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

University of Illinois

Status: Completed

Conditions: Sexually Transmitted Infection; Hiv

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05504954

UG3HD096875

Details and patient eligibility

About

Programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa are essential to meet global HIV targets. Informed, Motivated, Aware and Responsible Adolescents and Adults- South Africa (IMARA-SA) 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. This pilot study will assess feasibility in preparation for a randomized controlled trial (RCT). Additionally, the pilot will examine the preliminary effectiveness of IMARA-SA in reducing sexually transmitted infections (STI) and increasing uptake of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at follow-up among AGYW. About 60 AGYW-FC dyads will be enrolled and randomized to IMARA-SA or a health-promotion control arm. Following randomization, the dyads will participate in an ~2-day group workshop (~10 hours), which includes joint and separate mother and daughter activities. AGYW and FC will complete baseline assessments and follow-up assessments approximately 6 months later. Assessments will include surveys, STIs testing (for chlamydia and gonorrhea), and uptake of HTC and a 1-month PrEP prescription. Additionally, the intervention's implementation (e.g., acceptability) will be explored.

Enrollment: 61 patients

Sex: Female

Ages: 15 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for AGYW include:

1. Black or mixed race;
2. 15-19 years-old;
3. residing in Klipfontein/Mitchells Plain (K/MP);
4. speak isiXhosa or English or a combination of these languages.

Inclusion criteria for FC include:

1. identified by AGYW as a FC;
2. 24 years and older;
3. living with or in daily contact with the AGYW;
4. speak isiXhosa or English or a combination of these languages.

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:

1. are unable to understand the consent/assent process and provide written informed consent;
2. are currently enrolled in another research study addressing HIV/STIs/PrEP;
3. participated in the IMARA-SA adaptation process. 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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61 participants in 2 patient groups

IMARA-SA intervention arm

Experimental group

Description:

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

Treatment:

Behavioral: IMARA-SA (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