Highly Active Antiretroviral Therapy (HAART) Adherence Interventions
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ClinicalTrials.gov Identifier: NCT00273780 |
Recruitment Status
:
Completed
First Posted
: January 9, 2006
Last Update Posted
: August 27, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Adherence counseling Device: Alarm device | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Official Title: | HAART Adherence Interventions in Africa: An RCT |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
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 |
- Pill count [ Time Frame: 18 months ]
- CD4 count [ Time Frame: 18 months ]
- HIV-1 viral load [ Time Frame: 18 months ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273780
Kenya | |
Hope Center for Infectious Diseases | |
Nairobi, Kenya |
Principal Investigator: | Michael H Chung, MD, MPH | University of Washington |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00273780 History of Changes |
Other Study ID Numbers: |
29936-G 1K23AI065222-01 ( U.S. NIH Grant/Contract ) 5K23AI065222-02 ( U.S. NIH Grant/Contract ) |
First Posted: | January 9, 2006 Key Record Dates |
Last Update Posted: | August 27, 2012 |
Last Verified: | August 2012 |
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 |