title: Implementing antiretroviral resistance testing in a primary health care HIV treatment programme in rural KwaZulu-Natal, South Africa: early experiences, achievements and challenges.
abstract: BACKGROUND
  Antiretroviral drug resistance is becoming increasingly common with the expansion of human immunodeficiency virus (HIV) treatment programmes in high prevalence settings. Genotypic resistance testing could have benefit in guiding individual-level treatment decisions but successful models for delivering resistance testing in low- and middle-income countries have not been reported.
  
  
  METHODS
  An HIV Treatment Failure Clinic model was implemented within a large primary health care HIV treatment programme in northern KwaZulu-Natal, South Africa. Genotypic resistance testing was offered to adults (≥16 years) with virological failure on first-line antiretroviral therapy (one viral load >1000 copies/ml after at least 12 months on a standard first-line regimen). A genotypic resistance test report was generated with treatment recommendations from a specialist HIV clinician and sent to medical officers at the clinics who were responsible for patient management. A quantitative process evaluation was conducted to determine how the model was implemented and to provide feedback regarding barriers and challenges to delivery.
  
  
  RESULTS
  A total of 508 specimens were submitted for genotyping between 8 April 2011 and 31 January 2013; in 438 cases (86.2%) a complete genotype report with recommendations from the specialist clinician was sent to the medical officer. The median turnaround time from specimen collection to receipt of final report was 18 days (interquartile range (IQR) 13-29). In 114 (26.0%) cases the recommended treatment differed from what would be given in the absence of drug resistance testing. In the majority of cases (n = 315, 71.9%), the subsequent treatment prescribed was in line with the recommendations of the report.
  
  
  CONCLUSIONS
  Genotypic resistance testing was successfully implemented in this large primary health care HIV programme and the system functioned well enough for the results to influence clinical management decisions in real time. Further research will explore the impact and cost-effectiveness of different implementation models in different settings.
authors.affiliation: Africa Centre for Health and Population Studies, University of KwaZulu-Natal, PO Box 198, Mtubatuba, KwaZulu-Natal 3935, South Africa. rlessells@africacentre.ac.za.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Lessells
authors.forename: Katharine E
authors.initials: KE
authors.lastname: Stott
authors.forename: Justen
authors.initials: J
authors.lastname: Manasa
authors.forename: Kevindra K
authors.initials: KK
authors.lastname: Naidu
authors.forename: Andrew
authors.initials: A
authors.lastname: Skingsley
authors.forename: Theresa
authors.initials: T
authors.lastname: Rossouw
authors.forename: Tulio
authors.initials: T
authors.lastname: de Oliveira
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D024882:Drug Resistance, Viral; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests / Q000379:methods; D011320:Primary Health Care / Q000458:organization & administration; D019035:Rural Health Services / Q000458:organization & administration; D013019:South Africa / Q000453:epidemiology; D017211:Treatment Failure
chemical_list: D019380:Anti-HIV Agents