CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 212 enrolled
Drug / intervention
Daily oral PrEP +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04664998
NCT04664998Phase 4Completed

Alignment of PrEP Use With HIV Risk in Young Women and Men

University of Washington·interventional·Posted Dec 11, 2020·Updated Jun 17, 2025

In Brief

A Phase 4 clinical trial evaluating Daily oral PrEP for Pre-Exposure Prophylaxis and 2 related conditions. Completed, enrolled 212 participants across 1 site.

Detailed Summary

Oral pre-exposure prophylaxis (PrEP) is a recommended component of combination HIV prevention and its availability is rising through demonstration projects and full-scale national programs. In sub-Saharan Africa, young women are a priority population for HIV prevention and targeted to initiate PrEP, given their high HIV incidence rates and promising success from a strategy that can be used without the engagement of male partners. A key question in the field is whether young women using PrEP have ongoing HIV risk and adhere to PrEP sufficiently to have protection from HIV when they have condomless sex with HIV-infected partners. The only true way to know whether a heterosexual woman is sexually exposed to HIV or has a partner with high HIV risk is to test for HIV and STIs in her male partner(s) and quantify HIV viral levels, if any are detected. Yet engaging men in clinic-based HIV testing is challenging. More recent efforts have focused on using HIV self-testing kits to respond to demands on men's time and reluctance to seeking preventive healthcare. The availability of PrEP also provides a new incentive for men to test. By leveraging an ongoing study of bone health with concurrent use of PrEP and injectable DMPA (often known as Depo Provera® or depot medroxyprogesterone acetate), we have opportunity to engage a new cohort of young men and objectively measure HIV and common STIs in these young men and link the results to women's use of PrEP. The primary objective of this study is to determine whether young women's adherence to PrEP aligns with the HIV status and risk of their male partners. To address its primary objectives, this study will leverage: 1) an ongoing study among young women and 2) a novel cohort of young men who are current sexual partners of the young women in the ongoing study to objectively measure PrEP use, HIV, and HIV factors related to HIV risk. This study will provide a framework for understanding how and when young women and men decide to take PrEP, estimate the proportion of women that are benefitting from HIV protection when they have male partners with or at high risk of acquiring HIV, and provide a novel opportunity to engage young men in PrEP delivery and as supporters of women's PrEP use.

Study Details

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedDec 11, 2020
Enrollment StartMay 1, 2018
Primary CompletionDec 10, 2023
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 5.6 years ago

Interventions

Daily oral PrEPdrug

All participants will be offered daily oral PrEP at each visit

Daily oral PrEPdrug

All participants will be offered daily oral PrEP at each visit.