NCT05516602Completed
Improving HIV Prevention Among Adolescent Girls and Young Women (AGYW) in Uganda
Source: ClinicalTrials.gov · Last updated 16 Jan 2025
Brief summary (registry, in English)
Purpose: The purpose of the project is to evaluate a peer support intervention aimed at improving uptake of and adherence to oral PrEP. Main Study Aim: To evaluate a peer support intervention aimed at improving uptake of and adherence to oral pre-exposure prophylaxis (PrEP), and its effect on sexual behavioral and reproductive health outcomes Study Objectives: i. To evaluate the effect of a peer support intervention on uptake of and adherence to oral PrEP among 14-24-year-old AGYW at risk of HIV infection in Kampala, Uganda. ii. To evaluate the effect of the peer support intervention aimed at improving oral PrEP uptake and adherence, on sexual behavior and reproductive health outcomes among AGYW in Kampala, Uganda. Design An individually randomized controlled trial with parallel group design and 1:1 randomization in the intervention and control arms. Population: 14-24-year old AGYW at risk of HIV infection in Kampala. Control arm: Standard health worker counselling during clinic visits. Intervention arm: Standard health worker counselling during clinic visits + peer support groups over the weekend.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 394 (actual)
- First submitted
- 23 Aug 2022
- Start date
- Jan 2023
- Primary completion date
- Jun 2024
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Diseases
- HIV
- NCT number
- NCT05516602
What you commit to
- Study type: Interventional
- Participants enrolled: 394
- From Jan 2023 to the primary completion date, Jun 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.
Prior treatment
- Currently taking oral PrEP
Other illness
- HIV infection
- Known allergy to common medications, components of oral PrEP or contraceptives
- An acute or chronic illness that may affect volunteer participation or achieving study objectives
- A condition or situation that in the opinion of the PI/designee would preclude provision of informed consent, or otherwise interfere with achieving the study objectives
Other
- Pregnant
Who the study is looking for
- HIV negative (assessed through rapid blood test)
- Sexually active in the past 3 months
- 14-24 years
- Hepatitis B negative for those who initiate oral PrEP
- Willing to undergo study procedures
Age in the registry: 14 years to 24 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 |
|---|---|---|---|
| MRC/UVRI and LSHTM Coordinator of this site? Confirm its status | Entebbe | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.