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

NCT04664998 | Completed Phase 4 Results DMC

• 2 other identifiers: STUDY00008057R21HD098923
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

HIV acquisition; HIV risk; PrEP adherence

Outcome Measures

Primary Outcomes (2)

• Visits With PrEP Dispensation to Female Study Participants Reporting Sexual Behaviors or STI Symptoms

  Percentage of visits when PrEP was dispensed to female study participants at a visit when they self-reported sexual behaviors indicating potential HIV exposure (condomless sex, multiple sexual partners, Y-chromosome detection) or STI symptoms

  Six months of study participation

• Visits With PrEP Dispensation to Male Study Participants Reporting Sexual Behaviors or STI Symptoms

  Percentage of visits when PrEP was dispensed to male study participants at a visit when they self-reported sexual behaviors indicating potential HIV exposure (condomless sex, multiple sexual partners) or STI symptoms

  Six months

Study Arms (2)

Male participants

ACTIVE COMPARATOR

Male participants whose partners are enrolled in the parent study (Kampala Women's Bone study). All male participants will undergo the same study procedures at each visit, such as HIV and STI testing, and urine tenofovir testing if on PrEP.

Drug: Daily oral PrEP

Female participants

ACTIVE COMPARATOR

Female participants from the parent study (Kampala Women's Bone study) will be enrolled to recruit their male sexual partner(s). All female participants will receive HIV testing, STI testing, and urine tenofovir testing (if on PrEP) at quarterly visits.

Drug: Daily oral PrEP

Interventions

Daily oral PrEP DRUG

All participants will be offered daily oral PrEP at each visit

Female participants; Male participants

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• University of Washington: lead
• Makerere University: collaborator
• MU-JHU CARE: collaborator
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Infectious Disease Institute

Kampala, Uganda

Location

Related Publications (1)

• Wu L, Ssebuliba T, Muwonge TR, Bambia F, Stein G, Nampewo O, Sapiri O, Goetz BJ, Penrose KJ, Parikh UM, Mujugira A, Heffron R. Alignment of PrEP Use With Potential HIV Exposure in Young Women and Men in Uganda. J Acquir Immune Defic Syndr. 2025 Apr 1;98(4):326-333. doi: 10.1097/QAI.0000000000003573. Epub 2025 Feb 19.

  PMID: 39630076 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases, Bacterial; HIV Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Renee Heffron
• Organization: University of Washington

rheffron@uw.edu

2065203817

Study Officials

• Renee Heffron, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Official Title: Associate Professor, Global Health and Epidemiology Affiliation: University of Washington

Model Details: The two groups are male participants enrolled in the Align study, and their sexual partners enrolled in the parent study, Kampala Women's Bone study.

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 11, 2020
• Study Start: May 1, 2018
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)