This study focused on reasons for nonadherence in the Pre-exposure Prophylaxis Trial for HIV Prevention among African Women (FEM-PrEP) trial, which was discontinued because of low adherence to the study pill, oral emtricitabine/tenofovir disoproxil fumarate. The authors conducted 88 qualitative, semistructured interviews and 224 quantitative, audio computer-assisted self-interviews with former FEM-PrEP participants in Bondo, Kenya and Pretoria, South Africa. While women often cited several reasons for low adherence, their explanations mainly fell within these categories:
- Individual (e.g., social support and beliefs about the disease): 15 percent of participants reported that their non-adherence was influenced by being told by others—a family member, community member, or partner—not to take the study pill, and 22 percent were deterred by other participants’ nonadherence.
- Trial characteristics and the study pill regimen: many women explained that they or other participants believed that the regimen was ineffective, or were unsure about its effectiveness. Some women reported anxieties about the unknown risks of the investigational drug.
- The disease: participants were concerned that people would associate their participation in the trial as being HIV-positive.
The authors concluded that discouragement from others and concerns about the study pill appeared to have influenced non-adherence. They recommended alternative study designs or procedures, and enhanced community engagement for future studies.