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| ID | Type | Description | Link |
|---|---|---|---|
| 5R00DA053158-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP). The study is a pilot randomized controlled trial to evaluate the adaptation, feasibility, acceptability, and preliminary efficacy of a behavioral intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention-Control condition | Other | Participants randomized to the control condition will have six 1-on-1 sessions with a facilitator engaging in writing exercises. The sessions will be comparable in length to the intervention sessions but will not include any skills practice. Each session will include a neutral writing exercises. |
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| Experimental condition | Experimental | Participants randomized to the experimental condition (tailored behavioral intervention) will have a 1-on-1 session with a facilitator. The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. The intervention will be led by a CITI certified facilitator, who is also a member of the study team. The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks; (3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Positive Affect Intervention | Behavioral | The intervention consists of six individually delivered sessions (1-2 sessions per week, approximately 1.5 hours each). The intervention will be interactive and include rapport- and trust-building activities; didactic teaching; multimedia (e.g., videos) messages to facilitate modeling and discussion; role-playing and skills building, practice, and feedback. T The sessions are: (1) Positive affect skills; (2) Positive Conscious Networks broaden and building supportive personal networks;(3) Mindfulness; (4) Personal Strengths and Obtainable Goals; (5) Positive Reassessment; and (6) Compassion/solidarity to one-self as to others. Sessions/modules will be guided by Segmented Assimilation and Stress and Coping Theory. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of PrEP uptake | Changes in number of participants obtaining prescription to begin PrEP. Measured through documented evidence of an active prescription for PrEP. | From enrollment to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulant use (self-report) | Changes in the severity of participant stimulant use as measured by the Alcohol, Smoking, and Substance Involvement Screen Test (ASSIST) composite scores for cocaine and amphetamine-type stimulants. | Enrollment to 6 months |
| Condomless Anal Sex (CAS) |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender men
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Colon-Burgos, DrPH | Contact | (352) 273-9188 | jcolonburgos@phhp.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jose Colon-Burgos, DrPH | University of Florida | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, New Jersey: Lawrence Earlbaum Associates; 1988. | ||
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| Background | Molenberghs G, Verbeke G. Models for Discrete Longituidnal Data. New York: Springer- Verlag; 2005. | ||
| 20667681 |
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De-identified datasets from the study will be shared.
12 months after completion of the study
Data will be accessible via UF data repository
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| Contingency Management | Behavioral | Incentives will be provided as positive reinforcement of two key behaviors that are crucial to increase PrEP uptake. First, participants will receive incentives for documented evidence that they have completed a medical visit for PrEP clinical evaluation (including HIV testing). Second, participants completing PrEP clinical evaluation will receive incentives when they document evidence of an active prescription of PrEP. |
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Changes in the number of CAS partners who are not taking PrEP or virally suppressed. |
| From enrollment to 6 months |
| Social Network Composition | Changes in the number of social network alters who use stimulants and increases in the number of social network alters who are taking PrEP. | From enrollment to 6 months |
| Background |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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