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Counseling And Guidance |
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Clinical Trial: HAART Adherence Interventions
This study is not yet open for patient recruitment.
Verified by University of Washington January 2006
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Purpose
| Condition | Intervention |
|---|---|
| Patient Compliance | Behavior: Education counseling Device: Pocket alarm device |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title: HAART Adherence Interventions in Africa: an RCT
Secondary Outcomes: CD4 count; HIV-1 viral load
Expected Total Enrollment: 400
Study start: February 2006; Expected completion: August 2010
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.
Eligibility
Inclusion Criteria:
- Individuals must qualify for HAART treatment by WHO criteria (Clinical Stage IV disease) and/or CD4 count less than 200 and plan to start HAART therapy. They must be above 18 years of age, be HAART treatment-naïve, 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.
Location and Contact Information
Kenya
Hope Center for Infectious Diseases, Nairobi, Kenya
Michael H Chung, MD, MPH, Principal Investigator
Grace John-Stewart, MD, PhD, Sub-Investigator
James N Kiarie, MBChB, MMed, Sub-Investigator
Jane Simoni, PhD, Sub-Investigator
Jonathan Mayer, PhD, Sub-Investigator
Julie Overbaugh, PhD, Sub-Investigator
Barbra Richardson, PhD, Sub-Investigator
Michael H Chung, MD, MPH, Principal Investigator, University of Washington
More Information
Last Updated: January 6, 2006
Record first received: January 5, 2006
ClinicalTrials.gov Identifier: NCT00273780
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Children and Divorce. (American Association for Marriage and Family Therapy)
- Counseling And Guidance (National Women's Health Information Center)

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