About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
non-English speaking and
currently living with HIV
Trial design
Parallel
Treatments tested in this trial
Peer Navigation Group
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
PrEP initiation
Self-report of oral or injectable PrEP (Cabotegravir). Assessed from date of the most recent prescription.
Secondary outcomes
PrEP adherence
Biological assess of tenofovir (TFV) levels in client's urine
Sponsors and contacts
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Johns Hopkins Bloomberg School of Public Health
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator