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

Johns Hopkins Bloomberg School of Public Health

Status: Enrolling

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

Treatments: Behavioral: Peer Navigation Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06703060

R01MD019178 (U.S. NIH Grant/Contract)

IRB00018632

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Intervention Group (Peer Navigation)

Experimental group

Description:

Participants randomized to this arm will receive 4 weekly group sessions and 4 one-on-one sessions with a peer navigator

Treatment:

Behavioral: Peer Navigation Group

Control Group

Placebo Comparator group

Description:

Participants randomized to this group will receive a single group session

Treatment:

Behavioral: Peer Navigation Group