Highly Active Antiretroviral Therapy (HAART) Adherence Interventions

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: Adherence counseling; Device: Alarm device

• Registration Number: NCT00273780
• Lead Sponsor: University of Washington

Brief Summary

This study proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to determine the effect of cognitive and behavioral interventions on HAART adherence.

Detailed Description

The study will be a prospective randomized clinical control trial among HIV-1 seropositive adult participants beginning HAART (highly active antiretroviral therapy) for the first time. Patients who are eligible to be initiated on HAART at the UW/Coptic Hope Center for Infectious Diseases will be referred for enrollment. Eligible patients who are referred will learn about the study and be invited to enroll after signing a written informed consent.

Study participants will be randomized to one of four arms:educational counseling, a pocket alarm device, both education and alarm, or neither. Participants will be followed in the study for 1 ½ years after enrollment and randomization. Participants will return to clinic every month to pick up a renewal of their antiretroviral prescriptions at which time pill counts will be performed. During follow-up visits, blood will be drawn and stored for CD4 counts and HIV-1 viral analyses.

Within this trial, the study also proposes to identify sociodemographic and spatial correlates of adherence. The study hypothesizes that educational counseling and medication alarm devices may significantly improve adherence, and that poor adherence may be associated with low socioeconomic standing, increased mobility, and distance from clinic.

Study Timeline

• Study First Submitted: 2006-01-05
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Study Start: 2006-05
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-23
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Individuals must qualify for HAART treatment by World Health Organization (WHO) criteria (Clinical Stage IV disease) and/or CD4 count of less than 200 and plan to start HAART therapy.
• Must be above 18 years of age
• Must be HAART treatment-naïve
• Must agree to home visits, and plan to live in Kenya for at least two years.

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Exclusion Criteria

• Individuals who are mentally incompetent or are pregnant are excluded from the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Counseling and alarm	Alarm device	Participants in this arm will receive both education counseling and a pocket alarm device.
Alarm device	Alarm device	-
Adherence counseling	Adherence counseling	-
Counseling and alarm	Adherence counseling	Participants in this arm will receive both education counseling and a pocket alarm device.

Primary Outcome Measures

Name	Time	Method
Pill count	18 months

Secondary Outcome Measures

Name	Time	Method
HIV-1 viral load	18 months
CD4 count	18 months

Trial Locations

Locations (1)

Hope Center for Infectious Diseases; 🇰🇪 Nairobi, Kenya