Longitudinal Study of HAART, Social Networks, & Adherence
|ClinicalTrials.gov Identifier: NCT00272220|
Recruitment Status : Completed
First Posted : January 4, 2006
Last Update Posted : November 7, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Acquired Immunodeficiency Syndrome||Behavioral: modified directly observed therapy (mDOT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Longitudinal Randomized Controlled Study of Modified Directly Observed HAART in Mozambique|
|Study Start Date :||October 2004|
|Actual Study Completion Date :||June 2006|
receive 6-week intervention of peer-delivered mDOT
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.
|No Intervention: 2|
- Self-report - 7 & 30 day recall [ Time Frame: at 6 months and 12 months ]
- Change in CD4 count [ Time Frame: from baseline to 6 months and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272220
|Beira Day Hosptial - Central Hospital|
|Beira, Sofala, Mozambique|
|Principal Investigator:||Cynthia R Pearson, PhD(C)||University of Washington|
|Principal Investigator:||Stephen Gloyd, MD, MPH||University of Washington|