Health TrialsbyHealthPanel

PrEP Readiness Interventions for Sustained Motivation (PRISM)

ConditionsHIVMethamphetamine Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida International University

About this trial

This is a hybrid type I randomized controlled trial to test the effectiveness of contingency management (CM) alone versus CM with motivational interviewing (MI) for optimizing entry or re-entry into the HIV prevention or care continua. A total of 400 participants will be randomized to CM (n = 200) or MI+CM (n = 200), all delivered via telehealth. Monthly follow-up assessments will be completed over 12 months to examine effectiveness MI+CM for the primary outcome - filling a pre-exposure prophylaxis (PrEP) or anti-retroviral therapy (ART) prescription (verified using a digital photo). Secondary outcomes will include: self-reported PrEP or ART clinical evaluation by a provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Assigned male a birth

Self-reported methamphetamine use in the past 3 months

HIV-negative or unknown serostatus at baseline

Disqualifiers

Unwilling or unable to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Motivational Interviewing (MI)

    Behavioral

    This telehealth MI intervention seeks to increase intrinsic motivation and self-efficacy for starting or restarting PrEP in session one. Session two focuses on concomitant risk behaviors such as substance use and CAS.

  • Contingency Management (CM)

    Behavioral

    Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Contingency ManagementExperimental treatment 1 intervention
Group B: MI+CMExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of Participants with Verified PrEP or ART Use

The proportion of participants providing evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of medication from a medical record)

Time frame
12 Months

Secondary outcomes

1

Median Time to Verified PrEP or ART Use

The number of days after randomization until evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of medication from a medical record).

Time frame
12 Months
2

Clinical Cut Points for Self-Reported Methamphetamine Use Severity

Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores for the severity of amphetamine and other substance use (Mild = 0-3; Moderate = 4-26; Severe = 27+).

Time frame
12 Months
3

Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS)

Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS in the past 3 months. Changes in the mean number of insertive CAS partners will be examined.

Time frame
12 Months
4

Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS)

Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS in the past 3 months. Changes in the mean number of receptive CAS partners will be examined.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida International University

Lead sponsor

Source ClinicalTrials.gov
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