of MC'; providing post-operative care, including managing adverse events; preventing infection; and monitoring, evaluating, and supervising a male circumcision service.

eLearning course: Male Circumcision: Policy & Programming

Curran, K., Njeuhmeli, E., and Merriman Davis, C. Jhpeigo and U.S. Agency for International Development (2011).

This three-hour e-learning course uses reviews the evidence about the protective effect of male circumcision (MC) on HIV transmission and presents available data on the acceptability and safety of MC. It also addresses program and policy issues, such as implementation challenges, and provides policy and program guidance. Developed for policymakers and program managers, this training focuses primarily on the public health issues related to MC. The course presents information on providing MC in both high- and low-prevalence settings. Modules include key information on commodities and supply chain management; counseling, communication, and demand generation; and the cost and impact of expanding MC on HIV incidence.

A Guide to Indicators for Male Circumcision Programmes in the Formal Health Care System

Budge-Reid, H., Schmid, G., Samuelson, J., and Reed, J. World Health Organization and Joint United Nations Programme on HIV/AIDS (2009).

Indicators are needed to measure the degree to which an intervention or program is achieving its goals. This guide includes indicators related to creating demand for male circumcision (MC), generating supply for MC, and maximizing safer sexual behavior. When used, these indicators can help provide feedback for managing MC programs. Targeted indicators for indicators for advocacy include a strong policy component, and behavior/social change. Each indicator is described in detail, including what the indicator is intended to measure, recommended frequency of reporting, measurement tools needed, how the data will be collected, numerators, denominators, and how to interpret the indicator. Countries can choose to add specific indicators to their programs, or adapt them for use.

Considerations for Implementing Models for Optimizing the Volume and Efficiency of Male Circumcision Services (MOVE)

World Health Organization (2010).

This report outlines various considerations and options for organizing adult medical male circumcision (MMC) surgical services to improve efficiency and service volume while ensuring a safe service of high quality. It is a guide for both program managers involved in setting up or strengthening MC services, and funders and policymakers who need to make decisions about the costing and financing of MMC services.

Male Circumcision Situation Analysis Toolkit

Budge-Reid, H., Schmid, G., et al. World Health Organization. (2009).

A situation analysis is crucial to developing safe male circumcision (MC) services. Such an analysis can help program planners understand the determinants and scale of MC practices; assess current capacity to perform safe MC; and determine whether community support exists for MC. This toolkit contains six tools that can be used to obtain a situation analysis from which to build a successful MC program. These tools provide guidance on desk reviews, key informant interviews, stakeholders’ meetings, focus groups, assessments of service availability, feedback, and action.

Male Circumcision Services Quality Assessment Toolkit

Ashton, J., & Dickson, K. World Health Organization. (2009).

This tool can be used to assess the quality of male circumcision (MC) services, guide service set-up, and improve existing services. In addition to measuring a site’s progress towards meeting standards, it can be used for certification or accreditation. It includes an outline of how the toolkit should be used, how often assessments should take place, and what should be done with the findings. The toolkit contains extensive checklists that can be used to assess everything from infection prevention and control to conducting the surgical procedures, providing counseling, and managing adverse events.

Manual for Male Circumcision under Local Anesthesia

World Health Organization, Joint United Nations Programme on HIV/AIDS, and Jhpiego (2008).

This comprehensive manual describes the safest and most practical methods for male circumcision (MC) in resource-limited settings. It starts by describing the benefits and risks of MC, and how MC can be linked to other sexual and reproductive health services. The bulk of the manual provides technical guidance on the MC procedure, detailing the knowledge, skills, and attitudes providers need to safely carry out different procedures. Containing multiple photos and drawings, sample consent forms, information sheets for clients, stock cards, adverse event forms, the manual is an excellent training tool. It also contains chapters on counseling clients, obtaining informed consent for MC, preventing infection, managing complications, and running an MC service.

Framework for Clinical Evaluation of Devices for Male Circumcision

World Health Organization (WHO, September 2012).

To support rapid scale-up of medical male circumcision (MMC) for HIV prevention in settings with high HIV incidence and low prevalence, WHO and other health agencies sought to identify technologies to make MMC more cost-effective, safer, easier to implement than surgical methods, and with a shorter recovery time. Regulations on approval of such medical devices for use outside the body may only call for limited clinical trials. However, since MMC is a public intervention to be used on a large number of men, circumcision technology should receive rigorous review. This framework outlines a progressive series of clinical studies to establish the safety, efficacy, acceptability, and clinical function of devices for medical male circumcision when used by trained, mid-level health care providers in public health programs in resource-limited settings. It is intended for use by product developers, clinicians involved in testing devices, regulators, program managers, and donors. The document also notes some regulatory and manufacturing considerations, bridging studies, and implementation studies' and provides information on monitoring programs.

WHO Technical Advisory Group on Innovations in Male Circumcision: Evaluation of Two Adult Devices (Meeting Report)

World Health Organization (January 2013).

This report presents the background information and proceedings of the January 2013 meeting of the World Health Organization (WHO) Technical Advisory Group (TAG) on Innovations in Male Circumcision. The meeting focused on reviewing the clinical performance of two devices for adult male circumcision, ShangRing and PrePex. Data were insufficient to review other devices. In accordance with the WHO Framework for Clinical Evaluation of Male Circumcision Devices, staff compiled clinical data by reviewing all published information and contacting researchers evaluating the devices. Data were extracted into standardized formats and reviewed by the TAG for clarification and classification of adverse events, and across priority standardized outcomes: patient eligibility; successful circumcision; procedure time; time to complete wound healing; pain; and acceptability. The report includes summaries of the data used and key points raised by the TAG for each device. The meeting discussions also informed programmatic considerations included in WHO guidance and identified key information gaps and research needs.

Guideline on the Use of Devices for Adult Male Circumcision for HIV Prevention

World Health Organization (October 2013).

This document from the World Health Organization (WHO) is meant to inform policy and decision makers, program managers, health care providers, donors, and implementing agencies as they consider the role of circumcision devices for adult males. Developed according to WHO standards and requirements, it provides recommendations that WHO prequalified male circumcision devices have been shown to be efficacious, safe, and acceptable for men 18 years and older in settings where they are used by health care providers, and where surgical back-up facilities and skills are available. The guideline considers two specific devices, an elastic collar compression device and a collar clamp device; there was not enough evidence to assess other devices. The document is intended to inform use of these devices for HIV prevention in public health programs in settings with high HIV prevalence and limited resources. It includes a review of the clinical evidence and also outlines programmatic considerations.

PEPFAR's Best Practices for Voluntary Medical Male Circumcision Site Operations: A Service Guide for Site Operations

U.S. President’s Emergency Plan for AIDS Relief (PEPFAR, 2013).

This comprehensive guide is designed to provide facilities and other sites that work with PEPFAR clear and comprehensive information on the process of establishing and running a voluntary medical male circumcision (VMMC) service aimed at HIV prevention. The guide includes a wide range of practical materials that are based on guidelines from key international agencies such as the World Health Organization, the Joint United Nations Programme on AIDS, and the PEPFAR VMMC Technical Working Group, as well as on-the-ground experience implementing VMMC programs in eastern and southern Africa. It provides tools to guide specific activities such as site selection, readiness and assessment, forecasting and costing, communications, record keeping and reporting, training, and consent.

Clearinghouse on Male Circumcision for HIV Prevention

World Health Organization, Joint United Nations Programme on HIV/AIDS, AIDS Vaccine Advocacy Coalition, and Family Health International (n.d.).

This website is a comprehensive resource for people seeking information on male circumcision (MC) for HIV prevention. It was developed to provide evidence-informed information and guidance for countries that are scaling up MC as part of initiatives to provide comprehensive HIV prevention. Information is categorized by research findings, advocacy, policies and programs, and training. Readers can also browse through publications, browse site content by topic, or search through a resource database. Materials can be immediately downloaded, including training manuals, planning tools, and situation analysis toolkits.

It’s About the People: Tanzania’s VMMC Program Gets it Right

Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) and Maternal and Child Health Integrated Program (2015).

It's About the People: Tanzania's VMMC Program Gets it Right, is an 11-minute documentary film about scaling up the voluntary medical male circumcision (VMMC) program in Tanzania. It includes interviews with a client and his family members about their experiences with the decision-making process and the procedure for the adult man and his young son. It documents program and practical considerations and commitments in implementing a comprehensive VMMC program at both the community and national levels, and shows the commitment at the national level along with some of the challenges and successes with implementing the VMMC program in a remote island community. The film, narrated by Common, is available in both English and Kiswahili.

In It to Save Lives: Scaling Up Voluntary Medical Male Circumcision for HIV Prevention for Maximum Public Health Impact

AIDS Support & Technical Assistance Resources (AIDSTAR-One), U.S. President’s Emergency Plan for AIDS Relief (2011).

In this 15-minute film, award-winning filmmaker Lisa Russell tells the story of how governments in Kenya and Swaziland have embraced voluntary medical male circumcision (VMMC) for HIV prevention to turn the tide of the epidemic in their countries. Produced by the AIDS Support and Technical Resources, Task Order One (AIDSTAR-One) Project, the film features interviews with a variety of experts, policymakers, and implementers, and shows that VMMC programs can be replicated and expanded to reach the critical mass needed for maximum public health impact.

Manual for Early Infant Male Circumcision under Local Anaesthesia

World Health Organization (WHO) and Jhpiego, 2011.

This manual builds on the World Health Organization’s Manual for Male Circumcision under Local Anaesthesia and focuses entirely on early infant male circumcision. It was developed by WHO in collaboration with Jhpiego to help providers and program managers deliver high-quality, safe infant male circumcision services for the purposes of HIV prevention and other health benefits. It draws from experiences with service provision in Africa, the Eastern Mediterranean, and developed countries and was reviewed by actual and potential providers of male circumcision services representing a range of health care and cultural settings where demand for male circumcision services is high.

Medical Male Circumcision as HIV Prevention: Follow the Evidence: The Case for Aggressive Scale Up

Center for Global Health Policy. (2010).

This report first reviews the epidemiologic evidence of the effectiveness in male circumcision (MC) in reducing heterosexual HIV transmission. In the second section, the authors present a strategy for scaling up MC services in priority areas, identifying criteria for using MC as a way to reduce HIV rates, and defining what clinical services are needed, and how MC can have a synergistic effect on HIV when it is part of a package of HIV prevention interventions. Lastly, the document provides data on how this one-time, low-cost, cost-effective intervention has the potential to avert a significant number of HIV infections. The authors argue that the evidence presents a compelling argument for rapid scale-up of MC programs in HIV endemic areas.

Tetanus and Voluntary Medical Male Circumcision: Risk According to Circumcision Method and Risk Mitigation

World Health Organization, 2016.

In July 2016, the World Health Organization (WHO) issued a report that covered the risk of tetanus associated with various methods of male circumcision, as well as mitigation methods for each method. This report is an update from August 2016 that includes additional updates from the initial July release.