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Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA) approach that aims to re-engage participants in safe but pleasurable activities in life and addresses stimulant-abuse as well as associated factors including depression, as barriers to optimal PrEP adherence.
Enrolled participants will receive a referral to the Miriam Hospital for standard of care PrEP treatment. Once prescribed PrEP through the Miriam Hospital, the study participants will be randomly assigned to one of two treatment conditions. In the intervention condition, participants will receive a two-stepped intervention which could include up to 10 free BA and risk reduction (RR) counseling sessions. Participants assigned to the comparison condition will receive the standard of care for PrEP treatment at the Miriam Hospital, which includes information about PrEP and how to obtain it, assistance from medical staff in obtaining health insurance for study participants, and information regarding local community resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pepped on PrEP | Experimental | Using an efficient stepped care ("adaptive") model, all participants will receive three sessions of PrEP-STEPS counseling for PrEP adherence delivered by a Masters-level or above therapist. Some individuals may require a more intensive approach. These participants will receive an additional seven counseling sessions of behavioral activation with integrated cognitive behavioral therapy (CBT) designed to reduce stimulant use and promote positive behaviors. |
|
| Standard of Care | No Intervention | PrEP adherence counseling from the Miriam Hospital PrEP Clinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pepped on PrEP Package | Behavioral | A counseling and problem-solving adherence intervention with a Behavioral Activation approach to re-engage participants in safe but pleasurable activities in life and addresses stimulant abuse as well as associated factors, including depression, as barriers to optimal PrEP adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Uptake | >80% of participants who complete Stage 1 baseline and report PrEP initiation (verified by prescription) will progress to Stage 2 Baseline. | Baseline Stage 2 |
| Improve rate of PrEP adherence | Wisepill electronic pill dispenser will monitor when the pill dispenser is opened to measure medication adherence . | Daily beginning at Stage 2 Baseline up to the four month assessment visit |
| Improve rate of PrEP adherence | Self report adherence to assess for change in adherence. | Baseline Stage 2 and four month assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce Unsafe Sex | Self report sexual history to assess for change in sexual risk. | Baseline Stage 1,Baseline Stage 2 and four month assessment |
| Reduce Stimulant Use | Self report stimulant use to assess for change in drug use. |
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Inclusion Criteria:
Exclusion Criteria:
1.) Potential participants unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate.
Men who have sex with men and report stimulant use at screening
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Mimiaga, ScD, MPH | Brown University, School of Public Health, Center for Health Equity Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University School of Public Health | Providence | Rhode Island | 02903 | United States |
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Intervention Condition: Pepped-for-PrEP intervention counseling plus standard of care adherence counseling as part of their PrEP related care via The Miriam Hospital Control Condition: only the standard of care adherence counseling as part of their PrEP related care via The Miriam Hospital.
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Outcome assessor will be blind to the participant's assigned intervention.
|
| Baseline Stage 1,Baseline Stage 2 and four month assessment |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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