NCT04758390Completed
A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women
Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women
Source: ClinicalTrials.gov · Last updated 20 Jan 2025
Brief summary (registry, in English)
To achieve an AIDS-free generation, there is a critical need for programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa. Informed, Motivated, Aware, and Responsible Adolescents and Adults (IMARA) 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. The study will test whether AGYW receiving IMARA will have fewer sexually-transmitted infections (STI) and greater acceptance of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at 6-month follow-up compared to AGYW assigned to the health-promotion control intervention.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1290 (actual)
- First submitted
- 11 Feb 2021
- Start date
- 2 Oct 2021
- Primary completion date
- 7 Apr 2024
- Lead sponsor
- University of Illinois Chicago
- Diseases
- HIV
- NCT number
- NCT04758390
What you commit to
- Study type: Interventional
- Participants enrolled: 1290
- From 2 Oct 2021 to the primary completion date, 7 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- AGYW and FC will be excluded from the study if they are: a) unable to understand the consent/assent process and provide written informed consent; b) currently enrolled in another research study addressing HIV/STIs/PrEP.
Other
- AGYW will be excluded from the study if they do not have a FC to participate in the study.
- AGYW and FC must agree to participate as a dyad. AGYW refusal will supersede FC consent.
Who the study is looking for
- female;
- 15-19 years-old;
- residing in Klipfontein/Mitchells Plain (K/MP);
- speak isiXhosa or English or a combination of these languages;
- willing to have biometric data collected.
- 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;
- willing to have biometric data collected.
Age in the registry: 15 years to 19 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Desmond Tutu Health Foundation Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.