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Completed

NCT Number: NCT07133555

Safe Spaces 4 Sexual Health

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.

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Key information

Conditions

HIV Counseling and Testing HIV Prevention HIV Risk Behavior

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of adding care linkage assessed by retention rate

    Time frame: 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.

  2. Acceptability as assessed by participant satisfaction

    Time frame: 6 weeks

    A satisfaction rate of 75% or greater will be used as the acceptability threshold.

  3. Acceptability as assessed by number of participants with intent to repeat use of SS4SH

    Time frame: 6 weeks

    Acceptability will be measured as intention for repeat use of SS4SH testing/care linkage modality.

  4. Effectiveness as assessed by the number of Black MSM linked to HIV/PrEP

    Time frame: 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.

  5. Effectiveness as assessed by number of Black MSM lost to followup

    Time frame: 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 outcomes

  1. Reach/awareness of the geotargeted advertisement campaign assessed by cost per 1,000 impressions (CPM)

    Time frame: 12 weeks

    Defined by impressions, cost per 1,000 impressions (CPM)

  2. Website traffic of the geotargeted advertisement campaign assessed by cost per click (CPC)

    Time frame: 12 weeks

    Defined by clicks, cost per click (CPC)

  3. Cost per action conversion rate of the geotargeted advertisement campaign

    Time frame: 12 weeks

    Actions will include website actions (view schedule, scheduling appointments) and van actions (HIV/STI testing)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: SS4SH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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