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): 120
• 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 (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

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
• 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
Proportion of adolescent girls and young women (AGYW) with a sexually transmitted infection (STI) at baseline and follow-up	A positive test for at least one of two STIs: chlamydia and/or gonorrhea	~6 months (from baseline to follow-up)
Proportion of AGYW who complete HIV testing and counseling (HTC) at baseline and follow-up	Completion of HTC	~6 months (from baseline to follow-up)
Proportion of AGYW who elect to take pre-exposure prophylaxis (PrEP) at baseline and follow-up	Uptake of PrEP	~6 months (from baseline to follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of AGYW who report risky sexual behavior at baseline and follow-up	Sexual behavior (e.g., condom use, substance use during sex, number of partners, concurrent partners) will be measured via self-report using the AIDS Risk Behavior Assessment (ARBA) (Donenberg, 2001)	~6 months (from baseline to follow-up)
Proportion of AGYW who report adherence to PrEP at baseline and follow-up	Adherence to PrEP (where appropriate) will be measured via self-report using items from the Wilson scale (2017)	~6 months (from baseline to follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention reach	Reach will be assessed as the proportion of AGYW who consented/assented to participate in the study.	~6 months (from baseline to follow-up)
Intervention feasibility	Feasibility will be measured as the proportion of AGYW in the IMARA-SA group who attend at least one session and receive the full 10-hour intervention.	~6 months (from baseline to follow-up)
Intervention acceptability	Acceptability will be measured through survey items completed by AGYW in the IMARA-SA group (e.g., satisfaction with the intervention day, perceptions of their facilitators, etc.).	~6 months (from baseline to follow-up)
Intervention fidelity	Fidelity will be assessed by observers of the intervention using an adapted version of the Treatment Fidelity Questionnaire (Lane et al, 2004).	~6 months (from baseline to follow-up)

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

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 19, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

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

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