Implementation of an HIV Status-Neutral Nurse-Led Intervention to Improve Clinical Outcomes for Male HIV Self-Testers in Tanzania

There is a need for self-testers in Sub-Saharan Africa (SSA) for follow-up HIV care initiation, including antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP), following HIV self-testing (HIVST). We piloted the Self-Testing Education and Promotion (STEP) intervention, which included peer education and demand creation for HIVST combined with nurse-led distribution of HIVST kits in a community setting, and found low linkage to facility-up services following HIVST. Based on these findings, we have added the community-based Nurse-Initiated Management of ART (cbNIMART) component to include ART or PrEP initiation following HIVST. There are three aims to this study. Aim 1.) Tailor the STEP+cbNIMART intervention using the ADAPT-ITT model. In Aim 1, the intervention will be further tailored through a “theater test” and feedback from key stakeholders and topical experts, and later utilized for training peer educators and nurses who will help deliver the intervention. Aim 2.) Test the effectiveness of the STEP+cbNIMART intervention on ART or PrEP initiation and retention for self-testers. We will conduct a cluster randomized controlled trial using a hybrid type I implementation-effectiveness study design to assess the effectiveness of the intervention. The trial will include an intervention and control arm, with intervention participants receiving nurse-led community-based ART and PrEP initiation, and control arm participants receiving the standard of care. ART and PrEP adherence will be measured through a baseline survey and subsequent follow-ups of participants in both arms. Aim 3.) Evaluate the facilitators and barriers of implementing the STEP+cbNIMART intervention to refine the intervention for adoption in other settings.