TRACE INITIATIVE: Data Management

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BACKGROUND

Recency Data Collected Data will be collected on forms, in registers, and, in some cases, on tablets or computers Example data sources: Recency HIV Infection Surveillance Register or Recent Infection Results Documentation Form Collects lot number, expiry date, date of test, and result Electronic data collection forms Collects basic demographics and risk factor information Laboratory Requisition Form Collects client ID, date of test, date of transport, results, and viral load Return of Results Log Collects information required to return result if applicable Laboratory Log Book Collects information about testing done in laboratory including confirmation and viral load as well as final RITA result

Minimum Data Set Strongly suggested variables to collect in order to accurately assess the epidemic and track progress Included range of values for data quality checks

DATA PLATFORM

Data Platform Paper or electronic Solution based on central server in secure data center Access through web browser and optionally mobile tools

Example Solutions ODK Open source data collection software easily adaptable Works on most tablets and backs up to a cloud server Has offline capability in the case of poor internet REDCap Origins in research data management Large global presence, including and growing in LMIC Ease of use, standards support, privacy and confidentiality support Common Properties Web-based software with central server and browser based interface End-user configurable (meta-data driven) Rich feature sets for data capture/management Off-line data capture possible with mobile device application

Common Approach Build the electronic report form Based on DGHT HIV case-based surveillance initial CRF With recent infection test & algorithm added Data abstraction perspective Workflow aligned with transcription from source documentation Configure advanced data management features Data quality controls Single-field validation rules Multi-field logical consistency controls Branching logic Data capture workflow and quality support Program reports Basic analytics for program quality assurance

Example Case Report Form

Example Case Report Form Continued Client Rapid HIV Recent Infection Test Information Rapid HIV recent infection testing If the test was conducted or not If the test was conducted, indicate the test name and test date Rapid HIV recent infection test results Can be “Recent” OR “Long-term” OR “Inconclusive” Viral load confirmation for the HIV rapid recent infection test result A viral load test can be conducted to confirm recent infection among clients that test “recent” on the rapid HIV infection test If a viral load test was conducted, indicate the sample collection date, the test date and the results in copies/mL. Final rapid HIV recent infection testing algorithm result if viral load test conducted; recent is defined as tested recent on the recent HIV infection test and having HIV RNA >1,000 copies/mL Long-term is defined as tested long-term on the recent HIV infection test OR tested recent on the recent HIV infection test and having HIV RNA of 1,000 copies or lower

DATA SECURITY

Data Security Platform requires strong security support to store identified information on HIV status Use VPN if possible Use managed authentication system Confidentiality requires configurable data access rules to ensure that PII is only accessible to those individuals who are authorized

Data Security Data security is important at every stage: data collection, transfer, and storage All electronic devices, if used, will be physically secured when not in use. All electronic devices and databases will be encrypted, password protected and accessible only by appropriate staff. The database will be backed up monthly on a secure, external system. All staff with access to data will receive training in data security and confidentiality and must affirm that they will abide by data security and confidentiality principles and procedures.

Electronic Capture of Data For paper-based forms Data from all recency forms will be entered into a secured computer at the lab by data entry staff All forms will be kept in a locked cabinet after they have been entered Electronic data entry Data will be entered into a tablet kept in a secure place at the facility SOPs should be in place to ensure proper storage, charging of tablet and internet access (hotspots if wifi is not available at the facility) Tablets should be connected to the server daily for data upload

DATA CLEANING

Data Cleaning Data will be reviewed and cleaned by the data manager weekly Periodically, the entire database will be checked for errors Inconsistencies will be confirmed by reviewing the original source (data forms) If the data form is incorrect, the supervisor for that site will be called to confirm If all attempts to correct the error fail, the data will not be usable

Review All Forms Carefully Before Submission The success of the program depends on everyone doing their job with pride We owe it to the clients to handle their data with the utmost care PLEASE REVIEW ALL FORMS CAREFULLY AND ENSURE THEY ARE PROPERLY FILLED OUT AND ENTERED

DATA AGGREGATION & ANALYSIS

Data Aggregation Data will be aggregated at the sub- national/national level Data will be used to: Monitor trends in the proportion testing recent among newly diagnosed PLHIV by select demographic and HIV risk indicators Identify geographic locations associated with testing recent Inform targeted interventions by demographic variables, risk indicators, and/or geography

Data Analysis Implementing partner is responsible for ensuring analysis happens in conjunction with other stakeholders including the Ministry of Health Data should be analyzed and reviewed quarterly for action

E.g. age, sex, risk behavior, access to health services Objectives of Data Analysis Monitor trends in the proportion testing recent among newly diagnosed PLHIV by select demographic and HIV risk indicators to inform targeted interventions E.g. age, sex, risk behavior, access to health services Identify geographic locations associated with testing recent to inform geographic prioritization of interventions GIS software packages (ArcGIS, QGIS) Maps (dot maps, shaded maps, heat maps, bubble maps) help visualize the location of recent and long-term HIV infections by health facility GIS location or client residence

Monitor those who chose not to test for recent infection Objectives of Data Analysis Monitor those who chose not to test for recent infection Number and proportion of eligible clients who chose not to test for recent infection Comparison of demographic and behavioral characteristics of persons who did not receive testing for recent infection compared to those who were tested

Data Analysis New PEPFAR MER indicator: HTS_RECENT Percentage of persons aged ≥15 years newly diagnosed with HIV-1 infection who have a test for recent infection result of recent infection during the reporting period Reporting: Frequency: quarterly Level: facility and community Number of newly diagnosed HIV-positive persons aged ≥15 years with a test for recent infection result of recent infection during the past quarter Numerator Denominator Number of newly diagnosed HIV-positive persons aged ≥15 years with a test for recent infection result during the past quarter

Relationship with HTS_TST Facility or community where testing for recent infection is performed Newly diagnosed and recent infection HTS_RECENT (numerator) HTS_TST Testing for recent infection HTS_TST_POS (≥15 years) NOTE: Only persons who are newly diagnosed HIV-positive should be tested for recent infection. Persons who have been diagnosed HIV positive and are retesting or persons who are on ART should not receive testing for recent infection. Each country may use different methods for determining who is truly newly diagnosed HIV positive (e.g., additional post-test counseling to discuss prior diagnosis or ART history, review of registers to check whether a client is a silent transfer, and viral load testing to help eliminate those who test recent and are on ART and virally suppressed). Newly diagnosed HIV positive HTS_RECENT (denominator) Newly diagnosed and long-term infection Newly diagnosed HIV-positive persons aged ≥15 years who tested for recent infection and have a result HIV negative

Data Analysis: Table Shells Outcomes Number and percentage of recent infections Characteristics Sex Age Marital status Geography: testing site, residence, urban/rural, SNU Education level HTS point Priority/key population type Pregnancy status Number of sexual partners in last 12 months HIV testing history Violence in last 12 months

Example Analyses for HIV Recency Testing

Testing Coverage and % Recent by Quarter

% Recent by Assay and RITA

% Recent by Facility and Quarter

Not Tested for Recent Infection

Index Partners by Recent Infection Status

Index Testing Yield Example HIV yield among partners by index case recency status, Central America, January-August 2018, Guatemala, Nicaragua, and Honduras

Factors Associated with Recent Infection

Incidence Estimation

Recent Cases by Location Source: Data collected by the Ministries of Health in Guatemala, Honduras, and Nicaragua and presented at the 2018 PEPFAR Annual Meeting by Northbrook S et al.

Recent and Long-Term Cases by Location Source: A pragmatic approach to HIV hotspot mapping in a developing country available at http://proceedings.esri.com/library/userconf/proc17/papers/1688_462.pdf

SaTScan Analysis Source: Data collected by Nicaragua Ministry of Health and presented at the 2018 PEPFAR Annual Meeting by Northbrook S et al.

DATA REPORTING

Data Reporting Implementing partners are responsible for MER reporting and any other reporting required by the Ministry of Health MER reporting data will be made available All data Are the property of the country Ministry of Health Will be monitored by the project investigators Will be accessible to all investigators

Data Reporting Periodically, results will be presented to a meeting of a group of stakeholders such as the government (MOH), civil society, non- governmental organizations, donors, and international technical experts. Dissemination of results will take several forms, including reports for distribution and peer-reviewed publications.

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