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Effectiveness of Enhanced Counseling and Observed Therapy on Antiretroviral Adherence in People With HIV

NCT00602758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2016-05-20

No results posted yet for this study

Summary

This study will compare the effectiveness of enhanced counseling alone versus enhanced counseling combined with observed therapy at improving medication adherence in people with HIV.

Conditions

  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Interventions

BEHAVIORAL

Motivational interviewing with cognitive behavioral therapy

Counseling sessions are completed face-to-face or by telephone at baseline and Weeks 1, 2, 4, 6, 9, 11, 15, 19, and 23. Counselors are trained in motivational interview technique and focus on ART medication adherence.

BEHAVIORAL

Modified directly observed therapy

From baseline to Week 16, Monday through Friday, study staff meet the participants daily to observe one dose of their ART and to leave with the participants all other doses needed until the next observed dose. The frequency of observed doses begins to taper at Week 17 through to Week 24.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Missouri, Kansas City

    lead OTHER

Principal Investigators

  • Kathy Goggin, PhD · University of Missouri, Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2009-08-31
Completion
2009-08-31

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 NCT00602758 on ClinicalTrials.gov