A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women (IMARA-SA)

University of Illinois

Status: Completed

Conditions: Sexually Transmitted Infections; HIV Infections

Treatments: Behavioral: IMARA (intervention group); Behavioral: Health promotion control group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04758390

UH3HD096875 (U.S. NIH Grant/Contract)

2018-0709

Details and patient eligibility

About

To achieve an AIDS-free generation, there is a critical need for programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa. Informed, Motivated, Aware, and Responsible Adolescents and Adults (IMARA) is an evidence-based HIV-prevention intervention for adolescent girls and young women (AGYW) and their female caregivers, which has been adapted for a South African audience. The study will test whether AGYW receiving IMARA will have fewer sexually-transmitted infections (STI) and greater acceptance of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at 6-month follow-up compared to AGYW assigned to the health-promotion control intervention.

Full description

Reducing new HIV and STI infections among South African (SA) adolescent girls and young women (AGYW) is global public health priority. SA has the world's largest HIV epidemic, and SA AGYW acquire HIV at twice the rate of and seroconvert on average 5 - 7 years earlier than male peers. As new infections continue to outpace access to and availability of pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), primary prevention remains the most viable strategy to stem new transmission. SA efforts to prevent HIV transmission in youth focus mostly on individual-level behavior change, but AGYW's persistent HIV disparities are explained by broad social and structural inequities that shape and constrain HIV-risk behaviors. Comprehensive HIV prevention packages that are integrated, synergistic, and tailored to the local epidemiology and cultural context are likely to achieve and sustain maximum reductions in HIV-risk. Female caregivers (FC) are an untapped resource in the HIV prevention toolbox and offer a novel opportunity to strengthen AGYW prevention efforts. AGYW may also be change agents for their FC who want to be positive role models for AGYW, and thus, adopt HIV prevention behaviors, including HTC and PrEP.

This study will evaluate the effectiveness and cost-effectiveness of Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), a multilevel, innovative, family-based HIV prevention program that targets individual, social, and structural drivers of risk. IMARA demonstrated a 43% reduction in incident STI at 12-month follow-up among black 14-18-year-old girls in the US. IMARA has been systematically tailored for the SA context and piloted among AGYW and FC dyads. A two-arm RCT will now be conducted with about 645 AGYW (15-19 years old) and FC dyads. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (~12 hours) that includes joint and separate mother and daughter activities. AGYW and FC will complete baseline, 6-, and 12-month assessments, including testing for three STI (chlamydia, gonorrhea, and trichomoniasis). We will offer HTC and PrEP at each assessment and track uptake and linkage to care. AGYW and FC who are HIV-negative and interested in PrEP will receive a one-month supply and referral to a clinic. They will additionally receive treatment and counseling if testing positive for an STI and referral for care at an ART clinic if testing positive for HIV. Data will be collected to determine the costs of IMARA. Analyses will compare AGYW across the intervention and control programs on STI incidence, and PrEP and HTC uptake, in addition to secondary outcomes. We will also evaluate the costs and cost-effectiveness of IMARA with respect to the acquisition of STI and HIV, where possible considering power limitations. Additionally, the intervention's implementation will be explored. The study answers an urgent need to evaluate the effectiveness and cost-effectiveness of combination HIV prevention packages for AGYW.

Enrollment: 1,290 patients

Sex: Female

Ages: 15 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for AGYW include:

• female;
• 15-19 years-old;
• residing in Klipfontein/Mitchells Plain (K/MP);
• speak isiXhosa or English or a combination of these languages;
• willing to have biometric data collected.

Inclusion criteria for FC include:

• identified by AGYW as a FC;
• 24 years and older;
• living with or in daily contact with the AGYW;
• speak isiXhosa or English or a combination of these languages;
• willing to have biometric data collected.

Exclusion Criteria:

• AGYW will be excluded from the study if they do not have a FC to participate in the study.
• AGYW and FC will be excluded from the study if they are: a) unable to understand the consent/assent process and provide written informed consent; b) currently enrolled in another research study addressing HIV/STIs/PrEP.
• AGYW and FC must agree to participate as a dyad. AGYW refusal will supersede FC consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,290 participants in 2 patient groups

IMARA intervention arm

Experimental group

Description:

Participants randomized to the IMARA arm will receive the IMARA intervention (i.e., the intervention group).

Treatment:

Behavioral: IMARA (intervention group)

Health promotion control arm

Experimental group

Description:

Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).

Treatment:

Behavioral: Health promotion control group