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Recruiting NCT06703060

NCT06703060 A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women

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Clinical Trial Summary
NCT ID NCT06703060
Status Recruiting
Phase
Sponsor Johns Hopkins Bloomberg School of Public Health
Condition HIV Prevention
Study Type INTERVENTIONAL
Enrollment 300 participants
Start Date 2025-02-28
Primary Completion 2027-12

Trial Parameters

Condition HIV Prevention
Sponsor Johns Hopkins Bloomberg School of Public Health
Study Type INTERVENTIONAL
Phase N/A
Enrollment 300
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-02-28
Completion 2027-12
Interventions
Peer Navigation Group

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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.

Eligibility Criteria

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

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