Safe Spaces 4 Sexual Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-49
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male
18-49 years of age
Ability to read and speak English
Baltimore area resident
Disqualifiers
not male-self identified individual
Trial design
Design model
Parallel
Treatments tested in this trial
Healthcare counseling service
Other interventionUsing peer health navigators to support linkage to HIV prevention and treatment resources among Black MSM in online spaces following mobile testing.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Intervention group receiving peer health navigation follow-upExperimental treatment 1 intervention
Group B: Control group receiving standard of care referralNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 weeks2
Acceptability as assessed by participant satisfaction
A satisfaction rate of 75% or greater will be used as the acceptability threshold.
Time frame
6 weeks3
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.
Time frame
6 weeks4
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.
Time frame
30 daysSecondary outcomes
1
Reach/awareness of the geotargeted advertisement campaign assessed by cost per 1,000 impressions (CPM)
Defined by impressions, cost per 1,000 impressions (CPM)
Time frame
12 weeks2
Website traffic of the geotargeted advertisement campaign assessed by cost per click (CPC)
Defined by clicks, cost per click (CPC)
Time frame
12 weeks3
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)
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov