Integrating Gender-Based Violence Screening and Support into the Research Clinic Setting: Experiences from an HIV Prevention Open-Label Extension Trial in Sub-Saharan Africa.

HIV and gender-based violence (GBV) are syndemic in sub-Saharan Africa and provision of support for participants who disclose GBV constitutes part of comprehensive care. Consequently, a process was undertaken to develop, implement, and evaluate standard operating procedures (SOPs) in MTN-025/HOPE, a study of the dapivirine vaginal ring for HIV prevention. The SOP was developed using needs assessment surveys in addition to World Health Organization (WHO) guidelines and other literature. Sites tailored and implemented the SOP through HOPE implementation. At study end, staff reported increased training 32/35 (91.43%); improved confidence (18/26; 69.23%); and improved vicarious trauma prevention onsite (17/28; 60.71%). Leadership reported increased staff competence in GBV response. Obstacles included limited referral organizations and time for follow-up, continued training needs, and cultural norms. Development and implementation of an SOP is a feasible strategy to build a GBV response to improve health systems and support sustained effective use of HIV prevention products.

Counselors' acceptability of adherence counseling session recording, fidelity monitoring, and feedback in a multi-site HIV prevention study in four African countries.

Biomedical HIV prevention trials increasingly include evidence-based adherence counseling to encourage product use. To retain effectiveness, interventions must contain key components. Monitoring counseling fidelity ensures inclusion of components but is challenging in multinational contexts with different languages and scarce local supervision. The MTN-025/HOPE Study, a Phase 3b open-label trial to assess continued safety of and adherence to the dapivirine vaginal ring for HIV prevention, was the largest such trial to integrate fidelity monitoring using audio recordings of counseling sessions. We describe the monitoring process, along with counselor and participants' perceptions of it, which were collected via quantitative online survey (counselors only N = 42) and in-depth interviews with a subset of counselors (N = 22) and participants (N = 10). Sessions were conducted in five languages across 14 study sites in four countries. In total, 1238 sessions (23% of submitted sessions) were randomly selected and rated. Assessment of interrater reliability was essential to address drift in ratings. Counselors were apprehensive about being monitored, but appreciated clear guidance and found ratings very helpful (mean = 6.64 out of 7). Some participants perceived sessions as time-consuming; others found monitoring improved counseling quality. Fidelity monitoring of counseling sessions in mult-isite biomedical HIV studies is feasible and supportive for counselors.