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Implementation of a point mutation assay for HIV drug resistance testing in Kenya.
AIDS. 2018 10 23; 32(16):2301-2308.AIDS

Abstract

OBJECTIVES

An increasing prevalence of HIV pretreatment drug resistance (PDR) has been observed in Africa, which could decrease the effectiveness of antiretroviral therapy (ART) programs. We describe our experiences, the costs and challenges of implementing an oligonucleotide ligation assay (OLA) for management of PDR in Nairobi, Kenya.

DESIGN

An observational report of the implementation of OLA in a Kenyan laboratory for a randomized clinical trial evaluating whether onsite use of OLA in individuals initiating ART would decrease rates of virologic failure.

METHODS

Compared detection of mutations and proportion of mutants in participants' viral quasispecies by OLA in Kenya vs. Seattle. Reviewed records of laboratory workflow and performance of OLA. Calculated the costs of laboratory set-up and of performing the OLA based on equipment purchase receipts and supplies and labor utilization, respectively.

RESULTS

OLA was performed on 492 trial participants. Weekly batch-testing of median of seven (range: 2-13) specimens provided test results to Kenyan clinicians within 10-14 days of sample collection at a cost of US$ 42 per person tested. Cost of laboratory setup was US$ 32 594. Challenges included an unreliable local supply chain for reagents and the need for an experienced molecular biologist to supervise OLA performance.

CONCLUSION

OLA was successfully implemented in a Kenyan research laboratory. Cost was twice that projected because of fewer than predicted specimens per batch because of slow enrollment. OLA is a potential simple, low-cost method for PDR testing in resource-limited settings (RLS). Ongoing work to develop a simplified kit could improve future implementation of OLA in RLS.

Authors+Show Affiliations

Division of Infectious Diseases, Department of Pediatrics, University of Washington. Seattle Children's Research Institute, Seattle, Washington, USA.Seattle Children's Research Institute, Seattle, Washington, USA.Seattle Children's Research Institute, Seattle, Washington, USA.Coptic Hope Center for Infectious Diseases.Coptic Hope Center for Infectious Diseases.Kenya Medical Research Institute, Nairobi, Kenya. Department of Global Health, University of Washington, Seattle, Washington, USA.Coptic Hope Center for Infectious Diseases.Coptic Hope Center for Infectious Diseases. Department of Global Health, University of Washington, Seattle, Washington, USA.Division of Infectious Diseases, Department of Pediatrics, University of Washington. Seattle Children's Research Institute, Seattle, Washington, USA.

Pub Type(s)

Evaluation Study
Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

30005020

Citation

Duarte, Horacio A., et al. "Implementation of a Point Mutation Assay for HIV Drug Resistance Testing in Kenya." AIDS (London, England), vol. 32, no. 16, 2018, pp. 2301-2308.
Duarte HA, Beck IA, Levine M, et al. Implementation of a point mutation assay for HIV drug resistance testing in Kenya. AIDS. 2018;32(16):2301-2308.
Duarte, H. A., Beck, I. A., Levine, M., Kiptinness, C., Kingoo, J. M., Chohan, B., Sakr, S. R., Chung, M. H., & Frenkel, L. M. (2018). Implementation of a point mutation assay for HIV drug resistance testing in Kenya. AIDS (London, England), 32(16), 2301-2308. https://doi.org/10.1097/QAD.0000000000001934
Duarte HA, et al. Implementation of a Point Mutation Assay for HIV Drug Resistance Testing in Kenya. AIDS. 2018 10 23;32(16):2301-2308. PubMed PMID: 30005020.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Implementation of a point mutation assay for HIV drug resistance testing in Kenya. AU - Duarte,Horacio A, AU - Beck,Ingrid A, AU - Levine,Molly, AU - Kiptinness,Catherine, AU - Kingoo,James M, AU - Chohan,Bhavna, AU - Sakr,Samah R, AU - Chung,Michael H, AU - Frenkel,Lisa M, PY - 2018/7/14/pubmed PY - 2019/10/31/medline PY - 2018/7/14/entrez SP - 2301 EP - 2308 JF - AIDS (London, England) JO - AIDS VL - 32 IS - 16 N2 - OBJECTIVES: An increasing prevalence of HIV pretreatment drug resistance (PDR) has been observed in Africa, which could decrease the effectiveness of antiretroviral therapy (ART) programs. We describe our experiences, the costs and challenges of implementing an oligonucleotide ligation assay (OLA) for management of PDR in Nairobi, Kenya. DESIGN: An observational report of the implementation of OLA in a Kenyan laboratory for a randomized clinical trial evaluating whether onsite use of OLA in individuals initiating ART would decrease rates of virologic failure. METHODS: Compared detection of mutations and proportion of mutants in participants' viral quasispecies by OLA in Kenya vs. Seattle. Reviewed records of laboratory workflow and performance of OLA. Calculated the costs of laboratory set-up and of performing the OLA based on equipment purchase receipts and supplies and labor utilization, respectively. RESULTS: OLA was performed on 492 trial participants. Weekly batch-testing of median of seven (range: 2-13) specimens provided test results to Kenyan clinicians within 10-14 days of sample collection at a cost of US$ 42 per person tested. Cost of laboratory setup was US$ 32 594. Challenges included an unreliable local supply chain for reagents and the need for an experienced molecular biologist to supervise OLA performance. CONCLUSION: OLA was successfully implemented in a Kenyan research laboratory. Cost was twice that projected because of fewer than predicted specimens per batch because of slow enrollment. OLA is a potential simple, low-cost method for PDR testing in resource-limited settings (RLS). Ongoing work to develop a simplified kit could improve future implementation of OLA in RLS. SN - 1473-5571 UR - https://www.unboundmedicine.com/medline/citation/30005020/Implementation_of_a_point_mutation_assay_for_HIV_drug_resistance_testing_in_Kenya_ L2 - http://dx.doi.org/10.1097/QAD.0000000000001934 DB - PRIME DP - Unbound Medicine ER -