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| Sponsors and Collaborators: |
University of Washington Mozambique Ministry of Health United States PEPFAR |
|---|---|
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00272220 |
Purpose
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 | Intervention |
|---|---|
|
Acquired Immunodeficiency Syndrome |
Behavioral: modified directly observed therapy (mDOT) |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Longitudinal Randomized Controlled Study of Modified Directly Observed HAART in Mozambique |
| Enrollment: | 350 |
| Study Start Date: | October 2004 |
| Study Completion Date: | June 2006 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
| 2: No Intervention |
To test this hypothesis, we intend to randomize 350 ARV naïve patients starting HAART to either receive mDOT for the initial 6 weeks of treatment or standard adherence support. Both intervention and control groups will receive standard HIV care that includes HAART medications free of charge, clinical and laboratory follow-up, psychosocial adherence support by a trained social worker, and referral to community-based peer support groups.
Patients in the intervention group will in addition to stand care, receive their morning weekday dose of a twice-daily HAART regimen under DOT in clinic for 6 weeks. Nighttime and weekend doses are self-administered. A group of HIV-positive DOT activists, who are trained and paid lay-clinic personnel, will be primarily responsible for the direct observation of treatment in the mDOT group. In addition to observing treatment, DOT activists will provide counseling, education, and emotional support to patients, and will also locate patients not presenting for DOT on the same day. Although the HIV activists may also provide psychosocial and adherence support to specific patients in the control group, this support will only be a daily and formalized part of care in the group randomized to mDOT.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Mozambique, Sofala | |
| 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 |
More Information
| Study ID Numbers: | 03-9137-G 01, TAP:HIV-AIDS/MS-DPC/GACOPI/04 |
| Study First Received: | December 30, 2005 |
| Last Updated: | November 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00272220 History of Changes |
| Health Authority: | United States: Institutional Review Board; Mozambique: Ministry of Health (MISAU) |
|
Acquired Immunodeficiency Syndrome Antiretroviral Therapy, Highly Active Randomized Controlled Trials |
Africa Adherence Treatment Naive |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Disease Immune System Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes |
Virus Diseases Pathologic Processes HIV Infections Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
