Highly Active Antiretroviral Therapy (HAART) Adherence Interventions

Study Overview
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Brief Summary
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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
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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.

Official Title
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HAART Adherence Interventions in Africa: An RCT

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Adherence counseling
* Device: Alarm device


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Individuals who are mentally incompetent or are pregnant are excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adherence counseling<br> | Behavioral: Adherence counseling<br>* Three adherence counseling sessions will be given to participants in the trial. Two sessions will occur prior to initiation of antiretroviral medications and one session will be given one month after drug administration.<br>|
| Active Comparator: Alarm device<br> | Device: Alarm device<br>* This pocket alarm device will be set to ring at designated times during the day that the participant should take their antiretroviral medication.<br>* Other names: ALRT Med Reminder PC200;|
| Active Comparator: Counseling and alarm<br>Participants in this arm will receive both education counseling and a pocket alarm device. | Behavioral: Adherence counseling<br>* Three adherence counseling sessions will be given to participants in the trial. Two sessions will occur prior to initiation of antiretroviral medications and one session will be given one month after drug administration.<br>Device: Alarm device<br>* This pocket alarm device will be set to ring at designated times during the day that the participant should take their antiretroviral medication.<br>* Other names: ALRT Med Reminder PC200;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pill count |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 count |  | 18 months | 
| HIV-1 viral load |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient compliance