Actively Recruiting

Phase Not Applicable
Age: 15Years - 24Years
FEMALE
Healthy Volunteers
NCT07002866

Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda

Led by Washington University School of Medicine · Updated on 2025-11-05

600

Participants Needed

2

Research Sites

219 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

M

Makerere University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The study will employ a multilevel combination intervention focused on PrEP initiation and adherence among adolescent girls and young women (AGYW) (aged 15-24) living in HIV hotpots in Uganda. Specifically, the study will combine: 1) HIV risk reduction (HIVRR) that incorporates sessions on PrEP, 2) Peer Supporters (PS) with lived experiences taking PrEP to facilitate linkage to and continued care, share strategies to address misconceptions, manage disclosure and stigma, and model positive lifestyles while engaging in care services, and 3) an economic empowerment (EE) component that includes a matched savings account and financial literacy targeting poverty and financial barriers associated with PrEP access. Working within 30 health care systems, we will randomly assign 600 AGYW (at the community level) to one of three study arms (n=200 AGYW, n=10 sites per arm): 1) HIVRR only, 2) HIVRR+ PS, or 3) HIVRR + PS + EE. The interventions will be implemented for 20 months, and data collected at baseline, 12, 24, 36 months.

CONDITIONS

Official Title

Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda

Who Can Participate

Age: 15Years - 24Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 15-24 years
  • At high risk of HIV by reporting at least one of the following in the past six or twelve months: vaginal/anal sex with multiple partners of unknown HIV status, sex without a condom, sex for money/goods/services, injecting drugs, multiple STI diagnoses, post-exposure prophylaxis for HIV, or having an HIV-positive partner not on ART
Not Eligible

You will not qualify if you...

  • HIV positive
  • Unable to understand study procedures or participant rights during consent
  • Unwilling or unable to complete the study

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Washington University in St. Louis

St Louis, Missouri, United States, 63130

Active, Not Recruiting

2

International Center for Child Health and Development (ICHAD)

Masaka, Uganda

Actively Recruiting

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Research Team

F

Fred M Ssewamala, PhD

CONTACT

P

Proscovia Nabunya

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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