A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peer Navigation Group.
- Who it may be relevant to
- Registry conditions: HIV Prevention, PrEP, Women, Intimate Partner Violence (IPV). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Trauma-Informed HIV Prevention for Black Women in Baltimore
Overview
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
- Behavioral 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 measures
- PrEP initiation [Time frame: Post baseline up to 6 months]
Secondary outcome measures (1)
- PrEP adherence [Time frame: 2-months post-randomization, 4-months post-randomization, and 6-months post-randomization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Johns Hopkins Bloomberg School of Public Health — Baltimore
Identifiers
NCT: NCT06703060 · IRB00018632 · R01MD019178