Contingency Management (CM) for Pre-Exposure Prophylaxis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami School of Medicine, Miami, FLPre-Exposure Prophylaxis+2 MoreContingency Management (CM) - Behavioral
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial is testing whether a combination of two methods, contingency management and motivational interviewing, can help stimulant-using men who have sex with men enter into and continue PrEP care.

Eligible Conditions
  • Pre-Exposure Prophylaxis
  • Substance Use Disorder
  • Human Immunodeficiency Virus (HIV) Infection

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Prize-Based Contingency Management
2
Oral Lenacapavir (LEN)
2
PrEPsteps

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 6 Months

6 Months
Filling a prescription for PrEP
Self-reported PrEP clinical evaluation by a medical provider
6 months
Self-reported condomless insertive anal intercourse (CIAI)
Self-reported condomless receptive anal intercourse (CRAI)
Self-reported stimulant use severity

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Prize-Based Contingency Management
3
Oral Lenacapavir (LEN)
3
PrEPsteps

Side Effects for

Phase 2: DC Plus CM Only
10%Suicidal Ideation
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02896712) in the Phase 2: DC Plus CM Only ARM group. Side effects include: Suicidal Ideation with 10%.

Trial Design

4 Treatment Groups

MI+CM
1 of 4
Motivational Interviewing (MI) - Only
1 of 4
Contingency Management (CM) - Only
1 of 4
CM+MI
1 of 4

Experimental Treatment

70 Total Participants · 4 Treatment Groups

Primary Treatment: Contingency Management (CM) · No Placebo Group · N/A

MI+CMExperimental Group · 2 Interventions: Contingency Management (CM), Motivational Interviewing (MI) · Intervention Types: Behavioral, Behavioral
Motivational Interviewing (MI) - Only
Behavioral
Experimental Group · 1 Intervention: Motivational Interviewing (MI) · Intervention Types: Behavioral
Contingency Management (CM) - Only
Behavioral
Experimental Group · 1 Intervention: Contingency Management (CM) · Intervention Types: Behavioral
CM+MIExperimental Group · 2 Interventions: Contingency Management (CM), Motivational Interviewing (MI) · Intervention Types: Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contingency Management (CM)
2016
Completed Phase 2
~350
Motivational Interviewing (MI)
2010
Completed Phase 3
~2550

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

University of MiamiLead Sponsor
804 Previous Clinical Trials
387,004 Total Patients Enrolled
City University of New YorkOTHER
13 Previous Clinical Trials
4,934 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,269 Previous Clinical Trials
2,032,281 Total Patients Enrolled
Adam W Carrico, PhDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
850 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a sexually active man who identifies as a sexual minority.
You have used drugs that increase energy and alertness in the past three months.
References

Frequently Asked Questions

What is the scale of enrollment for this research project?

"Affirmative. Clinicaltrials.gov confirms that this study, first posted on October 16th 2020, is actively seeking participants for enrollment. A total of 70 people need to be recruited from 1 clinical site." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies available to participants in this research program?

"As obvious from clinicaltrials.gov, this trial is presently trying to find eligible applicants. It was originally published on October 16th 2020 and the most recent iteration of it occurred on October 13th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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