Elimination of mother-to-child transmission of HIV in Armenia (EMTCT)
National Center for AIDS Prevention

A. Problem Analysis

 1. What was the problem before the implementation of the initiative?
The major problem was absence of the prevention of mother-to-child HIV transmission prevention (PMTCT) services in the country, which affected a population large group, pregnant women - about 45,000 yearly (which made up nearly 3% of adult population aged 15-49 years old) and almost the same number of children born to them. Without treatment, up to 45% HIV positive children are born to HIV-positive mothers, and they need lifelong antiretroviral therapy (ART). PMTCT interventions reduce the likelihood of HIV passing from mother-to-child, and 98-99% of women with HIV give birth to HIV-negative children. Before 2001 no PMTCT was provided in Armenia, pregnant women almost did not have access to HIV testing and counseling, antiretroviral (ARV) prophylaxis for HIV-positive mothers and newborns was not available, prenatal services to pregnant women and those in childbirth in fact implied to be paid for. The problem was caused by several reasons - lack of regulatory framework, lack of trained personnel, lack of tests and ARV drugs, lack of the state and donor financing. Before the initiative was taken, only 3 HIV testing and counseling (TC) sites had been functioning in the country, with no one in antenatal clinics. 2645 of pregnant women were tested for HIV in 2000, and 812 - in 2001. The problem was aggravated by the fact that in general, before 2001 the national AIDS response in Armenia was not structured or systemized, separate activities were carried out, almost no intersectoral or multisectoral coordination was in place. Despite the fact that according to the Law of the Republic of Armenia on HIV/AIDS Prevention, pregnant women were subject to mandatory HIV testing, there were no established mechanisms to implement this law provision, guidelines on giving HIV testing to pregnant women did not exist, no financial provision was in place. The standard procedures on provision of outpatient obstetrician-gynaecological care under the state guaranteed free of charge medical care and services did not include HIV testing for pregnant women. There was no developed standard on organization of HIV Prevention and treatment under the state guaranteed free of charge medical care and services. That is why undertaking complex, task-oriented measures at the national level was required to addressed these problems.

B. Strategic Approach

 2. What was the solution?
To solve the problem, large-scale measures were undertaken and successively implemented over the past 15 years, aimed at systematization and coordination of the national AIDS response, establishment of HIV TC system, PMTCT provision, creation of regulatory basis and mechanisms, ensuring universal access to PMTCT countrywide, ensuring necessary financing and capacity, as well as sustainability, strengthening the heath care systems, which could contribute to attaining the Millennium Development Goals, and subsequently - the Sustainable Development Goals for health. Тhe initiative is about the State’s political will, coordinated and interrelated work of legislative and executive authorities, prioritization of the problem by the Ministry of Health (MoH), efforts of its different structures, especially of the Department of the Maternal and Child Health Care, local authorities, focused on developing the integrated system of HIV and perinatal care, creating of enabling legal environment, mobilization of domestic and external resources, addressed technical and donor assistance aimed at attaining the set goal - elimination of mother-to-child transmission of HIV (EMTCT). Considerable contribution into the initiative implementation was made by the National Center for AIDS Prevention State non-profit organization (NCAP) under MoH, which, through implementation of effective PMTCT model, ensured reaching by the country the WHO indicators and targets for receiving, among the first countries worldwide, the certificate on validating elimination of mother-to-child transmission of HIV (EMTCT) in close cooperation with the Institute of reproductive health,perinatology, obstetrics and gynecology, antenatal clinics countrywide via provision of HIV testing and counselling to pregnant women, perinatal medical services, as well as by the network of HIV testing laboratories.

 3. How did the initiative solve the problem and improve people’s lives?
By joining the UNGASS Declaration of Commitment on HIV/AIDS in 2001, strong political commitment was established in Armenia. In 2002 the first National AIDS Programme (NAP), 2002-2006 was approved by the Government and National Inter-Ministerial Council was established for coordinating the national AIDS response. PMTCT was one of the goals of the first NAP. The strategy of PMTCT system creation includes the following main objectives: 1. Access to HIV TC services for all pregnant women. 2. Creation of comprehensive free of charge antenatal care and perinatal services including delivery for all pregnant women and cesarean section for HIV-positive pregnant women. 3. Creation of access to ARV prophylaxis for all HIV-positive pregnant women and newborns. 4. Ensuring free of charge milk formula. 5. Review of existing legislation bringing it into consistency with UNAIDS International Guidelines on HIV/AIDS and Human Rights. 6. Capacity building of medical and non-medical personnel. 7. Reduction of stigma and discrimination towards people living with HIV, in particular to HIV-positive pregnant women. 8. Creation of oversight mechanisms for PMTCT introduction and implementation at the national and regional levels. 9. Setting of ambitious targets, composition of indicators, improvement of data collection, analysis and reporting system, M&E. 10. Integration of maternal and child health care HIV services. 11. Ensuring with financial resources and sustainability. To solve the problem, the Government adopted the first NAP, the Strategy on Maternal and Child Health Care for 2003-2015, under which establishment of HIV TC system was initiated, MoH approved the National PMTCT Strategy, multisectoral Country Coordination Mechanism on HIV/AIDS Prevention (CCM) was established. The country project proposal was developed, submitted to the Global Fund in Round2 Call for Proposals, and approved for funding. Financial resources were accumulated, Guidelines on HIV TC provision and National PMTCT Protocol were developed based on WHO recommendations and adopted by the MoH, relevant capacity was built, tests, consumables, ARV drugs were procured and distributed to the NCAP, antenatal clinics and HIV testing laboratories countrywide. Supply Chain Management and M&E systems were established at the national level. The establishment of HIV TC system in Armenia was initiated in 2004 under the first NAP. As a result, the number of HIV tests performed among pregnant women was sharply increased from 2004, and since 2012 TC sites are available in all antenatal clinics and more than 95% of pregnant women have been tested for HIV. This allowed them to know their HIV status and thanks to ARV prophylaxis and other preventive measures the number of HIV-negative children born to HIV-positive mothers was decreasing from year to year and since 2007 no HIV cases have been registered among children born to HIV-positive mothers who received PMTCT. The Government is consistently implementing activities in the health care sector aimed at improving medical services access and quality. Thus, starting from July 1, 2008 the Obstetric Care State Certificate Program has been implemented in the country, under which all pregnant women are entitled to receive Childbirth Certificate - the document certifying that health care services related pregnancy, labor, and delivery in Armenia are provided free of charge under the state health target programmes. The certificate introduction allows all pregnant women receiving free prenatal care in any appropriate facility, improving accessibility and affordability of antenatal clinics, ensuring increase in pregnant women’s early registration rate, which increased by 35%. As a result, HIV screening and STI testing for pregnant women increased. Also, in 2011 the Child Health State Certificate was introduced - the document certifying that in Armenia hospital care for children aged under 7 years old is provided free of charge under the state health target programmes.

C. Execution and Implementation

 4. In which ways is the initiative creative and innovative?
Introduction of TC system, under the Global Fund-supported project, into the existing health care system, which subsequently ensured its full state funding, programmatic and financial sustainability. At that time the trend of the donors-funded projects was establishing of separate structures with the involvement of new specialists, creation of infrastructures. However, the provided resources were used in a more optimal and creative way. PMTCT component was included into the Standard of organization of outpatient obstetrician-gynaecological care, provision of TC and other PMTCT services were included into the ToRs of physicians dealing with perinatal care, strong linkages were established between HIV and maternal and child health care services. Institutionalization of the advanced HIV training for medical workers through introduction of HIV Training Course into the National Institute of Health (NIH). The motivation of medical workers to undergo the free of charge Training Course was increased, since it is introduced into the credit system of advanced training. Оbstetrician-gynecologists and nurses from all antenatal clinics, laboratory doctors and assistants from all laboratories countrywide have undergone the Training Course. Mobile TC and laboratory support teams were established for regular provision of technical assistance and methodological support for the service providers from health care institutions country-wide.

 5. Who implemented the initiative and what is the size of the population affected by this initiative?
The National Centre for AIDS Prevention (NCAP) State non-profit organization, established in 2002 by the Decision of the Government, is an organization dealing with HIV prevention, treatment and monitoring under MoH system. NCAP is the principle implementer and coordinator of HIV/AIDS prevention activities in the Republic of Armenia, including this initiative. NCAP carries out HIV tests, makes final laboratory diagnosis of HIV infection, provides follow-up for HIV patients, gives them antiretroviral treatment, the treatment monitoring, provides ARV prophylaxis to prevent mother-to-child HIV transmission, makes diagnosis of opportunistic infections and HIV-associated illnesses, provides prevention and outpatient treatment of opportunistic infections, post-exposure prophylaxis, provides subspecialty consultation and referral related to HIV-associated illnesses. Follow-up includes immune status and viral load assessment, revealing HIV antiretroviral drug resistance-associated mutations, virus genotype determination, clinical examinations, and biochemistry tests. HIV patients are offered dermatovenereological, gynecological, sexopatological medical care, ultrasound and x-ray examinations are implemented, TB screening is performed. Psychosocial and legal, as well as medico-psychological counselling is provided at NCAP to HIV patients and their family members. The operation of the NCAP in the area of HIV prevention and monitoring is fixed by the Law of the Republic of Armenia on HIV/AIDS Prevention, which gives a special status to this organization in the overall AIDS response. The initiative was implemented in close cooperation and partnership with the Institute of reproductive health, perinatology, obstetrics and gynecology, antenatal clinics, HIV testing laboratories at primary health care system countrywide under the overall oversight of the Ministry of Health. Over the recent years, about 45,000 pregnant women (which makes more that 95% of this population) undergoing HIV testing annually benefit from the initiative.
 6. How was the strategy implemented and what resources were mobilized?
Maternal and child health improvement, perinatal infections, including PMTCT, are among the major challenges to the health care system of Armenia. • One of the goals of the NAP, approved by the Government as far back as 2002, was PMTCT. • In 2003 Strategy on Maternal and Child Health Care for 2003-2015 was approved by the Government Decision, which included PMTCT activities. • Implementing the NAP, the National Program for Prevention of Mother-To-Child HIV Transmission was approved and introduced by the MoH Order n 2002. The overall goal of the National Program for Prevention of Mother-To-Child HIV transmission was introduction of PMTCT. The Program envisaged provision of HIV TC at antenatal clinics, developing guidelines, on preventive treatment, training of health care workers, provision to the national and regional laboratories of test-kits required for HIV testing of pregnant women and ARVs for the preventive treatment. • Implementing the National Program for PMTCT, the National Guidelines on HIV TC, National HIV/AIDS Treatment and Care Protocols were developed, approved and introduced in 2002. • To support the response to the HIV epidemic in Armenia, including provision of HIV testing and ART to pregnant women, in 2003 the country project proposal was developed, submitted to the Global Fund and approved for funding. • Procedures of HIV testing and counseling, Guidelines on PMTCT, on specificities of provision of HIV TC to pregnant women were developed, approved and introduced into the health care institutions in 2004. Training-seminars were initiated for capacity building of health care workers. • Due to the system of HIV testing and counseling integrated into antenatal clinics in 2004, the access to HIV testing for pregnant women was enlarged. As a result, the number of HIV tests performed among pregnant increased. In recent years, almost all pregnant women (about 95%) have been tested for HIV. • To prevent mother-to-child HIV transmission provision of ARV prophylaxis began in 2005 under the Global Fund-supported NAP. • PMTCT has been one of the key objectives of all the subsequent National AIDS Programmes, through ensuring accessibility to HIV testing for pregnant women, providing ARV prophylaxis to HIV-positive pregnant women and infants born to them. Currently the key challenge is maintenance of the achieved status of EMTCT validation in the country. • The National Protocols on HIV/AIDS treatment and care and on HIV testing and counseling have been periodically updated based on new WHO recommendations and guidelines. • The Law of the Republic of Armenia on HIV/AIDS Prevention was revised in 2009, and mandatory HIV testing for pregnant women was changed into the health care provider-initiated HIV testing and counselling. Children born to HIV-positive mothers are included into the group subject to mandatory HIV testing. Accordingly, National Guidelines on HIV TC were updated and relevant mechanisms were set up. • Starting from 2010 training and retraining of health care workers on the HIV/AIDS has been institutionalized due to introduction of HIV Training Course into the NIH which, is introduced into the credit system of advanced training for health care workers. Before introduction of the NIH HIV Training Course the capacity building of health care workers on the HIV/AIDS issues was provided through training-seminars organized for various specialists. Those training-seminars were not integrated into any system of education, neither they applied any systematic approach. • Starting from 2016 test-kits for HIV testing for pregnant women, milk formula for infants born to HIV-positive mothers have been purchased from the State Budget allocations. ARVs are still provided by the Global Fund. However, it is envisaged to purchase also ARVs from the State Budget allocations to ensure the sustainability of the programme.

 7. Who were the stakeholders involved in the design of the initiative and in its implementation?
The Ministry of Health established the Working Group for developing and design of the National PMTCT Strategy under the National AIDS Programme, the Working Group core were specialists from the National Center for AIDS Prevention, MoH Department of the Maternal and Child Health Care, Institute of reproductive health, perinatology, obstetrics and gynecology. External Funding - separate component was included into the country project proposal submitted to the Global Fund in Round2 Call for Proposals. CCM members took part in the process of the project proposal development, including interested Ministries, local and international NGOs, UN Agencies, multilateral and bilateral organizations, people living with HIV, including HIV-positive women. Technical assistance for the development was provided by UNAIDS and WHO. Subsequently all interested stake-holders participated in the process of design and development of the initiative under National AIDS Programmes, as well as the country project proposals submitted to the Global Fund, where PMTCT component was included. They participated through their representation in the CCM, as well as by taking part in various national consultations and workshops organized as part of the development processes. Also, NGOs participated, by submitting, after discussions with their beneficiaries, solicited submissions for possible integration into the programmes and proposals, and by making relevant comments and recommendations.

 8. What were the most successful outputs and why was the initiative effective?
1. About 45,000 pregnant women undergo HIV testing annually, within the framework of the package of services provided free of charge under the Care State Certificate Program. 2. Relevant laboratory infrastructure has been created in 10 country regions and in Yerevan, the capital, which is used not only for performing HIV tests for pregnant women, but also for HIV testing of blood donors, of patients with clinical indicators, representatives of key and vulnerable populations (persons who inject drugs, sex workers, men who have sex with men, prisoners, migrants). Those laboratories also perform testing for other infections for large group of population. 3. There are some cases when pregnant women with unknown HIV status attend maternity hospitals during labour and delivery. To perform HIV test for such women before labour and delivery and, if needed, to provide them immediately with PMTCT, all maternity hospitals have been provided with rapid tests in recent years. 4. System of external quality control, exercised by NCAP annually, was set up for all HIV testing laboratories, with provision of on-job technical assistance. The NCAP reference laboratory itself also is undergoing regular external quality control and constant internal quality control for HIV tests. A clear-cut reporting system is functioning, approved by the MoH and sanctioned by the National Statistical Service. Also, there is an established system of referral of blood samples from TC sites to HIV testing laboratories and of positive blood samples to the reference laboratory. 5. There are trained personnel in all the antenatal clinics the laboratories countrywide - obstetrician-gynecologists and nurses from all the antenatal clinics, as well as laboratory doctors and assistants from all the laboratories countrywide have undergone the NIH HIV Training Course or training-seminars. Mobile CT and laboratory support teams were established for regular provision of technical assistance and methodological support for all service providers from health care institutions country-wide. 6. Decreased level of stigma and discrimination, strengthened human rights protection. The initiative was effective, due to the presence of the strong Government political commitment, MoH leadership, overall oversight, and consistent PMTCT introduction of strategy, strong management and M&E conducted by NCAP, cooperation between the Institute of reproductive health, perinatology, obstetrics and gynecology, antenatal clinics and HIV testing laboratories, as well as built capacity and high level of professionalism of the medical staff. Continuous technical assistance and methodological support for the initiative realization was provided also by NCAP.

 9. What were the main obstacles encountered and how were they overcome?
1. Limited number of HIV testing laboratories. Laboratory infrastructures, laboratory equipment, IT sets were supplied, personnel was trained, country-wide network was created. 2. Blood collection, storage and transportation from antenatal clinics to laboratories, due to lack of resources was carried out once or twice monthly, which complicated early HIV detection among pregnant women and timely services provision. Funds were envisaged in the State Budget for blood samples collection, storage, transportation. MoH issued a circular note, specifying one week as the maximum period for sample transportation. The State allocated additional funds to the laboratories testing donated blood for HIV testing among pregnant women. 3. No system of tests procurement and supply was available. Centralized procurement mechanism was established for procurement tests and consumables under MoH. From 2016 HIV tests for pregnant women are being procured from the State Budget. 4. There was no supply chain management. The whole chain of forecasting, procurement, shipment and supply was established. Staff was trained, electronic system for calculating ARV needs was created. 5. Pregnant women with unknown HIV status. All maternity hospitals were provided with rapid tests to perform HIV test for pregnant women with unknown HIV status attending maternity hospital during labour and delivery. 6. Quality of testing. System of external and internal quality control exercised by NCAP was established with provision of on-job technical assistance. The NCAP reference laboratory is undergoing regular external and internal quality control for HIV testing. 7. Providing with milk formula. Milk formula to HIV-positive women, who gave birth, was distributed through primary health care system. However, women did not apply for the milk formula due to fear of their HIV status disclosure, and had to purchase it ≈ USD 670. The Government initiated a new mechanism of distribution of milk formula through general network of pharmacies.

D. Impact and Sustainability

 10. What were the key benefits resulting from this initiative?
The established integrated system of PMTCT services countrywide ensured reaching by Armenia the EMTCT status, which was validated by WHO in 2016. Starting from 2007 no HIV case has been registered among the children born to HIV-infected mothers, when PMTCT prophylaxis was provided. As a result of implementation of this initiative all pregnant women countrywide have free access to PMTCT package of services, including HIV TC, antenatal care, ARV treatment and prophylaxis, treatment monitoring, follow-up, provision with milk formula. These services are widely accessible at national, regional and local levels. Infants born to HIV-positive mothers have access to free HIV early diagnosis by PCR method. The exposed infants are on follow-up until their status is determined. Maternal and child health protection, including, HIV-free infants born to HIV-positive mothers, are among the major challenges to the health care system of Armenia. Systematic target-oriented, efforts and consistent steps, undertaken over the past 15 years, towards creation of effective services on HIV/AIDS and perinatal care, as well as of integrated system of mother-to-child HIV transmission prevention have borne fruit. The country has created adequate structures to meet the modern challenges of the AIDS epidemic. As a result, starting from 2007 up to date no HIV case has been registered among the 150 children born to HIV-infected mothers, when PMTCT was provided. Armenia reached the WHO indicators and targets for validating EMTCT, based on which the country initiated the validation process. In December 2015 the working group was established by the MoH Order for investigating the possibility of initiating the process of EMTCT validation in Armenia. The working group collected the requested basic information, assessed impact, process and program indicators, analyzed and made a conclusion that the assessed indicators are relevant for WHO targets for EMTCT validation. Therefore it was possible to initiate the process of EMTCT validation in Armenia. In January 2016 the National Validation Committee for EMTCT validation was set up by the MoH Order. The National Validation Team, headed by the NCAP Director, prepared the draft National Report on EMTCT validation in Armenia, which was submitted to the WHO/Europe. On 25-29 April 2016 WHO and UNAIDS experts performed a validation mission to the country. The expert team worked at MoH, National Center for AIDS Prevention, attended the Institute of reproductive health, perinatology, obstetrics and gynecology, National Center of Disease Control and Prevention, NIH, a number of health care institutions in capital and regions. The official debriefing of the mission was held with MoH. Then the working meeting with the MoH representatives, National Validation Committee and other national and international stakeholders was held where preliminary results of the validation mission were presented. The mission report was drafted and submitted to the WHO Global Committee, which approved the country’s achievements in this area and awarded the EMTCT validation certificate to Armenia. On 07 June 2016 the certificate was awarded to Armenia at the EMTCT side event organized by WHO under the UN General Assembly High-level Meeting on HIV/AIDS held in New York City.

 11. Did the initiative improve integrity and/or accountability in public service? (If applicable)
The level of integration of HIV services achieved in Armenia is rarely seen in the eastern part of the WHO European region. An excellent integration and collaboration has also been achieved with obstetric&gynecology settings ensuring continuity of medical care for pregnant women. HIV positive pregnant women can get services in any medical facilities they choose, including maternities. Along with that there is specialized tertiary level maternity clinic in Yerevan providing high quality specialized services to HIV positive pregnant women as/if needed. Close and fruitful collaboration has been achieved with health information settings thus allowing quality data collection, analysis feedback and efficient data flow. In addition, on the NCAP basis, MoH assigned the posts of a gynecologist and a medical sexologist, who provide also medical consultation on the issues of reproductive health and family planning. This is also increases integration of HIV with maternal health services and management of the patients, allows achieving by them high ART adherence. At the same time, work is performed with the patients’ husbands, which increases the effectiveness of PMTCT activities resulting in birth of healthy HIV-negative babies. The Government is consistently implementing activities in the health care sector aimed at improving medical services access and quality. Thus, starting from 2008 the Obstetric Care State Certificate Program has been implemented in the country, under which all pregnant women are entitled to receive Childbirth Certificate - the document certifying that health care services related to related to the pregnancy, labor, and delivery in Armenia are provided free of charge in the scope of the state health target programmes. The introduction of the certificate allows all pregnant women receiving free perinatal care in any appropriate facility. In 2011 the Child Health State Certificate was introduced - the document certifying that in Armenia hospital care for children is provided free of charge in the scope of the state health target programmes. The above-mentioned Certificates aim to ensure sufficient state funding for the mentioned services to reimburse real expenses, to eliminate the practice of out-of-pocket informal payments, to improve access to and quality of children hospital care services, and to decrease children’s hospital mortality.

 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)
About 45,000 pregnant women annually benefit from the initiative. Thanks to the functioning of the comprehensive PTMCT system, they are provided with the opportunity of free of charge receipt of medical services package, including HIV TC with further access to MTCT packages (ARV prophylaxis for mothers and children, appropriate delivery of free milk formula, free of charge child health protection services until 7 years of old). To improve the accessibility and affordability of women’s reproductive health services also feasible for women in rural and remote areas, the Obstetric Care State Certificate Program has been introduced since 2008 to ensure the affordability and accessibility of free obstetric care services for women of all social groups. Mobile Clinics started provision of HIV medical services to partners of the most vulnerable to HIV population, migrants, in rural communities to increase their awareness and testing. The introduction of the certificate allows all pregnant women receiving free prenatal care in any appropriate facility. This measure focused first of all on socially unprovided sections of population to improve quality of obstetrics services and increasing their accessibility. That improved the accessibility and affordability of antenatal clinics, ensured increase in the early registration rate of pregnant women.

Contact Information

Institution Name:   National Center for AIDS Prevention
Institution Type:   Public Agency  
Contact Person:   Samvel Grigoryan
Title:   Director  
Telephone/ Fax:   (+37410) 61-07-30/(+37410) 61-57-46
Institution's / Project's Website:  
E-mail:   armaids@armaids.am  
Address:   2 Acharyan St.
Postal Code:   0040
City:   Yerevan
State/Province:  
Country:  

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