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Completed

NCT Number: NCT03137342

Pepped on Pre-exposure Prophylaxis (PrEP): A Counseling and Problem-Solving PrEP Adherence Intervention for Stimulant Using Men Who Have Sex With Men (MSM).

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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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Brown University School of Public Health

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 years or older
  • Sex: assigned male sex at birth
  • Self-reports having sex with another man in the past month while using stimulants
  • 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)
  • Not currently prescribed PrEP at initial visit
  • Able to speak and understand English (for consenting and counseling)
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. PrEP Uptake

    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.

  2. Improve rate of PrEP adherence

    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 .

  3. Improve rate of PrEP adherence

    Time frame: Baseline Stage 2 and four month assessment

    Self report adherence to assess for change in adherence.

Secondary outcomes

  1. Reduce Unsafe Sex

    Time frame: Baseline Stage 1,Baseline Stage 2 and four month assessment

    Self report sexual history to assess for change in sexual risk.

  2. Reduce Stimulant Use

    Time frame: Baseline Stage 1,Baseline Stage 2 and four month assessment

    Self report stimulant use to assess for change in drug use.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study title

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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 2, 2017
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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