Evaluating Adherence to Highly Active Antiretroviral Therapy with Use of Pill Counts and Viral Load Measurement in the Drug Resources Enhancement against AIDS and Malnutrition Program in Mozambique

ArticleinClinical Infectious Diseases 46(10):1609-16 · May 2008with11 Reads
DOI: 10.1086/587659 · Source: PubMed
Abstract
Maintaining treatment adherence among the growing number of patients receiving antiretroviral treatment in Africa is a dramatic challenge. The objective of our study was to explore the results of a computerized pill count method and to test the validity, sensitivity, and specificity of this method with respect to viral load measurement in an African setting. We performed a prospective, observational study involving patients who received first-line highly active antiretroviral therapy in Mozambique from 1 April 2005 through 31 March 2006. Enrolled patients had received treatment for at least 3 months before the study. For defining treatment adherence levels, pill counts were used, and the results were analyzed with viral load measurements at the end of the observation period. The study involved 531 participants. During the 12 months of observation, 137 patients left the program or discontinued first-line therapy. Of the remaining 394 patients, 284 (72.1%) had >95% treatment adherence; of those 284 patients, 274 (96.5%) had a final viral load <1000 copies/mL. A Cox proportional hazards analysis revealed that the relationship between >95% treatment adherence and the final viral load was closer than that between >90% treatment adherence and viral load. Treatment adherence >95% maximizes the results of the nonnucleoside reverse-transcriptase inhibitor-based regimen. The pill count method appears to be a reliable and economic tool for monitoring treatment adherence in resource-limited settings.
    • "The increasing accessibility to antiretroviral therapy (ART) for people with HIV infection that meet treatment criteria and the implementation of the Option B+ approach for pregnant and breast feeding women in resource-limited countries has impacted positively on the health and quality of life of treated patients and on the reduction of mother-to-child transmissions. However, one of the main challenges in HIV/AIDS clinical management is the need of a laboratory support to monitor treatment efficacy and to evaluate HIV diagnosis in the exposed infants (Stevens, 2008; Sigaloff and Rinke de Wit, 2015; Magnano San Lio, 2008). Reference laboratories, using nucleic acid based technologies providing accurate and reliable results, are few in sub-Saharan Africa and often concentrated in the main cities. "
    [Show abstract] [Hide abstract] ABSTRACT: Assessing treatment efficacy and early infant diagnosis (EID) are critical issues in HIV disease management. Point-of-care assays may greatly increase the possibility to access laboratory monitoring also in rural areas. Recently two new laboratory tests have been developed by Cepheid (Sunnyvale, California) the Xpert HIV-1 Viral Load for viral load determination and the Xpert HIV-1 Qualitative for early infant diagnosis. We conducted a study in Blantyre, Malawi, comparing the 2 methods versus the Abbott real time quantitative and qualitative assays, for viral load and EID respectively. We tested 300 plasma samples for viral load determination and 200 samples for infant diagnosis. HIV-1 RNA values of the 274 samples quantified by both assays were highly correlated (Pearson r = 0.95, R(2) = 0.90). In 90.9% of the cases the two methods were concordant in defining the HIV -1 RNA levels as detectable or undetectable. For EID, the Xpert HIV-1 Qualitative assay yielded the same identical results as the Abbott assay. Both the quantitative and the qualitative Xpert assays are promising tools to monitor treatment efficacy in HIV patients receiving treatment and for early diagnosis in HIV-exposed infants.
    Full-text · Article · Dec 2015
    • "Pill counts adherence rates have been shown to have reasonable correlations with electronic drug monitoring (EDM) and HIV viral load (Berg et al., 2006; Liu et al., 2001; Bangsberg et al., 2000). There are additional reports that data from pill count method agreed with data from viral load measurement; and pill counting was recommended as a reliable and economical tool for adherence measurement in a resource-limited setting (San Lio et al., 2008). Studies in Nigeria reported varying levels of adherence to ART ranging from 49.2% (Nwauche et al., 2006), 58.1% (Erah and Arute, 2008), 73.3% (Bello, 2011), 73.8% (Agu et al., 2010), and 44% (Afolabi et al., 2009) in Southern Nigeria, to 79.1% (Agu et al., 2011) and 80% (Mukhtar et al., 2006) in Northern Nigeria. "
    [Show abstract] [Hide abstract] ABSTRACT: This study evaluated medication adherence following interventions and its association with cluster of differentiation 4 (CD4) cells response among patients receiving antiretroviral therapy (ART) in Specialist Hospital Sokoto, North Western Nigeria. Longitudinal study design was used. Interventions included training of health workers on adherence counseling; pre- and post-ART adherence counseling were provided to patients. Out of 1300 patients on ART who were provided interventions, 365 patients were selected using simple random technique. The CD4-cell measurements at months 0, 6, 12, 18 and 24 were extracted from the patients’ hospital records; and announced pill counts were conducted. Chi square was used to test the association between groups of variables; and P < 0.05 indicated statistical significance. Out of 365 participants sampled, data from 297 (81.4%) participants were valid for analysis. The mean age of participants was 34.7 (95%CI, 33.6 to 35.8) years; 60.9% were females and 76.4% received Zidovudine/Lamivudine/Nevirapine (AZT/3TC/NVP) regimen. The mean percent adherence was 83.4% (95%CI, 80.8% to 86.0%). The mean CD4-cells count (cells/mm3) at ART initiation increased from 198.9 (95%CI, 180.7 to 217.1) to 396.5 (95%CI, 368.3 to 424.7) at 6 months, 428.0 (95%CI, 400.4 to 455.6) at 12 months, 427.2 (95%CI, 405.6 to 448.8) at 18 months, and 501.4 (95%CI, 469.5 to 533.3) at 24 months. This increase was statistically significant (P< 0.05). Participants’ employment and educational status, age, sex and type of ART regimens received had no significant association with medication adherence (P > 0.05). This study reported a mean adherence level that is below the required >95% necessary to achieve the goals of ART. The increase in CD4 cells count over the observation period was statistically significant at the estimated adherence level. Better immunologic outcomes may be achieved with higher adherence level.
    Full-text · Article · May 2013 · Value in Health
    • "Pill counts adherence rates have been shown to have reasonable correlations with electronic drug monitoring (EDM) and HIV viral load (Berg et al., 2006; Liu et al., 2001; Bangsberg et al., 2000). There are additional reports that data from pill count method agreed with data from viral load measurement; and pill counting was recommended as a reliable and economical tool for adherence measurement in a resource-limited setting (San Lio et al., 2008). Studies in Nigeria reported varying levels of adherence to ART ranging from 49.2% (Nwauche et al., 2006), 58.1% (Erah and Arute, 2008), 73.3% (Bello, 2011), 73.8% (Agu et al., 2010), and 44% (Afolabi et al., 2009) in Southern Nigeria, to 79.1% (Agu et al., 2011) and 80% (Mukhtar et al., 2006) in Northern Nigeria. "
    [Show abstract] [Hide abstract] ABSTRACT: This study evaluated medication adherence following interventions and its association with cluster of differentiation 4 (CD4) cells response among patients receiving antiretroviral therapy (ART) in Specialist Hospital Sokoto, North Western Nigeria. Longitudinal study design was used. Interventions included training of health workers on adherence counseling; pre-and post-ART adherence counseling were provided to patients. Out of 1300 patients on ART who were provided interventions, 365 patients were selected using simple random technique. The CD4-cell measurements at months 0, 6, 12, 18 and 24 were extracted from the patients' hospital records; and announced pill counts were conducted. Chi square was used to test the association between groups of variables; and P < 0.05 indicated statistical significance. Out of 365 participants sampled, data from 297 (81.4%) participants were valid for analysis. The mean age of participants was 34.7 (95%CI, 33.6 to 35.8) years; 60.9% were females and 76.4% received Zidovudine/Lamivudine/Nevirapine (AZT/3TC/NVP) regimen. The mean percent adherence was 83.4% (95%CI, 80.8% to 86.0%). The mean CD4-cells count (cells/mm 3) at ART initiation increased from 198.9 (95%CI, 180.7 to 217.1) to 396.5 (95%CI, 368.3 to 424.7) at 6 months, 428.0 (95%CI, 400.4 to 455.6) at 12 months, 427.2 (95%CI, 405.6 to 448.8) at 18 months, and 501.4 (95%CI, 469.5 to 533.3) at 24 months. This increase was statistically significant (P< 0.05). Participants' employment and educational status, age, sex and type of ART regimens received had no significant association with medication adherence (P > 0.05). This study reported a mean adherence level that is below the required >95% necessary to achieve the goals of ART. The increase in CD4 cells count over the observation period was statistically significant at the estimated adherence level. Better immunologic outcomes may be achieved with higher adherence level.
    Full-text · Article · May 2013
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