Pre-exposure Prophylaxis (PrEP) for Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University
About this trial
This randomized controlled trial will test the efficacy of "PrEP for Health," a behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in Lawrence and Boston/Cambridge, Massachusetts. The investigators will equally randomize 200 PWID to receive either (a) the "PrEP for Health" intervention condition involving theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation (n=100), or (b) the standard of care condition involving PrEP information and referrals (n=100). Successful PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) will be evaluated. The degree to which intervention efficacy occurs through specific conceptual mediators and differs according to hypothesized moderators will also be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HIV-uninfected (verified by rapid/4th generation test)
Reporting past-month injection of any drugs
One or more HIV risk behaviors (past-month receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner)
Not currently on and never taken PrEP
Disqualifiers
Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment
Living in Massachusetts (MA) for <3 months
Planning to move out of MA within a year
Trial design
Design model
Parallel
Treatments tested in this trial
HIV and PrEP education
Other interventionNavigators will deliver Social Cognitive Theory-informed HIV and PrEP education.
Motivational interviewing
BehavioralBachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.
Problem-solving and planning
BehavioralBachelors-level PrEP Navigators will assist participants with problem-solving and planning.
Patient navigation
BehavioralOngoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites
PrEP information
Other interventionA brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.
Referrals
Other interventionStudy staff will provide basic information about PrEP and referrals to PrEP clinicians.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: PrEP for healthExperimental treatment 5 interventions
Group B: Standard of careActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
PrEP uptake
PrEP uptake will be assessed via medical/pharmacy records
Time frame
3 months2
Post-treatment PrEP adherence
PrEP adherence will be assessed by drug levels in hair samples at the acute follow up time point (3 months post-baseline)
Time frame
3 monthsSecondary outcomes
1
Longer-term PrEP adherence
Longer-term PrEP adherence will be assessed by drug levels in hair samples at 6 and 12-month post-baseline
Time frame
6 and 12 monthsSponsors and contacts
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Brown University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
The Fenway Institute
Collaborator
AIDS Action Committee of Massachusetts
Collaborator
Greater Lawrence Family Health Center
Collaborator
University of California, San Diego
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Source ClinicalTrials.gov