Study Protocol for M-Suubi: A Multi-level integrated intervention to reduce the impact of HIV stigma on HIV treatment outcomes among adolescents living with HIV in Uganda (Preprint)

BACKGROUND HIV stigma remains a formidable barrier to HIV treatment adherence among adolescents living with HIV (ALHIV), contributing to low rates of medication adherence, viral suppression, and high attrition from HIV care. ALHIV in schools have lower levels of HIV treatment adherence due to high levels of HIV stigma within schools, rigid school structures and routines, lack of adherence support, and food insecurity. Thus, this paper presents a protocol for an evidence-informed multilevel intervention that will simultaneously address multiple family- and school-related barriers to HIV treatment adherence and care engagement among ALHIV attending boarding schools in Uganda. OBJECTIVE Aim 1: Examine the impact of M-Suubi on HIV viral suppression (primary outcome) and adherence to HIV treatment including keeping appointments, pharmacy refills, pill counts and retention in care Aim 2: Examine the effect of M-Suubi on HIV stigma (internalized, anticipated, and enacted), with secondary analyses to explore hypothesized mechanisms of change (e.g. depression) and intervention mediation; Aim 3: Assess the cost and cost-effectiveness of each intervention condition, and; Aim 4: Qualitatively examine: a) participants’ experiences with HIV stigma, HIV treatment adherence, and the intervention; and 2) educators’ attitudes towards ALHIV and experiences with GED-HIVSR, and program/policy implementation post-training. METHODS Study targets ALHIV aged 10 – 17 years and enrolled in a primary or secondary school with a boarding section. This longitudinal study will utilize a three-arm cluster randomized design across 42 HIV clinics in Southwestern Uganda. Participants will be randomized at clinic level to one of the 3 study conditions (n= 14 schools, n=280 students per study arm): 1) Bolstered usual care (BSOC) consisting of literature on ART adherence promotion and stigma reduction; 2) Group-based HIV stigma reduction for educators (GED-HIVSR); and 3) Multiple family groups for HIV stigma reduction plus family economic empowerment (MFG-HIVSR plus FEE) for ALHIV. For ALHIV randomized to treatment Arm 2 (i.e. MFG-HIVSR plus FEE and GED-HIVSR), we will include all the schools in the GED-HIVSR component, irrespective of the number of participants attending the school. M-Suubi will be provided for 20 months, with assessments at baseline, 12, 24, and 36 months. RESULTS The study is currently enrolling study participants. CONCLUSIONS Study findings will have important implications for HIV treatment adherence and engagement in care among ALHIV SSA. By targeting ALHIV, their caregivers, and educators, this multi-level study will generate evidence on effective intervention strategies for reducing stigma among HIV-infected and non-infected populations in Uganda and enable an ecological assessment of the cascading effects of multi-level HIV stigma reduction strategies. The study, currently recruiting study participants, would provide crucial evidence on effective and scalable strategies for addressing HIV stigma and improving HIV treatment outcomes among in-school ALHIV in resource-poor settings. CLINICALTRIAL NCT05307250