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This is a hybrid type I randomized controlled trial to test the effectiveness of contingency management (CM) alone versus CM with motivational interviewing (MI) for optimizing entry or re-entry into the HIV prevention or care continua. A total of 400 participants will be randomized to CM (n = 200) or MI+CM (n = 200), all delivered via telehealth. Monthly follow-up assessments will be completed over 12 months to examine effectiveness MI+CM for the primary outcome - filling a pre-exposure prophylaxis (PrEP) or anti-retroviral therapy (ART) prescription (verified using a digital photo). Secondary outcomes will include: self-reported PrEP or ART clinical evaluation by a provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contingency Management | Experimental | Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization. |
|
| MI+CM | Experimental | Two session MI counseling intervention delivered in the three months after randomization with CM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing (MI) | Behavioral | This telehealth MI intervention seeks to increase intrinsic motivation and self-efficacy for starting or restarting PrEP in session one. Session two focuses on concomitant risk behaviors such as substance use and CAS. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with Verified PrEP or ART Use | The proportion of participants providing evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of medication from a medical record) | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Verified PrEP or ART Use | The number of days after randomization until evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of medication from a medical record). | 12 Months |
| Clinical Cut Points for Self-Reported Methamphetamine Use Severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Carrico Professor, PhD | Contact | 305-348-7887 | acarrico@fiu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida International University | Recruiting | Miami | Florida | 33199 | United States |
De-identified data will be uploaded to a secure database after the team completes intent-to-treat analyses of the primary and secondary outcomes.
August 2027 (estimated start date) without an end date
These data will be publicly accessible.
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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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| Contingency Management (CM) | Behavioral | Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization. |
|
Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores for the severity of amphetamine and other substance use (Mild = 0-3; Moderate = 4-26; Severe = 27+). |
| 12 Months |
| Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS) | Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS in the past 3 months. Changes in the mean number of insertive CAS partners will be examined. | 12 Months |
| Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS) | Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS in the past 3 months. Changes in the mean number of receptive CAS partners will be examined. | 12 Months |
| Proportion of Participants with Prevention Effective PrEP or ART Use | Proportion of participants taking daily oral PrEP with tenofovir-diphosphate levels commensurate with at least four doses per week OR HIV viral load < 300 copies/mL from dried blood spot samples | 12 Months |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |