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

Trauma-Informed HIV Prevention for Black Women in Baltimore

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.

Study Overview

• Status: Recruiting
• Conditions: PrEP; HIV Prevention; Women; Intimate Partner Violence (IPV)
• Intervention / Treatment: Behavioral: Peer Navigation Group

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiara C. Willie, PhD, MA; Phone Number: 410-614-2686; Email: twillie2@jhu.edu
• Study Contact Backup: Name: Project Director, DrPH; Email: jmassie4@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins Bloomberg School of Public Health
      • Contact: Principal Investigator; Phone Number: 410-614-2686; Email: twillie2@jhu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (Peer Navigation); Participants randomized to this arm will receive 4 weekly group sessions and 4 one-on-one sessions with a peer navigator	Behavioral: Peer Navigation Group; 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.
Placebo Comparator: Control Group; Participants randomized to this group will receive a single group session	Behavioral: Peer Navigation Group; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Tiara C. Willie, PhD, MA, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB00018632; R01MD019178 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy, confidentiality, and ethical considerations. Protecting personal information is essential to comply with privacy laws (e.g., HIPAA) and the terms of informed consent. Sharing such data could breach confidentiality agreements and potentially expose sensitive information, even if anonymized. Additionally, there are concerns about data security, misuse, and the potential harm to participants, which researchers must carefully consider.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No