Longitudinal Study of HAART, Social Networks, & Adherence
This study has been completed.
Sponsor:
University of Washington
Collaborators:
Mozambique Ministry of Health
United States President's Emergency Plan for AIDS Relief
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00272220
First received: December 30, 2005
Last updated: November 6, 2007
Last verified: November 2007
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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Longitudinal Randomized Controlled Study of Modified Directly Observed HAART in Mozambique |
Resource links provided by NLM:
Further study details as provided by University of Washington:
Primary Outcome Measures:
- Self-report - 7 & 30 day recall [ Time Frame: at 6 months and 12 months ]
Secondary Outcome Measures:
- Change in CD4 count [ Time Frame: from baseline to 6 months and 12 months ]
| Enrollment: | 350 |
| Study Start Date: | October 2004 |
| Study Completion Date: | June 2006 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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 |
Detailed Description:
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272220
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272220
Locations
| Mozambique | |
| Beira Day Hosptial - Central Hospital | |
| Beira, Sofala, Mozambique | |
Sponsors and Collaborators
University of Washington
Mozambique Ministry of Health
United States President's Emergency Plan for AIDS Relief
Investigators
| Principal Investigator: | Cynthia R Pearson, PhD(C) | University of Washington |
| Principal Investigator: | Stephen Gloyd, MD, MPH | University of Washington |
More Information
| ClinicalTrials.gov Identifier: | NCT00272220 History of Changes |
| Other 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 |
| Health Authority: | United States: Institutional Review Board Mozambique: Ministry of Health (MISAU) |
Keywords provided by University of Washington:
|
Acquired Immunodeficiency Syndrome Antiretroviral Therapy, Highly Active Randomized Controlled Trials |
Africa Adherence Treatment Naive |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on September 29, 2016