A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJohns Hopkins Bloomberg School of Public Health

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Peer Navigation Group

    Behavioral

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Intervention Group (Peer Navigation)Experimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

PrEP initiation

Self-report of oral or injectable PrEP (Cabotegravir). Assessed from date of the most recent prescription.

Time frame
Post baseline up to 6 months

Secondary outcomes

1

PrEP adherence

Biological assess of tenofovir (TFV) levels in client's urine

Time frame
2-months post-randomization, 4-months post-randomization, and 6-months post-randomization

Other outcomes

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