Longitudinal Study of HAART, Social Networks, & Adherence

NCT00272220 | Completed DMC

• 2 other identifiers: 03-9137-G 01TAP:HIV-AIDS/MS-DPC/GACOPI/04
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acquired Immunodeficiency Syndrome

Keywords

Acquired Immunodeficiency Syndrome; Antiretroviral Therapy, Highly Active; Randomized Controlled Trials; Africa; Adherence; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Self-report - 7 & 30 day recall

  at 6 months and 12 months

Secondary Outcomes (1)

• Change in CD4 count

  from baseline to 6 months and 12 months

Study Arms (2)

1

EXPERIMENTAL

receive 6-week intervention of peer-delivered mDOT

Behavioral: modified directly observed therapy (mDOT)

2

NO INTERVENTION

Interventions

modified directly observed therapy (mDOT) BEHAVIORAL

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Physically or mental incapable to make daily clinic visits
• Psychotic or demented

Sponsors & Collaborators

• University of Washington: lead
• Mozambique Ministry of Health: collaborator
• United States President's Emergency Plan for AIDS Relief: collaborator

Study Sites (1)

Beira Day Hosptial - Central Hospital

Beira, Sofala, Mozambique

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Cynthia R Pearson, PhD(C)

  University of Washington

  PRINCIPAL INVESTIGATOR

• Stephen Gloyd, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2005
• First Posted: January 4, 2006
• Study Start: October 1, 2004
• Study Completion: June 1, 2006
• Last Updated: November 7, 2007

Record last verified: 2007-11

Locations

MO (1)