Safe Spaces 4 Sexual Health

Not Applicable

Recruiting

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

• Registration Number: NCT07133555
• Lead Sponsor: Johns Hopkins University

Brief Summary

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 Baltimore City) 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.

Detailed 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 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.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-10
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Primary Completion: 2025-12
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• not male-self identified individual

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of adding care linkage assessed by retention rate	6 weeks	Feasibility of adding care linkage will be measured based on the retention rate during follow-up period of Arm A participants in need of PrEP/HIV care linkage. Retention rate of 75% will be used as a feasibility threshold. Linkage is defined as completing a PrEP/HIV care related medical visit within 30 days of enrollment.
Acceptability as assessed by participant satisfaction	6 weeks	A satisfaction rate of 75% or greater will be used as the acceptability threshold.
Acceptability as assessed by number of participants with intent to repeat use of SS4SH	6 weeks	Acceptability will be measured as intention for repeat use of SS4SH testing/care linkage modality.
Effectiveness as assessed by the number of Black MSM linked to HIV/PrEP	30 days	Preliminary data on effectiveness will be assessed by number of Black MSM linked to HIV care and PrEP within 30 days of enrollment. Linkage is defined as completing a PrEP/HIV care related medical visit.
Effectiveness as assessed by number of Black MSM lost to followup	30 days	Preliminary data on Effectiveness assessed by number of Black MSM lost to follow up. Linkage is defined as completing a PrEP/HIV care related medical visit.

Secondary Outcome Measures

Name	Time	Method
Reach/awareness of the geotargeted advertisement campaign assessed by cost per 1,000 impressions (CPM)	12 weeks	Defined by impressions, cost per 1,000 impressions (CPM)
Website traffic of the geotargeted advertisement campaign assessed by cost per click (CPC)	12 weeks	Defined by clicks, cost per click (CPC)
Cost per action conversion rate of the geotargeted advertisement campaign	12 weeks	Actions will include website actions (view schedule, scheduling appointments) and van actions (HIV/STI testing)

Trial Locations

Locations (2)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States