ZAIMARA: Zambian Informed Motivated Aware and Responsible Adolescents and Adults - Worldwide, adolescent girls and young women (AGYW) are heavily impacted by HIV/STIs. In Zambia, AGYW are 4 times more likely to acquire HIV than their male peers (8.6% vs. 2.1%), HIV testing rates are low (45.4%), and 71.2% do not know their HIV status. The U.S.-developed CDC “best evidence” intervention, Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), demonstrated a 43% reduction in incident STIs at 12-month follow-up in the IMARA group compared with the control group. This study will adapt IMARA for Zambian AGYW and evaluate its effectiveness and implementation outcomes in 5 distinct areas of Lusaka province with the highest rates of HIV infection in Zambia, thus providing rapid access to a large population of participants, which would be infeasible in the U.S. Combined biomedical and behavioral HIV-prevention interventions are poised to significantly impact AGYW HIV/STI transmissions, but success requires careful attention to context-specific drivers and mechanisms of implementation. Failures in uptake and sustainability of effective interventions have been attributed to multi-level barriers and constraints within local contexts that have not been adequately understood or addressed. This study’s design is guided by the Exploration, Preparation, Implementation, Sustainment framework, which specifies the determinants and mechanisms of action that drive implementation outcomes and informs the selection of our implementation strategy. The study’s specific aims are to: (1) Tailor IMARA for the Zambian context to produce ZAIMARA. Using a modified ADAPT-ITT15 approach, we anticipate minor changes beyond the inclusion of new content, informed by preliminary focus groups. (2) Compare the effects of ZAIMARA vs. general health promotion on AGYW HIV testing uptake at 6 months (primary clinical outcome), incident STIs (including HIV), PrEP uptake, and sexual behavior (secondary clinical outcomes) at 6-, 12-, 18-, and 24 months. We will individually randomize 600 AGYW-mother-figure dyads to a condition. We expect greater uptake of HIV testing and PrEP, fewer incident STIs and HIV infections, and more self-reported condom use among AGYW in ZAIMARA. (3) Examine the impact of mental health screening and referral vs. a general check-in on peer leader job retention. We will individually randomize 60 peer leaders from in both treatment arms to condition and compare job retention and intervention fidelity (primary implementation outcomes) at 6-, 12-, 18-, & 24-months. We expect higher retention and better fidelity among screened peers. (4) Evaluate ZAIMARA implementation outcomes using mixed methods and key informant interviews. This study will address critical gaps in the HIV/STI prevention continuum not only for Zambian AGYW, but for youth in the United States, where HIV/STIs remain prevalent and contribute to substantial reproductive morbidity. The results will provide implementation evidence for family-based prevention strategies while advancing NIH priorities to end the HIV epidemic in the U.S. through implementation science
