Clinical trial NCT05504954: A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA
Official title: Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infection
Hiv
Keywords: HIV prevention
Adolescent girls and young women
South Africa
Mother-daughter intervention
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Desmond Tutu HIV Centre
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-08-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of adolescent girls and young women (AGYW) with a sexually transmitted infection (STI) at baseline and follow-up
timeFrame: ~6 months (from baseline to follow-up)
measure: Proportion of AGYW who complete HIV testing and counseling (HTC) at baseline and follow-up
timeFrame: ~6 months (from baseline to follow-up)
measure: Proportion of AGYW who elect to take pre-exposure prophylaxis (PrEP) at baseline and follow-up
timeFrame: ~6 months (from baseline to follow-up)
Secondary outcomes:
measure: Proportion of AGYW who report risky sexual behavior at baseline and follow-up
timeFrame: ~6 months (from baseline to follow-up)
measure: Proportion of AGYW who report adherence to PrEP at baseline and follow-up
timeFrame: ~6 months (from baseline to follow-up)
Other outcomes:
measure: Intervention reach
timeFrame: ~6 months (from baseline to follow-up)
measure: Intervention feasibility
timeFrame: ~6 months (from baseline to follow-up)
measure: Intervention acceptability
timeFrame: ~6 months (from baseline to follow-up)
measure: Intervention fidelity
timeFrame: ~6 months (from baseline to follow-up)
Locations:
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Centre
state: Western Cape
Study officials:
affiliation: University of Illinois Chicago
name: Geri R Donenberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Desmond Tutu HIV Centre
name: Linda-Gail Bekker, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References: