Enhanced Strategies to Improve the Quality of HIV Testing

1. Enhanced Strategies to Improve the Quality of HIV Testing ART in Pregnancy, Breastfeeding and Beyond June 18-20, 2012 Mireille Kalou, CGH/ILB Keisha Jackson, CGH/ILB Omotayo Bolu, CDC, Cameroon

2. Why Enhanced Focus on the Quality of HIV Rapid Testing? • First step to HIV prevention, care and treatment, and surveillance (ALL PROGRAMS) • Several reports of testing errors • >40 million people tested by RT in 2011 • 1% error = 400,000 wrong diagnosis • 5% error = 2 million wrong diagnosis • 10% error = 4 million wrong diagnosis • Impact of false HIV diagnosis at the individual and program level

3. Social/ Individual Implications of False HIV Diagnosis • False negative diagnosis • Not referred to care and treatment • Result in prevention failure (counseling and prophylaxis) • Can lead to more transmission to infant • False sense of security (negative HIV status) • False positive diagnosis • Individual/family stress • Stigma, discrimination • Personal and program cost • Side effects of ART • Loss of confidence in testing • Adverse impact on the program Huge Financial implications, when you have discordant, indeterminate test results

4. Anecdotal Reports: Rates of up 30 -50% false HIV negative/ positive results have been reported by some countries. Investigations are on going, but this reflects the need for improved quality improvement. • Boreas et al, JAIDS, 2012 (from Rwanda & Zambia):

5. Factors Impacting the Quality of HIV Testing • Use of sub-optimal test kits • Control specimens not used • Procedures not followed • Use of expired test kits • Deviation from country’s testing algorithm • Testing personnel not trained or under trained • Test results improperly recorded

6. Multi-step Approach: Ten Indicators of Quality Assurance Use of validated test kits (USAID-CDC validation) Testing Algorithm Hands-on training of trainers Certification Use of Local Partners for Scale-Up Standardized Logbook and Dried Tube Specimen (DTS) Proficiency Testing (PT) Data collection and analysis Corrective Actions Annual Refresher Training New Kit Lot Verification and Post-market surveillance Parekh, et al., Am J Clin Pathol. 2010 (134) 573-584

7. Approaches used for Improving Quality of RT • Proficiency testing using Dried Tube Specimen (DTS) • Standardized Log Book • Training Curriculum on Improving the Quality of RT

8. I. Proficiency Testing Program Using Dried Tube Specimens • Dried tube specimens (DTS) concept • Developed in the Serology laboratory, CDC/DGHA/ILB • Cost effective and practical alternative for proficiency testing programs • Easy to prepare and stable at room temperature for at least 4 weeks compared with traditional approach of shipping PT panels that require a cold chain system • Objectives • Panels of coded specimens sent to multiple test sites by reference laboratory • Test sites perform tests and report results • Results indicate quality of personnel performance and test site operations

9. Country Experience: DTS-PT Survey 2010 Performance Rate at PMTCT Sites (N=200) Staff turnover, Limited supervision

10. II. Standardized Log Book

11. Critical Variables to Add • HIV Test 1, 2, 3: • kit name, lot number, expiration date • Operator doing the test • Final QA Results

12. Example of Uganda Standardized Logbook

13. Implementation of Standardized logbook at Testing Sites • Revision of existing logbooks to include key QA elements • Training of supervisors and end-users • Monthly review of logbook data • Monthly supervision and corrective actions, if any • Feedback to MOH, CDC HQ and in Country programs, key stakeholder

14. Agreement Rates Between Test 1 and Test (2011), using the Log book Corrective Actions

15. Percentage of Invalid Results by Test Kit (2010), Using the Log Book

16. Percentage of Kit Stock-out Overtime, Using the Log Book , 2011

17. III. RT Quality Improvement Training Curriculum • Requires some adaptation • Country Experiences (Katy Yao et al, AJCP, 2010): • Uganda, Botswana: • All lab and non lab staff performed RT well • For non-lab staff regular supervision was critical • Staff not conducting test regularly did not do so well on proficiency test

18. Challenges in implementing the QA activities for HIV testing • DTS PT program • Lack of buy-in from PMTCT stakeholders and testing facilities • Staff not trained due to attrition or transfers of trained staffs • Logistics for PT panel distribution and result data collection • Standardized logbook • Multiple registers being used at PMTCT sites • Misplaced logbooks or only used by trained staff • Cost of printing registers and monthly supervision • Logistics for data collection • When used, logbook QA data not used for decision making • Training • Need for continuous training and retraining

19. Considerations for National Scale up • Advocacy to allocate resources to national and regional level to implement EQA approaches • Use of a combination of indigenous NGOs and a decentralized approach for the EQA program • National Reference Laboratory to provide oversight , coordinate supervisory visits and corrective actions • Involvement of in-country USG PMTCT team and national key stakeholders • Development of strategies for corrective actions • i.e. Standardized site visit tools which include testing QA elements • Decision tree for correctives • Include as part of other supportive supervisory visit (clinical/ lab related visits)

20. We need to have both lab and program teams working together to achieve better results PMTCT Cascade is achieved, when we work together as a team PMTCT Cascade is NOT achieved

21. Participation rate of PMTCT Sites in 2011 (N=200)