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

NCT ID: NCT05504954

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-26
• Study Completion Date: 2021-05-15

Brief Summary

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.

Conditions

Sexually Transmitted Infection; Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

IMARA-SA intervention arm

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

Group Type: EXPERIMENTAL

IMARA-SA (intervention group)

Intervention Type: BEHAVIORAL

The IMARA-SA intervention aligns with an ecological framework, emphasizing the intersection of individual, social, and structural determinants of women's sexual health and behavior. Separate FC and AGYW groups run simultaneously and cover parallel content, while joint activities enhance FC credibility as a resource for HIV/STI prevention and facilitate practice of communication skills. Interventionists use interactive and experiential activities. IMARA-SA's goals and motto emphasize strong FC-AGYW relationships, sisterhood, community empowerment, and motivation for HIV prevention, and build group cohesion. FC and AGYW sign a pact to confirm commitment to the program. At the end of Workshop Day 1, participants receive homework to complete during the week. Woven throughout IMARA-SA is the impact of mental health issues, alcohol and drug use, and violence on HIV-risk.

Health promotion control arm

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

Group Type: EXPERIMENTAL

Health promotion control group

Intervention Type: BEHAVIORAL

The health promotion control intervention is a family-based intervention previously delivered to families in SA and translated into isiXhosa. The intervention promotes healthy living by encouraging good nutrition, exercise, and violence reduction. It will be delivered in the same format as IMARA and will be identical in length and intensity.

Interventions

IMARA-SA (intervention group)

The IMARA-SA intervention aligns with an ecological framework, emphasizing the intersection of individual, social, and structural determinants of women's sexual health and behavior. Separate FC and AGYW groups run simultaneously and cover parallel content, while joint activities enhance FC credibility as a resource for HIV/STI prevention and facilitate practice of communication skills. Interventionists use interactive and experiential activities. IMARA-SA's goals and motto emphasize strong FC-AGYW relationships, sisterhood, community empowerment, and motivation for HIV prevention, and build group cohesion. FC and AGYW sign a pact to confirm commitment to the program. At the end of Workshop Day 1, participants receive homework to complete during the week. Woven throughout IMARA-SA is the impact of mental health issues, alcohol and drug use, and violence on HIV-risk.

Intervention Type: BEHAVIORAL

Health promotion control group

The health promotion control intervention is a family-based intervention previously delivered to families in SA and translated into isiXhosa. The intervention promotes healthy living by encouraging good nutrition, exercise, and violence reduction. It will be delivered in the same format as IMARA and will be identical in length and intensity.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Desmond Tutu HIV Centre

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Natasha Crooks

Assistant Professor, Human Development Nursing Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geri R Donenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Chicago

Linda-Gail Bekker, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Desmond Tutu HIV Centre

Locations

Desmond Tutu HIV Centre

Cape Town, Western Cape, South Africa

Countries

South Africa

References

Merrill KG, Atujuna M, Emerson E, Blachman-Demner D, Bray BC, Bekker LG, Donenberg GR. Preliminary effectiveness and implementation outcomes of the IMARA-South Africa sexual health intervention on adolescent girls and young women: A pilot randomized trial. PLOS Glob Public Health. 2023 Feb 15;3(2):e0001092. doi: 10.1371/journal.pgph.0001092. eCollection 2023.

Reference Type: DERIVED

PMID: 36962830 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: ICF for Girls between the ages of 18-19

View Document

Document Type: Informed Consent Form: Parent ICF for Minors

View Document

Document Type: Informed Consent Form: ICF for Caregiver's own participation

View Document

Document Type: Informed Consent Form: Assent for Minors

View Document

Other Identifiers

UG3HD096875

Identifier Type: NIH

Identifier Source: org_study_id

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