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Phase 4 N=212 Prevention

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

Pre-Exposure Prophylaxis · Sexually Transmitted Diseases, Bacterial · HIV Infections

Enrolled (actual)
212
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Visits With PrEP Dispensation to Female Study Participants Reporting Sexual Behaviors or STI Symptoms — 211 Visits

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Daily oral PrEP (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
University of Washington
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Visits With PrEP Dispensation to Female Study Participants Reporting Sexual Behaviors or STI Symptoms
211
PRIMARY
Visits With PrEP Dispensation to Male Study Participants Reporting Sexual Behaviors or STI Symptoms
151

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.

Eligibility Criteria

Inclusion Criteria

  • Men ages ≥18
  • Has a female sexual partner enrolled in the Kampala Women's Bone Study
  • Willing and able to provide informed consent

Exclusion Criteria

  • Has any other condition that would preclude the ability to provide informed consent, make study participation unsafe, complicate the interpretation of study findings or otherwise interfere with achievement of the study objectives, in the investigator's discretion.

Eligibility for women:

Inclusion criteria

  • Participating in the Kampala Women's Bone Study
  • Willing to talk with male sex partners about the new study for men and refer men for study recruitment

Exclusion criteria

  • Has concerns about potential social harm stemming from anticipated conversations with male sex partners about the new study for men such that study staff would discourage the women from participation
  • Investigator discretion
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04664998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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