Safe Spaces 4 Sexual Health (SS4SH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Prevention; HIV Risk Behavior; HIV Counseling and Testing
• Intervention / Treatment: Other: Healthcare counseling service

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Huettner; Phone Number: 410 302 2103; Email: shuettn1@jhmi.edu
• Study Contact Backup: Name: Errol Fields, MD, PhD, MPH; Phone Number: 14105028317; Email: errol.fields@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins
      • Contact: Research Program Manager; Phone Number: 410-302-2103; Email: shuettn1@jhmi.edu
      • Contact: Senior Research Program Coordinator; Phone Number: 413-636-7746; Email: gnewton3@jh.edu
    • Baltimore, Maryland, United States, 21287
      • Not yet recruiting
      • Johns Hopkins School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Healthcare counseling service; Using peer health navigators to support linkage to HIV prevention and treatment resources among Black MSM in online spaces following mobile testing.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of adding care linkage assessed by retention rate	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.	6 weeks
Acceptability as assessed by participant satisfaction	A satisfaction rate of 75% or greater will be used as the acceptability threshold.	6 weeks
Acceptability as assessed by number of participants with intent to repeat use of SS4SH	Acceptability will be measured as intention for repeat use of SS4SH testing/care linkage modality.	6 weeks
Effectiveness as assessed by the number of Black MSM linked to HIV/PrEP	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.	30 days
Effectiveness as assessed by number of Black MSM lost to followup	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.	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Errol L Fields, MD, PhD, MPH, Johns Hopkins University

Publications and helpful links

General Publications

• Fields EL, Thornton N, Huettner S, Schumacher C, Barrow G, Greenbaum A, Jennings JM. Safe Spaces 4 Sexual Health: A Status-Neutral, Mobile Van, HIV/STI Testing Intervention Using Online Outreach to Reach MSM at High Risk for HIV Acquisition or Transmission. J Acquir Immune Defic Syndr. 2022 Jul 1;90(S1):S84-S89. doi: 10.1097/QAI.0000000000002968.
• Rosenberg ES, Millett GA, Sullivan PS, Del Rio C, Curran JW. Understanding the HIV disparities between black and white men who have sex with men in the USA using the HIV care continuum: a modeling study. Lancet HIV. 2014 Dec;1(3):e112-e118. doi: 10.1016/S2352-3018(14)00011-3.
• Oster AM, Wiegand RE, Sionean C, Miles IJ, Thomas PE, Melendez-Morales L, Le BC, Millett GA. Understanding disparities in HIV infection between black and white MSM in the United States. AIDS. 2011 May 15;25(8):1103-12. doi: 10.1097/QAD.0b013e3283471efa.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: August 18, 2025
• First Posted (Actual): August 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: peer health navigator; geosocial networking application; peer health coach; hiv mobile testing; black msm; online spaces; linkage to HIV treatment; linkage to HIV prevention
• Other Study ID Numbers: IRB00442069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No