Clinical trial NCT00272220: Longitudinal Study of HAART, Social Networks, & Adherence
Official title: Longitudinal Randomized Controlled Study of Modified Directly Observed HAART in Mozambique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Immunodeficiency Syndrome
Keywords: Acquired Immunodeficiency Syndrome
Antiretroviral Therapy, Highly Active
Randomized Controlled Trials
Africa
Adherence
Treatment Naive
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Mozambique Ministry of Health
name: United States President's Emergency Plan for AIDS Relief
First posted: 2006-01-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self-report - 7 & 30 day recall
timeFrame: at 6 months and 12 months
Secondary outcomes:
measure: Change in CD4 count
timeFrame: from baseline to 6 months and 12 months
Other outcomes:
Locations:
city: Beira
country: Mozambique
facility: Beira Day Hosptial - Central Hospital
state: Sofala
Study officials:
affiliation: University of Washington
name: Cynthia R Pearson, PhD(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Stephen Gloyd, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: