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Improving HIV Prevention Among Adolescent Girls and Young Women (AGYW) in Uganda

NCT05516602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2025-01-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Peer Support

Peer-led support groups over the weekend will include the following activities: * Peer leader counselling on oral PrEP and HIV risk reduction * Peer leader discussion to dispel myths and misconceptions around oral PrEP * Peer leader sharing of experiences of daily pill taking * Participants sharing experiences of influencers and barriers to oral PrEP uptake and adherence followed by a discussion by group members. * 1-2 role plays per support group session.

Sponsors & Collaborators

  • Uganda Virus Research Institute (UVRI)

    collaborator UNKNOWN

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Karolinska Institutet

    collaborator OTHER

  • MRC/UVRI and LSHTM Uganda Research Unit

    lead OTHER

Principal Investigators

  • Yunia Mayanja · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2024-06-11
Completion
2024-06-11

Countries

  • Uganda

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05516602 on ClinicalTrials.gov