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

NCT06703060 | Recruiting DMC

• 2 other identifiers: IRB00018632R01MD019178
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PrEP adherence

  2-months post-randomization, 4-months post-randomization, and 6-months post-randomization

Study Arms (2)

Intervention Group (Peer Navigation)

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

Participants randomized to this group will receive a single group session

Behavioral: Peer Navigation Group

Interventions

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.

Control Group; Intervention Group (Peer Navigation)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender Black women (Black women who were born with female genital and also identify as women)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• non-English speaking and
• currently living with HIV

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

RECRUITING

Study Officials

• Tiara C. Willie, PhD, MA

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiara C. Willie, PhD, MA

CONTACT

410-614-2686; twillie2@jhu.edu

Project Director, DrPH

CONTACT

jmassie4@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 25, 2024
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)