Safe Spaces 4 Sexual Health

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07133555
Status
Recruiting
Apply to this trial

Conditions

  • HIV Counseling and Testing
  • HIV Prevention
  • HIV Risk Behavior

Eligibility Criteria

Sex
MALE
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • Healthcare counseling service — OTHER
    Using peer health navigators to support linkage to HIV prevention and treatment resources among Black MSM in online spaces following mobile testing.

Study Details

In an earlier study, the study team carried out an HIV/Sexually transmitted infection (STI) testing approach which found men who have sex with men (MSM) at-risk of getting or spreading HIV in online spaces and linked them to testing services on a mobile van. The goal of this present study is to add on to this approach by connecting participants (MSM aged 18-49 residing in the Baltimore area) with a peer health navigator to support them with getting pre-exposure prophylaxis (PrEP) or HIV care services after testing. Researchers will compare using a peer health navigator approach to using a referrals-only approach to get PrEP or HIV care services. Participants will be assigned to either Arm A (group that receives peer health navigator help) or Arm B (group that gets referred) to get PrEP or HIV care.

Key Dates

Start date
Aug 10, 2025
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention group receiving peer health navigation follow-up
    Participants randomly assigned to Arm A will receive a navigation/care linkage needs assessment followed by peer navigation once weekly after discussing their test results with the navigator to support their linkage to PrEP or HIV care over a six-week period. Navigators will complete the following care linkage steps: 1) assess interest in linkage, 2) identify preferred clinic for care linkage, and 3) assist with scheduling initial PrEP/HIV provider appointment. Additionally, the investigators will use the qualitative data collected from in-depth interviews (IRB00375934) of Black MSM and key informant interviews of care linkage stakeholders on barriers and facilitators to HIV prevention and care linkage strategies to inform the peer navigation that Arm A receives.
  • No Intervention: Control group receiving standard of care referral
    Participants randomly assigned to Arm B will go through the standard of care referral process to a local community site providing PrEP or HIV care after discussing their test results with a navigator. During this discussion with a navigator, participants will receive information about the PrEP/HIV care sites where the participants can go for services. Six weeks following this initial follow-up, participants will meet virtually with the navigator to complete a PrEP/care linkage status assessment to determine if the participants attended the initial PrEP/HIV provider appointment.

Primary Outcome Measure

Feasibility of adding care linkage assessed by retention rate [ Time Frame: 6 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns HopkinsBaltimoreMaryland21287
Research Program Manager
[email protected]
410-302-2103
Senior Research Program Coordinator
[email protected]
413-636-7746
Johns Hopkins School of MedicineBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins· Baltimore, MDJohns Hopkins School of Medicine· Baltimore, MD

Related Studies