Actively Recruiting
Trauma-Informed HIV Prevention for Black Women in Baltimore
Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2026-03-23
300
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins Bloomberg School of Public Health
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a multilevel trauma-informed approach to increase HIV pre-exposure prophylaxis (PrEP) initiation among Black cisgender women in Baltimore, who are considered a high-risk group for HIV. This study aims to address socio-structural challenges such as intimate partner violence and gendered racism that may limit access to PrEP, focusing on both women with and without experiences of intimate partner violence. The research is sponsored by the Johns Hopkins Bloomberg School of Public Health and involves a randomized design without masking. Participants will be randomly assigned to one of two groups. The intervention group will receive behavioral lifestyle education related to biomedical HIV prevention, consisting of four weekly group sessions and four individual sessions with a peer navigator. The control group will receive a single group session. These sessions aim to increase understanding and uptake of PrEP among eligible Black women. During the study, researchers will monitor PrEP initiation up to six months after baseline and assess adherence at two, four, and six months post-randomization. Participant involvement includes attending scheduled educational sessions and follow-up assessments. The study will track how well participants start and continue PrEP use, with safety and sustainability of the intervention also evaluated. The total study duration extends through February 2028.
CONDITIONS
Brief Title
A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identified Black cisgender woman
- Self-reported HIV-negative status
- 18 years of age or older
- Reports unprotected vaginal or anal sex with a male sexual partner in the past 6 months
- Has at least one substantial HIV risk factor in the past 6 months according to CDC PrEP Eligibility Guidelines (e.g., HIV-positive sexual partner, recent bacterial STD, multiple sex partners, inconsistent or no condom use, commercial sex work, living in high HIV prevalence area or network)
- Never taken PrEP
You will not qualify if you...
- Non-English speaking
- Currently living with HIV
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants randomized to the intervention group receive behavioral lifestyle education through 4 weekly group sessions and 4 one-on-one sessions with a peer navigator. Participants in the control group receive a single group session.
4 weekly group sessions and 4 one-on-one sessions for intervention group; 1 group session for control group
Duration - Up to 6 months post-baseline
Participants are followed to assess PrEP initiation and adherence after the treatment period.
Visits at 2 months, 4 months, and 6 months post-randomization
Trial Site Locations
Total: 1 location
1
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
T
Tiara C. Willie, PhD, MA
P
Project Director, DrPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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