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Safe Spaces 4 Sexual Health

Expanding Safe Spaces 4 Sexual Health, a Mobile Van HIV/STI Testing and Care Linkage Strategy, for MSM in Online Spaces

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07133555
Acronym
SS4SH
Enrollment
100
Registered
2025-08-21
Start date
2025-08-10
Completion date
2026-06-30
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Counseling and Testing, HIV Prevention, HIV Risk Behavior

Keywords

geosocial networking application, peer health coach, peer health navigator, hiv mobile testing, black msm, online spaces, linkage to HIV treatment, linkage to HIV prevention

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 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.

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 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.

Interventions

OTHERHealthcare counseling service

Using peer health navigators to support linkage to HIV prevention and treatment resources among Black MSM in online spaces following mobile testing.

Sponsors

Johns Hopkins University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of adding care linkage assessed by retention rate6 weeksFeasibility 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 satisfaction6 weeksA 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 SS4SH6 weeksAcceptability 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/PrEP30 daysPreliminary 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 followup30 daysPreliminary 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

MeasureTime frameDescription
Reach/awareness of the geotargeted advertisement campaign assessed by cost per 1,000 impressions (CPM)12 weeksDefined by impressions, cost per 1,000 impressions (CPM)
Website traffic of the geotargeted advertisement campaign assessed by cost per click (CPC)12 weeksDefined by clicks, cost per click (CPC)
Cost per action conversion rate of the geotargeted advertisement campaign12 weeksActions will include website actions (view schedule, scheduling appointments) and van actions (HIV/STI testing)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORErrol L Fields, MD, PhD, MPH

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026