Brown University School of Public Health
Providence, Rhode Island, 02903, United States
NCT Number: NCT03137342
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.
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Notify Me18 year and older
Male
Interventional
Not applicable
Providence, Rhode Island, 02903, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
Time frame: Baseline Stage 2
>80% of participants who complete Stage 1 baseline and report PrEP initiation (verified by prescription) will progress to Stage 2 Baseline.
Time frame: 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 .
Time frame: Baseline Stage 2 and four month assessment
Self report adherence to assess for change in adherence.
Time frame: Baseline Stage 1,Baseline Stage 2 and four month assessment
Self report sexual history to assess for change in sexual risk.
Time frame: Baseline Stage 1,Baseline Stage 2 and four month assessment
Self report stimulant use to assess for change in drug use.
Brown University
Other
Pepped on Pre-exposure Prophylaxis (PrEP): Pilot-randomized Controlled Trial (RCT) to Assess the Feasibility/Acceptability of the Pepped-for-PrEP Package (Counseling and Problem-solving PrEP Adherence Intervention With Behavioral Activation (BA) Approach) Among Stimulant Abusing MSM.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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