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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA046367 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| City University of New York | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men (MSM) into the pre-exposure prophylaxis (PrEP) care continuum.
In Stage 1, participants will be randomized to receive either: 1) three months of CM; or 2) two sessions of MI. All participants will be assessed at three months post-randomization for non-response. In Stage 2, a second randomization where non-responders (i.e., those who have not filled a PrEP prescription) are assigned to: 1) Switch to sequentially receive the other intervention (i.e., CM+MI or MI+CM); or 2) Continue with assessments only (i.e., CM-Only or MI-Only). All participants will complete a final assessment at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contingency Management (CM) - Only (Non-Responder) | Experimental | Non-responders to CM financial inancial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 1 that were randomized to assessments only in Stage 2. |
|
| Motivational Interviewing (MI) - Only (Non-Responder) | Experimental | Non-responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use in Stage 1 that were randomized to assessments only in Stage 2 |
|
| CM+MI | Experimental | Non-responders CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 1 that were randomized to receive two sessions of MI in Stage 2. |
|
| MI+CM | Experimental | Non-responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use in Stage 1 that were randomized to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 2. |
|
| CM-Only (Responder) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing (MI) | Behavioral | Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Filling a Prescription for PrEP | The proportion of participants who provide evidence that they have filled a PrEP prescription | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP. | 6 Months |
| Clinical Cut Points for Self-reported Methamphetamine Use Severity |
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Inclusion Criteria:
Exclusion Criteria:
Male
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| Name | Affiliation | Role |
|---|---|---|
| Adam W Carrico, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami School of Medicine | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39992777 | Derived | Davis Ewart L, Larson ME, Ghanooni D, Verhagen R, Manuel J, McCollister K, Fardone E, DeVries B, Dilworth S, Blackstock M, Doblecki-Lewis S, Nahum-Shani I, Grov C, Carrico AW. Getting to yes: Pilot sequential multiple assignment randomized trial of motivational enhancement interventions targeting preexposure prophylaxis use in sexual minority men who use stimulants. Health Psychol. 2025 Mar;44(3):310-320. doi: 10.1037/hea0001489. | |
| 37831485 | Derived |
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Participants completed a run-in period where they were asked to provide a saliva sample via mail to confirm they were not living with HIV. Those who did not provide a saliva sample or those with reactive HIV results were excluded.
A US national sample of sexual minority men taking pre-exposure prophylaxis (PrEP) who reported using stimulants (i.e., methamphetamine, powder cocaine, or crack-cocaine) in the past three months was recruited from social networking applications and existing consent-to-contact databases.
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| ID | Title | Description |
|---|---|---|
| FG000 | Contingency Management (CM) - Only (Non-Responder or Lost to Follow Up During Stage 1) | Participants randomized in Stage 1 to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription that were non-responders. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during Stage 1 and we not re-randomized during Stage 2. |
| FG001 | Motivational Interviewing (MI) - Only (Non-Responder or Lost to Follow Up During Stage 1) | Participants randomized in Stage 1 two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom.. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during stage 1 and were not re-randomized during Stage 2. |
| FG002 | CM+MI | Sequential delivery of CM(Stage 1) and then MI (Stage 2) for non-responders at the stage-two randomization to "switch." |
| FG003 | MI+CM | Sequential delivery of MI (Stage 1) and then CM (Stage 2) for non-responders at the stage-two randomization to "switch." |
| FG004 | CM-Only (Responder) | Responders randomized to receive CM financial incentives for PrEP clincial evaluation and uptake in Stage 1 who provided evidence of a recent PrEP prescription. |
| FG005 | MI-Only (Responder) | Responders randomized to receive two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Stage Intervention (Months 1-3) |
| |||||||||||||
| Second Stage Intervention (Months 4-6) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CM-Only (Non-Responder) | Participants randomized in Stage 1 to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription that were non-responders. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during Stage 1 and we not re-randomized during stage 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Geometric Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Filling a Prescription for PrEP | The proportion of participants who provide evidence that they have filled a PrEP prescription | Posted | Count of Participants | Participants | 6 Months |
|
Adverse event data were collected for each participant for 6 months.
The AEs and SAEs conformed to standard definitions for clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CM - Non-Responder | Contingency Management (CM): CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription. |
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This was a pilot sequential multiple assignment randomized trial (SMART) of sequentially delivered CM and MI interventions. Only non-responders after three months (i.e., those who had not started or restarted PrEP) were randomized to Switch or Continue with assessments only. Given the sample size and sequential randomization, effect sizes should be interpreted with caution. In fact, the most appropriate purpose of a pilot trial is feasibility and acceptability to guide a more definitive trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam W. Carrico, PhD | Florida International University | 305-348-7887 | acarrico@fiu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Aug 7, 2024 | May 8, 2025 | Prot_ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2024 | Mar 18, 2025 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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Sequential Multiple Assignment Randomized Trial (SMART)
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Respnders to CM financial incentives for CM will include financial incentives for rEP clinical evaluation and filling a PrEP prescription in Stage 1. |
|
| MI-Only (Responder) | Experimental | Responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered in Stage 1. |
|
| Contingency Management (CM) | Behavioral | CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription. |
|
Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores indexing the severity of methamphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater). |
| 6 months |
| Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS. The proportion of participants reporting any receptive CAS will be reported. | 6 months |
| Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS. The proportion of participants reporting any insertive CAS will be reported. | 6 months |
| Davis-Ewart L, Grov C, Verhagen R, Manuel J, Viamonte M, Dilworth S, O'Dell N, Valentin O, Carr S, Cherenack E, Henderson C, Doblecki-Lewis S, Nahum-Shani I, Carrico AW. Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial. JMIR Res Protoc. 2023 Oct 13;12:e48459. doi: 10.2196/48459. |
| 37131755 | Derived | Davis-Ewart L, Grov C, Verhagen R, Manuel J, Viamonte M, Dilworth S, Valentin O, Cherenack EM, Carr S, Doblecki-Lewis S, Nahum-Shani I, Carrico AW. Randomized Controlled Trial of Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants. Res Sq [Preprint]. 2023 Apr 20:rs.3.rs-2787003. doi: 10.21203/rs.3.rs-2787003/v1. |
| 37101251 | Derived | Davis-Ewart L, Lee JY, Viamonte M, Colon-Burgos J, Harkness A, Kanamori M, Duncan DT, Doblecki-Lewis S, Carrico AW, Grov C. "The familiar taste of poison": a qualitative study of multi-level motivations for stimulant use in sexual minority men living in South Florida. Harm Reduct J. 2023 Apr 26;20(1):58. doi: 10.1186/s12954-023-00787-w. |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 |
| MI-Only (Non-Responder) |
Participants randomized in Stage 1 two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during stage 1 and were not re-randomized during stage 2. |
| BG002 | CM+MI (Non-Responder) | Sequential delivery of CM (Stage 1) and MI (Stage 2) for non-responders that were randomized in Stage 2 to "switch." |
| BG003 | MI+CM (Non-Responder) | Sequential delivery of MI (Stage 1) and CM (Stage 2) for non-responders that were randomized in Stage 2 to "switch." |
| BG004 | CM-Only (Responder) | Responders randomized to receive CM financial incentives for PrEP clinical evaluation and uptake in Stage 1 who provided evidence of a recent PrEP prescription. |
| BG005 | MI-Only (Responder) | Responders randomized to receive two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom. |
| BG006 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Annual Income | Annual income in the past year | Count of Participants | Participants | No |
|
| OG002 | CM+MI | Sequential delivery of CM (Stage 1) and MI (Stage 2) for non-responders that were randomized in Stage 2 to "switch." |
| OG003 | MI+CM | Sequential delivery of MI (Stage 1) and CM (Stage 2) for non-responders that were randomized in Stage 2 to "switch." |
| OG004 | CM-Only (Responder) | Randomized in Stage 1 to CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription and provided evidence of a recent PrEP prescription. |
| OG005 | MI-Only (Responder) | Randomized in Stage 1 to two MI sessions focusing on stimulant use, sexual risk, and PrEP use, and provided evidence of a recent PrEP prescription. |
|
|
| Secondary | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP. | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| Secondary | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores indexing the severity of methamphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater). | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS. The proportion of participants reporting any receptive CAS will be reported. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS. The proportion of participants reporting any insertive CAS will be reported. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | MI - Non-Resonder | Motivational Interviewing (MI): Two MI counseling sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | CM+MI | Sequentially delivered CM+MI for non-responders who were randomized at the stage-two randomization to switch to the other condition. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | MI+CM | Sequentially delivered MI+CM for non-responders who were randomized at the stage-two randomization to switch to the other condition. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG004 | CM - Responder | Contingency Management (CM): CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription. These participants responded before Stage 2 randomization. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG005 | MI - Responder | Motivational Interviewing (MI): Two MI counseling sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom. These participants responded before Stage 2 randomization. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| No |
|
| Moderate (4-26) |
|
| Severe (27 or greater) |
|
| No |
|
| No |
|