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Modified Directly Observed Therapy for Improving Antiretroviral Therapy Adherence in People With HIV

NCT00339092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-04-19

No results posted yet for this study

Summary

This study will evaluate the effectiveness of a modified directly observed therapy program in increasing antiretroviral therapy adherence in poor, HIV-infected residents of urban communities.

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

Modified Directly Observed Therapy

Treatment includes storefront modified directly observed therapy (MDOT) of prescribed antiretrovirals. Participants in the MDOT program will report to the study site each morning for 3 months, Monday through Friday, to take their HIV medication and any other medications prescribed by their primary care doctors. At the end of 3 months, participants will no longer attend the study site for medication assistance. Participants will then attend Action Point, a county program that helps participants adhere to taking medication, for an additional 3 months.

BEHAVIORAL

Standard Care

Participants assigned to standard care will report to the study site once a month for 9 months, but will not receive any assistance with taking HIV medications. Information about medication adherence, housing, income, use of health services, drug use, sexual practices, and mental health services will be collected at each visit.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • David R. Bangsberg, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2008-04-30
Completion
2008-04-30

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 NCT00339092 on ClinicalTrials.gov