What is this study trying to find out about HIV prevention in Black women?

This study is evaluating a trauma-informed approach to increase the initiation of HIV pre-exposure prophylaxis (PrEP) among Black women in Baltimore. Researchers want to understand if group and peer navigation sessions can improve PrEP start rates despite challenges like intimate partner violence. The study is led by the Johns Hopkins Bloomberg School of Public Health and focuses on addressing HIV disparities in this group.

Who may be eligible for this HIV prevention clinical trial?

Adults 18 years and older who self-identify as Black cisgender women, report HIV-negative status, and have had unprotected vaginal or anal sex with a male partner in the past 6 months may be eligible. Participants must also have at least one substantial HIV risk factor and never have taken PrEP. Please review eligibility criteria for more details.

Is there any cost to participate in this HIV prevention clinical trial?

Study-related care, including the study sessions and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

FEMALE

ID06703060

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

Research Sites

8 weeks

Total Duration

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

Age: 18Years +

FEMALE

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

Research Team

Tiara C. Willie, PhD, MA

Project Director, DrPH

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