Participants' Explanations for Nonadherence in the FEM-PrEP Clinical Trial

摘要: Background: FEM-PrEP -- a clinical trial of daily oral emtricitabine / tenofovir disoproxil fumarate for HIV prevention among women in sub-Saharan Africa did not show reduction acquisition because low adherence to the study pill. We conducted follow-up identify reasons nonadherence. Methods: Qualitative semi-structured interviews (n=88) and quantitative audio computer-assisted self-interviews (n=224) were with former participants Bondo Kenya Pretoria South Africa. Thematic analysis was used analyze qualitative data descriptive statistics describe ACASI responses. Data are presented within five categories Ickovics’ Meisler’s conceptual framework on adherence: 1) individual 2) characteristics pill regimen 3) patient-provider relationship 4) setting 5) disease. Results: Participants’ explanations non-adherence primarily situated three framework’s categories: Concerns about investigational nature drug being tested side effects prominent reported non-adherence. Participants also described discouraged from taking by members community their sexual partners other these same concerns. Limited acceptability pill’s attributes influenced nonadherence some as concerns HIV-related stigma. Additionally many that others continued while trial’s ancillary benefits visit reimbursement factors related setting. Negative relationships infrequently factor Conclusion: Despite substantial staff engagement communities discouragement appeared have considerably. Alternative designs or procedures enhanced paradigms may be needed future studies. Copyright: 2015 Wolters Kluwer Health Inc.