PrEP Intervention in Prince George's County, Maryland
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorGeorge Mason University
About this trial
The goal of the proposed research is to design a peer-based community intervention focused on addressing HIV stigma, and peer support to increase PrEP initiation in Prince George's County, MD. Participants will attend intervention events focused on stigma reduction and building community. Researchers will compare intervention and control group participants to see if there in a difference in PrEP initiation and adherence.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male
Black
HIV-negative
18 years of age or older
Disqualifiers
HIV Positive
Refusal of HIV testing
Trial design
Design model
Parallel
Treatments tested in this trial
MPowerment PrEP Promotion Intervention
BehavioralIn-person events will focus on five specific goals: Fostering a sense of community acceptance and social connection, promoting self-acceptance of sexual identity, teaching skills for navigating healthcare, reducing PrEP stigma, and providing education on HIV risk. In accordance with the MPowerment model, In collaboration with the PI, the core group and volunteers would lead the development, implementation, and evaluation of all intervention events. Both peer leaders and the primary investigator will collaborate to develop specific events ("M-Groups"), guided by the findings in both the quantitative and qualitative studies. M-Groups will be held once every month. Events will be 2 hour activities focused on the aforementioned goals.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: MPowerment PrEP Promotion InterventionExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants with a PreP prescription within one month of intervention completion.
This is the number of participants who receive an initial prescription for Pre-exposure prophylaxis. Investigators will refer individuals participating in the intervention for PrEP use. Those who provide either a PrEP prescription, or a PrEP bottle with their prescription information, will be considered as initiating PrEP use.
Time frame
Within 1 month of intervention completion.2
Number of participants with a positive blood spot test for PrEP 6 months following the intervention.
6 months following the intervention completion, investigators will mail a blood spot collection kit to participants, with return postage. When mailed back, investigators will test the dried blood spots for the presence of PrEP using a chemistry analyzer. Those who test positive will be considered as "PrEP adherent".
Time frame
6 months post-intervention.Sponsors and contacts
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Source ClinicalTrials.gov