HIV Case Surveillance in [country]
HIV Case Surveillance in [country]
Principal Investigator(s):
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2. Name
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Co-investigators
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CDC Project Officers:
Sponsoring institution:
Table of Contents
1.0 PROJECT GOALS 3
1.1 Goals 3
1.2 Introduction 3
1.3 Request for Non-Research Determination 4
2.0 PROJECT OBJECTIVES 4
3.0 PROGRAM NEEDS TO BE ADDRESSED 5
4.0 POPULATIONS TO BE STUDIED 5
5.0 BACKGROUND 5
6.0 SAMPLING METHODOLOGY 6
7.0 INCENTIVES TO BE PROVIDED 6
8.0 PLANS FOR DATA COLLECTION AND ANALYSIS 6
8.1 Data Collection 6
8.2 Patient Data Routinely Collected at each Facility 6
8.3 Data collection and management 6
8.4 Data Analysis 6
9.0 CONFIDENTIALITY PROTECTIONS 7
10.0 OTHER ETHICAL CONCERNS/ISSUES 7
11.0 PROJECT TIME FRAME 7
12.0 PLANS FOR PUBLICATION AND DISSEMINATION OF THE PROJECT FINDINGS 7
13.0 REFERENCES 7
14.0 APPENDICIES 7
APPENDIX 1: [country] HIV Case Report Form
1.0 PROJECT GOALS
1.1 Goals
The goal of this protocol is to provide technical assistance to the [country] Ministry of Health (MOH) and National HIV Program in strengthening of HIV case reporting, analysis and use of their surveillance data, and strengthening the capacity of the MOH’s surveillance programs.
1.2 Introduction
One of CDC's major initiatives under PEPFAR is to strengthen HIV surveillance. The primary areas of focus are (1) HIV case surveillance, (2) biological and behavioral surveillance, (3) size estimation for populations at highest risk for HIV, and (4) data analysis and use. CDC is working in a tiered manner providing technical assistance to countries to support them in these areas.
CDC will support the strengthening of HIV case reporting as a method and process of reporting all HIV positive cases in [country]. HIV case reporting refers to the method used to capture individual-level information on persons with HIV infection; each person with HIV is reported using a single case report form containing information that pertains only to that person.[1] HIV case reporting involves confidential reporting of HI V infection by name or unique code regardless of the stage of HI V disease. It allows countries to better determine the trends and magnitude of their epidemics and provides critical information for strategic planning and programming.
By implementing case reporting, each person with HIV infection is reported using a single case report form containing information that pertains only to that person. By implementing HIV case reporting, the country health systems are able to capture information on HIV-infected persons at any stage of HI V disease.
Include a summary of any existing surveillance process that is currently in place…. Such as… [country] has had AIDS case reporting since the late 1980's, in line with WHO guidelines. Per [country]’s Standard Operating Procedures, a case report should be generated for each HIV-related sentinel/reportable event. This leverages the public health ordinance (Reference #) that requires that sexually transmitted diseases be reported to the national health authorities. This ordinance applies to all health care providers diagnosing and/or providing medical care and treatment to HIV infected persons.
Under the HIV-specific procedure, all HIV infected individuals, regardless of their clinical stage at diagnosis, should be reported to the Ministry of Health (MOH) using the HIV case report form.
At this juncture, the [country] MOH is interested in receiving technical assistance to improve the quality and completeness of data, organizational capacity to support data collection and use, and improved data utilization
The CDC, with implementation assistance from the National Alliance of State and Territorial AIDS Directors (NASTAD) will provide technical assistance to [country] by strengthening capacity within the National Surveillance Unit (NSU). This will be accomplished through technical assistance to improve and standardize current HIV reporting practices. Technical assistance activities will involve guidance on data collection methods, routine data quality monitoring, analysis of data, standardization of data collection forms, epidemiological reports, technical support with case reporting databases, and overall streamlining of data collection and reporting.
1.3 Request for Non-Research Determination
Data on patient characteristics and outcomes are not collected for research purposes, but rather for routine disease surveillance and monitoring purposes. All patient codes and names will be removed prior to data analysis. CDC will not have contact with human subjects. No additional data will be collected for the purpose of the analysis. For these reasons, we are requesting that this project be classified as a non-research project.
2.0 PROJECT OBJECTIVES
The development of this protocol will assist in accomplishing the following objectives:
1. Provide technical support in strengthening the HIV surveillance program, including standardization of data collection tools, forms, methods, reports for all health facilities and strengthening of surveillance skills.
2. Update manuals for HIV surveillance to include: standard operating procedures on HIV case reporting, evaluating the timeliness, accuracy, completeness and consistency of reporting of HIV data.
3. Analyze data and characterize diagnosed HIV cases in the general population; particularly to monitor the distribution by age, sex, risk factors and identify vulnerable populations.
4. Assess and determine trends in HIV incidence and prevalence in the country.
5. Provide technical assistance to ensure the completion of HIV surveillance reports.
6. Evaluate the success of [country]’s national response in reaching the population at an early stage of HIV infection, and success in getting individuals into care and treatment.
7. Provide technical assistance in development of surveillance databases.
3.0 PROGRAM NEEDS TO BE ADDRESSED
Analyses of the HIV case reporting data will produce reports that will better characterize the HIV epidemic in [country]. Furthermore, the analyses will assist in the evaluation of the overall efficiency of the case reporting system through providing information on the timeliness, accuracy and completeness of data collection. The analyses of the data as well as evaluation of the efficiency of the case reporting will help identify any gaps within the national HIV surveillance program that need to be addressed. Results from the evaluation and data analysis may be used to modify or refine the program, reallocate resources, and/or develop and implement new policies and strategies that will further strengthen surveillance systems in [country].
4.0 POPULATIONS TO BE STUDIED
The population to be studied is all individuals who have been diagnosed with HIV in [country] and have been reported to the MOH via routine HIV case surveillance.
5.0 BACKGROUND
Include a summary of any existing surveillance process that is currently in place…. And what you seek to implement.
[country] has had some level of HIV case surveillance in place since 1985, guided by the NSU within the MOH. Related specifically to HIV surveillance, all HIV infected individuals, regardless of their clinical stage at diagnosis, should be reported to the MOH using the HIV Case Report Form (Appendix 1). All HIV-infected individuals should be reported when they are first diagnosed with HIV and when they pass through one of the MOH-defined sentinel/reportable events: First diagnosis of HIV; first clinical visit (including CD4 value, if available); first stage 3 diagnosis (including CD4 value, if available); first stage 4 diagnosis (including CD4 value, if available); and death. In 2012, after review of their HIV case surveillance system, a revised HIV Case Report Form (Appendix 1) was developed to allow for this level or data collection and to improve the quality of HIV-related data reporting and collection in [country].
HIV cases are diagnosed at the facility level (HIV testing sites and/or clinical sites, confirmed by a reference laboratory) and reported to the national level on individual case report forms. Disease progression and sentinel/reportable events are monitored and reported by clinical sites and/or a reference laboratory. Case report forms are collected by regional epidemiological nurses on a monthly basis and delivered to the MOH. After these forms are received at the national level, they are entered into a dedicated HIV case surveillance database. The MOH’s NSU is responsible for cleaning, deduplicating and managing all reported cases and events and generating HIV surveillance reports. The NSU is also responsible for providing feedback, and monitoring and evaluation and quality improvement support to reporting facilities, as well as ensuring adherence to the national privacy, security and confidentiality guidelines.
All HIV-related surveillance activities at the facility, regional and national levels are dictated by a standardized protocol .This protocol includes data security and confidentiality safeguards that are enforced at all levels.
6.0 SAMPLING METHODOLOGY
N/A. These data do not involve sampling methodology. Data are collected for surveillance and monitoring and evaluation purposes. The population to be studied is all individuals who have been diagnosed with HIV and have been reported via routine HIV case surveillance. There are no additional inclusion or exclusion criteria.
7.0 INCENTIVES TO BE PROVIDED
N/A. Client data are collected and recorded as part of normal HIV testing and reporting of positive cases to the MSPP. No incentives are provided.
8.0 PLANS FOR DATA COLLECTION AND ANALYSIS
8.1 Data Collection
As described above, data are routinely collected through case surveillance activities. Data to be used in routine analyses will be generated from the national HIV surveillance database. Currently, cases to be analyzed are recorded using unique identifiers. Data are stored in password protected computers and secured within the MOH offices. All patient identifiers, codes and names will be removed prior to analyses.
8.2 Patient Data Routinely Collected at each Facility
Health facilities routinely report all HIV positive results to the MOH by completing a case report form for each case or sentinel/reportable event that is identified. The paper-based case report form is transmitted from the reporting site to the MOH via the regional epidemiological nurses. Cases report forms are collected each month, hence HIV cases must be reported within one month of diagnosis. All case report forms are delivered to the MOH, specifically the NSU, where data entry, cleaning and management occurs.
The variables collected include: Patient Information (including demographics); Exposure Categories (including likely mode of HIV transmission and other HIV-related risk factors); HIV Test Results (including name and type of test, and test date); Clinical Information on Advanced HIV (including CD4 values below 350 cells/µL and clinical staging (stage 3 and 4); Reporting Facility Information; and MOH-driven quality management information. This is depicted on the case report form (Appendix 1).
8.3 Data collection and management
All data are collected and stored in the national HIV surveillance database. These data are stored in a password protected computer within a locked space at the MOH. Per confidentiality standards, all paper data are locked in file cabinets and are stored securely once they are entered into the database. In order to improve the utility and quality of the data being collected, a revised supervisory structure may be put into place to support higher quality data reported from all clinical sites and medical facilities. Data cleaning exercises are regularly conducted to eliminate duplicate entries and to ensure accuracy and completeness of the data.
8.4 Data Analysis
Analysis will continue to be conducted on an on-going basis to improve the data quality and for generalized epidemiologic reports where individual patients cannot be identified. Such reports will be used in updates and to describe national statistics and trends. These may include simple analyses that describe the characteristics of the demographics of the population living with HIV, basic trends of the HIV epidemic, and identification of characteristics and risk factors among individuals with HIV. In addition to simple frequencies, more advanced statistical analyses such as multivariate analyses of patient outcomes may be conducted using SAS or SPSS. CDC will provide analytic support to these efforts. All patient identifiers will be removed prior to analysis.
9.0 CONFIDENTIALITY PROTECTIONS
Patient-level data are routinely collected as part of ongoing testing, treatment and management of patients in health care facilities. These patient records are stored in a secure and confidential location at the respective health facilities. Forms submitted containing patient-level data are locked in file cabinets and are stored securely once data is entered into the database. At the MOH, the data are stored in the secured and password protected database. Access to databases and forms is only given to authorized staff. CDC will not have access to codes or names in the database. All data will be de-identified prior to analysis.
10.0 OTHER ETHICAL CONCERNS/ISSUES
None. Case reporting data are routinely collected for surveillance as well as monitoring and evaluation purposes, not for research purposes. Data from the existing HIV surveillance databases are secured, password protected and located at the MOH offices. No contact with human subjects is involved for the proposed analyses. No extra data are or will be collected for the purpose of these analyses. CDC will not have access to patient names or codes from this surveillance databases or other databases.
11.0 PROJECT TIME FRAME
Program data collection, analysis and reporting are ongoing.
12.0 PLANS FOR PUBLICATION AND DISSEMINATION OF THE PROJECT FINDINGS
Analyses of the HIV case reporting data will produce reports that will better characterize the HIV epidemic in [country]. Reports from these surveillance data may be used for enhanced resource allocation, program modification or refinement, and/or the development and implementation of policies that will strengthen the country’s surveillance system. The dissemination of findings will be critical to inform the MOH and NAP as to the trends and characteristics of the HIV epidemic. Findings related to disease trends or process outcomes related to the establishment of the surveillance system in [country] may be utilized in abstracts, forwarded to peer-reviewed journals and/or utilized for internal reporting and evaluation.
13.0 REFERENCES
HIV Clinical Staging and Case Reporting. World Health Organization, 2007.
14.0 APPENDICIES
Appendix I: [country] Case Report Form
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[1] HlV Clinical Staging and Case Reporting. World Health Organization. 2007.