Appendix 3.4.6: BBSS Data Management Operations Manual Biological and Behavioural Surveillance Survey (BBSS) among MSM [Country]

Appendix 3.4.6: BBSS Data Management Operations Manual Biological and Behavioural Surveillance Survey (BBSS) among MSM [Country] Data Management Manual

Contents a. Introduction... 3 b. Glossary of Terms... 4 c. Diagram of Directory Layout... 7 d. Questionnaire Development System Software... 8 e. Data Storage and Transfer initial steps... 9 f. Behavioral data... 10 g. RDSCM data... 13 h. Biological data... 16 i. Back up Protocol... 18 j. Data Manager Reviews... 19 k. Central Databases and Data Access... 21 l. IT Support Protocol... 24 m. Process monitoring... 26 i. Recruitment monitoring report... 26 ii. Sample characteristics report... 26 iii. Seed characteristics report... 36 2

a. Introduction The HIV/AIDS Coordinating Unit (HCU) of the Ministry of Health is conducting a survey supported by MOH ICT. The purpose of this survey is to conduct a biological and behavioral surveillance survey (BBSS) among Key Populations. The BBSS will run for six to seven months at two locations in [city] and one in [city] and is earmarked to commence March 2013. All data collected from the survey will be managed centrally at the HCU. This operations manual sets out information related to data management for the BBSS activity. It is intended to be a comprehensive reference for data management processes. 3

b. Glossary of Terms Audio Computer-Assisted Self Interview (ACASI): This is a program that automatically reads a questionnaire out loud to participants. It is a method of collecting the questionnaire data. Acquired Immune Deficiency Syndrome (AIDS): The syndrome caused by the human immunodeficiency virus that presents with opportunistic infections, immunosuppression and other symptoms. Biological and Behavioural Surveillance Survey (BBSS): Data collection consisting of two elements: 1) a survey of behaviours and knowledge related to risk of acquiring the disease(s) of interest, and 2) biological testing to determine the participant s disease status with respect to each disease. Biological test database: This database has all the biological test data for participants who do the biological survey at sites. It includes participants survey ID and status of all tests that participants conduct during the survey. Boxcryptor: This is the software that is used to encrypt files. It acts as a virtual hard drive on the computer. Any files that are placed into the hard drive space are encrypted and can only be read if the user has the proper permission. For our purposes the software has been embedded into the Drop box software so that all folders involving the BBSS are saved in a Boxcryptor encrypted folder. Co-investigators: Persons who oversee the implementation of the BBSS project. Computer Administered Personal Interview (CAPI): This program works like the ACASI version, but without the automatic reading of the questionnaire. Coupon: This is a card that is given to potential participants for them to be able to participate in the project. Each coupon has a unique ID number which is used as the participant s survey ID number. Data correction log: A log that documents all data issues that arise at the field site and the status of those issues. Data Manager (DM): The person responsible for maintaining and creating the databases used at the survey site. The DM also uploads the data to the MOH servers and produces data monitoring reports for the study team. Data monitoring reports: These reports are produced to show the progress of the survey by summarizing data collected each week. Drop box: This is the internet-based storage being used for this survey. It has been configured with encryption software to secure files within its folders. External Hard Drive: An external memory hard drive used to carry data securely. 4

Human immunodeficiency virus (HIV): A virus transmitted by the transfer of bodily fluids that targets human immune cells, leading to immunodeficiency and AIDS. Incentive: An object or non-tangible gift offered to participants to compensate them for their time and effort during their participation. An incentive may be of monetary value or it may be a health screening test, which has value only to the participant receiving it. Informed consent: A participant s informed decision to participate in an interview after having received information about the purpose, procedures, risks and benefits, and that participation is voluntary. Men who have sex with men (MSM): The term is applied irrespective of the individual s sexuality or self-identification, and is used to identify men who engage in anal or oral sex with other men. Key Populations One of various sub-groups that is at elevated risk of HIV infection or transmission because they engage in specific, known high-risk behaviours. Key Populations Steering Committee: Multi-sectorial Advisory Committee to MoH consisting of individuals with local content expertise in service provision and policy formulation for Key Populations. Ministry of Health: The Ministry of Health is the national authority charged with oversight of the entire health system in [country]. The Ministry plays a central role in the protection of the population s health and in ensuring that all organisations and institutions that produce health goods and services conform to standards of safety. National Alliance of State and Territorial AIDS Directors (NASTAD): Technical assistance partner supporting the Ministry of Health in the implementation of Key Populations surveillance in [country]. Questionnaire Development System (QDS): This software is used to develop a questionnaire that collects information about an individual s behavior. The software has three main programs: The Design Studio which is used to create the questionnaire, the ACASI/CAPI modules which are used to collect the data and the Warehouse Manager which is used to store and process the data. Recruitment: In respondent-driven sampling, the process of providing coupons to participants and following up on coupons distributed, with the ultimate goal of enrolling enough eligible participants to reach the stated sample size. Respondent-driven sampling (RDS): Chain-referral sampling that starts with a limited number of seeds who refer their peers. RDS is based on the theory that bias in recruitment is overcome after recruitment proceeds through a sufficiently large number of waves. Statistical adjustment is accomplished through the use of RDSAT based on respondents network size. Respondent Driven Sampling Coupon Manager (RDSCM): This program is used to manage all coupons and incentives given to successful participants within the project. The program 5

allows the user to keep track of all the distributed coupons and is able to be converted for use in RDSAT which would allow all the data from the program to be statistically analyzed. Respondent-Driven Sampling Analysis Tool (RDSAT):A statistical software that is used to adjust RDS survey and to display participant recruitment patterns. Seed: An individual who is well-connected within the networks of the surveyed community. Each seed will recruit individuals within his network to start the waves of sampling in RDS. Statistical Package for the Social Sciences (SPSS): This is a software package used for statistical analysis. This package is able to analyze data from various sources and will be used to help produce data monitoring reports and final results analyses. Survey ID: This is a unique number that is given to every participant that has a valid coupon. The survey ID is located on the coupon the participant brings with them. Surveillance Study Coordinator (SSC): The person who oversees the Data Manager and Field supervisors and coordinates all operations of the study. Principal Investigator (PI): The person who oversees the entire project for the MOH. Virtual Private Network (VPN): This is a secure network that allows a user to connect to a network or set of files over the internet. Only users on the VPN will be allowed to view the files and have access to information on the network. 6

c. Diagram of Directory Layout Below is a diagram of the directory containing the folders and files for the survey. This diagram contains: Behavioral data This folder contains all the data that is collected from the ACASI/CAPI and data extracted using the warehouse manager. Biological data This folder contains all the testing data, including HIV, Glucose, HSV, Syphilis, Hepatitis B, Chlamydia, Gonorrhoea. There are four excel databases that make up the biological data: one database for each of the survey sites and the master database used by the data manager. Site data This folder contains all data from the sites, including data from the visit checklists and other internal monitoring documents. This data is used to show the progress of the sites and areas affecting their performance. Documents- This folder contains documents for the survey such as manuals for RDSCM and ACASI/CAPI, the ops manual for the survey, the interviewer guide and the paperbased version of the questionnaire. RDSCM data This includes the data collected by RDSCM and the converted SPSS format data. Dropbox Behavioral Data (questionnaire data in Data Warehouse) Biological Data (All testing data e.g. HIV testing log) Site data (site monitoring information) Documents (all data management and site operation documentation) RDSCM data (coupon manager data) 7

d. Questionnaire Development System Software In order to gather participant data in the behavioral questionnaire, we ll be using QDS software. QDS software has three different modules: a questionnaire design studio module, a data collection module (several different options are available) and a data warehouse module. In this study, we ll be using ACASI and CAPI as the methods of administering the questionnaire to participants. CAPI is similar to ACASI but does not have an audio component and is administered to the participant by an interviewer on a computer. The data warehouse module is used to maintain and manage all the interviews collected. It is also the module that batches the interviews into single database file. This database file can be either in SPSS format, SAS format or Microsoft Access format. The following link is to a video on the QDS software website showing how to export files from the data collection module to the data warehouse for storage. http://www.novaresearch.com/products/qds/qdsvideoplayer.cfm?vid=10 8

e. Data Storage and Transfer initial steps Each day that field sites are open and enrolling participants, they will collect electronic and site data, both of which need to be securely stored at the end of each work day. Electronic data will be encrypted when the interviewer exits the survey interface, and will be stored locally on each computer. This electronic data needs to be transferred to the central server at the end of each day for its security. The Field Supervisor is responsible for performing the data transfer on a daily basis. The laptops at the field site have wireless internet connections. The Field Supervisor has a VPN connection to a cloud hard drive that the data manager is also connected to. If the VPN or the internet is not working, study staff will transport the survey and RDSCM data to the MoH office via external hard drive and upload the data to the network. If that is not possible, copies of the encrypted.qad files (i.e. CAPI and ACASI survey files) and the Coupon Manager file will be saved on a CD and stored in a locked file cabinet at the field site. The CD will be physically destroyed after successful data transfer. 9

f. Behavioral data Table 1: Behavioral data components ACASI data Data Member Name Description Type Survey ID Identification Number of survey Integer subject. Consent Eligible Participants have given their consent for Information on whether participants are eligible or not. Additional Type Information <specify max and min length and any specifically disallowed characters> Mandatory? Unique? Yes Yes Character Yes/No Yes No Character Yes/No Yes No Data from the ACASI/CAPI program is transferred from the site via Drop box by the field supervisors. The data is saved in a.qad file which is then renamed in order to identify it. The code for the naming of this file will be the date eg 190313 followed by the interview initials eg LH followed by the site initials eg SEA and finally if it was the first, second or third interview for the day eg 01. An example of the renamed.qad file would look like 190313LHSEA01. This data is then collected by the data manager who saves it in the directory folder Behavioral data. The data is then entered into a QDS warehouse that is managed and maintained by the data manager. After the data manager has validated the data, the data is then batched into a single SPSS.sav file. This file is then saved in the behavioral data folder and used to create weekly monitoring reports by SPSS statistical tools. This data has a destruction date of 7 years. Access to this data is restricted to the Principal Investigator, Co-investigators, Surveillance Study Coordinator who will oversee any updates carried out by the Data manager and the Data manager. Steps for data transfer of questionnaire data 1) Data is collected from participant via ACASI/CAPI data collection. 2) This data is saved as a QAD file eg: Survey_CAPI_030713SBSF02.QAD 3) The Field supervisor copies and pastes this file onto a flash drive off the ACASI/CAPI computer. 4) The flash drive is then entered into the Field supervisor laptop where the file is then copied and pasted into the Behavioral folder on the cloud drive. 5) Data is then collected by the data manager using the drop box software by copying the files into the data manager folder in drop box. 6) After the data is in the data manager folder the QDS warehouse software is opened and the data is added to the appropriate warehouses by collecting source data as described below. 7) Data is validated by data manager 10

8) The data is then batched into a single SPSS format.sav file with the date of the batch added to the file name (i.e. [city]&[city]_interview_03.6.13.sav using the QDS warehouse software that allows the exporting of interviews. 9) This file is then saved in the behavioral data folder named SPSS and used to create monitoring reports using the SPSS analyze function. 10) The QAD file that is on the Field supervisor s flash drive is not deleted until the data manager has validated the data and uploaded it to the server. This means that the data will be kept on the flash drive a minimum of 3 to 5 days in order to avoid prematurely deleting the source data. Flow of data transfer Data Flash drive FS laptop Dropbox Boxcryptor.bc BBSS database Site location Behavioral data Data for data manager Collecting source data File Open warehouse (warehouse will then appear) File open source data (the QAD file that was just copied into data manager folder) Drag QAD file into warehouse save new warehouse by clicking saved button. Validating data Data is checked in a variety of different ways. The 3 main checks done on the behavioral data are as follows: The data collected is checked against the biological and RDSCM databases for interview date accuracy, STI data accuracy, CD accuracy, and valid recruiter data. Site data is checked such as interviewer ID, accurate survey site entered. The pattern of answering questions is checked as well for example if the participant only clicked button 3 throughout the entire process or if a question was left out or if the survey was not completed but states completed. Flow of data batching File Open warehouse Export interviews Name the batch file and use.sav format file Click export 11

QDS Warehouse layout 12

g. RDSCM data Table 2: RDSCM data components Coupon Manager Data Member Name Description Type Additional Type Information Mandatory? Unique? Survey ID Identification number of survey Integer <specify max and min length Yes Yes subject. and any specifically disallowed characters> Coupon ID Identification number of coupon. Integer <specify a range if known> Yes Yes Coupon Validation <describe the meaning of the data member in the problem domain> Character Valid or Void Yes No Recruiter ID Identification number of recruiter Character Specfic recruiter code Yes Yes Seed? Is participant a seed Character Yes/No No No Physical Marks Physical marks on the participant Character 100 character limit Yes Yes to help identify them Date of interview Date participant comes in Date mm/dd/yyyy Yes No Duration Duration of interview TIme hr:mins Yes Yes Start time of Interview Time participant starts interview Time hr:mins Yes Yes Finish time of Interview Time participant finished interview Time hr:mins Yes Yes Number of Coupons Number of Coupons given to participants Integer Yes No Data from RDSCM is transferred from the site via Drop box by the field supervisors. This data contains all the data related to the incentives and recruitment. Data is collected by the coupon manager and saved in the directory folder RDSCM by the field supervisors. This data should only be present on the coupon manager s computer and the field supervisor s computer. The field supervisor then accesses this folder to transfer it to the data manager at HCU. RDSCM does not allow data back ups to merge files, therefore in order to get coupon IDs from other sites, sites will call other sites to inform them that a participant from the north has appeared in south. The data manager will create new merged data backup files that will allow information to be shared between sites. This new data will be sent to the sites via the drop box software and copied directly into the coupon manager laptop so that the RDSCM is updated. This data has a destruction date of 7 years. Access will be restricted to the Principal Investigator, Coinvestigators, Surveillance Study Coordinator, Data manager and the Coupon manager and Field Supervisor, who will maintain the coupon manager database on-site. When the data is being uploaded to the server, all data except for the physical markers of participants is uploaded. RDSCM data transfer steps 1) Data is collected and entered by the coupon manager. 2) The data backup file is then copied on a flash drive by the Field supervisors who then copy the data onto their laptops. 3) Data is then uploaded via Drop box by the field supervisor to the data manager daily in the RDSCM data folder. 13

4) The data is checked by the data manager. 5) The data is then left on the field supervisor flash drive until the data manager confirms the data has been backed up on the HCU server. (The length of time that data is meant to stay on the flash drive is set for a minimum of 3 to 5 days to avoid premature deletion of data.). 6) The data is then uploaded to the server by the data manager. Flow of data transfer Data Flash drive FS laptop Dropbox Boxcryptor.bc BBSS database Site location RDSCM Data Data for data manager Checking data RDSCM data is checked by the following steps: The Interviewer ID and survey ID are checked against the ACASI/CAPI database and biological database. The RDSCM is checked for any errors in records such as duplicate coupon ID distributed. The RDSCM is exported to test that the RDSCM outputted text file is compatible with the RDSAT software. Check results presented for recruiter information taking care to be aware of outstanding coupons. RDSCM merging process RDSCM data is merged by the following steps: The RDSCM data from the [city] site is opened and examined for new survey IDs and status information such as paid or voided coupons. The RDSCM data from the [city] site is opened and examined for new survey IDs and status information such as paid or voided coupons. Any new information from either site is recorded by entering data in an Excel or word document. The latest merged RDSCM data backup file is opened and the new data is added to it. The new merged RDSCM data backup is then copied into [city] and [city] site folders on dropbox. 14

An email is then sent to the Field supervisors to alert them of the presence of the merged RDSCM and the new details that were added to it. The email will include the survey IDs of the records that were added to the database or updated with new information. Field supervisors then view the new RDSCM file on dropbox and check for updates on the noted survey IDs. The accuracy or inaccuracy of the merged database is confirmed with the Data Manager. If the update is accurate, the Field Supervisors use their flash drives to copy the merged RDSCM file onto the Coupon Manager laptop. The Coupon Managers deletes all existing data backup files from the RDSCM folder and then copies the new merged RDSCM file. In the RDSCM program the Coupon Manager goes into administrative tasks and restores the database using the restore database tool located in administrative tasks. The database will then be restored using the new merged RDSCM file and be up to date. 15

h. Biological data Table 3: Biological data components Biological testing data Data Member Name Description Type Survey ID Identification Number of survey Integer subject. Additional Type Information <specify max and min length and any specifically disallowed characters> Mandatory? Unique? Yes Yes Location/group Identifies the site or location the Integer <specify a range if known> Yes No subject went for the survey Date of visit Date of the survey subject's visit Date <specify max and min Yes No values, no of decimal points and unit of measurement> Hypertension Screening Test for Hypertension Chatacter <specify the values that the No No field can take on> Results Received varables Shows whether the subject Character Yes/No No No received there results or not HIV Test Shows results for HIV test Character Negative/Postive/not tested Yes No Glucose test Shows results for Glucose test Character Negative/Postive/not tested Yes No Syphilis Shows results for Syphilis Character Negative/Postive/not tested Yes No Gonorrhea Shows results for Gonorrhea Character Negative/Postive/not tested Yes No Chlamydia Shows results for Chlamydia Character Negative/Postive/not tested Yes No HSV II Shows results for HSV II Character Negative/Postive/not tested Yes No HEP B Shows results for HEP B Character Negative/Postive/not tested Yes No A comprehensive biological testing log is maintained at the MoH central office. One database will be maintained for each of the three sites so that Field Supervisors at each site can make edits to their own databases at the same time. The Field Supervisor is responsible for entering results for test results from each field site through Drop Box. This data has a destruction date of 2 years. Access is restricted to the Principal Investigator, Coinvestigators, Surveillance Study Coordinator, Data manager, and the Field Supervisors who enter or retrieve test results. Steps for data transfer of Biological testing data 1) Data is collected and entered into excel in the Biological data folder by field supervisors 2) Data is kept on a flash drive so that a previous database is always backed up. This data is kept until the database is updated. 3) When the database is updated the older version is then saved on the flash drive until which ever time the database is next updated. 4) Data is uploaded via Drop Box to the data manager who updates the master database by copying the new information into the master database. Flow of data transfer 16

Data Flash drive FS laptop Dropbox Boxcryptor.bc BBSS database Site location Biological Data Update existing document How the data will look: 17

i. Back up Protocol Backing up the data uploaded to the server is the responsibility of the data manager and is overseen by the study lead. At the survey sites, the Field Supervisors back up data. Back ups for all data will be stored locally (on-site) and off-site using either server tapes or other external storage devices such as high memory flask drives. All external storage devices will be encrypted. Data transferred to the server and data backed up on external storage devices will be backed up daily. Passwords on all back ups change every two months. There will be three back ups available in case any information is lost. Field supervisors will have a back up on their flash drives that are encrypted. The data manager will have a back up on his computer which will be encrypted and a back up available on a server tape that will be encrypted and secured in a locked area. Steps for data manager backing up uploaded data: i) Data from site is reviewed by data manager. ii) Data is checked for errors. iii) Data is backed up or copied into an encrypted folder marked back up on data manager s computer. iv) Data is then uploaded to server. v) A back up of the data on the server will be created using server tapes once a week by the data manager. Steps for data manager backing up data on the server: i) Data manager goes to the server. ii) Using a server tape, data manager obtains back up data from server. iii) Data manager then secures/encrypts data on server tape. iv) Data manager then places server tape in a secure area. Steps for field supervisor backing up to external storage: i) Data from RDSCM is reviewed by field supervisor. ii) Data is checked for errors. iii) Field supervisors upload data to an external storage, such as a flask drive. iv) Flask drive is encrypted. v) Flask drive is secured on the field supervisor s person. vi) Field supervisor carries external storage to the data manager to be uploaded to the server. 18

j. Data Manager Reviews The Data Manager reviews survey data for data quality after it has been uploaded and backed up. These checks are conducted by running data frequency commands to look for overly frequent don t know and refused responses, or excessive responses of one kind such as no to all questions or yes to all questions. In addition, errors in skip patterns due to ACASI programming errors should be identified and fixed. The data manager will check for: Inclusion of unique identifiers such as Survey ID, Coupon ID etc Consent for behavioral questionnaire and biological testing Interviewer comments Data correction log Non-random patterns in questionnaire (excessive similar responses or refusals) Duplicate surveys Inconsistent data Missing data After reviewing data, the data manager will export it from the QDS Data Warehouse into SPSS. The export steps are as follows: b. Open the QDS Data Warehouse containing the data. c. Select the records you wish to export to SPSS. Note: To select all non-deleted records: Go to edit Select all d. Go to File Export Interviews e. Enter password f. A Save As box will pop up. Save the data as an SPSS file. g. Type in the file name for the SAS transport file, keeping the file name to 8 characters or less. Note: Some versions of SAS will truncate file names longer than 8 characters. h. Before saving the file, Click on the options box in the bottom right corner. i. Click on Recode to Specified Values. In the boxes there should be:.d for Don t know.r for Refused.N for Not applicable.s for Skipped 19

j. Click on OK when done. Note: SAS programs created by CDC may not run properly if steps 6-8 are not completed) k. Hit Save. 20

k. Central Databases and Data Access Figure 1: Database Flowchart Full dataset with all data elements Questionnaire RDSCM Testing data Paper based forms HIV Rapid & chronic disease HIV confirmation and Hep B Syphilis HSV, CT/NG Figure 1 shows the different data sources in the BBSS, and their relation to each other. Table 4 below shows the data sources, where the information comes from, how it needs to be transferred and who has access to it. The Data Manager is responsible for maintaining all databases centrally at the MoH administrative base. Four databases will be maintained concurrently: The Data Warehouse, RDSCM, biological test results, and an SPSS or Epi Info dataset to hold and analyze survey and test results. The Field Supervisor will enter test results into the cloud hard drive during their spare time. Test results should be entered into the database the same day that they are available, or every other day, at a minimum. The Field supervisor is responsible for assuring the accuracy and completeness of test results entered. To check the completeness of the test results database, once a week, the Coupon Manager at each site compares paper test records with the electronic test result database to check for errors. The Data Manager is responsible for entering test results coming from outside laboratories (hepatitis B, syphilis, herpes, Chlamydia, gonorrhea, HIV confirmatory testing) at the MoH administrative base. The results are entered by survey ID. The results originating from the survey site (HIV, blood pressure, glucose) will be entered into the local database by the Field Supervisor daily, or every other day via a VPN connection to a cloud hard drive. The central results database will be downloaded at the 21

field sites daily so results are available to participants for their second visit. The test result database will thus be updated regularly by the Data Manager at the office, and by the Field Supervisors at the field sites. As a result, the test result database will be updated bi-directionally. Table 4: Data Inventory MSM BBSS Where Data type collected/ge nerated Identifying information Transfer needs Transfer mechanism Destruction Date Access Questionnair e Survey site Age, borough, test date RDSCM Survey site Physical markers & unique codes (Needs to be deleted after the final analysis database is completed) HIV rapid testing HIV confirmatory and Hep B testing Syphilis testing HSV, CT/NG testing To MoH central server for secure storage Each site s database updated daily by merging changes in MoH central server Survey site Test results To MoH central server for secure storage [name of lab] Test results To survey site to deliver results, to MoH for secure storage [name of lab] Test results To survey site to deliver results, to MoH for secure storage [name of lab(s)] Test results To survey site to deliver results, to MoH for VPN connection VPN connection VPN connection 7 years [initials of responsi ble individu als] 7 years [initials of responsi ble individu als] 2 years [initials of responsi ble individu als] Secure courier 2 years [initials of responsi ble individu als] Secure courier 2 years [initials of responsi ble individu als] Passwordprotected document in email 2 years [initials of responsi ble individu 22

Paper based forms Full data set combining all data elements secure storage Survey site Test result To MoH for secure storage MoH office Age, borough, test date, test results No transfer needed als] By field staff 2 years [initials of responsi ble individu als] N/A 7 years [initials of responsi ble individu als] 23

l. IT Support Protocol 1. Designate a single point of contact (the Data Manager) for the IT Helpdesk whereby problem request initiation, feedback and resolution can be directed via phone or e- mail. 2. The interface should begin with: a. with a phone call to the following numbers: xxx-xxxx and xxx-xxxx, or b. e-mail the Request to: [include email address] 3. The following information should be provided to the IT Helpdesk Attendant: a. Problem Description and other related system messages where applicable, b. Application being used c. Contact Number, d. User Name e. User Department etc 4. The IT Helpdesk Attendant enters the details into the system and would provide you with the problem request ID which should be kept for further reference. 5. 1st Level Support would begin with the assigned Technician/s who would resolve these reported issues within a 3 day period. These issues would largely pertain to Network, Virus and Spyware problems. The assigned Technician would provide updates on subsequent follow-ups regarding his work on the problem request. 6. When Vendor intervention is required, 2nd Level Support would begin and the Vendor s representative would be contacted by telephone and e-mail by the Helpdesk Attendant/and Technician. The affected Department (assigned contact person) would again be notified of the escalation. The Vendor s representative would follow up with the related Vendor staff both locally and internationally for a resolution which could be effective in 1-5 days based on the problem severity and complexity. The Vendor representative would update the IT Helpdesk personnel who would continue to update the affected Department (assigned contact person). 24

Updates would continue to be provided by the IT Helpdesk s assigned Technician and would also be available via the Helpdesk Attendants until resolution. (Please note that this resolution period would be dependent on the severity and priority of the request, and the extent to which the vendor intervention which may be necessary). 7. The problem request is closed by the Helpdesk personnel and the system updated, when the request is resolved. 8. Any queries related to outstanding requests and service delivery should be directed to: [include email address or contact number] 25

m. Process monitoring Weekly reports will be produced by the Data Manager to inform the PI and Co-Investigators on the progress of the study. The three weekly reports will provide information on different aspects of the study process. The reports below are sample reports and may be modified as needed. This data is generated from the questionnaire, consent documents and eligibility screener. i. Recruitment monitoring report The recruitment monitoring report provides information on recruitment in the study. The reports should reflect the total number of persons recruited per site on a weekly basis as well as the total number of participants recruited across all sites. Recruitment monitoring report Week # Dates # Screened # Eligible # Completed Interview # Consented to HIV test # Consented to STI tests # Consented to CD tests # Coupons Distribute d % Valid Coupons Returned Week # Dates # Interviewed Agreed to Recruit % Agreed to Recruit # Given 0 # Given 1 # Given 2 # Given 3 # Given 4 # Given 5 # Distribut ed # Retur ned % Returned ii. Sample characteristics report The sample characteristics report provides information on study participants by key demographics. The sample characteristics report helps to assure that all of the important sub-groups of MSM are being reached. For this study, age, education, ethnicity, socioeconomic status, HIV status, geographic location and sexual identity will be monitored in the sample characteristics report. 26

Eligibility (Data generated from Eligibility Screener) frequency percent cumulative percent Included in analysis Ineligible, age Ineligible, residence Ineligible, transgender Ineligible, no male partners Ineligible, not alert Ineligible, previous participant Ineligible, no consent [site location] [site location] [site location] Interview site (Data generated from Questionnaire) Among eligible participants with valid interviews frequency percent cumulative percent 1. Sociodemographics areas of Other: Outside [country] don t know Missing 18-24 25-29 30-34 35-39 40-44 45-49 50+ Don t know Missing African Caucasian Area of residence Among eligible participants with valid interviews frequency percent cumulative percent Age Among eligible participants with valid interviews frequency percent cumulative percent Race/Ethnicity Among eligible participants with valid interviews frequency percent cumulative percent 27

Mixed-African and Caucasian Mixed-Other Other Ethnic Group Don t know Missing Baptist Catholic Anglican Pentecostal Other Christian No religion Other religion Don t know Missing Yes No Don t know Missing Religion Among eligible participants with valid interviews frequency percent cumulative percent Born abroad Among eligible participants with valid interviews Frequency percent cumulative percent Gay Homosexual Bisexual Transsexual Heterosexual Drag Queen Transgender Other Don t know Missing Sexual identity Among eligible participants with valid interviews frequency Percent cumulative percent Income 28

gross income Among eligible participants with valid interviews frequency percent cumulative percent None <$500 $500 - $1499 per month $1500 - $1999 per month $2000 - $2999 per month $3000 - $3999 per month $4000 - $4999 per month $5000 - $5999 per month $6000 - $6999 per month $7000 - $7999 per month $8000 - $8999 per month $9000 - $10999 per month $11000 - $12999 per month $13000 - $14999 per month >$15000 per month Don t know Missing 2. HIV (this template will be used for all biological tests) related variables Yes No Consent for HIV testing Among eligible participants with valid interviews frequency percent cumulative percent Serological HIV status Among eligible participants with valid interviews who consented to HIV test frequency percent cumulative percent Negative Positive Pending No consent 29

Serological HIV status Negative Positive Don t know Missing Self-reported HIV status Among eligible participants with valid interviews Self-reported HIV status Negative Positive Not known Yes No Don t know HIV test in the last 12 months Among self-reported HIV negative participants with valid interviews frequency percent cumulative percent 3. Sexual risk behaviors 1 2-4 5-9 10+ Don t know Missing Number of total sex partners in last 12 months Among eligible participants with valid interviews frequency percent cumulative percent Sex with women in last 12 months Among eligible participants with valid interviews frequency percent cumulative percent Yes No Never had sex with women Knew HIV status of last female sex partner Among eligible participants with valid interviews frequency percent cumulative percent Yes No Never had sex with women 30

Yes No Yes No Don t know Yes No Don t know Knew HIV status of last male sex partner Among eligible participants with valid interviews frequency percent cumulative percent Condom use at last male sexual encounter Among eligible participants with valid interviews frequency percent cumulative percent Unprotected anal sex with last male sex partner Among eligible participants with valid interviews frequency percent cumulative percent Yes No Unprotected anal sex with male sex partner of unknown HIV status in 12 months Among eligible participants with valid interviews frequency percent cumulative percent 4. RDS related variables Yes No Seed Recruited by a stranger Among all participants frequency percent cumulative percent Waves by seed Among all participants Seed number Wave 1 2 3 4 5 1 2 3 4 5 6 7 31

8 9 10 Seed 1 2 3 4 5 Interview date Characteristics of individual seeds Among all participants Age Race Foreign birth sex Residence HIV status Date of last recruit 32

5. Cross-group recruitment Cross-site recruitment Among all participants Recruiter site visited Recruitee site visited site] site] site] site] site] site] Area of residence Among all participants Recruiter s area of residence recruiter's area of Recruitee s area of residence 33

Outside [country] 34

Age Among all participants Recruiter s age Recruitee s age 18-29 30-39 40-49 50+ 18-29 30-39 40-49 50+ Race Among all participants Recruiter s race Recruitee s race African Caucasian Mixed-African and Caucasian African Caucasian Mixed- African and Caucasian Mixed-Other Other Mixed- Other Other HIV status Among all participants Recruiter s HIV status Recruitee s HIV status Negative Positive Unknown Negative Positive Unknown Income Among all participants Recruiter s Monthly Income Recruitee s Monthly Income $0-$2999 $0 - $2.9K $3 - $5.9K $6 - $8.9K $9 - $12.9K $13 - $15K + 35

$3000-$5999 $6000-$8999 $9000-$12999 $13000-$15000+ iii. Seed characteristics report This report provides summary information on the seeds that are recruited to start the recruitment chains in the RDS study. Date Survey ID# Race Age Geographic Area Met MSM Definition 36