PrEP Affect Regulation Treatment Innovation (PARTI)

  • End date
    Jul 1, 2026
  • participants needed
  • sponsor
    University of Miami
Updated on 27 May 2022
Accepts healthy volunteers


This multi-site randomized controlled trial enrolling sexual minority men who use stimulants and are currently taking pre-exposure prophylaxis (PrEP). This randomized controlled trial will test the efficacy of a PrEP Affect Regulation Treatment Innovation (PARTI) condition comprised of a 5-session positive affect intervention delivered during smartphone-based Contingency Management (CM) for directly observed PrEP doses (PARTI+CM) compared to an attention-control condition delivered during CM. The primary outcome is HIV acquisition risk measured using a combination of tenofovir-diphosphate levels in dried blood spots that are indicative of sub-optimal adherence to PrEP and recent condomless anal sex.

Condition Medication Adherence, HIV Prevention, Stimulant Use
Treatment Attention-Control, PARTI, Contingency Management for PrEP Adherence
Clinical Study IdentifierNCT04899024
SponsorUniversity of Miami
Last Modified on27 May 2022


Yes No Not Sure

Inclusion Criteria

Assigned male at birth
Identifies as male
Age 18 or older
Reads and speaks English
Past 6 months, reports condomless anal sex (CAS) with men
HIV negative
Currently has an active prescription for daily oral PrEP and reports any non-adherence in the past month
Has an iPhone or Android smartphone
Screens positive for a moderate or severe stimulant use disorder with an abbreviated version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Lives within catchment area (South Florida, San Francisco Bay area)

Exclusion Criteria

Unable to provide informed consent
Unwilling to participate in smartphone-based CM for directly observed PrEP doses
Unwilling to provide dried blood spot (DBS) specimen
Plans to move out of the state in the next 6 months
Not taking PrEP daily (e.g., if taking intermittent 2-1-1 dosing)
Switched from Truvada to Descovy in the last 5 months
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note