An individually randomized controlled trial of a mother-daughter HIV/STI prevention program for adolescent girls and young women in South Africa: IMARA-SA study protocol

BACKGROUND: South Africa has the world’s largest HIV epidemic, but South African adolescent girls and young women (AGYW) acquire HIV at twice the rate of and seroconvert on average 5–7 years earlier than their male peers. Female caregivers (FC) are an untapped resource for HIV/STI prevention in South Africa and offer a novel opportunity to strengthen AGYW prevention efforts. This study will evaluate the effectiveness and cost-effectiveness of an evidence-based mother-daughter HIV/STI prevention program tested in the United States and adapted for South Africa, Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), to decrease STI incident infections and increase HIV testing and counseling (HTC) and PrEP uptake in AGYW. METHODS: This is a 2-arm individually randomized controlled trial comparing IMARA to a family-based control program matched in time and intensity with 525 15–19-year-old Black South African AGYW and their FC-dyads in Cape Town’s informal communities. AGYW will complete baseline, 6-, and 12-month assessments. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (total 10 h) that includes joint and separate mother and daughter activities. Primary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 6 months. Secondary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 12 months, sexual behavior (e.g., condom use, number of partners), HIV incidence, and ART/PrEP adherence and intervention cost-effectiveness. AGYW who test positive for a STI will receive free treatment at the study site. HIV positive participants will be referred to ART clinics. DISCUSSION: Primary prevention remains the most viable strategy to stem new STI and HIV transmissions. HIV and STI disparities go beyond individual level factors, and prevention packages that include supportive relationships (e.g., FC) may produce greater reductions in HIV-risk, improve HTC and PrEP uptake, and increase linkage, retention, and adherence to care. Reducing new HIV and STI infections among South African AGYW is global public health priority. TRIAL REGISTRATION: ClinicalTrials.gov Number NCT04758390, accepted 02/16/2021.