SUMMARY Adolescent girls and young women (AGYW; ages 15-24) in sub-Saharan Africa face the dual threats of HIV infection and unintended pregnancy that severely undermine their long-term wellbeing. However, despite the urgent need to reach AGYW with sexual and reproductive health (SRH) services, health systems are often ill equipped to overcome the numerous barriers to health care services faced by AGYW. The goal of the study is to evaluate Malkia Klabu (“Queen Club”) in Tanzania, a loyalty program intervention that creates AGYW- friendly drug shops where AGYW can access HIV prevention services and contraception. The motivation for this approach is the growing recognition that drug shops, which are widely distributed and vastly outnumber health facilities, can promote beneficial health behaviors, bridge gaps in health services, and mitigate health workforce shortages. Furthermore, although HIV testing is the gateway to HIV prevention and care, self-testing with oral fluid has not been widely adopted by AGYW, despite government adoptions across the Region. Based on promising data from a pilot study, we hypothesize that the creation of a welcoming environment through the Malkia Klabu intervention will attract AGYW and bolster uptake of SRH services, including HIV self-test (HIVST) kits and contraception, thereby increasing the proportion of AGYW who are aware of their HIV status and empowered to avoid unintended pregnancy. We have designed an innovative, mixed-methods study to evaluate the Malkia Klabu intervention, which was designed for and by AGYW to create AGYW-friendly drug shops where HIVST is available alongside contraception and linkages to care. Specifically, our 5-year study includes a cluster-randomized trial (C-RCT) in 40 health facility catchment areas to evaluate the intervention’s effectiveness on HIV diagnoses and antenatal care registrations among AGYW at the population level (Aim 1). We will then link these outcomes to individual-level behaviors (e.g., recent HIV testing, unmet for contraception, linkage to care) and other demand-side pathways leading to impact with a RDS survey and focus groups with AGYW (Aim 2). Finally, a mixed-methods, implementation science study will pinpoint supply- side factors influencing effectiveness (e.g., implementation models, intervention fidelity, shop characteristics; Aim 3). At the study’s conclusion, we will have rigorously evaluated Malkia Klabu, uncovered factors that enhance program success, and described potential pathways of impact, consistent with an implementation science approach to close the gap between evidence and practice. The research team is a collaboration between the University of California (San Francisco and Berkeley), Health for a Prosperous Nation, the Tanzania Ministry of Health, Community Development, Gender, Elderly, and Children, and the Tanzania Pharmacy Council. The proposed study will rigorously explore, for the first time, whether AGYW-friendly drug shops can be used to distribute HIV prevention and SRH services to AGYW and whether this community-based platform of distribution is worthy of scaling to reach vulnerable AGYW across Tanzania and the Region.

NARRATIVE New and innovative strategies are urgently needed to increase the uptake of HIV prevention and sexual and reproductive health services among adolescent girls and young women (AGYW) in sub-Saharan Africa. In this study, we will rigorously evaluate an innovative intervention intended to create AGYW-friendly drug shops in Tanzania that includes the distribution of HIV self-test kits alongside contraception and linkages to care. The results from the study will provide guidance about whether community-based distribution of HIV testing at drug shops is an effective strategy for decreasing the incidence of HIV and unintended pregnancies among AGYW.