Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
Longitudinal Randomized Controlled Study of Modified Directly Observed HAART in Mozambique
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.
Status | Completed |
Enrollment | 350 |
Est. completion date | June 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - HIV+ persons initiating HAART - Adults and children over the age of 18 - Reside in or around Beira Mozambique - Willing and able to provide consent to participate Exclusion Criteria: - Physically or mental incapable to make daily clinic visits - Psychotic or demented |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mozambique | Beira Day Hosptial - Central Hospital | Beira | Sofala |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Mozambique Ministry of Health, United States President's Emergency Plan for AIDS Relief |
Mozambique,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-report - 7 & 30 day recall | at 6 months and 12 months | ||
Secondary | Change in CD4 count | from baseline to 6 months and 12 months |
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