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

Trauma-Informed HIV Prevention for Black Women in Baltimore

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06703060
Acronym
MATCH
Enrollment
300
Registered
2024-11-25
Start date
2025-02-28
Completion date
2028-02-01
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Prevention, Intimate Partner Violence (IPV), PrEP, Women

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.

Interventions

BEHAVIORALPeer 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.

Sponsors

Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PrEP initiationPost baseline up to 6 monthsSelf-report of oral or injectable PrEP (Cabotegravir). Assessed from date of the most recent prescription.

Secondary

MeasureTime frameDescription
PrEP adherence2-months post-randomization, 4-months post-randomization, and 6-months post-randomizationBiological assess of tenofovir (TFV) levels in client's urine

Countries

United States

Contacts

CONTACTTiara C. Willie, PhD, MA
twillie2@jhu.edu410-614-2686
CONTACTProject Director, DrPH
jmassie4@jhu.edu
PRINCIPAL_INVESTIGATORTiara C. Willie, PhD, MA

Johns Hopkins Bloomberg School of Public Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026