Case
Teaching Notes
Supplementary Resources
Abstract
Roger Osayende, a former management consultant, must advise the Ministry of Health of Ektu, a fictional country in Central Africa, on how to implement a new point-of-care diagnostic test for infants with HIV. In Ektu, mothers often transmitted HIV infection to infants during pregnancy, delivery, or breastfeeding due to inadequate resources to invest in prevention efforts. The existing procedure to diagnose infants with HIV required collecting dried blood samples at more than two hundred healthcare facilities around the country and transporting them to a central laboratory in the capital for testing. This process was characterized by significant delays due to long transportation times, batching of samples in transportation and processing in the lab, and concomitant congestion in the lab. This delay resulted in loss to follow-up, that is, lost patients due to mothers not collecting their infants' results. A new point-of-care device was about to be introduced, which would obviate the need for this centralized processing and the resulting diagnostic delay. The key decision under consideration is where to place the devices to maximize their effectiveness.
This case was prepared for inclusion in Sage Business Cases primarily as a basis for classroom discussion or self-study, and is not meant to illustrate either effective or ineffective management styles. Nothing herein shall be deemed to be an endorsement of any kind. This case is for scholarly, educational, or personal use only within your university, and cannot be forwarded outside the university or used for other commercial purposes.
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Resources
Exhibit 1: HIV Disease Burden for Selected Countries in Sub-Saharan Africa
Country | Disease Burden | Number of Central Labs Capable of Performing Infant DBS Testing |
Botswana | 33.7% of pregnant women infected in 2007 | 1 |
Kenya | > 100,000 pregnant women HIV infected/year | 3 |
Uganda | 91,000 HIV-exposed infants born per year | 8 |
Zambia | 35,374 infants were tested for HIV in 2009 | 3 |
Sources:
Botswana: William Jimbo, “Early Infant Diagnosis Data Collection, Management, and Analysis for Program Monitoring,” presented at Early Infant HIV Diagnosis Conference, Arusha, Tanzania, May 13–15, 2010.
Kenya: Shobha N. Vakil, “Early Infant Diagnosis: Improving PMTCT and Paediatric HIV Programs,” presented at Early Infant HIV Diagnosis Conference, Arusha, Tanzania, May 13–15, 2010.
Uganda: Julie Nabweteme Mugerwa, “Postnatal Followup Among HIV-Exposed Infants Whose Mothers Received ARVs During Antenatal Clinic in Mulago Hospital,” presented at 4th National Paediatric HIV Conference, Kampala, Uganda, September 28–30, 2010, http://www.upa.or.ug/dloads/E.%20Julie%20Nabweteme-%20Postnatal%20follow-up%20.pdf.
Zambia: Rokaya Ginwalla, “Zambia EID Program Overview,” presented at Early Infant HIV Diagnosis Conference, Arusha, Tanzania, May 13–15, 2010.
Exhibit 2: Summary of Dried Blood Spot Testing Procedure
Source: International Center for AIDS Care and Treatment Programs, Mailman School of Public Health, Columbia University, “Collection, Storage and Transportation of Dried Blood Spots for Infant Diagnosis,” http://www.columbia-icap.org/resources/peds/files/CollectionstoragetransDBS.ppt (accessed May 15, 2011).
Exhibit 3: Details of the Healthcare Pyramid in Ektu
Provider Level | Typical Location | Description | Example of Services | Infant DBS Testing | Infant HIV Testing Capabilities | DBS Sample Transportation |
5 | Capital/major city | Flagship government-run teaching hospital | Extensive services including surgery | Infant testing performed on-site | PCR machines available on-site for infant DBS testing | N/A |
4 | Major cities | Small hospital | Simple surgeries, moderate imaging, communicable disease treatment | DBS cards collected, but not tested on-site | None | Transported to central lab multiple times per week on a well-established schedule |
3 | Major cities or rural economic centers | Large clinic | Communicable disease, dental, x-rays, maternal and child health | DBS cards collected, but not tested on-site | None | Transported to central lab once per week on a well-established schedule |
2 | Cities or rural towns | Medium clinic | Communicable disease, maternal and child health | DBS cards collected, but not tested on-site | None | Urban: Transported to central lab using a motorbike when a large number has been collected Rural: Transported by NGO couriers on a varying schedule, a few times each month |
1 | Rural areas | Small clinic | Communicable disease | DBS cards collected, but not tested on-site | None | Transported by NGO couriers on a varying schedule about once a month |
Exhibit 4: Kimwame Clinic Infant HIV Test Result Storage
Exhibit 5: Timeline of Geradine's Story
Exhibit 6: Study of Dispatch of DBS Samples from Remote Clinics to the Central Lab
Clinic Number | Dispatch 1 | Dispatch 2 | Dispatch 3 |
1 | 6/5/2010, 4 samples | 6/19/2010, 5 samples | 7/3/2010, 5 samples |
2 | 6/5/2010, 5 samples | 6/30/2010, 4 samples | 7/22/2010, 4 samples |
3 | 6/13/2010, 3 samples | 6/23/2010, 3 samples | 7/1/2010, 3 samples |
4 | 6/11/2010, 3 samples | 6/25/2010, 3 samples | 7/7/2010, 2 samples |
5 | 6/16/2010, 2 samples | 6/21/2010, 2 samples | 7/3/2010, 2 samples |
6 | 6/14/2010, 4 samples | 7/3/2010, 4 samples | 7/16/2010, 4 samples |
7 | 6/10/2010, 2 samples | 6/18/2010, 2 samples | 7/1/2010, 2 samples |
8 | 6/11/2010, 4 samples | 7/19/2010, 3 samples | 8/25/2010, 3 samples |
9 | 6/3/2010, 6 samples | 6/14/2010, 6 samples | 7/1/2010, 7 samples |
10 | 6/10/2010, 3 samples | 6/23/2010, 3 samples | 7/12/2010, 3 samples |
11 | 6/15/2010, 9 samples | 6/30/2010, 9 samples | 7/17/2010, 11 samples |
12 | 6/17/2010, 24 samples | 7/1/2010, 21 samples | 7/11/2010, 20 samples |
13 | 6/10/2010, 3 samples | 6/24/2010, 3 samples | 7/10/2010, 3 samples |
14 | 6/6/2010, 6 samples | 6/10/2010, 6 samples | 6/19/2010, 5 samples |
15 | 6/17/2010, 8 samples | 6/28/2010, 8 samples | 7/9/2010, 12 samples |
16 | 6/14/2010, 11 samples | 7/11/2010, 17 samples | 8/6/2010, 16 samples |
17 | 6/9/2010, 7 samples | 7/5/2010, 5 samples | 8/1/2010, 5 samples |
18 | 6/12/2010, 3 samples | 6/18/2010, 3 samples | 6/24/2010, 3 samples |
19 | 6/12/2010, 7 samples | 6/27/2010, 7 samples | 7/13/2010, 6 samples |
20 | 6/12/2010, 3 samples | 6/22/2010, 3 samples | 7/5/2010, 3 samples |
21 | 6/6/2010, 6 samples | 6/16/2010, 7 samples | 6/30/2010, 6 samples |
22 | 6/4/2010, 5 samples | 6/19/2010, 6 samples | 7/3/2010, 5 samples |
23 | 6/6/2010, 9 samples | 6/18/2010, 8 samples | 7/2/2010, 8 samples |
24 | 6/17/2010, 7 samples | 7/9/2010, 7 samples | 7/31/2010, 7 samples |
25 | 6/15/2010, 7 samples | 7/3/2010, 7 samples | 7/16/2010, 6 samples |
26 | 6/15/2010, 18 samples | 7/2/2010, 15 samples | 7/16/2010, 15 samples |
27 | 6/10/2010, 15 samples | 6/25/2010, 12 samples | 7/12/2010, 12 samples |
28 | 6/9/2010, 11 samples | 6/28/2010, 15 samples | 7/19/2010, 15 samples |
29 | 6/8/2010, 23 samples | 6/22/2010, 1 samples | 7/11/2010, 30 samples |
30 | 6/5/2010, 4 samples | 6/15/2010, 4 samples | 7/1/2010, 4 samples |
31 | 6/10/2010, 2 samples | 6/25/2010, 2 samples | 7/6/2010, 2 samples |
32 | 6/16/2010, 4 samples | 7/6/2010, 4 samples | 7/25/2010, 5 samples |
33 | 6/10/2010, 3 samples | 6/28/2010, 3 samples | 7/15/2010, 3 samples |
34 | 6/7/2010, 3 samples | 6/26/2010, 3 samples | 7/17/2010, 4 samples |
35 | 6/6/2010, 11 samples | 6/23/2010, 14 samples | 7/12/2010, 14 samples |
36 | 6/12/2010, 15 samples | 6/25/2010, 15 samples | 7/6/2010, 17 samples |
37 | 6/6/2010, 9 samples | 7/11/2010, 9 samples | 8/18/2010, 9 samples |
38 | 6/9/2010, 19 samples | 6/26/2010, 22 samples | 7/8/2010, 15 samples |
39 | 6/16/2010, 7 samples | 7/3/2010, 6 samples | 7/20/2010, 5 samples |
40 | 6/5/2010, 8 samples | 6/23/2010, 7 samples | 7/9/2010, 7 samples |
41 | 6/16/2010, 5 samples | 6/30/2010, 5 samples | 7/19/2010, 6 samples |
42 | 6/3/2010, 3 samples | 6/22/2010, 2 samples | 7/13/2010, 2 samples |
43 | 6/12/2010, 17 samples | 7/15/2010, 26 samples | 8/14/2010, 25 samples |
44 | 6/7/2010, 23 samples | 6/30/2010, 26 samples | 7/18/2010, 20 samples |
45 | 6/9/2010, 30 samples | 7/18/2010, 28 samples | 8/27/2010, 30 samples |
46 | 6/7/2010, 3 samples | 6/20/2010, 4 samples | 7/3/2010, 4 samples |
47 | 6/12/2010, 6 samples | 7/1/2010, 4 samples | 7/20/2010, 6 samples |
48 | 6/14/2010, 8 samples | 7/2/2010, 11 samples | 7/15/2010, 8 samples |
49 | 6/5/2010, 23 samples | 6/27/2010, 18 samples | 7/25/2010, 23 samples |
50 | 6/7/2010, 5 samples | 7/2/2010, 5 samples | 7/19/2010, 4 samples |
Exhibit 7: Study of Transport Time Between Clinic and Central Lab
Clinic Number | From Clinic to Central Lab (days) | From Central Lab to Clinic (days) |
1 | 5 | 4 |
2 | 6 | 5 |
3 | 4 | 3 |
4 | 5 | 6 |
5 | 3 | 4 |
6 | 6 | 5 |
7 | 3 | 3 |
8 | 9 | 10 |
9 | 5 | 5 |
10 | 5 | 6 |
11 | 5 | 5 |
12 | 6 | 5 |
13 | 4 | 4 |
14 | 3 | 3 |
15 | 4 | 5 |
16 | 7 | 6 |
17 | 8 | 7 |
18 | 3 | 2 |
19 | 6 | 6 |
20 | 5 | 6 |
21 | 6 | 5 |
22 | 5 | 6 |
23 | 4 | 4 |
24 | 7 | 6 |
25 | 6 | 7 |
26 | 5 | 5 |
27 | 7 | 6 |
28 | 8 | 7 |
29 | 6 | 6 |
30 | 5 | 5 |
31 | 5 | 6 |
32 | 8 | 7 |
33 | 6 | 6 |
34 | 8 | 9 |
35 | 7 | 6 |
36 | 4 | 4 |
37 | 12 | 10 |
38 | 6 | 5 |
39 | 7 | 6 |
40 | 7 | 6 |
41 | 5 | 5 |
42 | 8 | 7 |
43 | 9 | 8 |
44 | 6 | 6 |
45 | 10 | 9 |
46 | 4 | 3 |
47 | 6 | 5 |
48 | 6 | 6 |
49 | 8 | 7 |
50 | 6 | 6 |
Exhibit 8: Central Lab DBS Sample Arrival Log Book (March 2, 2010 to April 26, 2010)
Date | Clinic | Samples |
3/2/2010 | 7 | 3 |
3/2/2010 | 15 | 4 |
3/2/2010 | 38 | 6 |
3/2/2010 | 46 | 5 |
3/3/2010 | 2 | 4 |
3/3/2010 | 9 | 13 |
3/3/2010 | 11 | 5 |
3/3/2010 | 14 | 18 |
3/3/2010 | 22 | 6 |
3/3/2010 | 33 | 8 |
3/3/2010 | 40 | 6 |
3/3/2010 | 42 | 6 |
3/3/2010 | 45 | 11 |
3/4/2010 | 9 | 8 |
3/4/2010 | 16 | 13 |
3/4/2010 | 17 | 11 |
3/4/2010 | 30 | 2 |
3/4/2010 | 31 | 4 |
3/4/2010 | 47 | 8 |
3/4/2010 | 48 | 9 |
3/5/2010 | 3 | 8 |
3/5/2010 | 7 | 9 |
3/5/2010 | 11 | 9 |
3/5/2010 | 15 | 10 |
3/5/2010 | 19 | 2 |
3/5/2010 | 24 | 7 |
3/5/2010 | 27 | 16 |
3/5/2010 | 34 | 8 |
3/5/2010 | 38 | 5 |
3/5/2010 | 42 | 7 |
3/5/2010 | 46 | 6 |
3/5/2010 | 50 | 3 |
3/6/2010 | 3 | 8 |
3/6/2010 | 4 | 2 |
3/6/2010 | 6 | 5 |
3/6/2010 | 13 | 1 |
3/6/2010 | 18 | 3 |
3/6/2010 | 34 | 11 |
3/6/2010 | 35 | 2 |
3/6/2010 | 37 | 10 |
3/6/2010 | 44 | 7 |
3/6/2010 | 49 | 9 |
3/9/2010 | 1 | 6 |
3/9/2010 | 3 | 4 |
3/9/2010 | 10 | 6 |
3/9/2010 | 11 | 11 |
3/9/2010 | 26 | 31 |
3/9/2010 | 32 | 8 |
3/9/2010 | 34 | 6 |
3/9/2010 | 41 | 9 |
3/9/2010 | 42 | 5 |
3/9/2010 | 43 | 8 |
3/10/2010 | 7 | 19 |
3/10/2010 | 9 | 15 |
3/10/2010 | 13 | 21 |
3/10/2010 | 38 | 8 |
3/10/2010 | 40 | 7 |
3/10/2010 | 44 | 3 |
3/11/2010 | 2 | 11 |
3/11/2010 | 4 | 15 |
3/11/2010 | 8 | 6 |
3/11/2010 | 11 | 2 |
3/11/2010 | 17 | 13 |
3/11/2010 | 30 | 3 |
3/11/2010 | 33 | 9 |
3/11/2010 | 35 | 3 |
3/11/2010 | 39 | 12 |
3/11/2010 | 41 | 12 |
3/11/2010 | 42 | 3 |
3/11/2010 | 43 | 9 |
3/11/2010 | 45 | 9 |
3/11/2010 | 48 | 8 |
3/12/2010 | 18 | 3 |
3/12/2010 | 23 | 9 |
3/12/2010 | 49 | 6 |
3/13/2010 | 3 | 3 |
3/13/2010 | 10 | 3 |
3/13/2010 | 20 | 3 |
3/13/2010 | 21 | 7 |
3/13/2010 | 34 | 15 |
3/13/2010 | 41 | 15 |
3/13/2010 | 43 | 8 |
3/16/2010 | 1 | 6 |
3/16/2010 | 8 | 10 |
3/16/2010 | 29 | 31 |
3/16/2010 | 32 | 6 |
3/16/2010 | 39 | 9 |
3/16/2010 | 41 | 6 |
3/16/2010 | 43 | 5 |
3/17/2010 | 5 | 4 |
3/17/2010 | 6 | 9 |
3/17/2010 | 16 | 5 |
3/17/2010 | 17 | 12 |
3/17/2010 | 22 | 10 |
3/17/2010 | 36 | 15 |
3/17/2010 | 37 | 12 |
3/17/2010 | 47 | 5 |
3/17/2010 | 48 | 6 |
3/18/2010 | 1 | 5 |
3/18/2010 | 3 | 4 |
3/18/2010 | 32 | 5 |
3/18/2010 | 34 | 6 |
3/19/2010 | 12 | 22 |
3/19/2010 | 28 | 13 |
3/20/2010 | 7 | 20 |
3/20/2010 | 15 | 22 |
3/20/2010 | 15 | 8 |
3/20/2010 | 18 | 1 |
3/20/2010 | 27 | 15 |
3/20/2010 | 38 | 3 |
3/20/2010 | 46 | 3 |
3/20/2010 | 46 | 7 |
3/20/2010 | 49 | 3 |
3/23/2010 | 4 | 12 |
3/23/2010 | 10 | 4 |
3/23/2010 | 15 | 8 |
3/23/2010 | 19 | 4 |
3/23/2010 | 21 | 13 |
3/23/2010 | 23 | 8 |
3/23/2010 | 25 | 7 |
3/23/2010 | 41 | 9 |
3/23/2010 | 43 | 12 |
3/23/2010 | 46 | 5 |
3/23/2010 | 50 | 7 |
3/24/2010 | 5 | 24 |
3/24/2010 | 6 | 5 |
3/24/2010 | 7 | 5 |
3/24/2010 | 20 | 8 |
3/24/2010 | 24 | 21 |
3/24/2010 | 36 | 11 |
3/24/2010 | 37 | 6 |
3/24/2010 | 38 | 3 |
3/25/2010 | 13 | 7 |
3/25/2010 | 18 | 3 |
3/25/2010 | 30 | 5 |
3/25/2010 | 44 | 6 |
3/25/2010 | 49 | 8 |
3/26/2010 | 12 | 21 |
3/26/2010 | 31 | 2 |
3/27/2010 | 4 | 3 |
3/27/2010 | 5 | 1 |
3/27/2010 | 9 | 5 |
3/27/2010 | 16 | 16 |
3/27/2010 | 18 | 19 |
3/27/2010 | 36 | 6 |
3/27/2010 | 47 | 5 |
3/27/2010 | 49 | 11 |
3/30/2010 | 2 | 3 |
3/30/2010 | 19 | 5 |
3/30/2010 | 21 | 6 |
3/30/2010 | 28 | 13 |
3/30/2010 | 30 | 5 |
3/30/2010 | 33 | 7 |
3/30/2010 | 45 | 10 |
3/30/2010 | 50 | 4 |
3/31/2010 | 4 | 3 |
3/31/2010 | 6 | 4 |
3/31/2010 | 37 | 15 |
4/1/2010 | 2 | 7 |
4/1/2010 | 8 | 5 |
4/1/2010 | 13 | 21 |
4/1/2010 | 14 | 5 |
4/1/2010 | 15 | 3 |
4/1/2010 | 33 | 11 |
4/1/2010 | 39 | 8 |
4/1/2010 | 44 | 4 |
4/1/2010 | 45 | 8 |
4/1/2010 | 46 | 3 |
4/2/2010 | 3 | 4 |
4/2/2010 | 9 | 17 |
4/2/2010 | 10 | 7 |
4/2/2010 | 26 | 14 |
4/2/2010 | 34 | 8 |
4/2/2010 | 40 | 5 |
4/2/2010 | 41 | 13 |
4/2/2010 | 43 | 6 |
4/3/2010 | 5 | 1 |
4/3/2010 | 7 | 1 |
4/3/2010 | 36 | 14 |
4/3/2010 | 38 | 5 |
4/6/2010 | 13 | 3 |
4/6/2010 | 16 | 5 |
4/6/2010 | 17 | 7 |
4/6/2010 | 44 | 6 |
4/6/2010 | 47 | 6 |
4/6/2010 | 48 | 7 |
4/7/2010 | 7 | 2 |
4/7/2010 | 25 | 10 |
4/8/2010 | 10 | 4 |
4/8/2010 | 14 | 4 |
4/8/2010 | 14 | 25 |
4/8/2010 | 18 | 3 |
4/8/2010 | 29 | 30 |
4/8/2010 | 41 | 6 |
4/8/2010 | 43 | 9 |
4/8/2010 | 49 | 5 |
4/9/2010 | 3 | 4 |
4/9/2010 | 11 | 12 |
4/9/2010 | 11 | 8 |
4/9/2010 | 12 | 21 |
4/9/2010 | 17 | 11 |
4/9/2010 | 34 | 9 |
4/9/2010 | 42 | 7 |
4/9/2010 | 42 | 9 |
4/9/2010 | 48 | 11 |
4/10/2010 | 3 | 3 |
4/10/2010 | 15 | 10 |
4/10/2010 | 26 | 25 |
4/10/2010 | 34 | 5 |
4/10/2010 | 46 | 5 |
4/13/2010 | 5 | 16 |
4/13/2010 | 14 | 5 |
4/13/2010 | 36 | 11 |
4/14/2010 | 2 | 1 |
4/14/2010 | 9 | 6 |
4/14/2010 | 10 | 9 |
4/14/2010 | 31 | 4 |
4/14/2010 | 33 | 6 |
4/14/2010 | 40 | 2 |
4/14/2010 | 41 | 7 |
4/14/2010 | 43 | 6 |
4/14/2010 | 45 | 9 |
4/15/2010 | 7 | 1 |
4/15/2010 | 17 | 11 |
4/15/2010 | 18 | 3 |
4/15/2010 | 21 | 15 |
4/15/2010 | 24 | 10 |
4/15/2010 | 48 | 7 |
4/15/2010 | 49 | 7 |
4/16/2010 | 4 | 5 |
4/16/2010 | 5 | 6 |
4/16/2010 | 7 | 19 |
4/16/2010 | 16 | 4 |
4/16/2010 | 19 | 8 |
4/16/2010 | 20 | 3 |
4/16/2010 | 35 | 2 |
4/16/2010 | 36 | 8 |
4/16/2010 | 47 | 3 |
4/16/2010 | 50 | 8 |
4/17/2010 | 1 | 4 |
4/17/2010 | 4 | 14 |
4/17/2010 | 9 | 7 |
4/17/2010 | 19 | 6 |
4/17/2010 | 29 | 30 |
4/17/2010 | 32 | 5 |
4/17/2010 | 35 | 3 |
4/17/2010 | 50 | 6 |
4/20/2010 | 6 | 8 |
4/20/2010 | 7 | 4 |
4/20/2010 | 11 | 11 |
4/20/2010 | 12 | 23 |
4/20/2010 | 20 | 4 |
4/20/2010 | 37 | 9 |
4/20/2010 | 41 | 12 |
4/20/2010 | 42 | 8 |
4/21/2010 | 1 | 4 |
4/21/2010 | 2 | 3 |
4/21/2010 | 5 | 17 |
4/21/2010 | 8 | 5 |
4/21/2010 | 18 | 19 |
4/21/2010 | 21 | 6 |
4/21/2010 | 32 | 4 |
4/21/2010 | 33 | 7 |
4/21/2010 | 36 | 16 |
4/21/2010 | 39 | 10 |
4/21/2010 | 45 | 7 |
4/21/2010 | 49 | 5 |
4/22/2010 | 1 | 6 |
4/22/2010 | 5 | 6 |
4/22/2010 | 9 | 6 |
4/22/2010 | 16 | 14 |
4/22/2010 | 27 | 13 |
4/22/2010 | 30 | 3 |
4/22/2010 | 31 | 1 |
4/22/2010 | 32 | 2 |
4/22/2010 | 36 | 9 |
4/22/2010 | 40 | 3 |
4/22/2010 | 47 | 5 |
4/23/2010 | 2 | 4 |
4/23/2010 | 33 | 7 |
4/23/2010 | 45 | 2 |
4/24/2010 | 4 | 3 |
4/24/2010 | 6 | 3 |
4/24/2010 | 8 | 6 |
4/24/2010 | 19 | 8 |
4/24/2010 | 28 | 13 |
4/24/2010 | 35 | 3 |
4/26/2010 | 37 | 10 |
4/26/2010 | 39 | 16 |
4/26/2010 | 50 | 7 |
Exhibit 9: Central Lab DBS Sample Post-Processing Log Book
Processing Complete | Results From Clinics | Date Results Ready For Dispatch |
9/1/2010 | 7, 10, 46, 39, 38, 3, 42, 37, 25, 44, 53, 1, 47 | 9/3/2010 |
9/8/2010 | 1, 39, 8, 22, 23, 12, 52, 41, 27, 33, 49, 17, 16, 5, 40, 28, 47, 35, 24, 32 | 9/13/2010 |
9/22/2010 | 48, 8, 19, 52, 15, 46, 33, 36, 50, 18, 3, 6 | 9/22/2010 |
9/29/2010 | 36, 22, 25, 8, 43, 46 | 10/4/2010 |
10/6/2010 | 39, 27, 6, 16, 1, 31, 30, 41, 53, 3, 48, 10, 29, 51 | 10/8/2010 |
10/13/2010 | 29, 35, 4, 19, 32, 43, 49, 11, 18, 6 | 10/14/2010 |
10/27/2010 | 36, 23, 47, 43, 44, 27, 35, 46, 32, 15, 37 | 10/29/2010 |
11/10/2010 | 10, 47, 18, 46, 45, 49, 44, 19 | 11/12/2010 |
11/17/2010 | 45, 1, 21, 3, 9, 30, 28, 24 | 11/18/2010 |
11/24/2010 | 38, 46, 23, 14, 39, 44, 7 | 11/24/2010 |
Exhibit 10: Remote Clinics Infant HIV Sample Data
Clinic Number | Number of Infants Seen in 2010 | Samples Positive | (+) Results Collected by Mother | (-) Results Collected by Mother | Infants Put on ARV Therapy |
1 | 85 | 12 | 5 | 32 | 4 |
2 | 110 | 17 | 7 | 39 | 5 |
3 | 109 | 16 | 10 | 59 | 8 |
4 | 112 | 18 | 12 | 66 | 10 |
5 | 97 | 15 | 10 | 58 | 8 |
6 | 101 | 16 | 10 | 55 | 8 |
7 | 95 | 15 | 9 | 50 | 7 |
8 | 90 | 13 | 4 | 24 | 3 |
9 | 209 | 32 | 21 | 117 | 17 |
10 | 91 | 13 | 6 | 37 | 5 |
11 | 256 | 41 | 21 | 115 | 17 |
12 | 257 | 37 | 19 | 114 | 16 |
13 | 99 | 14 | 8 | 50 | 6 |
14 | 95 | 14 | 8 | 47 | 6 |
15 | 297 | 49 | 31 | 161 | 26 |
16 | 253 | 39 | 15 | 85 | 12 |
17 | 115 | 17 | 7 | 43 | 5 |
18 | 105 | 16 | 8 | 49 | 6 |
19 | 110 | 17 | 9 | 54 | 7 |
20 | 114 | 17 | 8 | 48 | 6 |
21 | 274 | 43 | 21 | 116 | 17 |
22 | 107 | 16 | 11 | 62 | 9 |
23 | 97 | 15 | 10 | 56 | 8 |
24 | 255 | 41 | 20 | 106 | 17 |
25 | 90 | 13 | 8 | 50 | 6 |
26 | 433 | 69 | 43 | 228 | 36 |
27 | 278 | 41 | 22 | 128 | 18 |
28 | 227 | 37 | 18 | 94 | 15 |
29 | 541 | 83 | 46 | 258 | 39 |
30 | 115 | 17 | 9 | 56 | 7 |
31 | 91 | 14 | 8 | 45 | 6 |
32 | 84 | 13 | 8 | 44 | 6 |
33 | 113 | 17 | 8 | 50 | 6 |
34 | 91 | 14 | 6 | 36 | 5 |
35 | 243 | 39 | 23 | 124 | 19 |
36 | 517 | 79 | 45 | 253 | 38 |
37 | 98 | 15 | 4 | 24 | 3 |
38 | 575 | 94 | 47 | 244 | 39 |
39 | 111 | 18 | 10 | 54 | 8 |
40 | 267 | 43 | 28 | 149 | 23 |
41 | 100 | 15 | 8 | 47 | 6 |
42 | 93 | 14 | 7 | 41 | 5 |
43 | 261 | 41 | 16 | 89 | 13 |
44 | 260 | 42 | 24 | 129 | 20 |
45 | 460 | 75 | 23 | 122 | 19 |
46 | 91 | 14 | 9 | 50 | 7 |
47 | 93 | 14 | 6 | 38 | 5 |
48 | 256 | 41 | 22 | 116 | 18 |
49 | 233 | 36 | 20 | 110 | 17 |
50 | 98 | 16 | 10 | 51 | 8 |
Exhibit 11: MSU POC Testing Device Details
The MSU infant HIV diagnostic test was a p24 antigen rapid lateral flow assay designed for point-of- care use in resource-limited settings. Specifically, the test measured the presence of p24 antigens rather than HIV antibodies. p24 is a core protein that surrounds the RNA genome within the HIV virus. 19
The p24 test took thirty minutes and could be used starting six weeks after birth. Similar to DBS testing, the p24 test used approximately three drops of blood from the infant. The p24 test had 95 percent sensitivity, 100 percent specificity, and was run entirely on rechargeable battery power. The price of each device was US$400–700 and the price of the consumables required for each test (lancet, filter, buffer, assay strip, etc.) was US$7–15. Consumables were sold in packages of ten or fifty and had a shelf life of eighteen months. Approximately one hundred tests could be performed on each battery charge; batteries could be recharged using a standard AC outlet.
Attribute | Description |
Test duration | 30 minutes |
Blood collection requirements | 3 drops (∼75 μL) |
Blood collection | Safe-Tec MICROSAFE® collection and dispensing tube |
Accuracy | 95% sensitivity and 100% specificity |
Cost | US$7–15 per test, US$400–700 per device |
Power source | Battery |
Result format | Visually read, qualitative result |
Availability | 2012 |
Source: UNITAID, “2011 HIV/AIDS Diagnostic Technology Landscape: Semi-Annual Update,” October 2011, http://www.unitaid.eu/about/MarketApproaches/Publications/2011_Update_HIV-Diagnostic-Technology-Landscape.pdf.
Exhibit 12: Ektu Stakeholder Points of View on POC Testing
Technical Working Group Member | Role | View on POC Infant HIV Testing |
GOVERNMENT | ||
Ministry of Health | Ultimate decision-making authority | The ministry was primarily concerned with maximizing the health of the citizens of Ektu given its budgetary constraints. While it was concerned about test accuracy, it was also concerned about its cost and potential impacts on the healthcare system. The ministry had to balance the clinical and economic impacts of all new therapies, products, and procedures. The ministry was also concerned that POC testing would dramatically change the workflow at local clinics and hospitals. Previously, nurses collected samples and then the infant and mother were free to leave. With this device, they would have to remain at the clinic until the specimen was processed and results given. If there were a long line, bottlenecks could result and mothers would have to wait for long periods of time. While it may not be optimal for every clinic and hospital within a country to adopt this new technology, implementing POC testing at some clinics would not impact patient load or transportation times at clinics without POC testing. |
Central Lab | Provided technical expertise | The central lab was very concerned about POC testing. Specifically, it was worried that nurses and clinic staff could not be adequately trained to conduct and read the results of diagnostic testing. Incorrectly diagnosing an infant with HIV could have profound consequences. A false positive could result in infant neglect, significant emotional trauma for the mother, and unnecessary treatment. A false negative would prevent the infant from receiving life-saving treatment. Furthermore, clinics had to be able to maintain POC devices and a repair network had to be established in order to ensure prompt servicing of malfunctioning devices. |
Global Center for Disease Control | Provided technical expertise | The GCDC was willing to assist with clinic trials to compare POC testing to central lab-based testing in Ektu. It saw the potential advantages of POC testing, but was concerned about the accuracy of current tests and with how Ektu would service malfunctioning devices. |
NON-GOVERNMENT ORGANIZATION | ||
President's HIV/AIDS Initiative | Negotiated low prices for HIV/AIDS drugs and consumables for Ektu and also provided expertise on PMTCT programs | The President's HIV/AIDS Initiative was primarily concerned with the potential increase in costs associated with POC testing. |
Ektu Prevention, Care, and Treatment Partnership | Ran PMTCT services in the northern and central provinces of Ektu | EPCTP was excited about POC testing because it provided results quickly, but was worried about distributing supplies and testing consumables. EPCTP also shared some of the ministry's workflow concerns. |
Churches Health Initiative of Ektu | Ran PMTCT services in Ektu's southern provinces | Churches Health Initiative of Ektu was excited about POC testing because it provided results quickly, but was worried about distributing supplies and testing consumables. It also shared some of the ministry's workflow concerns. |
LOGISTICS PARTNERS | ||
Supply chain management systems (SCMS) | Ordered and distributed all healthcare supplies throughout Ektu | SCMS was worried about distributing supplies and testing consumables, especially if POC testing consumables had to be maintained within a tight temperature range during shipping. |
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