Longitudinal Study of HAART, Social Networks, & Adherence

NCT ID: NCT00272220

Last Updated: 2007-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2006-06-30

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.

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.

Conditions

Acquired Immunodeficiency Syndrome

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

receive 6-week intervention of peer-delivered mDOT

Group Type: EXPERIMENTAL

modified directly observed therapy (mDOT)

Intervention Type: 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.

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mozambique Ministry of Health

UNKNOWN

Sponsor Role: collaborator

United States President's Emergency Plan for AIDS Relief

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Principal Investigators

Cynthia R Pearson, PhD(C)

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Stephen Gloyd, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Beira Day Hosptial - Central Hospital

Beira, Sofala, Mozambique

Countries

Mozambique

Other Identifiers

TAP:HIV-AIDS/MS-DPC/GACOPI/04

Identifier Type: -

Identifier Source: secondary_id

03-9137-G 01

Identifier Type: -

Identifier Source: org_study_id