MINISTRY OF HEALTH OF THE REPUBLIC OF MOLDOVA
NATIONAL CENTER OF PUBLIC HEALTH,
AIDS CENTER
National Protocol and Operational Manual in HIV/AIDS second generationa surveillance
Republic of Moldova
Chişinău 2011
Contents
Abbreviations
1. Introduction
2. Classification of the HIV epidemic
3. HIV surveillance
3.1 Routine HIV surveillance
3.2 HIV case registration
3.3 HIV case assessment and reporting
3.4 Case analysis
3.5 Types of referral forms and reports
3.6. Diagnosis of breastfed children
3.7 Diagnosis in children receiving ARV therapy for PMTCT process
3.8 Diagnosis in children born from mothers who receive ART
3.9 Diagnosis of HIV-infection in children under 18 months.
3.10 AIDS case reporting
3.11 AIDS case analysis
3.12 Reporting types
4. Behavioural and biological HIV surveillance
4.1 General provisions
4.2. Geographical distribution
4.3 Selection of sentinel populations
4.4 Selection of sentinel sites
4.5 Sample size calculation
4.6 Sampling methods
4.7. Testing methods
4.8 Procedure of blood samples collecting, registration, transportation and testing
4.9 Data porcessing and analysis
4.10 Personnel training
4.11 Guidance and control
4.12 Submission of the surveillance results
5. Estimation of the most-at-risk population
6. Ethical Considerations
7. HIV testing quality control
8. Assessment of the effectiveness of HIV surveillance system
Operational Manual of HIV surveillance
Introduction
1.HIV surveillance
1.1 Routine HIV surveillance
1.2 HIV case registration
2. Laboratory
2.1 Requirements for ELISA test on blood samples (serum, plasma).
2.2 ELISA reaction validation
2.3 Registration of investigation results and release of results.
2.4 UNAIDS/WHO recommendations according to the selection of specimen used for HIV testing
3. HIV testing strategy
3.1 Selection of test-kits
4. Behavioural and biological HIV surveillance
4.1 General provisions
4.2 Geographical distribution
4.4 Population surveyed
4.5 Slection of sentinel sites
4.6 Sample size calculation
4.7 Sampling methods
4.8 Testing methods
4.9 Procedure of blood samples collecting, registration, transportation amd testing
4.10 Data processing and analysis
4.11 Personnel training
4.12 Guidance and control
4.13 Submission of the surveillance results
4.14 HIV biological and behavioural surveillance description, methods and activities
5. Estimation of the size of the most-at-risk population
5.1 Process for estimating the size of hidden populations
5.2 Define the population
5.3 Improve your definitions with formative research and mapping
5.4 Choose a method then collect data, Steps 5-6
5.5 Overview of the methods
5.6 Summary of methods for estimating population size
5.7 Guidance on selecting methods to estimate the size of at-risk populations
6. Ethical considerations in HIV surveillance
6.1 Protect participants' privacy and rights
6.2 Provide benefits to the community
6.3 Handle incentives for participation ethically
6.4 Protect young people
6.5 Provide protection to participants with illegal behaviours
6.6 Ethical aspects in HIV surveillance
6.7 Potential benefits from participating in the study
6.8 Potential risks from participating in the study
7. Assessment of the effectiveness of HIV surveillance system
Abbreviations
AIDS Acquired Immune Deficiency Syndrome
AC Antenatal clinic
ARV Anti-retroviral treatment
BCC Behavioral Change Communication
BSS Behavioral Surveillance Survey
CSW Commercial Sex Workers
DHS Demographic and Health Survey
EIA Enzyme immunoassay
GFATM Global Fund for AIDS, Tuberculosis, and Malaria
HIV Human Immunodeficiency Virus
IDU Injecting Drug User
MARPs Most-at-risk population
MoH Ministry of Health
MoIA Ministry of Internal Affairs
MoLSPF Ministry of Labour, Social Protection, and Family
MoYS Ministry of Youth and Sports
MSM Men Having Sex with Men
NAC National AIDS Center
NAP National AIDS Program
NCC National Coordination Council for HIV/AIDS and TB
NCHM National Center for Health Manangement
NCPI National Composite Policy Index
NGO Non-governmental Organization
PLHA Persons Living With HIV/AIDS
PMTCT Prevention of Mother-to-Child Transmission
QA Quality assurance
QC Quality control
STI Sexually Transmitted Infection
TB Tuberculosis
UNAIDS Joint United Nations Program on HIV/AIDS
UNICEF United Nations Children Fund
UNFPA United Nations Popualiton Fund
VCT Voluntary Counselling and Testing
WHO World Health Organization
1. Introduction
In the Republic of Moldova HIV Surveillance is conducted since 1987. The experience gained in the field of HIV prevention all over the world in the past years has generated an imperative need in new approaches to HIV surveillance and in conducting surveys by new methodology. This protocol is the one unified document presenting the methodology of routine and sentinel HIV surveillance, ways and procedures of its conducting. Also, the “Operational manual for conducting HIV surveillance” has been developed. The Manual provides more details on the issues of routine and sentinel HIV surveillance conducting.
According to the general definition of the HIV surveillance of infectious disease, adopted by WHO (1969), HIV surveillance can be defined as a continuous process of colecting and analizing data about new HIV/AIDS cases, epidemiologicaly high risc behaviours that favors the appearance and spread of the infection in human population, development and dissemination of information for action (HIV/AIDS infection control). Data colection about new HIV/AIDS cases for the surveillance system are performed according to the case definition developed and approved in 1987 rely on AIDS- indicated disease approved by the Prevention and Control Center of Atlanta (USA) and revised by the Center of HIV/AIDS surveillance of European Office in 1993 and by the Ministry of Health no. 385 from 12.10.2007 „ On the approval of case definitionfor diagnosis, evidence and reporting of infection diseases in the Republic of Moldova” (appendix 1,2,3).
The standard has the purpose to develop and optimize the HIV/AIDS surveillance system in Republic of Moldova taking into consideration the actual trends of HIV/AIDS epidemic, availability of human and financial resources, support in development of diagnosis laboratory network, extension of the access of population to counseling and testing, medical care, including antiretroviral treatment and social assistance. The Standard establish the system of evidence and control, collection and circulation of information, carrying out of epidemiological surveillance for elaboration of priority prevention strategies, evaluation of activities and interventions efficiency, improvement and their correction having the final target to stop the epidemic extension, ensure treatment conditions and support of persons living with HIV, reduce the impact of medical, social, demographic consequences of the epidemic.
The standard is developed based on the “WHO Recommended Epidemiological Surveillance Standards” second edition, october 1991, and UNAIDS “Guidelines for Second Generation HIV Epidemiological Surveillance”, 2002 and “Implementation of Second Generation HIV/AIDS Epidemiological Surveillance System: Guideline”.
The control of infectious diseases is possible only when an effective epidemiological surveillance is carried out. A single national system of infectious diseases surveillance lies at the basis of the infectious disease control and prevention measures with a high socio-economic impact, which represents a priority for the public health. The epidemiological surveillance is a continuous and systematic process of collecting, processing, assessing, analyzing and interpreting data and disseminating information. It is the key-element in the decision making process, in establishing the priorities, planning, resource mobilization, detection and prognostication of epidemic in early phase, monitoring and assessing the efficacy of control measures and of morbidity prevention and control programmes.
Epidemiological surveillance of infection diseases is made at national and territorial level , and for those extremely dangerous or of pandemic spread, including HIV/AIDS infection at regional and global level.
Specific primary objectives in HIV surveillance:
1. Epidemic detection, estimates the changes in HIV prevalence and distribution in high-risk population (IDUs, CSWs, CSWs clients, MSM) and other risk groups (youth practicing risky behaviours, etc.).
2. Monitoring the HIV infection trends in general population, epidemic prognosis and estimating the impact;
3. Identifying groups with high-risks of infection (including aferent groups) in order to plan interventions;
4. Using the results of the impact of the intervention programmes and further asistance to establish new priorities if indicated;
6.Deviationdetection from the supposed trends of the disease spread;
7.Obtaining and providing baseline information for medical surveillance, ART,prophylactic treatment for prevention of mother to child transmissions in case of exposure; 8. Assuring the security of blood transfusion;
9. Providing information for planning health programmes and giving rational for necessary resources.
Secondary objectives of epidemiological surveillance:
1. Increased sensitivity according to the disrpibution and apread of the epidemic; Intensificarea sensibilizării cu privire la răspîndirea şi distribuţia epidemiei;
2. Clarifying population groups that practice high-risk behaviours and contributing to new activities design in order to reduce their vulnerability;
3. Develop criterias and policies makimg decisions according to resource allocation for preventive programmes;
4. Participating at evaluation process of other preventive programmes ( TB control programme).
HIV surveillance serves as the basis for:
– trends projection in carryimg the epidemic;
– evaluating the impact of the epidemic on public health and demographic situation;
– designing/drawing intervention strategies;
– promoting activities and projection interventions for society, community and individuals;
– facilitating and performing patients counseling;
– evidence making and medical surveillance of HIV/AIDS affected persons;
– planning and ensuring specific treatment - depending on the means (resources) accumulated.
2. Classification of the HIV epidemic
UNAIDS/WHO and partners have identified three epidemic categories to help countries focus surveillance activities.
Each country has a unique epidemic and usually has multiple subepidemics within different parts of the country. Because of the diversity among HIV epidemics, it is critical to “know your epidemic”. That means understanding how the epidemic differs within subpopulations and geographical areas. Surveillance data will provide the information to allow programme managers to better know their epidemics. Moreover, they will allow programme managers to respond more effectively to the epidemic. As more surveillance data become available, surveillance officers should evaluate their surveillance system to ensure that it is appropriate for the type of epidemic.
Tabelul 1.1 Base surveillance activities on the type of epidemic
Epidemic state, situation / Surveillance focusLow-level
- HIV has not reached significant levels in populations most at risk for HIV infection as a result of high-risk behaviour.
-HIV is largely confined to people within population most at risk for HIV infection as a result of high-risk behaviour. / - Focus surveillance activities in population most at risk for HIV.
Concentrated
- HIV has spread rapidly in one or more populations most at risk for HIV infection as a result oh high-risk behaviour.
- The epidemic is not yet well established in the general population. / - Continue surveillance among most at risk populations.
- Begin surveillance activities in the general population, especially in urban areas.
Generalized
- The epidemic has matured to a level where transmission occurs in the general population, independent of population most at risk for HIV.
- Without effective prevention, HIV transmission continues at high rates in population most at risk.
- With effective prevention, prevalence will drop down in population most at risk before they drop in general population. / -Focus routine surveillance on the general population.
- Conduct surveillance among populations most at risk for HIV.
Table 1.2 Planning and conducting surveillance among populations most at risk for HIV according to the WHO/UNAIDS recommendations 2011
Plan surveillance / Conduct surveillance / Use results/EvaluateStep 1: Prepare to set up the surveillance system
Step 2: Decide on the surveillance design
Step 3: Consider sampling methodologies / Step 4: Address operational issues
Step 5: Manage data
Step 6: Analyse data / Step 7: Disseminate and use the result
Step 8: Evaluate the surveillance system
Plan surveillance of population most at rosk for HIV:
The first three steps of the prpocess are general preparations for conducting surveillance among populations most at risk for HIV. The Republic of Moldova have its own surveillance system, but it might still be useful to review the first steps to ensure that the system is well designed.
Step 1: prepare to set up the surveillance system
While preparing the surveillance system, it is important to develop a study protocol to ensure the success of the surveillance system among PMR. This will help ensure that accurate and useful data will be captured by the surveillance system. Be sure the protocol covers the following areas:
- how surveillance stakeholders will be involved in activities;
- planned pre-surveillance assessment;
- populations of interest, with explicit definitions of these populations, based on behaviours that put them at increased risk for HIV;
- the size of the population;
- geographical boundaries, sites or location of surveillance;
- coverage and descriptions of the representativeness of the population;
- frequency of surveillance;
- how surveillance activities will be merged with other monitoring and evaluation plans.
Collaborate with stakeholders
HIV surveillance cannot be done in isolation Use a team approach to improve the quality and credibility of the results. Table 1.3 provides a list of possible stakeholders and what can they bring to the surveillance activities. Plan to involve members of HIV prevention programme, monitoring and evaluation programmes, and resource planning structures. Identify a team of stakeholders to help in designing ativities.
Table 1.3 Roles of institutions responsible for monitoring and evaluation of the Program
Mandated institution / Frequency of reporting / CommentsPREVENTION
National Center for Public Health / Every six months / Data from territorial Public Health Centers, aggregated, validated and inserted in SIDATA
National AIDS Center / Quarterly / Aggregated data inserted in SIDATA. Validation of data per program sector
Ministry of Education / Annually / Data from educational institutions and NGOs, aggregated, validated and inserted in SIDATA
Ministry of Youth and Sports / Annually / Data from local public administration on activities carried out by youth specialists and NGOs, aggregated and inserted in SIDATA
District-level public health facilities (VCT) / Quarterly / Data per counseling sessions entered in the automated VCT system
District-level public health facilities (STI) / Quarterly / Data per case diagnosed, aggregated and entered in the automated SIME- ITS system with personal information coded, at NCDV (National Center for Dermatovenereology) level. Validation and entering in SIDATA
NGO umbrella networks / Quarterly / Data from NGOs and public institutions acting as implementers, aggregated, validated and entered in SIDATA
"National Youth Resource Center " NGO / Quarterly / Data from local and district level youth resource Centers and local peer educators teams, aggregated and entered in SIDATA. Validation shall be carried out by MYS
Department of Penitentiary Institutions (HR and VCT) / Quarterly / Aggregated, validated data entered in SIDATA
Republican Narcological Dispensary / Quarterly / Data aggregated from territorial narcological services, validates and entered in SIDATA
AIDS Center Tiraspol / Quarterly / Data aggregated for the region
National Blood Transfusion Center / Quarterly / Data aggregated, validated and entered in SIDATA
“Neovita” Youth Friendly Health Center / Quarterly / Data aggregated from district YFHS, validated and entered in SIDATA
The National Center for Reproductive Health and Medical Genetics / Every six months / Data aggregated from district reproductive health offices
Trade unions and private sector / Every six months / Data reported to MLSP, responsible for the aggregation and entering into SIDATA
NGO / Quarterly / Data reported to the respective umbrella network responsible for the aggregation and entering into SIDATA
Religious sector / Quarterly / Data reported to the respective umbrella network responsible for the aggregation and entering into SIDATA
Donors / Every six months / Information by types of assistance and implementers
TREATMENT AND CARE
Regional Centers of ARV treatment / Quarterly / Clinic case management; coded data entered into SIME-HIV
National Clinical Hospital of Infectious Disease ”Toma Ciorba" (ART and palliative inpatient treatment) / Quarterly / Aggregated data on ARV treatment coming from SIME-HIV, entered into SIDATA. Administrative data on inpatient palliative care entered into SIDATA. The National AIDS Center is responsible for validation.
AIDS Center Tiraspol (treatment) / Quarterly / Data from Infectious Diseases doctors aggregated
NGO / Quarterly / Data on palliative care services provided by social Centers and NGOs entered in SIDATA. Validation by NGO umbrella networks
MITIGATION AND SOCIAL SUPPORT
Ministry of Labor, Social Protection and Family / Every six months / Data from affiliated institutions (non-automated and automated verticals) and NGOs, aggregated, validated and entered into SIDATA
National Council for Medical expertise of Vitality / Every six months / Data aggregated in the informational software on people infected and affected by HIV beneficiaries of the social protection system
National Population Social Support Fund / Every six months / Data aggregated in the informational software on people infected and affected by HIV beneficiaries of the social protection system
National Social Insurance House (NSIH) / Every six months / Data aggregated in the informational software on people infected and affected by HIV beneficiaries of the social protection system
ENABLING ENVIRONMENT
CCM (NCC) secretariat / Quarterly / Aggregated data, entered in SIDATA. Validation-National AIDS Center
Networks secretariat / Quarterly / Aggregated data, entered in SIDATA. Validation-National AIDS Center
NGO / Quarterly / Data submitted to NGO networks or directly entered in SIDATA
National AIDS Center / Quarterly / Data on the implementation of the NAP, coordination, M&E system strengthening, entered in SIDATA
Conduct a pre-surveillance assessment
The purpose of this assessment is to understand the epidemic in the country. Review existing HIV and STI surveillance results as well as findings from behavioural surveys. Consider which populations are at increased risk for HIV and how their behaviours put them at increased risk.
Pre-surveillance activities should gather information on the subpopulations and geographical areas to included in the surveillance. The assessment should include qualitive fieldwork: