Ssimusango: A Multi-level intervention to reduce stigma to improve HIV prevention and treatment outcomes for people struggling to access and remain in care - PROJECT SUMMARY/ABSTRACT Despite the availability of HIV prevention and treatment, people at risk of and living with HIV, including health workers, still struggle to access HIV services. Stigma is a documented barrier that results in poor engagement in care and suboptimal adherence to HIV pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), undermining investments in these services, in addition to leading to poorer outcomes. We will adapt and combine two evidence based ISD-reduction interventions for the Ugandan context --(1) Health Policy Plus (HP+) Total Facility Approach (TFA) to Stigma Reduction (a clinic-level intervention) and (2) HIV Education, Empathy and Empowerment (HIVE3) (an individual level intervention focused on internalized stigma). HP+ and HIVE3 are complementary interventions that could be combined to reduce health facility- and individual-level internalized stigma. However, research is needed to show if the adapted multi-level HP+/HIVE3 intervention, Ssimusango (means “no self-blame or blaming others” in Luganda), decreases stigma and improves HIV outcomes for people at risk for HIV or living with HIV who struggle to engage with and remain in care. To address these questions, we will conduct a randomized wait-list controlled trial to test the preliminary eƯectiveness of Ssimusango on PrEP adherence and viral suppression, compared with standard of care, using a status-neutral approach i.e., engagement in care regardless of HIV status. We will also use qualitative methods to assess mechanisms and synergies of intervention delivery. Leveraging the multi- disciplinary expertise of our multi-national research team, and working at four health facilities in Kampala ranked lowest on the PEPFAR Uganda HIV stigma scorecard, we propose the following specific aims: (1) adapt the HP+ and HIVE3 stigma-reduction interventions to address stigma for people at risk of or living with HIV who struggle to access or remain in care in Uganda (intervention adaptation); (2) conduct a hybrid type 1 eƯectiveness-implementation trial with 120 persons who struggle to access and remain in HIV care to pilot test the preliminary eƯectiveness of Ssimusango on (a) PrEP adherence and (b) viral suppression (intervention implementation); and (3) evaluate Ssimusango using qualitative methods and the Intersectionality-Enhanced Consolidated Framework for Implementation Research (intervention evaluation). Clinic-level implementation outcomes are adoption, fidelity, and sustainability assessed using key informant interviews, training attendance sheets, observation checklists, and rapid feedback surveys. Individual-level outcomes: (1) PrEP adherence at 3-months post-intervention, measured by urine tenofovir levels (primary outcome) and (2) viral suppression (HIV RNA <50 copies/mL) and (3) stigma reduction 3 months post-intervention (secondary outcomes). This multi-level approach to implementing HIV stigma reduction interventions will improve PrEP and ART adherence outcomes among people at risk of or living with HIV who struggle to engage in care, build stigma research capacity in Uganda, and generate actionable data for scale-up and program implementation in Uganda, sub-Saharan Africa and beyond.
