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

December 30, 2005
November 6, 2007
October 2004
Not Provided
Self-report - 7 & 30 day recall [ Time Frame: at 6 months and 12 months ]
  • Self-report - 7 & 30 day recall
  • Adherence to HAART:visual analogue scale (VAS)
  • Pharmacy refill data
Complete list of historical versions of study NCT00272220 on ClinicalTrials.gov Archive Site
Change in CD4 count [ Time Frame: from baseline to 6 months and 12 months ]
  • Clinical outcome: change in CD4 counts,
  • Change in HIV/AIDS clinical phase
Not Provided
Not Provided
 
Longitudinal Study of HAART, Social Networks, & Adherence
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acquired Immunodeficiency Syndrome
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.
  • Experimental: 1
    receive 6-week intervention of peer-delivered mDOT
    Intervention: Behavioral: modified directly observed therapy (mDOT)
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
June 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mozambique
 
NCT00272220
03-9137-G 01, TAP:HIV-AIDS/MS-DPC/GACOPI/04
Yes
Not Provided
University of Washington
  • Mozambique Ministry of Health
  • United States PEPFAR
Principal Investigator: Cynthia R Pearson, PhD(C) University of Washington
Principal Investigator: Stephen Gloyd, MD, MPH University of Washington
University of Washington
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP