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.

Study Overview

• Status: Completed
• Conditions: Acquired Immunodeficiency Syndrome
• Intervention / Treatment: Behavioral: modified directly observed therapy (mDOT)

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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mozambique
  • Sofala
    • Beira, Sofala, Mozambique
      • Beira Day Hosptial - Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Self-report - 7 & 30 day recall	at 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in CD4 count	from baseline to 6 months and 12 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: United States President's Emergency Plan for AIDS Relief; Mozambique Ministry of Health
• Investigators: Principal Investigator: Cynthia R Pearson, PhD(C), University of Washington; Principal Investigator: Stephen Gloyd, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: December 30, 2005
• First Submitted That Met QC Criteria: December 30, 2005
• First Posted (Estimate): January 4, 2006

Study Record Updates

• Last Update Posted (Estimate): November 7, 2007
• Last Update Submitted That Met QC Criteria: November 6, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Adherence; Antiretroviral Therapy, Highly Active; Randomized Controlled Trials; Acquired Immunodeficiency Syndrome; Africa; Treatment Naive
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: 03-9137-G 01; TAP:HIV-AIDS/MS-DPC/GACOPI/04