A hybrid effectiveness implementation trial testing an HIV and STI prevention program for mother figures and their adolescent girls and young women delivered by peer leaders: ZAIMARA study protocol

Background: Zambia is struggling to meet the 95-95-95 targets established by the Joint United Nations Programme on HIV/AIDS for adolescent girls and young women (AGYW), and HIV incidence remains high. The Zambian government has declared adolescent HIV prevention and sexual health as priorities, but new strategies are needed to facilitate HIV testing uptake among AGYW. Mother figures (MF), who are the center of Zambian families, may hold the key. The excessive burden on the healthcare workforce has impeded the implementation of effective HIV prevention programs. To sustain effective programs, implementation strategies are needed that reduce worker burnout and improve job satisfaction and employee retention. Task shifting to peer leader intervention delivery and attention to healthcare worker stress has the potential to strengthen and sustain program delivery. This study will test an intervention called ZAIMARA for AGYW and MF to improve HIV testing uptake and evaluate implementation outcomes when delivered by peer leaders. Methods: This 2-arm individually randomized hybrid effectiveness-implementation trial will compare ZAIMARA to a health promotion (HP) program across five sites in Lusaka. We will enroll up to 650 dyads comprised of 15-19-year-old Zambian AGYW and their MF. Peer leaders randomized and trained to deliver ZAIMARA or HP will receive mental health distress screening and referral versus nutrition and exercise screening. AGYW-MF dyads will participate in a 2-day group workshop and complete 6-, 12-, 18-, and 24-month assessments. Peer leaders will complete 6- and 12-month assessments. Primary outcomes are HIV-testing uptake for AGYW and job retention for peer leaders at 6-months. Secondary outcomes include incident sexually transmitted infections, including HIV, uptake of pre-exposure prophylaxis, and safer sexual behavior at 12-, 18-, and 24-months. We will evaluate implementation outcomes and intervention costs. Discussion: This study is poised to add a novel approach to HIV prevention among AGYW in Zambia and inform implementation considerations. ZAIMARA may provide a scalable solution to improve HIV testing and prevention practices for AGYW and identify features of implementation that strengthen sustainability. Findings will inform national HIV prevention strategies in Zambia and offer insights into the broader application of family-based interventions in similar low-resource settings globally. Trial registration: ClinicalTrials.gov, NCT06503666, Registered on 10 July 2024.