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New program boosts PrEP adherence in Stimulant-Using men

NCT ID NCT04899024

Prevention Sponsor: Florida International University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a program called PARTI to help gay and bisexual men who use stimulants (like meth or cocaine) take their daily HIV prevention pill (PrEP) consistently. The program combined positive affect skills training with a smartphone-based reward system for taking PrEP. Researchers enrolled 239 men across multiple sites to see if this approach reduced HIV risk by improving medication adherence and reducing risky sex.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral intervention (PARTI: positive affect skills training plus contingency management)
What this could lead to
If successful, this approach could help high-risk men better adhere to PrEP and reduce new HIV infections.
What could go wrong
This is a completed behavioral study, not a drug trial. Results may not apply to all populations, and adherence improvements may not last long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

239 people

The number who actually took part.

Started

Jan 2022

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Assigned male at birth * Identifies as male * Age 18 or older * Reads and speaks English * Reports condomless anal sex (CAS) with men in the past 6 months * self-reported HIV negative * Active prescription for daily oral PrEP for at least 2 months and reports any non-adherence in the past month OR initiated daily oral PrEP in the past 2 months, regardless of self-reported adherence * 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; total score of 4 or more) OR reports using stimulants at least weekly in the past 3 months. * Lives in California or Florida with no plans to move out of state in the next 6 months Exclusion Criteria: * Unable or unwilling to provide informed consent * Unwilling to upload upload 3 video recordings of directly observed PrEP doses using a smartphone application * Identifies as transfeminine (e.g., transgender woman) * Unable or Unwilling to provide dried blood spot (DBS) specimen at baseline * Switched from daily oral PrEP with disoproxil fumarate (TDF) to daily oral PrEP with tenofovir alafenamide (TAF) in the past 5 months

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Conditions

The condition(s) this trial relates to.

Medication Adherence HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV prevention Medication adherence Stimulant use

Contacts and locations

Locations

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

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