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

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: Adherence counseling Device: Alarm device


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label
Official Title:	HAART Adherence Interventions in Africa: An RCT

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Adherence counseling	Behavioral: Adherence 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.
Active Comparator: Alarm device	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. Other Name: ALRT Med Reminder PC200
Active Comparator: Counseling and alarm Participants in this arm will receive both education counseling and a pocket alarm device.	Behavioral: Adherence 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. Other Name: ALRT Med Reminder PC200
No Intervention: Control

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Marson KG, Tapia K, Kohler P, McGrath CJ, John-Stewart GC, Richardson BA, Njoroge JW, Kiarie JN, Sakr SR, Chung MH. Male, mobile, and moneyed: loss to follow-up vs. transfer of care in an urban African antiretroviral treatment clinic. PLoS One. 2013 Oct 24;8(10):e78900. doi: 10.1371/journal.pone.0078900. eCollection 2013.

Chung MH, Richardson BA, Tapia K, Benki-Nugent S, Kiarie JN, Simoni JM, Overbaugh J, Attwa M, John-Stewart GC. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes. PLoS Med. 2011 Mar;8(3):e1000422. doi: 10.1371/journal.pmed.1000422. Epub 2011 Mar 1.


Responsible Party:	University of Washington
ClinicalTrials.gov Identifier:	NCT00273780 History of Changes
Other Study ID Numbers:	29936-G 1K23AI065222-01 5K23AI065222-02
Study First Received:	January 5, 2006
Last Updated:	August 23, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:


Patient compliance

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 27, 2016