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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA051848 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PARTI and CM (Contingency Management) | Experimental | The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence |
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| Attention-Control and CM (Contingency Management) | Active Comparator | The 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PARTI | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Persistence | Percentage of participants who continue taking PrEP medication | Up to 12 months |
| Retention in PrEP Care | Percentage of participants who report attending a medical visit with the PrEP provider in the past three months |
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Inclusion Criteria:
Exclusion Criteria:
Assigned male at birth and identifies as male.
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| Name | Affiliation | Role |
|---|---|---|
| Adam W Carrico, PhD | Florida International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| University of Miami Miller School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42114867 | Derived | 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. |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Attention-Control | Behavioral | 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. |
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| Contingency Management for PrEP Adherence | Behavioral | 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. |
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| Up to 12 months |
| 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). | Up to 12 months |
| 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. | Up to 12 months |
| PrEP Self-Efficacy | A 10-item self-reported measure where higher scores (Range = 9-90) reflect greater perceived self-efficacy for managing PrEP. | Up to 12 months |
| Miami |
| Florida |
| 33136 |
| United States |
| D001519 | Behavior |