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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins Bloomberg School of Public Health
Study ID
NCT06703060
Status
Recruiting
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Conditions

  • HIV Prevention
  • Intimate Partner Violence (IPV)
  • PrEP
  • Women

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group (Peer Navigation)
    Participants randomized to this arm will receive 4 weekly group sessions and 4 one-on-one sessions with a peer navigator
  • Placebo Comparator: Control Group
    Participants randomized to this group will receive a single group session

Primary Outcome Measure

PrEP initiation [ Time Frame: Post baseline up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bloomberg School of Public HealthBaltimoreMaryland21205
Principal Investigator
[email protected]
410-614-2686

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By research site
Johns Hopkins Bloomberg School of Public Health· Baltimore, MD

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