Pre-exposure Prophylaxis Adherence Intervention for MSM (PrEPare)

February 8, 2016 updated by: Kenneth H. Mayer, MD, Fenway Community Health

Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM

Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • The Fenway Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male sex at birth
  • being 18 years old or older
  • testing HIV-negative at screening
  • evidence of high risk for HIV acquisition defined by having unprotected anal sex (insertive or receptive) with an HIV-positive male partner OR at least a total of three episodes of unprotected anal sex with at least two partners in the last three months
  • medically cleared to take the study drug (ambulatory performance >=60 on Karnofsky scale, adequate renal function, negative glucose and protein in urine, adequate hepatic function, adequate hematologic function)
  • able to understand and speak English (for consenting and counseling).

Exclusion Criteria:

  • participants who are not able to consent due to psychiatric or cognitive concerns
  • those who have already been prescribed PrEP
  • having a history of or current medical conditions that would preclude taking the study drug (e.g., previously diagnosed active and serious infections, acute or chronic hepatitis B, history of pathological bone fractures not related to trauma)
  • receiving ongoing therapy with ART, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion, or other investigational agents
  • receiving or possibly receiving antiretroviral drugs for an anti-HIV vaccine in a clinical trial
  • active alcohol or drug use that would interfere with study participation
  • having other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CBT-based counseling
Cognitive behavioral based intervention to promote PrEP adherence.
Behavioral: CBT-based counseling
Cognitive Behavior Therapy for PrEP adherence
ACTIVE_COMPARATOR: Health education and supportive counseling
Time matched supportive counseling
Behavioral: Health education and supportive counseling
Time matched general supportive therapy of the type commonly available from community therapists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to PrEP over time
Time Frame: At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months)
This is primarily a feasiblity pilot RCT. However, the primary eventual endpoint is PrEP adherence measured daily via electronic medication adherence monitoring (Wisepill™).
At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Risk Compensation
Time Frame: At each of the 9 study visits spread over up to six months.
This is primarily a feasiblity RCT. Sexual risk compensation is defined as a potential change in sexual risk taking behaviors (unprotected anal sex). This is measured daily with text message assessments for sexual risk as well as at each study visit with self-report measure(s).
At each of the 9 study visits spread over up to six months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fenway Community Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (ESTIMATE)

July 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R34MH095584-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Medication Adherence

Clinical Trials on CBT-based counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe