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

NCT05504954 | Completed Results

• 1 other identifier: UG3HD096875
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Keywords

HIV prevention; Adolescent girls and young women; South Africa; Mother-daughter intervention

Outcome Measures

Primary Outcomes (3)

• Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)

  A positive test for at least one of two STIs: chlamydia and/or gonorrhea

  8-17 months post baseline

• Number of AGYW Completing HIV Testing and Counseling (HTC)

  Completion of HIV Testing and Counseling (HTC)

  8-17 months post baseline

• Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)

  Uptake of Pre-Exposure Prophylaxis (PrEP) assessed as receipt of PrEP prescription from research team or other care provider after the baseline survey.

  8-17 months post baseline

Secondary Outcomes (5)

• AGYW's Report of Adherence to PrEP

  6-10 months post baseline

• AGYW Condom Use at Last Sex

  6-10 months post baseline

• AGYW Consistency of Condom Use

  6-10 months post baseline

• AGYW Substance Use During Sex in the Past 6 Months

  6-10 months post baseline

• Number of Partners in the Past 6 Months

  6-10 months post baseline

Other Outcomes (10)

• Intervention Fidelity

  Same day the IMARA intervention was conducted

• Intervention Reach

  Enrollment

• Intervention Feasibility: Completed the First Intervention Day of IMARA

  Baseline

Study Arms (2)

IMARA-SA intervention arm

EXPERIMENTAL

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

Behavioral: IMARA-SA (intervention group)

Health promotion control arm

EXPERIMENTAL

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

Behavioral: Health promotion control group

Interventions

IMARA-SA (intervention group) 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.

IMARA-SA intervention arm

Health promotion control group 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.

Health promotion control arm

Eligibility Criteria

• Age: 15 Years - 19 Years
• Gender Eligibility Details: Participants will be eligible to participate if they are female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Black or mixed race;
• years-old;
• residing in Klipfontein/Mitchells Plain (K/MP);
• speak isiXhosa or English or a combination of these languages.
• identified by AGYW as a FC;
• years and older;
• living with or in daily contact with the AGYW;
• speak isiXhosa or English or a combination of these languages.

You may not qualify if:

• 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 unable to understand the consent/assent process and provide written informed consent;
• are currently enrolled in another research study addressing HIV/STIs/PrEP;
• participated in the IMARA-SA adaptation process. AGYW and FC must agree to participate as a dyad. AGYW refusal will supersede FC consent.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Desmond Tutu HIV Centre: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Desmond Tutu HIV Centre

Cape Town, Western Cape, 7925, South Africa

Location

Related Publications (1)

• 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.

  PMID: 36962830 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Geri Donenberg
• Organization: Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois Chicago

gerid@uic.edu

312-996-8602

Study Officials

• Geri R Donenberg, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

• Linda-Gail Bekker, MBChB, PhD

  Desmond Tutu HIV Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Human Development Nursing Science

Model Details: Adolescent girl and young women-female caregiver (AGYW-FC) dyads will be randomized to the IMARA-SA intervention arm or a health promotion control arm matched in time and intensity. IMARA-SA and the health promotion program will be delivered as group interventions.

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: October 26, 2019
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following all study publications

Locations

ZA (1)