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Completed

NCT Number: NCT05504954

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

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.

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Key information

Conditions

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

Age range

15 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Desmond Tutu HIV Centre

Cape Town, Western Cape, 7925, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for AGYW include:

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

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.

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 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 8-17 months post baseline

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

  2. Number of AGYW Completing HIV Testing and Counseling (HTC)

    Time frame: 8-17 months post baseline

    Completion of HIV Testing and Counseling (HTC)

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

    Time frame: 8-17 months post baseline

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

Secondary outcomes

  1. AGYW's Report of Adherence to PrEP

    Time frame: 6-10 months post baseline

    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.

  2. AGYW Condom Use at Last Sex

    Time frame: 6-10 months post baseline

    Self-reported condom use at last vaginal or anal sex using the AIDS Risk Behavior Assessment (ARBA).

  3. AGYW Consistency of Condom Use

    Time frame: 6-10 months post baseline

    Self-reported consistency of condom use during vaginal and anal sex in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).

  4. AGYW Substance Use During Sex in the Past 6 Months

    Time frame: 6-10 months post baseline

    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).

  5. Number of Partners in the Past 6 Months

    Time frame: 6-10 months post baseline

    Self-reported number of vaginal or anal sex partners in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).

Other outcomes

  1. Intervention Fidelity

    Time frame: Same day the IMARA intervention was conducted

    Number of IMARA intervention activities completed as planned.

  2. Intervention Reach

    Time frame: Enrollment

    The number of dyads who were eligible and consented/assented to participate in the study.

  3. Intervention Feasibility: Completed the First Intervention Day of IMARA

    Time frame: Baseline

    The number of dyads in the IMARA-SA group who attend at least one IMARA-SA session

  4. Intervention Feasibility: Completed the Second Intervention Day of IMARA

    Time frame: Baseline

    The number of dyads in the IMARA-SA group who attended the second IMARA-SA session

  5. Intervention Acceptability: How Knowledgeable Were Your Group Leaders About the Information Presented Today?

    Time frame: Immediately post-intervention Day 1 and Day 2

    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.

  6. Intervention Acceptability: How Satisfied Were You With Today's Workshop?

    Time frame: Immediately post-intervention Day 1 and Day 2

    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.

  7. Intervention Acceptability: How Comfortable Were You With the Group Leaders Who Worked With You Today?

    Time frame: Immediately post-intervention Day 1 and Day 2

    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.

  8. Intervention Acceptability: How Much Did You Feel the Group Leaders Valued What You Said?

    Time frame: Immediately post-intervention Day 1 and Day 2

    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.

  9. Intervention Acceptability: How Honest Did You Feel You Could be During Today's Workshop?

    Time frame: Immediately post-intervention Day 1 and Day 2

    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.

  10. Intervention Acceptability: How Much Did You Feel You Were Involved or Engaged in the Activities?

    Time frame: Immediately post-intervention Day 1 and Day 2

    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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Desmond Tutu HIV Centre
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: IMARA-SA pilot

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2022
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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