Safe Spaces 4 Sexual Health (SS4SH)

Johns Hopkins University

Status: Enrolling

Conditions: HIV Risk Behavior; HIV Prevention; HIV Counseling and Testing

Treatments: Other: Healthcare counseling service

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07133555

IRB00442069

Details and patient eligibility

About

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.

Full description

In the SS4SH pilot study, utilizing a data-driven approach in partnership with the local health department, the investigators analyzed local public health surveillance data to identify online sex partner meeting spaces frequently reported by (majority Black) MSM newly diagnosed with HIV and/or syphilis. The identified online spaces were used to advertise mobile van HIV/STI testing for MSM > 18 years of age and less than 49 years of age over a 14-month period. The strategy and advertisements were informed by a community advisory board (CAB) of MSM hosted at a local Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ) community-based organization to ensure local relevance, acceptability and feasibility.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male
• 18-49 years of age
• Ability to read and speak English
• Baltimore area resident
• Report sex with a male in the past 12 months

Exclusion criteria

• not male-self identified individual

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention group receiving peer health navigation follow-up

Experimental group

Description:

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.

Treatment:

Other: Healthcare counseling service

Control group receiving standard of care referral

No Intervention group

Description:

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.