A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women

Not Applicable

Recruiting

• Conditions: HIV Prevention; PrEP; Women; Intimate Partner Violence (IPV)

• Registration Number: NCT06703060
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-22
• Study First Posted: 2024-11-25
• Study Start: 2025-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2027-12
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• self-identified Black cisgender woman;
• self-reported HIV-negative status, and
• ≥18 years.
• reports unprotected vaginal or anal sex in the past 6 months with a male sexual partner,
• have at least one substantial HIV risk factor in the past 6 months according to the 2021 Centers for Disease Control (CDC) PrEP Eligibility Guidelines (i.e., HIV-positive sexual partner, recent bacterial Sexually Transmitted Disease (STD), 2+ sex partners, history of inconsistent or no condom use, commercial sex work, and residing in high HIV prevalence area or network), and
• never taken PrEP

Exclusion Criteria

• non-English speaking and
• currently living with HIV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PrEP initiation	Post baseline up to 6 months	Self-report of oral or injectable PrEP (Cabotegravir). Assessed from date of the most recent prescription.

Secondary Outcome Measures

Name	Time	Method
PrEP adherence	2-months post-randomization, 4-months post-randomization, and 6-months post-randomization	Biological assess of tenofovir (TFV) levels in client's urine

Trial Locations

Locations (1)

Johns Hopkins Bloomberg School of Public Health; 🇺🇸 Baltimore, Maryland, United States