What We Know

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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