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

Hiv Clinical Trial

— IMARA-SA pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504954
• Other study ID #: UG3HD096875
• Status: Completed
• Phase: N/A
• Start date: October 26, 2019
• Est. completion date: May 15, 2021

Study information

• Verified date: August 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hiv
• Sexually Transmitted Diseases
• Sexually Transmitted Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
South Africa	Desmond Tutu HIV Centre	Cape Town	Western Cape

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Desmond Tutu HIV Centre, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)