Safe Spaces 4 Sexual Health

NCT07133555 | Recruiting

• 1 other identifier: IRB00442069
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Counseling and Testing; HIV Risk Behavior; HIV Prevention

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

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

  12 weeks

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

  12 weeks

• Cost per action conversion rate of the geotargeted advertisement campaign

  12 weeks

Study Arms (2)

Intervention group receiving peer health navigation follow-up

EXPERIMENTAL

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

Control group receiving standard of care referral

NO INTERVENTION

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.

Interventions

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.

Intervention group receiving peer health navigation follow-up

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Male self-identified individuals are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• not male-self identified individual

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 35703759 BACKGROUND

• 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.

  PMID: 25530987 BACKGROUND

• 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.

  PMID: 21505305 BACKGROUND

Study Officials

• Errol L Fields, MD, PhD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Huettner

CONTACT

410 302 2103; shuettn1@jhmi.edu

Errol Fields, MD, PhD, MPH

CONTACT

14105028317; errol.fields@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 21, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)