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Integration of gender-based violence screening and support into the research clinic setting: experiences from an HIV prevention open label extension trial in sub-Saharan Africa

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BACKGROUND: HIV and gender-based violence (GBV) are often co-endemic among women in sub-Saharan Africa, with shared risk factors. Research sites working with vulnerable populations have an ethical obligation to provide GBV support. Standard operating procedures (SOPs) were implemented in MTN-025/HOPE, an open-label extension study of the dapivirine vaginal ring for HIV prevention, to systematically guide GBV identification, management, and referral. SOP development, implementation, and evaluation is described here to inform integration of GBV response in research and programmatic settings.
METHODS: Site staff (n=32) and leadership (n=17) completed a questionnaire assessing GBV knowledge, resources, and referral capabilities to supplement WHO guidelines and other literature in informing the development of a GBV response SOP template. Sites tailored and implemented the SOP through ~1.5 years of study implementation. At closeout, a questionnaire assessed SOP implementation experiences among staff (n=35) and leadership (n=17), including recommendations regarding staff training and support mechanism needs, processes for identifying and maintaining suitable referral networks, and confidence in quality of staff GBV response. Participant report of baseline and follow-up experiences of GBV and participant engagement activity (PEA) reports were also reviewed.
RESULTS: Among 1360 participants at sites where the SOP was implemented, 104 (7.65%) reported experiencing GBV in the year prior to enrollment, and 86/1353 (6.36%) reported any GBV during follow-up, with 52/86 (60.47%) reporting GBV after SOP implementation. At study end, staff reported increased training 32/35 (91.43%); improved confidence in GBV response (18/26; 69.23%); and increased compassion fatigue prevention on-site (17/28; 60.71%). Leadership reported increased staff competence with SOP implementation. Strength of referral networks depended on availability of referral organizations and varied by site, with less than 20% (3/16) of leadership reporting improvements and PEA reports revealing differing partner organization engagement. Site-reported obstacles to comprehensive GBV care included: limited local referral organizations, limited time for participant follow-up, continued staff training needs, and prevailing cultural norms and misconceptions surrounding GBV.
CONCLUSIONS: Development and implementation of an SOP is a feasible, effective strategy to build a systematic GBV response that can improve health system capacity and participant health. Adequate community-based referral networks are essential to effective GBV response and were limited in some settings.