Longitudinal Study of HAART, Social Networks, & Adherence

This study has been completed.
Sponsor:
Collaborators:
Mozambique Ministry of Health
United States PEPFAR
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00272220
First received: December 30, 2005
Last updated: November 6, 2007
Last verified: November 2007
  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
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

Locations
Mozambique
Beira Day Hosptial - Central Hospital
Beira, Sofala, Mozambique
Sponsors and Collaborators
University of Washington
Mozambique Ministry of Health
United States PEPFAR
Investigators
Principal Investigator: Cynthia R Pearson, PhD(C) University of Washington
Principal Investigator: Stephen Gloyd, MD, MPH University of Washington
  More Information

No publications provided

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014