Longitudinal Study of HAART, Social Networks, & Adherence

Not Applicable

Completed

• Conditions: Acquired Immunodeficiency Syndrome
• Interventions: Behavioral: modified directly observed therapy (mDOT)

• Registration Number: NCT00272220
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-12-30
• Study First Submitted QC: 2005-12-30
• Study First Posted: 2006-01-04
• Study Completion: 2006-06
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-06
• Last Update Posted: 2007-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	modified directly observed therapy (mDOT)	receive 6-week intervention of peer-delivered mDOT

Primary Outcome Measures

Name	Time	Method
Self-report - 7 & 30 day recall	at 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Change in CD4 count	from baseline to 6 months and 12 months

Trial Locations

Locations (1)

Beira Day Hosptial - Central Hospital; 🇲🇿 Beira, Sofala, Mozambique