Cited by 109HIV/AIDS Research and InterventionsMedication Adherence and ComplianceHIV/AIDS drug development and treatment

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A Randomized Controlled Trial Comparing the Effects of Counseling and Alarm Device on HAART Adherence and Virologic Outcomes

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Chung, Michael H., Richardson, Barbra A., Tapia, Kenneth, Benki-Nugent, Sarah, Kiarie, James N., Simoni, Jane M., Overbaugh, Julie, Attwa, Mena, John-Stewart, Grace C.·2011·PLoS Medicine

DOI 10.1371/journal.pmed.1000422PMC PMC3046986

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Abstract

BACKGROUND: Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting. METHODS AND FINDINGS: A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART) in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine) were randomized to one of four arms: counseling (three counseling sessions around HAART initiation), alarm (pocket electronic pill reminder carried for 6 months), counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49-1.01; p = 0.055) and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml) (HR 0.41; 95% CI 0.21-0.81; p = 0.01) compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p = 0.7) or viral failure (HR 0.99; 95% CI 0.53-1.84; p = 1.0) compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution. CONCLUSIONS: Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure during 18-month follow-up, while use of an alarm device had no effect. As antiretroviral treatment clinics expand to meet an increasing demand for HIV care in sub-Saharan Africa, adherence counseling should be implemented to decrease the development of treatment failure and spread of resistant HIV.

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Figure 1 Trial profile. TB, tuberculosis.CC BY · PubMed Central

Figure 2 Lowess curves of percent adherence over time in months since HAART initiation by intervention. Thick lines indicate average percent adherence. Thin lines indicate 95% CIs. Solid lines indicate intervention. Dashed lines indicate no intervention. (A) Counseling versus no counseling. (B) Alarm versus no alarm.CC BY · PubMed Central

Figure 3 Kaplan-Meier survival curves comparing counseling versus no counseling and alarm versus no alarm. Study outcomes include (A) adherence <80%, (B) viral failure (≥5,000 copies/ml), and (C) mortality. Solid line indicates intervention and dashed line indicates no intervention. The number of participants at risk at each time point is listed below the graph with the number of failure events in parentheses.CC BY · PubMed Central

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Implementation and Operational Research
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Authors: Chung, M. H., Richardson, B. A., Tapia, K., Benki-Nugent, S., Kiarie, J. N., Simoni, J. M., Overbaugh, J., Attwa, M., & John-Stewart, G. C.
Affiliations: University of Washington (US)
University of Nairobi (KE)
Fred Hutch Cancer Center (US)
Corresponding author: Chung, Michael H.
ORCID: Chung, Michael H.
Richardson, Barbra A.
Tapia, Kenneth
Benki-Nugent, Sarah
Kiarie, James N.
Simoni, Jane M.
John-Stewart, Grace C.
Venue: PLoS Medicine
Publisher: Public Library of Science (PLoS)
Published: 2011-03-01
Volume: 8
Issue: 3
Pages: e1000422
ISSN: 1549-1277 (ISSN-L)
1549-1676
DOI: 10.1371/journal.pmed.1000422
PMC: PMC3046986
OpenAlex: W2160766775
Cited by: 109
References: 50
Citations by year: 2025: 1 · 2024: 2 · 2023: 5 · 2022: 1 · 2021: 5 · 2020: 8 · 2019: 3 · 2018: 11 · 2017: 12 · 2016: 9 · 2015: 8 · 2014: 13 · 2013: 14 · 2012: 13
FWCI: 9.54
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (unspecified)
Locations: PLoS Medicine (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Figshare (submittedVersion, cc-by)
Greater South Information System
Funders: University of Washington
U.S. President’s Emergency Plan for AIDS Relief (U62/CCU024512, U62/CCU024512-04)
Hope Center for Neurological Disorders
National Institutes of Health
Centers for Disease Control and Prevention (U62/CCU024512)
U.S. Public Health Service (U62/CCU024512-04)
Center for AIDS Research, University of Washington (P30 AI027757)
National Institute on Aging
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute on Drug Abuse
National Cancer Institute
National Institute of Allergy and Infectious Diseases (K23AI065222, P30AI027757)
National Center for Complementary and Alternative Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (K24HD054314)
Topics: Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
Keywords: medication adherence, HIV, highly active antiretroviral therapy, adherence counseling, virological failure, HIV-1 RNA, CD4 count, immune reconstitution, antiretroviral-naive patients, fixed-dose combination antiretroviral therapy, resource-limited settings, sub-Saharan Africa, mortality
MeSH terms: Adult, Counseling, Drug Combinations, Female, Humans, Kenya, Male, Memory, Patient Compliance, RNA, Viral, HIV-1, HIV Infections, Proportional Hazards Models, Treatment Outcome, Reminder Systems, CD4 Lymphocyte Count, Antiretroviral Therapy, Highly Active, Anti-Retroviral Agents

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A Randomized Controlled Trial Comparing the Effects of Counseling and Alarm Device on HAART Adherence and Virologic Outcomes

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