Recruiting

HIV PrEP

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT06703060

Conditions

HIV Prevention

PrEP

Women

Intimate Partner Violence (IPV)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Peer Navigation Group

Study Details

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)

Study ID

NCT06703060

Start date

Feb 28, 2025

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

placebo comparator: Control Group

Participants randomized to this group will receive a single group session

Interventions

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.

Primary outcome measure

  • PrEP initiation [ Time Frame: Post baseline up to 6 months ]

Central Contacts and Locations

Central contacts

Tiara C. Willie, PhD, MA

410-614-2686twillie2@jhu.edu

Project Director, DrPH

jmassie4@jhu.edu

Locations

Johns Hopkins Bloomberg School of Public Health

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Principal Investigator

410-614-2686twillie2@jhu.edu

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-03-23.