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Pre-exposure Prophylaxis Adherence Intervention for MSM

NCT01632397 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2016-02-09

No results posted yet for this study

Summary

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.

Conditions

  • Medication Adherence

Interventions

BEHAVIORAL

CBT-based counseling

Cognitive Behavior Therapy for PrEP adherence

BEHAVIORAL

Health education and supportive counseling

Time matched general supportive therapy of the type commonly available from community therapists.

Sponsors & Collaborators

  • Fenway Community Health

    lead OTHER

Principal Investigators

  • Kenneth Mayer, MD · Fenway Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01632397 on ClinicalTrials.gov