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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04205487
Other study ID # 20180823
Secondary ID R34DA046367
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2020
Est. completion date July 28, 2023

Study information

Verified date October 2023
Source Florida International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date July 28, 2023
Est. primary completion date July 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Motivational Interviewing (MI)
Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.
Contingency Management (CM)
CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.

Locations

Country Name City State
United States University of Miami School of Medicine Miami Florida

Sponsors (3)

Lead Sponsor Collaborator
Florida International University City University of New York, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Filling a prescription for PrEP The proportion of participants who provide evidence that they have filled a PrEP prescription 6 Months
Secondary Self-reported PrEP clinical evaluation by a medical provider The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP. 6 Months
Secondary Self-reported stimulant use severity 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). 6 months
Secondary Self-reported condomless receptive anal sex (Receptive CAS) Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS. The proportion of participants reporting any receptive CAS will be reported. 6 months
Secondary Self-reported condomless insertive anal sex (Insertive CAS) Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS. The proportion of participants reporting any insertive CAS will be reported. 6 months
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