EARLY INFANT DIAGNOSIS & TREATMENTThe Swaziland Experience<br />Makaria Reynolds<br />Call to Action Project Director<br /...
Outline<br />Mortality of HIV-Infected Children<br />Importance of Early Initiation of Treatment<br />EID in Swaziland<br ...
Children Continue to Be Left Behind<br />Children constitute: <br />10% of new HIV infections each year<br /><ul><li>(280,...
90% in sub-Saharan Africa</li></ul>UNAIDS, 2008<br />3<br />
Mortality of HIV-infected Infants<br />4<br />Newell ML et al Lancet 2004; 364: 1236-43<br />1 Year = 35% mortality<br />2...
Early Initiation Saves Lives<br />From the Children with HIV Early Antiretroviral Therapy Study (CHER), Violari, NEJM 2008...
Key Steps in Reducing HIV-Related Mortality in Infants<br />Strong PMTCT programs<br />Follow up of mother-baby pairs and ...
The Swaziland experience<br />7<br />
EGPAF’s Programs in Swaziland<br />8<br /><ul><li>EGPAF began supporting PMTCXT in Swaziland in 2004
Technical assistance at the national level
Support for direct service delivery support
47 sites
All 4 regions</li></li></ul><li>HIV in Swaziland<br />42% HIV prevalence in ANC<br />1,651 new infant infections recorded ...
EID in Swaziland: Background<br />2007: EID using DNA PCR started<br />Health care workers trained in DBS collection<br />...
Establishing Country Capacity to Perform DNA PCR <br />Equipment:<br />Dedicated thermo cycler (PCR machine)<br />Two 48-w...
Main Impact of DNA PCR Equipment at NRL: Improved Turnaround Time<br />85% time savings<br />(from 18.1 to 2.7 days)<br />...
National EID Program Expansion <br />> 66% increase in samples run since December 2008<br />EGPAF sites = 47 (44% of total...
Quality Improvement Initiatives in the EID Program<br />Regular monitoring of sample quality and communication with sites ...
Knowing:Is it Really half the battle?<br />15<br />
Swaziland: Putting the 2008 WHO Recommendations into Practice<br />Adopted 2008 recommendation for initiation of ART in al...
Data Findings<br /><ul><li>124 infants were identified:
46 LTFU with no contact information
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Early Infant Diagnosis & Treatment: The Swaziland Experience

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  • Data from UNAIDS shows that in 2008 10% of all new HIV infections were in children, almost all of which occurred through mother-to-child transmission.In that same year, children made up about 6% of the total number of people living with HIV in the world.You may ask why there is such a discrepancy between these 2 numbers. Much of the reason is reflected in the third data point which shows that children accounted for 13% of AIDS-related deaths in 2008.
  • The progression of AIDS in children accelerates more quickly than in adults, leading to extremely high rates of mortality.At the bottom of this graph you will see a pink line indicating the relatively low mortality rates for children not infected with HV.Compare this now to the green line at the top of the graph which tracks the mortality rates of HIV-infected children over time. You will notice that by 1 year of age, 35% of HIV-infected infants have died. And by 2 years, that number reaches 53% and continues to climb over time.
  • But these high rates of infant mortality do not need to be accepted as inevitable. The progression of AIDS in a child can be slowed down and even paused by the timely initiation of antiretroviral therapy. Research has shown that a significant number of lives can be saved by initiating ART for HIV-infected infants immediately after diagnosis within the first few months of life. The chart here shows results from the CHER study in South Africa which demonstrated a 76% reduction in mortality when infants were started on treatment in those first 13 weeks after birth.
  • With the ultimate goal being prompt initiation of treatment, we need to recognize that there are several steps along the path to reaching this objective, many of which require complex systems and processes to be established.As other presenters are addressing many of the aspects listed on this slide, I will focus on steps 3-5.Knowing that an infant has been exposed, the earlier their HIV status can be confirmed, the quicker treatment can begin. In the earlier days of PTMCT programming, this required waiting for an infant to be old enough for standard HIV antibody testing to be done, often when the child was 12 months or older. Fortunately, more advanced testing methods are increasingly feasible in resource-limited settings, including the virological DNA PCR test using dried blood spots from an infant usually around 6 weeks of age. This allows HIV-infected infants to be diagnosed within weeks of birth rather than months.Scaling up programs for early infant diagnosis has been a priority within the Call to Action project.
  • To illustrate the key steps of early infant diagnosis and treatment, I’d like to share with you some of EGPAF’s experiences in Swaziland.
  • Since 2004 EGPAF has supported the Government of the Kingdom of Swaziland to scale up the national PMTCT and HIV care and treatment programsEGPAF supports the MOH through the provision of technical assistance at the national level and support for service delivery in 47 health facilities in all 4 regions of the country.
  • Swaziland currently has the highest HIV prevalence rates of any country in the world.42% of pregnant women attending ANC are HIV-positiveLast year, there were 1,651 new infant infections recordedThe impact of the AIDS epidemic in Swaziland is seen health indicators such as the under-5 mortality rate, which has doubled since the early nineties.
  • With a strong national PMTCT program in place, Swaziland has been aggressively addressing the issue of HIV infection in children.The national early infant diagnosis program using DNA PCR testing was officially launched in 2007Health care workers were trained by the Ministry of Health and partners on how to collect Dried Blood Spots from infants for testing and continual on-site mentoring was provided.Testing supplies were provided by the Clinton Foundation HIV/AIDS Initiative .And up until early 2009, all DBS samples were collected and sent to a labin South Africa for testing, as Swaziland did not have the capability at that time to run the tests in-country.
  • -That system changed in 2009, with the establishment of DNA PCR testing at the national reference laboratory in Swaziland.UNICEF procured equipment that allows 96 samples to be tested every day, of which 8 are quality control samples.As a side note in honor of the World Cup, I’d like to point out that funding for this lab equipment was raised by the soccer club FCBarcelona, which donated 40,000 Euros to UNICEF in Swaziland.The ministry of health has dedicated a full-time lab technician to run the tests with the support of a trainee technician. Additionally, there is a logistician who helps to manage the packaging of samples, data entry, and the crucial component of communicating test results to the individual health facilities.A new laboratory building was provided to house the equipment and the staff implementing this program.
  • The impact of Swaziland’s in-country testing capabilities is shown in this chart.On the right, you can see that it took an average of 18 days for testing to be done at the lab in South Africa and for the results to be ready for dissemination back to the health facilities.Compare that to the bar on the left which shows an average of 3 days turn around time with the in-country testing.The quicker the test results are sent back to facilities, the quicker infants can be initiated on life-saving treatment.
  • Since December of 2008, there has been a 66% increase in the number of DBS samples tested nationwide.This is due to both an increase in the number of sites provided early infant diagnosis services as well as the in-country testing capabilities.
  • While the shorter turn around times have been a major achievement, the Swaziland program has also put systems in place to ensure the quality of the DNA PCR testing program.Quality assurance samples are tested daily and the lab technician communicates directly with sites about any potential problems or issues with samples.The ministry of health has developed and distributed memos to health facility staff on improving sample quality, the proper storage of DBS cards and the appropriate packaging of samples.And to ensure that information sharing is taking place, there are semi-annual EID feedback meetings and regular reporting updates at meetings of the pediatric HIV/AIDS technical working group.
  • There is a saying that knowing is half the battle. But when it comes to early infant diagnosis, is that really rue?I don’t want to downplay the vital importance of knowing an HIV-infected child’s status.But I do want to highlight the tremendous efforts required to move from knowing to treating.
  • In 2008, Swaziland adopted the WHO’s recommendation that all HIV-positive infants be initiated on treatment, regardless of clinical stage or CD4 percentage.These changes were first piloted in 3 health facilities.The impact of the pilot was studied through a patient record review in late 2008. Staff looked through records at 2 high-volume sites to find all the infants who had been found to be HIV-positive through DNA PCR that were still under the age of 12 months.
  • This is what they found.Out of 124 infants identified, ten had died and 18 were on ART.46 were lost to follow up, meaning there was no contact information available and no return appointments had been kept.50 other infants had not been initiated on ART, possibly due to the DNA PCR results not having been returned to the caregivers.The staff undertook intenseive efforts to track down these 50 infants and to bring them back to the facilities for initiation of treatment. EGPAF provided mobile phones and airtime for staff to call caregivers to urge them to bring in their child to the facility. Patient charts were also flagged indicating the need for treatment initiation during the next encounter with a health provider.
  • So, the final results of this initiative were an unfortunate total of 47% of the infants lost to follow up,15% died before treatment,3% refused treatment,And 35% initiated on ART, more than doubling the number of infants being treated before the intervention.
  • Despite the improvement in treatment initiation in the last example, I think we can all agree that there is an unacceptable number of HIV-positive infants being lost before treatment.One of the major hurdles is getting the DNA PCR results back to families so that they can act upon that information. I won’t go into the details of the challenges in doing this, but will give a quick overview of some of the strategies employed by EGPAF in Swaziland as they support health facilities to disseminate test results to caregivers.A first step is to educate staff and caregivers about importance of prompt follow up for infant diagnosis and the possible consequences to delaying treatment for any amount of time. Parents and caregivers want what’s best for their child, but they need to be counseled on WHY this is such a critical issue.Staff need to be trained on how to thoroughly capture contact information for caregivers, with multiple phone numbers, addresses, etc so that there is no excuse for a child to be lost to follow up.Each health facility should specifically identify someone who is responsible for contacting families with results and to schedule follow-up appointments. This could be a health provider, a trained counselor, or village health worker who is assigned to this task.In order for this person to do their job, they need to have the resources to actively follow-up on each case. They should be provided mechanisms such as cell phones and airtime, a bicycle, or travel stipends to physically track down families.A register should be established that tracks the status of test result delivery so there is no confusion on if or when caregivers have been informed.Finally, sites should consider adding program indicators to track their progress on delivering results and to encourage improvement over time.
  • Early Infant Diagnosis & Treatment: The Swaziland Experience

    1. 1. EARLY INFANT DIAGNOSIS & TREATMENTThe Swaziland Experience<br />Makaria Reynolds<br />Call to Action Project Director<br />Elizabeth Glaser Pediatric AIDS Foundation<br />June 17, 2010<br />
    2. 2. Outline<br />Mortality of HIV-Infected Children<br />Importance of Early Initiation of Treatment<br />EID in Swaziland<br />Knowing: Is it really half the battle?<br />Programming for Early Initiation of Treatment<br />Conclusions<br />2<br />
    3. 3. Children Continue to Be Left Behind<br />Children constitute: <br />10% of new HIV infections each year<br /><ul><li>(280,000 out of 2.7 million) </li></ul>6% of the persons living with HIV<br /><ul><li>(2 million out of 33 million)</li></ul>13% of HIV/AIDS deaths each year <br /><ul><li>(270,000 out of 3 million)
    4. 4. 90% in sub-Saharan Africa</li></ul>UNAIDS, 2008<br />3<br />
    5. 5. Mortality of HIV-infected Infants<br />4<br />Newell ML et al Lancet 2004; 364: 1236-43<br />1 Year = 35% mortality<br />2 Years = 53% mortality<br />
    6. 6. Early Initiation Saves Lives<br />From the Children with HIV Early Antiretroviral Therapy Study (CHER), Violari, NEJM 2008<br />5<br />
    7. 7. Key Steps in Reducing HIV-Related Mortality in Infants<br />Strong PMTCT programs<br />Follow up of mother-baby pairs and tracking exposure status of infants<br />Clinical monitoring & evaluation<br />Test infants early (DNA PCR) and get results back<br />Prompt treatment<br />6<br />
    8. 8. The Swaziland experience<br />7<br />
    9. 9. EGPAF’s Programs in Swaziland<br />8<br /><ul><li>EGPAF began supporting PMTCXT in Swaziland in 2004
    10. 10. Technical assistance at the national level
    11. 11. Support for direct service delivery support
    12. 12. 47 sites
    13. 13. All 4 regions</li></li></ul><li>HIV in Swaziland<br />42% HIV prevalence in ANC<br />1,651 new infant infections recorded in 2009<br />Under-5 mortality rate has doubled:<br />60 per 1,000 live births in 1992 <br />120 per 1,000 live births in 2007<br />9<br />
    14. 14. EID in Swaziland: Background<br />2007: EID using DNA PCR started<br />Health care workers trained in DBS collection<br />Testing supplies provided by CHAI<br />Samples were sent to South Africa for testing<br />10<br />
    15. 15. Establishing Country Capacity to Perform DNA PCR <br />Equipment:<br />Dedicated thermo cycler (PCR machine)<br />Two 48-well heating blocks<br />Auto Puncher<br />*All equipment was donated to NRL in 2008 by UNICEF (with funds from FC Barcelona)<br />Personnel:<br />1 dedicated Lab Technician + 1 trainee<br />Can test 96 samples/day (each set of 96 includes 8 controls)<br />Dedicated logistician/data clerk to manage sample packaging, results communication, data entry, etc.<br />Space:<br />New laboratory building with adequate space for all equipment and personnel<br />11<br />
    16. 16. Main Impact of DNA PCR Equipment at NRL: Improved Turnaround Time<br />85% time savings<br />(from 18.1 to 2.7 days)<br />12<br />
    17. 17. National EID Program Expansion <br />> 66% increase in samples run since December 2008<br />EGPAF sites = 47 (44% of total); EGPAF samples = 6,310 (68% of total)<br />13<br />
    18. 18. Quality Improvement Initiatives in the EID Program<br />Regular monitoring of sample quality and communication with sites about issues<br />Memos for health facilities on improving sample quality, storage of DBS cards, packaging of samples, etc.<br />Information-sharing at EID feedback meetings and Pediatric HIV/AIDS Technical Working Group Meetings<br />14<br />
    19. 19. Knowing:Is it Really half the battle?<br />15<br />
    20. 20. Swaziland: Putting the 2008 WHO Recommendations into Practice<br />Adopted 2008 recommendation for initiation of ART in all infants<br />Piloted in 3 sites with good partner support <br /><ul><li>Between Aug and Nov 2008, staff reviewed records from 2 high-volume sites to find all HIV-positive infants under 12 months of age</li></ul>16<br />
    21. 21. Data Findings<br /><ul><li>124 infants were identified:
    22. 22. 46 LTFU with no contact information
    23. 23. 10 died
    24. 24. 18 on ART
    25. 25. Intensive efforts were made to track down the 50 eligible children and initiate them on ART
    26. 26. Phone communication and/or chart flagging was attempted for the 50 who had not previously qualified for ARVs or who hadn’t returned</li></ul>10 Died<br />18 on ART<br />46<br />LTFU<br />124<br />50 not on ART<br />17<br />
    27. 27. 50<br />8 Died<br />12 LTFU<br />Contacted<br />26 Initiated<br />ART<br />4 Refused<br />Swaziland Active Follow-Up Results<br /><ul><li>Phone calls were more effective than chart flagging
    28. 28. Staff invested significant time in calling patients
    29. 29. Many clients had incorrect information recorded
    30. 30. Some infants had died</li></ul>18<br />
    31. 31. This initiative More than Doubled the Number of Infants Initiating ART<br />46<br />LTFU<br />58<br />LTFU<br />Total 124 infants identified:<br /><ul><li>47% LTFU
    32. 32. 15% died before initiation
    33. 33. 3% refused
    34. 34. 35% started ART</li></ul>10 Died<br />50 not on ART<br />18 Died<br />4 Refused<br />18 Already<br />on ART<br />26 Started<br />On ART<br />44<br />18 on ART<br />ART<br />August 2008<br />October 2008<br />19<br />
    35. 35. Getting Results to Families<br />Scale-up plans must include site preparation to systematize follow-up and ensure that results get to families:<br /><ul><li>Educate staff and caregivers about importance of prompt follow up for diagnosis and treatment
    36. 36. Recording detailed contact information
    37. 37. Identify a person who will contact families
    38. 38. Provide mechanism for follow up (phones and airtime)
    39. 39. Set up register to easily identify when results are given
    40. 40. Add program indicators on % PCR results given to families and percent of PCR positive initiating treatment</li></ul>20<br />
    41. 41. Conclusions<br /><ul><li>EID is a process,not a lab test
    42. 42. Scale-up plans must include site preparation to systematize follow-up and ensure that results get to families
    43. 43. Investment in DNA PCR technology must be connected to an investment in programming to use the test results
    44. 44. “EID” must be followed by “T”</li></ul>21<br />
    45. 45. THANK YOU!<br /><ul><li>Mary Pat Kieffer, Mohammed Mahdi, Caspian Chouraya and all the EGPAF Swaziland Team
    46. 46. BhekieLukhele
    47. 47. Swaziland Ministry of Health
    48. 48. Swaziland National AIDS Program
    49. 49. USAID & PEPFAR
    50. 50. Baylor International Pediatric AIDS Initiative
    51. 51. Johnson & Johnson
    52. 52. Bill & Melinda Gates Foundation
    53. 53. Abbott Fund
    54. 54. Clinton Foundation (CHAI)
    55. 55. UNICEF
    56. 56. Collaborating Partners & Donors</li></ul>22<br />DISCLAIMER: This program was made possible through support provided by the Office of HIV/AIDS, Global Bureau Center for Population, Health and Nutrition, of the United States Agency for International Development (USAID), through the President’s Emergency Plan for AIDS Relief, as part of the Elizabeth Glaser Pediatric AIDS Foundation's International Family AIDS Initiatives (“Call To Action Project”/ Cooperative Agreement No. GPH-A-00-02-00011-00). Private donors also supported costs of activities in many countries. The opinions expressed herein are those of the authors and do not necessarily reflect the views of USAID. <br />

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