Clinical trial NCT00273780: Highly Active Antiretroviral Therapy (HAART) Adherence Interventions
Official title: HAART Adherence Interventions in Africa: An RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Patient compliance
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2006-01-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

Eligibility 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.

Primary outcomes:
measure: Pill count
timeFrame: 18 months
Secondary outcomes:
measure: CD4 count
timeFrame: 18 months
measure: HIV-1 viral load
timeFrame: 18 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Hope Center for Infectious Diseases
Study officials:
affiliation: University of Washington
name: Michael H Chung, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.