Highly Active Antiretroviral Therapy (HAART) Adherence Interventions - Full Text View

Sponsors and Collaborators:	University of Washington National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00273780

Purpose

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.

Condition	Intervention
HIV Infections	Behavioral: Education counseling Device: Alarm device

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	HAART Adherence Interventions in Africa: An RCT

Further study details as provided by University of Washington:

Primary Outcome Measures:

Pill count [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CD4 count [ Time Frame: 18 months ] [ Designated as safety issue: No ]
HIV-1 viral load [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	400
Study Start Date:	May 2006
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Behavioral: Education counseling 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.
2: Active Comparator	Device: Alarm device This pocket alarm device will be set to ring at designated times during the day that the participant should take their antiretroviral medication.
3: Active Comparator Participants in this arm will receive both education counseling and a pocket alarm device.	Behavioral: Education counseling 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. Device: Alarm device This pocket alarm device will be set to ring at designated times during the day that the participant should take their antiretroviral medication.
4: No Intervention

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273780

Locations

Kenya
Hope Center for Infectious Diseases
Nairobi, Kenya

Sponsors and Collaborators

University of Washington

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Michael H Chung, MD, MPH

University of Washington

More Information

Responsible Party:	University of Washington ( Michael H. Chung )
Study ID Numbers:	06-1342-G, 1K23AI065222-01, 5K23AI065222-02
Study First Received:	January 5, 2006
Last Updated:	February 15, 2008
ClinicalTrials.gov Identifier:	NCT00273780
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Patient compliance

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009