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Longitudinal Study of HAART, Social Networks, & Adherence

NCT00272220 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2007-11-07

No results posted yet for this study

Summary

Our study is a randomized controlled trial that aims to evaluate the effectiveness of modified directly observed therapy (mDOT) to (1) increase both short and long term adherence to HAART treatment, and (2) improve clinical outcomes associated with HAART therapy.

Our hypothesis is that modified directly observed therapy (mDOT) during the initial 6 weeks of HAART, supervised primarily by HIV-positive lay activists, will improve adherence and clinical outcomes compared with those that do not have supervised mDOT. We also hypothesize that the benefits of mDOT will be achieved through a variety of mediators that will result from the social interactions the patients will have with the activists. These mediators include improved social support, improved knowledge about HAART, reduced stigma, and improved self-efficacy.

Conditions

  • Acquired Immunodeficiency Syndrome

Interventions

BEHAVIORAL

modified directly observed therapy (mDOT)

Peers individually administered the 6-week mDOT intervention at the Beira Day Clinic to mDOT participants during their morning weekday dose. Evening and weekend doses were not observed. Nighttime and weekend doses were self-administered. As part of the daily interaction with participants, peers provided social support, information about the benefits and side effects of HAART, how to address stigma's effect on adherence, and encouragement to participate in community support groups. The peers also provided an important link between the individual and other members of the HIV clinic team and the community.

Sponsors & Collaborators

  • Mozambique Ministry of Health

    collaborator UNKNOWN

  • United States President's Emergency Plan for AIDS Relief

    collaborator FED

  • University of Washington

    lead OTHER

Principal Investigators

  • Cynthia R Pearson, PhD(C) · University of Washington

  • Stephen Gloyd, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Completion
2006-06-30

Countries

  • Mozambique

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 NCT00272220 on ClinicalTrials.gov