Adherence, Medication, PrEP Uptake, Stimulant Abuse
Conditions
Keywords
PrEP, Adherence, Risk Reduction, Stimulant Use
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPepped on PrEP Package
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.
Sponsors
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will be blind to the participant's assigned intervention.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: 18 years or older 2. Sex: assigned male sex at birth 3. Self-reports having sex with another man in the past month while using stimulants 4. Self-reports behavioral risk for HIV infection (consistent with the Center for Disease Control guidelines) for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the preceding six months) 5. Not currently prescribed PrEP at initial visit 6. Able to speak and understand English (for consenting and counseling) 7. Lives in New England
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Uptake | Baseline Stage 2 | \>80% of participants who complete Stage 1 baseline and report PrEP initiation (verified by prescription) will progress to Stage 2 Baseline. |
| Improve rate of PrEP adherence | Daily beginning at Stage 2 Baseline up to the four month assessment visit | Wisepill electronic pill dispenser will monitor when the pill dispenser is opened to measure medication adherence . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduce Unsafe Sex | Baseline Stage 1,Baseline Stage 2 and four month assessment | Self report sexual history to assess for change in sexual risk. |
| Reduce Stimulant Use | Baseline Stage 1,Baseline Stage 2 and four month assessment | Self report stimulant use to assess for change in drug use. |
Countries
United States
Outcome results
None listed