Innovation for HIV diagnosis in infants born to infected mother using Realtime-PCR and Dried Bloo
Department of Medical Sciences

A. Problem Analysis

 1. What was the problem before the implementation of the initiative?
Thailand’s annual newborns are currently recorded approximately 800,000, of which 5,000 are born to HIV-infected mothers. The mother-to-child transmission is viable throughout the pregnancy with the highest risk during the stage of labor or breastfeeding. Although proved effective to a certain extent, treatment with HIV medicines is still not 100 percent effective. Many newborns were found to be HIV positive, where this group is highly susceptible to fatality within a very short period after birth unless the virus is detected and treatment is given in a proper time. Due to presence of maternal anti-HIV antibody up to 8-24 months, antibody testing for HIV are difficult and not accurate for newborns. Thus, special laboratory protocols are required for diagnosis of HIV infection in infants and children. Early diagnosis by those protocols and proper treatment can help to lower HIV infection rate and mortality rate, and contribute to better treatment and prevention strategies later. Although Thailand has employed the WHO recommended PCR protocols to detect HIV from the newborns of infected mothers, only 70 percent of those were diagnosed during their first year. In addition, of these numbers, only 37 percent were treated with antiviral medicines in the first year of age. The main obstacles to this problem was the inaccessibility to early diagnosis of HIV infection in new born, and the lack of systematic early diagnosis and treatment strategies for newborns at hospitals in remote areas of the country.

B. Strategic Approach

 2. What was the solution?
The initiative to solve this problem are: 1. Developing specimen collection technique using dried blood spot(DBS) which is easy to collect and transport to laboratory; 2. Shortening the time for laboratory process by changing Conventional PCR system to Real-Time PCR system. 3. Setting up a collaborative network covered nationwide to work for prevention of mother to child transmission(PMTCT) and implementation of at birth HIV testing program

 3. How did the initiative solve the problem and improve people’s lives?
By using the Dried Blood Spot (DBS) technique applied with Real-Time PCR, officials at the central laboratory of Department of Medical Sciences could shorten the time required for diagnosis and the test result from 7 days to less than 2 days . The specimen could also be immediately collected from the newborns instead of waiting until a month old or more, and dispatched via the postal to the laboratory. All government hospitals in remote areas of the country in particular could have a more convenient access to the lab services, thus providing a better healthcare to their patients. In 2016, more than 90 percent of newborns from HIV infected mothers were tested by the central laboratory, while only 30-40 percent was recorded in 2012. In addition, approaches to identify the HIV positive children have been improved tremendously, especially from mothers who did not receive antiretroviral drug before delivery, failed to take the medication regularly, or did not attend antenatal care. As a results, virtually all HIV infected newborns would be promptly treated in accordance with national standard procedures. The establishment of an extensive network of healthcare providers from concerned operation units including the Department of Medical Sciences, the Department of Disease Control and the Department of Health has strengthened the cooperation among officials working on the cases. A project manager is appointed at each of the levels of hospital, regional and department to follow up with all the HIV positive pregnant women to ensure that they receive proper diagnosis and antiretroviral medication regularly. Researches to study the effectiveness of treatment in children with HIV are also conducted concurrently to improve the children’s quality of life. As a result, some 70 percent of children tested to have the HIV infection could be treated with antiretroviral medication within 8 weeks from birth. This could be considered very prompt and effective as compared to the former procedures. In 2012, for example, only 18 percent of infected infants received the antiretroviral treatment before reaching 6 months old, and some 52 percent received before one year old, thus resulting in a considerable fatality.

C. Execution and Implementation

 4. In which ways is the initiative creative and innovative?
From the Conventional PCR protocols which are used to test HIV in newborns of infected mothers, the Department of Medical Science has developed a new technology based procedure by implementing the Real-Time PCR machine, leading to the reduction of the analytical time from 6 hours to just 2 hours. A newly-developed software also helps minimize human errors in result interpretation. Collecting specimen by means of Dried Blood Spot is more convenient for all parties involved. Hospitals and their patients in remote areas of the country could have more easier access to the test which could be performed immediately for a newborn, instead of having to wait for the child to reach his/her first month of age. The extensive network of responsible officials contributes significantly the success of the entire process. The reporting and follow up systems have been reinforced, starting from the hospitals to the laboratories and related departments. The hospitals are informed of the test result promptly by online system, and all designated officials follow up with the cases earnestly, locating the infected child and starting their proper treatment.

 5. Who implemented the initiative and what is the size of the population affected by this initiative?
Annually, approximately 5,000 newborns from HIV positive mothers need to be tested for mother to child transmission of HIV. As national reference laboratory to provide the testing, the Department of Medical Sciences has improved its service accessibility by employing an up-to-date technology which could accommodate the Dried Blood Spot (DBS) technique for specimen collecting. The DBS is more convenient while the specimen is also easy to transport to the Department of Medical Sciences. The system of test reporting and treatment follow up will help ensure the success of this initiative. The Thailand Ministry of Public Health aims to reduce the mother to child transmission rate to less than 2 percent as recommended by UNAID. Also its ultimate goal is to achieve no new case of overall HIV patients derived from mother to child transmission. The test also extends to cover no less than 300 newborns of immigrant mothers from the neighboring countries of Myanmar, Cambodia and Laos, including hill tribes who are not yet granted the Thai citizenship. All the children tested HIV positive will be treated according to the national standard procedures regardless of their status of nationality. The DMSc, as the national reference lab for diagnosis of HIV transmission from mother to child, take the major role in implementing this innovation. From a total of 800,000 pregnant Thai women per year, about 5,000 (0.6%) are HIV-infection. Furthermore, we also provide testing to non-Thai including Myanmar, Cambodia, Laos, and Tribe peoples. This provided testing is for humanity to every children born to HIV-positive mothers in Thailand. A total of 321 children born to non-Thai citizen mothers received this service package which were 263(79.5%) of Myanmar, 17(5.1%) of Laos PDR, 31(9.4%) of Cambodia, 14(4.2%) of Non-Thai hill tribe and 6(1.8%) of others countries. Early diagnosis, early treatment and management will improve quality of life of the infected child. Uninfected children also will get proper care as normal and not be stigmatized form social.
 6. How was the strategy implemented and what resources were mobilized?
To reach the goal that all children born to HIV positive mother in Thailand can access to this testing and infected children will be treated within the first year, The DMSc implemented following activities: 1. Development of molecular diagnostic method and applied standard Quality Assurance system (ISO 15189: 2005). The DMSc supported 1.1) professional personals, 1.2) advanced equipment such as automate DNA extractor and Real-Time PCR for high throughput to support a large number of samples, 1.3) laboratory design that comply with standard requirement for good laboratory practice whereby safety protection for all staffs was strictly implemented. This testing participated into two proficiency testing programes; US-CDC and UK-QCMD in good standing, This testing was listed as benefit in the national universal health coverage scheme which supported by National Health Security Officer (NHSO). 2. Integrating laboratory information technology with social network for report alerting system. Persons in charge from hospitals can track the positive cases and bring them into proper treatment efficiently. Training program and social network eg. line@ group were established for rapid communication among experts and hospital team for treatment and management of the infected cases. 3. Implementation via a collaborative network among all related departments within the Ministry of Public Health (MOPH), and between MOPH and medical universities by means of: 1) National Guideline 2014 for standard practice of HIV diagnosis and treatment. 2) Brochure to promote HIV testing in children born to HIV positive mothers. 3) Seminar and workshop for management review and update for new information related to HIV infection, especially in children.

 7. Who were the stakeholders involved in the design of the initiative and in its implementation?
The focal stakeholders in initiating and implementing the Dried Blood Spot (DBS) technique for specimen collecting are a group of researchers in Department of Medical Sciences who has attempted to seek for the most convenient way for specimen transfer, particularly by post, due to the difficulties in regular specimen transfer system and the need from hospitals in remote areas. To successfully operate the initiation, collaboration from all parties involved is required; especially the joint integration between technical teams and research network, HIV expert team, as the supervisory board and operating committee to plan and establish the operation management for government. These included Department of Disease Control, Department of Health and Department of Medical Sciences with the partnerships; for example, National Health Security Office (NHSO), Thailand MOPH - U.S. CDC Collaboration and Thai Red Cross AIDS Research Centre. The Department of Disease Control has the responsibility to impose the preventive policy on the mother-to-child transmission of HIV. The Department of Health has the responsibility to support powdered milk to the children born to HIV-infected mother up to 18 months and coordinate with the provincial healthcare providers to accommodate early virological testing (HIV-PCR) by of infants for HIV. On the other hand, the Department of Medical Sciences implemented HIV-PCR diagnosis package to all children born to HIV-infected mother. The reporting system has been set to inform a project manager in case of positive results, starting from the hospital to the labs and related departments, in order to follow up with all the HIV positive pregnant women to ensure that they receive proper diagnosis and antiretroviral medication regularly. This comprehensive follow up system is expected to improve the children’s quality of life.

 8. What were the most successful outputs and why was the initiative effective?
The outputs from this testing system for early diagnosis of HIV infection in childrens born to infected mothers were summarized as follows; 1. Two key innovations include: 1.1 The implementation of dried blood spot technique for collecting specimens allows easy access to these services from the remote areas in Thailand, because of easier blood specimen collection and transportation. 1.2 The development of a Real-Time PCR which is more rapid than the conventional PCR in our prior usage. With improved sensitivity and specificity of the system, the target childrens are diagnosed earlier and thus get the proper treatment more timely. 2. This is a self-sustainable model for any peer countries who want to develop HIV mother-to-child diagnostic system. Not only the testing system itself, but also how to include PCR based testing into Thailand National Guideline for Prevention of Mother to child Transmission (PMTCT) could be shared among neighboring countries. 3. Establishment of Thailand National Data Center and networking for the data management. The data provide insight figures for monitoring and evaluation of all actions to combat HIV Prevention of Mother to Child Transmission(PMTCT) program. From this data center, WHO has announced successfully on June 2015, that Thailand is the first country in Asia that can stop the transmission of HIV from mother to child, with 90 % testing coverage and 90 % infant treatment in the first year of life. The service service network comprises of all parties over Thailand

 9. What were the main obstacles encountered and how were they overcome?
A few obstacles were encountered and overcome as follows: 1. During the initial phase, specimen collection, storage and transportation had to be harmonized for all hospitals in Thailand. This required country-level training courses for all parts of Thailand by which a lot of efforts and budget had been spent. 2. Stigmatization is still the obstacle even though Thai people get sufficient information about from all various sources for many years. It is quite a hard task to get fully compliance from the infected mothers to participate the treatment course actively, since such mothers are quite young and do not have enough social supports while getting the treatment for herself and her infant. Establishment of counseling teams with extensive experiences in counseling , strict confidentiality and utilization of data center for database and collaboration among case officers, provincial officers and regional case officers helped resolve such problems, especially on the follow-up. Some mobile applications such as Line@ group communication help in follow-up and notification for the infected case management.

D. Impact and Sustainability

 10. What were the key benefits resulting from this initiative?
This initiative has allowed approximately 5000 children born to HIV infected mothers to get early diagnosis and standard treatment within 6 months after birth annually. This early diagnostic and treatment system offers the service to all, including illegal foreign workers and the people without Thai nationality. Data from the Department of Health in 2015, confirmed that the diagnostic coverage increases from 70 % to 90 % of all affected infants, while the treatment and successful follow-up rate increases from 52 % to 90% during the same period. Meanwhile, all infected mothers get antiretroviral drugs before and after delivery and get suggestions from counselors on how to look after herself and her infant. The system allows healthcare providers to save 70 % of lives of the infected annually. The system is accessible by all people who live in all areas of Thailand. In 2014, there were only 152 hospitals participating. After introduction of this system, there were 394 hospitals participating, most are the ones from remote areas of Thailand.

 11. Did the initiative improve integrity and/or accountability in public service? (If applicable)
Accessibility to HIV tests for newborns in Thailand’s hospitals has increased substantially with this initiative, regardless of their residential locations or their nationalities. In this initiative,The Thai Red Cross Society’s AIDS Research Centre is the main sponsored for laboratory tests for the newborns of HIV infected immigrant mothers, while HIV infected mothers of Thai nationality received the tests through national health insurance system. Prior to the initiative, children in remote areas or those not yet eligible for the tests were unable to have a convenient access to the service. In 2016, some 352 children born to immigrants were tested under the auspice of this scheme; and those found infected have since been treated in accordance with the national standard. The improvement in the laboratory and data management and analysis techniques and procedures enables officials to work more efficiently, thus ensuring better service rendered to the customers. Patients’ privacy and confidentiality are also enhanced. Feedbacks from the patients and the general public have been taken into account. The Department of Medical Sciences service performance is usually rated as very good (90-95 percent) in its annual service satisfaction survey report.

 12. Were special measures put in place to ensure that the initiative benefits women and girls and improves the situation of the poorest and most vulnerable? (If applicable)
This initiative was especially made to ensure the well-beings of the disadvantaged and the most vulnerable in the country. HIV positive mothers do not have to worry about their newborns’ health condition in spite of their own infection. The test is conducted indiscriminately with all the costs paid for by the Thai government. The infected children will also be taken care of according to the country’s standard procedures.

Contact Information

Institution Name:   Department of Medical Sciences
Institution Type:   Government Department  
Contact Person:   Sukhum Karnjanapimai
Title:   Medical Doctor  
Telephone/ Fax:   6625899850-8 ext 99001
Institution's / Project's Website:  
E-mail:   sukhum.k@dmsc.mail.go.th  
Address:   88/7 Tiwanon rd.
Postal Code:   11000
City:   Nonthaburi
State/Province:   Nonthaburi
Country:  

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