PrEP Readiness Interventions for Supporting Motivation (PRISM)
Study Details
Study Description
Brief Summary
The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men (MSM) into the pre-exposure prophylaxis (PrEP) care continuum.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
In Stage 1, participants will be randomized to receive either: 1) three months of CM; or 2) two sessions of MI. All participants will be assessed at three months post-randomization for non-response. In Stage 2, a second randomization where non-responders (i.e., those who have not filled a PrEP prescription) are assigned to: 1) Switch to sequentially receive the other intervention (i.e., CM+MI or MI+CM); or 2) Continue with assessments only (i.e., CM-Only or MI-Only). All participants will complete a final assessment at 6 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Contingency Management (CM) - Only CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription. |
Behavioral: Contingency Management (CM)
CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.
|
| Experimental: Motivational Interviewing (MI) - Only Two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered. |
Behavioral: Motivational Interviewing (MI)
Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.
|
| Experimental: CM+MI CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription. Participants who do not fill a PrEP prescription at 3 months will then receive 2 sessions of MI. |
Behavioral: Motivational Interviewing (MI)
Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.
Behavioral: Contingency Management (CM)
CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.
|
| Experimental: MI+CM Two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered. Participants who do not fill a PrEP prescription at 3 months will receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription. |
Behavioral: Motivational Interviewing (MI)
Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.
Behavioral: Contingency Management (CM)
CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.
|
Outcome Measures
Primary Outcome Measures
- Filling a prescription for PrEP [6 Months]
The proportion of participants who provide evidence that they have filled a PrEP prescription
Secondary Outcome Measures
- Self-reported PrEP clinical evaluation by a medical provider [6 Months]
The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP.
- Self-reported stimulant use severity [6 months]
Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores indexing the severity of cocaine and amphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).
- Self-reported condomless receptive anal intercourse (CRAI) [6 months]
Participants will complete a detailed behavioral assessment to report the number of men with whom they have had CRAI. The proportion of participants reporting any CRAI will be reported.
- Self-reported condomless insertive anal intercourse (CIAI) [6 months]
Participants will complete a detailed behavioral assessment to report the number of men with whom they have had CIAI. The proportion of participants reporting any CIAI will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
At least 18 years of age
-
Sexually active cisgender sexual minority man
-
Reports using stimulants in the past three months
-
HIV-negative serostatus
-
Meets Centers for Disease Control and Prevention (CDC) criteria for PrEP eligibility
Exclusion Criteria:
-
Currently prescribed PrEP
-
Unable to provide informed consent
-
Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami School of Medicine | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
- City University of New York
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Adam W Carrico, PhD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20180823
- R34DA046367