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NCT Number: NCT06703060

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

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.

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Key information

Conditions

HIV Prevention Intimate Partner Violence (IPV) PreP Women

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

[email protected]

410-614-2686

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Navigation Group

Behavioral

Participants randomized to the intervention will receive behavioral lifestyle education on topics related to biomedical HIV prevention. This will include 4 group sessions and 4 one-on-one sessions with a peer navigator.

Primary outcomes

  1. PrEP initiation

    Time frame: Post baseline up to 6 months

    Self-report of oral or injectable PrEP (Cabotegravir). Assessed from date of the most recent prescription.

Secondary outcomes

  1. PrEP adherence

    Time frame: 2-months post-randomization, 4-months post-randomization, and 6-months post-randomization

    Biological assess of tenofovir (TFV) levels in client's urine

Study contacts

Contact information is provided by the study sponsor or research team.

Project Director, DrPH

CONTACT

[email protected]

Tiara C. Willie, PhD, MA

CONTACT

[email protected]

410-614-2686

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Trauma-Informed HIV Prevention for Black Women in Baltimore

Acronym: MATCH

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 25, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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