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

Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women

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.

Study Overview

• Status: Completed
• Conditions: Hiv; Sexually Transmitted Infection
• Intervention / Treatment: Behavioral: Health promotion control group; Behavioral: IMARA-SA (intervention group)

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • Desmond Tutu HIV Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health promotion control arm; Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).	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.
Experimental: IMARA-SA intervention arm; Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AGYW's Report of Adherence to PrEP	Adherence to PrEP is measured using an adapted version of the Wilson scale (2017). Measure Description: (0=low adherence to 100=high adherence) Scale is comprised of 3 items: number of days dose missed, how often did you take PrEP in the way you were supposed to, how good a job did you do at taking PrEP. Items were transformed to a 0-100 scale and averaged. Thirty was subtracted from number of days missed and multiplied by 3.33. Responses for remaining 2 items: never/very poor=0, rarely/poor=20, sometimes/fair=40, usually/good=60, almost always/very good=80, always/excellent=100.	6-10 months post baseline
AGYW Condom Use at Last Sex	Self-reported condom use at last vaginal or anal sex using the AIDS Risk Behavior Assessment (ARBA).	6-10 months post baseline
AGYW Consistency of Condom Use	Self-reported consistency of condom use during vaginal and anal sex in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).	6-10 months post baseline
AGYW Substance Use During Sex in the Past 6 Months	Self-reported number of times had vaginal or anal sex while drinking or taking drugs in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).	6-10 months post baseline
Number of Partners in the Past 6 Months	Self-reported number of vaginal or anal sex partners in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).	6-10 months post baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Fidelity	Number of IMARA intervention activities completed as planned.	Same day the IMARA intervention was conducted
Intervention Reach	The number of dyads who were eligible and consented/assented to participate in the study.	Enrollment
Intervention Feasibility: Completed the First Intervention Day of IMARA	The number of dyads in the IMARA-SA group who attend at least one IMARA-SA session	Baseline
Intervention Feasibility: Completed the Second Intervention Day of IMARA	The number of dyads in the IMARA-SA group who attended the second IMARA-SA session	Baseline
Intervention Acceptability: How Knowledgeable Were Your Group Leaders About the Information Presented Today?	Single item: How knowledgeable were your group leaders about the information presented today? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.	Immediately post-intervention Day 1 and Day 2
Intervention Acceptability: How Satisfied Were You With Today's Workshop?	Single item: How satisfied were you with today's workshop? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.	Immediately post-intervention Day 1 and Day 2
Intervention Acceptability: How Comfortable Were You With the Group Leaders Who Worked With You Today?	Single item: How comfortable were you with the group leaders who worked with you today? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.	Immediately post-intervention Day 1 and Day 2
Intervention Acceptability: How Much Did You Feel the Group Leaders Valued What You Said?	Single item: How much did you feel the group leaders valued what you said? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.	Immediately post-intervention Day 1 and Day 2
Intervention Acceptability: How Honest Did You Feel You Could be During Today's Workshop?	Single item: How honest did you feel you could be during today's workshop? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.	Immediately post-intervention Day 1 and Day 2
Intervention Acceptability: How Much Did You Feel You Were Involved or Engaged in the Activities?	Single item: How much did you feel you were involved or engaged in the activities? Participants responded on a 1 (Not at all) to 5 (Extremely) scale. High scores indicate greater acceptability.	Immediately post-intervention Day 1 and Day 2

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Desmond Tutu HIV Centre
• Investigators: Principal Investigator: Geri R Donenberg, PhD, University of Illinois Chicago; Principal Investigator: Linda-Gail Bekker, MBChB, PhD, Desmond Tutu HIV Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2019
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: HIV prevention; South Africa; Adolescent girls and young women; Mother-daughter intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: UG3HD096875 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available on request, pending discussion with the study team about the planned use of the data.
• IPD Sharing Time Frame: Following all study publications
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No