HIV Counseling and TestingSS4SHNCT07133555
Safe Spaces 4 Sexual Health
A study testing Healthcare counseling service in people with HIV Counseling and Testing and HIV Risk Behavior, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Counseling and Testing, HIV Risk Behavior, HIV Prevention
- What is being tested?
- Healthcare counseling service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- not male-self identified individual
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Johns Hopkins
Baltimore, Maryland, 21287
About this study
Official title: 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.
Read the 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.
- Being tested
- Healthcare counseling service
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthcare counseling serviceOther
Using peer health navigators to support linkage to HIV prevention and treatment resources among Black MSM in online spaces following mobile testing.
| Study group | Role | What they receive |
|---|---|---|
| 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. 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Acceptability as assessed by participant satisfaction
A satisfaction rate of 75% or greater will be used as the acceptability threshold.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Secondary outcomes (3)
Reach/awareness of the geotargeted advertisement campaign assessed by cost per 1,000 impressions (CPM)
Defined by impressions, cost per 1,000 impressions (CPM)
Measured: 12 weeks
Website traffic of the geotargeted advertisement campaign assessed by cost per click (CPC)
Defined by clicks, cost per click (CPC)
Measured: 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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start10 Aug 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV Counseling and TestingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Errol L Fields, MD, PhD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133555
- Sponsor's protocol ID
- IRB00442069
- Acronym
- SS4SH
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35703759Rosenberg 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.
PubMed 25530987Oster 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.
PubMed 21505305
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Safe Spaces 4 Sexual Health, a Mobile Van HIV/STI Testing and Care Linkage Strategy, for MSM in Online Spaces
- ClinicalTrials.gov ID
- NCT07133555
- Acronym / sponsor ID
- SS4SH / IRB00442069
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group receiving peer health navigation follow-up | Experimental | Other: Healthcare counseling serviceParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- not male-self identified individual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthcare counseling serviceUsing peer health navigators to support linkage to HIV prevention and treatment resources among Black MSM in online spaces following mobile testing. | Other | Intervention group receiving peer health navigation follow-up |
Primary outcome
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.
Acceptability as assessed by participant satisfaction
Time frame: 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
Time frame: 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
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.
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.
3 secondary outcomes
Reach/awareness of the geotargeted advertisement campaign assessed by cost per 1,000 impressions (CPM)
Time frame: 12 weeks
Website traffic of the geotargeted advertisement campaign assessed by cost per click (CPC)
Time frame: 12 weeks
Cost per action conversion rate of the geotargeted advertisement campaign
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 35703759Fields 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.
- Background: PubMed 25530987Rosenberg 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.
- Background: PubMed 21505305Oster 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Errol L Fields, MD, PhD, MPH principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthcare counseling service in people with HIV Counseling and Testing and HIV Risk Behavior, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of adding care linkage assessed by retention rate (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07133555, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.