Testing a Multi-Level Approach to Reduce Stigma for Women Living With HIV

This study will evaluate the effectiveness and implementation of a multilevel HIV stigma reduction intervention that integrates two evidence-based, culturally tailored components previously adapted for Tanzania: the Total Facility Approach (TFA) to reduce health care facility (HCF) stigma among clinical and nonclinical staff, and Labda Siku Moja (LSM) to reduce internalized stigma among WLWH through ethnodrama-based group sessions guided by motivational interviewing techniques. Using a hybrid type 1 effectiveness-implementation design, we will conduct a hierarchical 2×2 factorial cluster-randomized controlled trial in 20 Ministry of Health and non-profit faith-based HCF offering ART in Dar es Salaam region. Facilities will be randomized to TFA or standard of care (SOC). Within each facility, 34 WLWH who have missed clinic visits or attended the most recent clinic visit 14 or more days late (N=680) will be individually randomized to receive LSM or SOC. Primary outcomes are QoL (WHOQOL-BREF) and viral suppression (\<50 copies/ml) measured over 12 months. A prospective mixed methods process evaluation will assess implementation fidelity, mechanisms and mediators of change (including stigma and psychosocial constructs), contextual influences on outcomes, and preliminary intervention costs using programmatic data, surveys, qualitative focus groups, and micro-costing methods. A Study Advisory Group (SAG) comprising WLWH, community partners, providers, and Ministry of Health representatives will guide intervention refinement, interpret findings, and develop recommendations to optimize the study for broader implementation. If effective, the study will provide scalable evidence to improve QoL and viral suppression among WLWH and advance Tanzania's and global goals for ending the HIV epidemic.