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1. Kericho CLinic-based ART Diagnostic Evaluation (CLADE): design, accrual, and baseline characteristics of a randomized controlled trial conducted in predominately rural, district-level, HIV clinics of Kenya.

Author

Fredrick K Sawe, Eunice Obiero, Peter Yegon, Rither C Langat, Appolonia Aoko, Jemutai Tarus, Ignatius Kiptoo, Raphael K Langat, Jonah Maswai, Margaret Bii, Samoel Khamadi, Kibet P Shikuku, Nicole Close, Samuel Sinei, and Douglas N Shaffer

Subjects
Medicine, Science
Abstract

Prospective clinical trial data regarding routine HIV-1 viral load (VL) monitoring of antiretroviral therapy (ART) in non-research clinics of Sub-Saharan Africa are needed for policy makers.CLinic-based ART Diagnostic Evaluation (CLADE) is a randomized, controlled trial (RCT) evaluating feasibility, superiority, and cost-effectiveness of routine VL vs. standard of care (clinical and immunological) monitoring in adults initiating dual nucleoside reverse transcriptase inhibitor (NRTI)+non-NRTI ART. Participants were randomized (1:1) at 7 predominately rural, non-research, district-level clinics of western Kenya. Descriptive statistics present accrual patterns and baseline cohort characteristics.Over 15 months, 820 adults enrolled at 7 sites with 86-152 enrolled per site. Monthly site enrollment ranged from 2-92 participants. Full (100%) informed consent compliance was independently documented. Half (49.9%) had HIV diagnosed through voluntary counseling and testing. Study arms were similar: mostly females (57.6%) aged 37.6 (SD = 9.0) years with low CD4 (166 [SD = 106]) cells/m3). Notable proportions had WHO Stage III or IV disease (28.7%), BMI

Published
2015
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2. Kericho CLinic-based ART Diagnostic Evaluation (CLADE): design, accrual, and baseline characteristics of a randomized controlled trial conducted in predominately rural, district-level, HIV clinics of Kenya

Author

Nicole Close, Eunice Obiero, Jonah Maswai, Samoel Khamadi, Margaret Bii, Samuel S. Sinei, Ignatius Kiptoo, Appolonia Aoko, Kibet P. Shikuku, Jemutai Tarus, Peter Yegon, Raphael K. Langat, Fredrick Sawe, Rither C. Langat, and Douglas Shaffer

Subjects
Adult, Male, medicine.medical_specialty, Efavirenz, Nevirapine, Anti-HIV Agents, Voluntary counseling and testing, Cost-Benefit Analysis, lcsh:Medicine, HIV Infections, law.invention, chemistry.chemical_compound, Randomized controlled trial, Acquired immunodeficiency syndrome (AIDS), law, Internal medicine, medicine, Humans, Prospective Studies, lcsh:Science, Multidisciplinary, business.industry, Stavudine, lcsh:R, Lamivudine, Middle Aged, Viral Load, medicine.disease, Kenya, Clinical trial, Treatment Outcome, chemistry, Research Design, Immunology, HIV-1, Reverse Transcriptase Inhibitors, Female, lcsh:Q, business, Zidovudine, medicine.drug, Research Article
Abstract

Background Prospective clinical trial data regarding routine HIV-1 viral load (VL) monitoring of antiretroviral therapy (ART) in non-research clinics of Sub-Saharan Africa are needed for policy makers. Methods CLinic-based ART Diagnostic Evaluation (CLADE) is a randomized, controlled trial (RCT) evaluating feasibility, superiority, and cost-effectiveness of routine VL vs. standard of care (clinical and immunological) monitoring in adults initiating dual nucleoside reverse transcriptase inhibitor (NRTI)+non-NRTI ART. Participants were randomized (1:1) at 7 predominately rural, non-research, district-level clinics of western Kenya. Descriptive statistics present accrual patterns and baseline cohort characteristics. Results Over 15 months, 820 adults enrolled at 7 sites with 86–152 enrolled per site. Monthly site enrollment ranged from 2–92 participants. Full (100%) informed consent compliance was independently documented. Half (49.9%) had HIV diagnosed through voluntary counseling and testing. Study arms were similar: mostly females (57.6%) aged 37.6 (SD = 9.0) years with low CD4 (166 [SD = 106]) cells/m3). Notable proportions had WHO Stage III or IV disease (28.7%), BMI

Published
2015

3. Occurrence of etravirine/rilpivirine-specific resistance mutations selected by efavirenz and nevirapine in Kenyan patients with non-B HIV-1 subtypes failing antiretroviral therapy

Author

Tiffany E. Hamm, Dorothy Njeru, James Munyao, Jemutai Tarus, Samoel Khamadi, Jane Kimetto, Duncan Apollo, Lawrence Gitonga, Appolonia Aoko, Milton Omondi, Raphael Langat, Jonah Maswai, and Keith W. Crawford

Subjects
Nevirapine, Efavirenz, Anti-HIV Agents, Immunology, Molecular Sequence Data, Mutation, Missense, Etravirine, HIV Infections, chemistry.chemical_compound, Acquired immunodeficiency syndrome (AIDS), Drug Resistance, Viral, medicine, Immunology and Allergy, Humans, Treatment Failure, Selection, Genetic, Reverse-transcriptase inhibitor, business.industry, Sequence Analysis, DNA, medicine.disease, Antiretroviral therapy, Virology, Kenya, Reverse transcriptase, Infectious Diseases, Cross-Sectional Studies, chemistry, Rilpivirine, HIV-1, business, medicine.drug
Abstract

Resistance to efavirenz and nevirapine has not been associated with mutations at position 138 of reverse transcriptase. In an evaluation of virologic suppression rates in PEPFAR (President's Emergency Plan For AIDS Relief) clinics in Kenya among patients on first-line therapy (RV288), 63% (617/975) of randomly selected patients on antiretroviral therapy were suppressed (HIV RNA

Published
2014

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