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Medication AdherencePARTINCT04899024

PrEP Affect Regulation Treatment Innovation

A study testing PARTI and Contingency Management for PrEP Adherence in people with Medication Adherence and HIV Prevention, run by Florida International University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
What is being tested?
PARTI and Contingency Management for PrEP Adherence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
239 participants
Where
2 sitesUnited States
Study dates
31 Jan 2022to 1 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants

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.

Being tested
PARTI, Attention-Control, Contingency Management for PrEP Adherence
Keywords
Sexual Minority Men, HIV, PrEP Adherence, Contingency Management
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PARTIBehavioural

    PARTI will provide positive affect skills. Each 1-hour session delivered via Zoom consists of a didactic portion with in vivo skills practice and participants are asked to complete home practice of the skills between sessions. Many sessions include formal exercises that have been utilized in Mindfulness-Based Relapse Prevention to cultivate mindfulness and meta-cognitive awareness.

  • Attention-ControlBehavioural

    Attention-Control will provide a core set of coping and affect measures as well as neutral writing exercises. Each 1-hour attention-control session will be administered via Zoom.

  • Contingency Management for PrEP AdherenceBehavioural

    Participants will complete a 12-week contingency management protocol via their smartphone that consists of uploading brief videos taking PrEP medications up to four times per week. Total possible contingency management incentive for completing 48 observed PrEP doses is $360.

Study groups in NCT04899024
Study groupRoleWhat they receive
PARTI and CM (Contingency Management)ExperimentalThe PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence
Receives: Behavioral: PARTI; Behavioral: Contingency Management for PrEP Adherence
Attention-Control and CM (Contingency Management)Active comparatorThe attention-control condition will consist of five individual sessions where participants complete self-report measures and neutral writing exercises during a 12-week contingency management protocol for PrEP adherence
Receives: Behavioral: Attention-Control; Behavioral: Contingency Management for PrEP Adherence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Engaging HIV Acquisition Risk

    Percentage of participants engaging in HIV acquisition risk (i.e., defined as tenofovir - diphosphate levels from dried blood spots that are indicative of less than four oral PrEP doses per week AND any self-reported recent condomless anal sex)

    Measured: Up to 12 months

Secondary outcomes (5)

  1. PrEP Persistence

    Percentage of participants who continue taking PrEP medication

    Measured: Up to 12 months

  2. Retention in PrEP Care

    Percentage of participants who report attending a medical visit with the PrEP provider in the past three months

    Measured: Up to 12 months

  3. Self-Reported Stimulant Use Severity

    The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) provides validated composite scores indexing the severity of cocaine and amphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).

    Measured: Up to 12 months

  4. Positive Affect

    Mean positive affect score as measured by the modified Differential Emotions Scale (Range 0-104) with higher scores being indicative of higher positive affect.

    Measured: Up to 12 months

  5. PrEP Self-Efficacy

    A 10-item self-reported measure where higher scores (Range = 9-90) reflect greater perceived self-efficacy for managing PrEP.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2021
  2. Study start31 Jan 2022
  3. Primary completion1 Feb 2026
  4. Study completion1 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04899024
Sponsor's protocol ID
20200231
Other IDs
R01DA051848
Acronym
PARTI
Status last verified
May 2026
First submitted
7 May 2021
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Valentin OR, Henderson C, Coffin LS, Paredes-Gotamco J, Olem D, Farrales W, Neilands TB, Dilworth SE, Doblecki-Lewis S, Page K, Moskowitz JT, Anderson PL, Johnson MO, Carrico AW. Positive psychological intervention to reduce HIV acquisition risk with men who use stimulants: protocol for a randomised controlled trial. BMJ Open. 2026 May 11;16(5):e120232. doi: 10.1136/bmjopen-2026-120232.

    PubMed 42114867

Questions about this trial

What is this clinical trial studying?

A study testing PARTI and Contingency Management for PrEP Adherence in people with Medication Adherence and HIV Prevention, run by Florida International University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Engaging HIV Acquisition Risk (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04899024, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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