Oligonucleotide Ligation Assay (OLA) Resistance Study
OLA
Drug-resistance Testing in Kenya to Improve ART Suppression of HIV Replication
1 other identifier
interventional
991
1 country
2
Brief Summary
The investigators propose to gauge improvements in the rate of durable suppression of viral replication by ART when OLA is used to guide clinical decisions at the PEPFAR Coptic Hope Center in Kenya, and to determine the cost-effectiveness of implementing this strategy at Coptic Hope Center.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 9, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
November 17, 2021
CompletedMarch 12, 2025
March 1, 2025
3.6 years
July 9, 2013
October 18, 2021
March 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Virologic Failure With OLA-guided ART vs. Standard of Care
The primary endpoint will be a comparison of the rates of viral non-suppression \>400 copies/mL between study arms at 12 months
12 months
Secondary Outcomes (7)
The Difference in Virologic Failure Among Participants With Transmitted Drug-resistance (TDR) ≥10% Associated With Use of OLA-guided ART vs. SOC
15 months
Difference in Virologic Failure in the Subgroup of Participants With Prior or Ongoing ART Use Associated With Use of OLA-guided ART vs. SOC
15 months
Prevalence of TDR by Consensus Sequencing and OLA
15 months
Proportion of Subgroup With TDR With Virologic Failure by Randomization Arm
15 months
Estimates of Medical Resource Utilization During the One-year Trial Period
15 months
- +2 more secondary outcomes
Other Outcomes (3)
Descriptions of Technology Transfer of OLA to the Hope Center Laboratory, Including Intra- and Inter-assay the Reproducibility, and Discussion of Obstacles and Possible Solutions
15 months
A Comparison of OLA Results Obtained Using DBS in Kenya to Retesting of Same Specimens With Input of Viral Templates Measured in Seattle
15 months
Detection of Resistance Mutations at OLA Codons by OLA vs. Consensus Sequencing
Enrollment
Study Arms (2)
Pre-ART Oligonucleotide Assay (OLA)
EXPERIMENTALPre-ART OLA will be tested for resistance at 5 pol codons conferring high-level resistance to NNRTI and 3TC (K103N, V106M, Y181C, G190A and M184V)
No OLA (Standard of Care [SOC])
NO INTERVENTIONThe participants will receive standard of care as per Kenya guidelines but will be offered OLA resistance testing after 12 months
Interventions
Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
Eligibility Criteria
You may qualify if:
- Confirmed HIV infection
- \>2 years of age
- Qualifying for 1st-line ART based on Kenyan Guidelines
- Plan to reside in area for \>1 year
- Adult patient or parent of minor agrees to study and provides informed consent
You may not qualify if:
- Received ART previously from Hope Center
- Ongoing ART
- Plan to start 2nd-line ART
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Seattle Children's Hospitalcollaborator
- University of Nairobicollaborator
Study Sites (2)
Coptic Hospital
Maseno, Kenya
Coptic Hospital
Nairobi, Kenya
Related Publications (2)
Chung MH, McGrath CJ, Beck IA, Levine M, Milne RS, So I, Andersen N, Dross S, Coombs RW, Chohan B, Yatich N, Kiptinness C, Sakr SR, Kiarie JN, Frenkel LM. Evaluation of the management of pretreatment HIV drug resistance by oligonucleotide ligation assay: a randomised controlled trial. Lancet HIV. 2020 Feb;7(2):e104-e112. doi: 10.1016/S2352-3018(19)30337-6. Epub 2019 Dec 7.
PMID: 31818716DERIVEDSilverman RA, Beck IA, Kiptinness C, Levine M, Milne R, McGrath CJ, Bii S, Richardson BA, John-Stewart G, Chohan B, Sakr SR, Kiarie JN, Frenkel LM, Chung MH. Prevalence of Pre-antiretroviral-Treatment Drug Resistance by Gender, Age, and Other Factors in HIV-Infected Individuals Initiating Therapy in Kenya, 2013-2014. J Infect Dis. 2017 Dec 19;216(12):1569-1578. doi: 10.1093/infdis/jix544.
PMID: 29040633DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Lisa Frenkel
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Frenkel, MD
University of Washington, Seattle Children's Research Institute
- PRINCIPAL INVESTIGATOR
Michael H Chung, MD, MPH
Department of Global Health, University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 9, 2013
First Posted
July 12, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
March 12, 2025
Results First Posted
November 17, 2021
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share