A Multilevel Integrated Intervention to Reduce the Impact of HIV Stigma on HIV Treatment Outcomes Among Adolescents Living With HIV in Uganda: Protocol for a Randomized Controlled Trial
Authors: Mutumba Massy , Ssewamala Fred , Namirembe Rashida , Sensoy Bahar Ozge , Nabunya Proscovia , Neilands Torsten , Tozan Yesim , Namuwonge Flavia , Nattabi Jennifer , Acayo Laker Penina , Mukasa Barbara , Mwebembezi Abel 
Published: June 2022

Background
HIV stigma remains a formidable barrier to HIV treatment adherence among school-attending adolescents living with HIV, owing to high levels of HIV stigma within schools, rigid school structures and routines, lack of adherence support, and food insecurity. Thus, this protocol paper presents an evidence-informed multilevel intervention that will simultaneously address family- and school-related barriers to HIV treatment adherence and care engagement among adolescents living with HIV attending boarding schools in Uganda.

Objective
The proposed intervention—Multilevel Suubi (MSuubi)—has the following objectives: 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; examine the effect of M-Suubi on HIV stigma (internalized, anticipated, and enacted), with secondary analyses to explore hypothesized mechanisms of change (eg, depression) and intervention mediation; assess the cost and cost-effectiveness of each intervention condition; and qualitatively examine participants’ experiences with HIV stigma, HIV treatment adherence, and intervention and educators’ attitudes toward adolescents living with HIV and experiences with group-based HIV stigma reduction for educators, and program or policy implementation after training.

Methods
MSuubi is a 5-year multilevel mixed methods randomized controlled trial targeting adolescents living with HIV aged 10 to 17 years enrolled in a primary or secondary school with a boarding section. This longitudinal study will use a 3-arm cluster randomized design across 42 HIV clinics in southwestern Uganda. Participants will be randomized at the clinic level to 1 of the 3 study conditions (n=14 schools; n=280 students per study arm). These include the bolstered usual care (consisting of the literature on antiretroviral therapy adherence promotion and stigma reduction), multiple family groups for HIV stigma reduction plus family economic empowerment (MFG-HIVSR plus FEE), and Group-based HIV stigma reduction for educators (GED-HIVSR). Adolescents randomized to the GED-HIVSR treatment arm will also receive the MFG-HIVSR plus FEE treatment. MSuubi will be provided for 20 months, with assessments at baseline and 12, 24, and 36 months.

Results
This study was funded in September 2021. Participant screening and recruitment began in April 2022, with 158 dyads enrolled as of May 2022. Dissemination of the main study findings is anticipated in 2025.

Conclusions
MSuubi will assess the effects of a combined intervention (family-based economic empowerment, financial literacy education, and school-based HIV stigma) on HIV stigma among adolescents living with HIV in Uganda. The results will expand our understanding of effective intervention strategies for reducing stigma among HIV-infected and noninfected populations in Uganda and improving HIV treatment outcomes among adolescents living with HIV in sub-Saharan Africa.

Trial Registration
ClinicalTrials.gov NCT05307250; https://clinicaltrials.gov/ct2/show/NCT05307250

International Registered Report Identifier (IRRID)
PRR1-10.2196/40101