ATTACHMENT G.pdf

NHBS-HET2 Operations Manual

Version Date: May 26, 2010 i

1 Introduction ........................................................................................................... 1-1

1.1 Overview ........................................................................................................ 1-1

1.2 Justification .................................................................................................... 1-1

1.3 Responsibilities .............................................................................................. 1-1

1.4 NHBS-HET2 Method: Respondent-Driven Sampling................................... 1-1

1.4a RDS methods ......................................................................................... 1-2

1.4b RDS theory and assumptions ................................................................ 1-2

1.4c RDS implementation and affects on bias .............................................. 1-3

1.5 Pre-implementation Checklist ........................................................................ 1-4

2 Staffing .................................................................................................................. 2-1

2.1 Overview ........................................................................................................ 2-1

2.2 Principal Investigator ..................................................................................... 2-1

2.3 Project Coordinator ........................................................................................ 2-2

2.4 Field Supervisor ............................................................................................. 2-4

2.5 Interviewers and HIV Test Counselors .......................................................... 2-5

2.5a Interviewers ........................................................................................... 2-5

2.5b HIV test counselors ............................................................................... 2-5

2.6 Coupon Manager ............................................................................................ 2-6

2.7 Data Manager ................................................................................................. 2-6

2.8 Spanish-speaking Staff................................................................................... 2-7

2.9 Staff Training ................................................................................................. 2-7

2.10 Staff Evaluations ............................................................................................ 2-7

2.11 Interviewer Improvement Report ................................................................... 2-8

3 Project Preparation .............................................................................................. 3-1

3.1 Overview ........................................................................................................ 3-1

3.2 Study Logo and Marketing Materials ............................................................ 3-1

3.3 Supplies .......................................................................................................... 3-1

3.3a Materials for the field site(s) .................................................................. 3-1

3.3b Prevention materials and referrals ......................................................... 3-1 ii

3.3c Binder for project forms and logs .......................................................... 3-2

3.3d Survey Software ..................................................................................... 3-2

3.4 Safety Guidelines ........................................................................................... 3-3

3.4a General principals of field safety ........................................................... 3-3

3.4b Local safety procedures ......................................................................... 3-3

3.4c Dangerous/difficult situations ................................................................ 3-5

3.4d Safeguard the handheld computers ........................................................ 3-5

3.4e Field incident reporting procedures ....................................................... 3-6

4 Field Sites ............................................................................................................... 4-1

4.1 Overview ........................................................................................................ 4-1

4.2 Field Site Location ......................................................................................... 4-1

4.2a Location, location, location .................................................................... 4-1

4.2b Storefront locations ................................................................................ 4-2

4.2c Mobile van unit locations ....................................................................... 4-2

4.3 Field Site Set-up ............................................................................................. 4-2

4.3a Talk with neighbors and police .............................................................. 4-3

4.3b Field site safety ...................................................................................... 4-3

4.4 Multiple Field Sites ........................................................................................ 4-3

4.4a Operation of more than one field site ..................................................... 4-3

4.4b Cross-recruitment ................................................................................... 4-4

4.5 Hours of Operation ........................................................................................ 4-4

4.6 Crowd Control ............................................................................................... 4-5

4.7 Appointment System ...................................................................................... 4-5

4.7a General scheduling procedures .............................................................. 4-6

4.7b Developing an appointment scheduling system ..................................... 4-7

4.7c Developing a standby appointment system ............................................ 4-7

5 Seeds ........................................................................................................................ 5-1

5.1 Overview ........................................................................................................ 5-1

5.2 Identifying and Recruiting Seeds ................................................................... 5-1

5.3 Assessing Seeds ............................................................................................. 5-3

5.4 Screening and Interviewing Seeds ................................................................. 5-4

5.4a Screening and interviewing by appointment .......................................... 5-4 iii

5.4b Screening and interviewing in the field ................................................. 5-5

5.5 Referral Cards ................................................................................................ 5-5

5.5a Making referral cards ............................................................................. 5-6

6 Coupons .................................................................................................................. 6-1

6.1 Overview ........................................................................................................ 6-1

6.2 Coupon Number ............................................................................................. 6-1

6.3 Coupon Options ............................................................................................. 6-1

6.3a Number of coupons distributed .............................................................. 6-1

6.3b Changing the number of coupons distributed ........................................ 6-4

6.3c Coupon activation dates ......................................................................... 6-4

6.3d Coupon expiration dates ........................................................................ 6-5

6.4 Making Coupons ............................................................................................ 6-6

6.5 Coupon Tracking System ............................................................................... 6-8

6.5a Tracking coupons distributed ................................................................. 6-9

6.5b Tracking coupons returned .................................................................... 6-9

7 Check-in, Interviewing, and Check-out .............................................................. 7-1

7.1 Overview ........................................................................................................ 7-1

7.2 RDS Coupon Manager ................................................................................... 7-1

7.3 Check-in ......................................................................................................... 7-3

7.3a Validate coupon or referral card ............................................................ 7-4

7.3b Create record in RDSCM ....................................................................... 7-5

7.3c Escort participant to interviewer ............................................................ 7-5

7.4 NHBS-HET2 Interview ................................................................................. 7-6

7.4a Eligibility Screener................................................................................. 7-6

7.4b Consent .................................................................................................. 7-8

7.4c NHBS-HET2 Survey .............................................................................. 7-9

7.5 Data Corrections Log ................................................................................... 7-12

7.6 HIV Testing ................................................................................................. 7-12

7.7 Recruiter Training ........................................................................................ 7-13

7.7a Eligibility to recruit others ................................................................... 7-13

7.7b Presenting the opportunity to recruit others ......................................... 7-13

7.7c Conducting recruiter training ............................................................... 7-14 iv

7.8 Check-out ..................................................................................................... 7-14

7.8a Interviewer check-out activities ........................................................... 7-15

7.8b Coupon manager check-out activities .................................................. 7-15

8 Recruiter Reward Process .................................................................................... 8-1

8.1 Overview ........................................................................................................ 8-1

8.2 Verify Recruiter Identity ................................................................................ 8-1

8.3 Administer Recruiter Questions ..................................................................... 8-3

8.4 Verify and Pay Reward .................................................................................. 8-4

9 HIV and Other Laboratory Testing .................................................................... 9-1

9.1 Overview ........................................................................................................ 9-1

9.2 HIV Testing ................................................................................................... 9-1

9.3 Other Laboratory Testing ............................................................................... 9-3

9.4 Specimen Collection and Testing in the Field ............................................... 9-4

9.4a Rapid testing........................................................................................... 9-4

9.4b Laboratory testing .................................................................................. 9-5

9.5 Rapid Test and Specimen Storage, Specimen Processing, and

Transport/Shipping Procedures ...................................................................... 9-5

9.6 Anonymity, Test Results and Referral to Care .............................................. 9-6

9.6a Providing laboratory test results............................................................. 9-6

9.6b Anonymous referrals .............................................................................. 9-7

9.6c Referral to care and counseling and testing by outside agencies ........... 9-7

9.7 HIV Test Results Log Data Entry .................................................................. 9-8

9.8 Optional Appointment Reminder Procedures ................................................ 9-9

10 Process Monitoring and Ongoing Formative Research .................................. 10-1

10.1 Overview ...................................................................................................... 10-1

10.2 Process Monitoring ...................................................................................... 10-1

10.2a Seed Monitoring Report ..................................................................... 10-1

10.2b Seed Report ........................................................................................ 10-2

10.2c Recruitment Monitoring Report ......................................................... 10-2

10.2d Sample Characteristics Report ........................................................... 10-2

10.2e Respondent-Driven Sampling Report ................................................ 10-3

10.3 Ongoing Formative Research ...................................................................... 10-4 v

11 Data Submissions and Process Goals ................................................................ 11-1

11.1 Overview ...................................................................................................... 11-1

11.2 Data Submissions ......................................................................................... 11-1

11.3 Process Goals ............................................................................................... 11-2

Appendices

Appendix A Pre-Implementation Checklist ................................................................. A-1

Appendix B Field Supervisor Evaluation Form........................................................... B-1

Appendix C HIV Counseling and Testing Evaluation Form ...................................... C-1

Appendix D Interviewer Monitoring Form ................................................................. D-1

Appendix E Coupon Manager Evaluation Form .......................................................... E-1

Appendix F Interviewer Improvement Report ............................................................. F-1

Appendix G Field Site Checklist ................................................................................. G-1

Appendix H Field Incident Report .............................................................................. H-1

Appendix I Instructions for Creating Referral Cards, Coupons, and Cards ................ I-1

Appendix J Participant Tracking Form ....................................................................... J-1

Appendix K RDSCM Hardcopy Log .......................................................................... K-1

Appendix L Model Recruiter Training Script .............................................................. L-1

Appendix M Model Recruiter Training Talking Points .............................................. M-1

Appendix N Model Information Card ......................................................................... N-1

Appendix O Specimen Shipping Log .......................................................................... O-1

Appendix P HIV Test Results: Appointment and Phone Results Cards ...................... P-1

AppendixQ Phone Results Log .................................................................................. Q-1

Appendix R Appointment Reminder Call Form ......................................................... R-1

Appendix S Seed Monitoring Report ........................................................................... S-1

Appendix T Seed Report .............................................................................................. T-1

Appendix U Recruitment Monitoring Report .............................................................. U-1

Appendix V Sample Characteristics Report ................................................................ V-1

Appendix W Respondent-Driven Sampling Report .................................................... W-1

Appendix X List of Abbreviations and Acronyms ...................................................... X-1

Appendix Y Glossary .................................................................................................. Y-1

Appendix Z References ................................................................................................ Z-1

NHBS-HET2 Operations Manual 1-1

1 Introduction

1.1 Overview

The NHBS-HET2 Operations Manual is designed to guide project staff during implementation of NHBS-HET2. NHBS-HET2 is conducted using Respondent-Driven

Sampling (RDS) to obtain a cross-sectional survey of heterosexuals at increased risk of

HIV (HET) who live within the metropolitan statistical area (MSA). All project staff should read the NHBS-HET2 Operations Manual and the NHBS-HET2 Model

Surveillance Protocol in order to prepare for NHBS-HET2 activities. The NHBS-HET2

Operations Manual should also be available at each field site as well as at the project office.

The manual describes in detail procedures needed to conduct NHBS-HET2 using RDS.

This includes staffing the project, preparing materials, selecting field sites, identifying seeds, creating and tracking coupons, training recruiters, distributing recruiter rewards, conducting HIV testing, reviewing process monitoring reports and conducting ongoing formative research.

1.2 Justification

The primary purpose of an operations manual is to develop and document procedural strategies to be used in conducting NHBS-HET2 activities. The manual ensures operational standardization of NHBS-HET2 activities across all project sites.

1.3 Responsibilities

The CDC investigators are principally responsible for writing the NHBS-HET2

Operations Manual and supporting appendices and will provide technical assistance to project sites during implementation. The local NHBS project staff will implement the procedures described and submit necessary data to CDC through the Data Coordinating

Center (DCC) Data Portal in a timely manner.

1.4 NHBS-HET2 Method: Respondent-Driven Sampling

RDS is a type of peer-driven chain-referral sampling method (Heckathorn 1997, Broadhead et al. 1998). There are biases associated with chain-referral sampling that can affect the composition of the sample achieved; RDS controls for these biases through its implementation design and through data analyses. In addition, RDS is capable of

NHBS-HET2 Operations Manual 1-2 producing population estimates by conducting data analysis through the RDS Statistical

Analysis Tool (RDSAT) software program.

It is important for NHBS project staff to have basic knowledge of RDS methods and theory, so that they understand the importance of implementing RDS and NHBS-HET2 survey methods in ways that will minimize bias.

1.4a RDS methods

RDS begins with the non-random selection of a small number of initial recruiters or

“seeds.” These seeds recruit peers who in turn recruit other peers. Recruiters are limited to the amount of peers they can recruit based on the number of recruitment coupons they are given (1-5 for NHBS-HET2). Recruiters are linked to their recruits by the encoded number on the recruitment coupon. Participants receive dual incentives: an incentive for participating in the study and an incentive for each eligible recruit who participates in the study. This recruitment chain continues for several “waves” (see Figure 1.1).

Figure 1.1: RDS recruitment waves

Source: Behavioral Surveillance Introduction to Respondent-Driven Sampling Participant Manual, CDC Global AIDS Program, September, 2007

1.4b RDS theory and assumptions

RDS is based on two theoretical models: the Markov process and the homophily model

(Heckathorn 1997; 2002). According to Heckathorn (2007), there are six assumptions about the chain-referral sampling process that must be met for RDS:

• Respondents know one another as members of the target population.

• Respondents are linked by a network composed of a single component.

o Social networks have to be sufficiently connected for the chain-referral process to work.

NHBS-HET2 Operations Manual 1-3

• Sampling occurs with replacement.

o The sampling fraction (ratio of the sample size to the population size) is small enough for a sampling-with-replacement model to be appropriate.

• Respondents can accurately report their personal network size (accurate personal network size is needed for data weighting).

o Personal network size is defined as the number of relatives, friends, and acquaintances who fall within the target population.

• Peer recruitment is a random selection from the recruiter’s network.

o Recruitment is not preferential with respect to key variables, such as race and gender.

• Respondents recruit peers with whom they have a reciprocal relationship.

One of the concerns with chain-referral sampling is that the final sample will be composed of individuals with characteristics similar to those of the seeds. If sampling follows a Markov process, then the theory is that with each wave of recruitment (as the recruitment chain becomes longer), the sample will reach “equilibrium.” Equilibrium is the point at which the composition of the sample will no longer change, even with further waves of recruitment, and the sample becomes independent of the seeds.

One bias with chain-referral sampling is that people tend to know others who are like themselves. This tendency for “within-group” association is called homophily and affects recruitment (i.e. participants tend to recruit others who are like themselves). A second bias with chain-referral sampling is that people with large personal networks (i.e. who know more people) are likely to be overrepresented. These biases can be minimized by limiting the number of coupons given to each recruiter.

By conducting data analysis in RDSAT, data are weighted by the probabilities of one group recruiting another (e.g. men recruiting women) and by participants’ personal network sizes (those with smaller networks are given more weight and those with larger networks are given less weight). This weighting reduces some of the biases associated with chain-referral sampling and is how RDS is able to produce population estimates.

1.4c RDS implementation and affects on bias

RDS has to be implemented appropriately so that these assumptions are not violated and bias is minimized. For instance, recruiters should not give coupons to strangers; this needs to be adequately addressed when training participants to recruit others and patterns of recruiting strangers should be assessed during ongoing formative research. Hours of operation and locations of field sites, within or accessible to High Risk Areas (HRAs), should be considered carefully so that certain sub-populations will not be limited in their access and therefore be underrepresented. Seeds should not be chosen from networks that are so sparse and disconnected that peer-recruitment would be unsuccessful.

The NHBS-HET2 questionnaire has a series of “Network Questions” that ask participants to 1) describe their relationship to their recruiter, 2) estimate their personal network size, NHBS-HET2 Operations Manual 1-4 and 3) describe the characteristics of their personal network. As these questions are related to some of the RDS assumptions, it is important to clarify potentially inaccurate responses to these questions.

1.5 Pre-implementation Checklist

The Pre-implementation Checklist is found in Appendix A. Project sites should complete the checklist and send it to their CDC Project Officer along with the requested attachments at least one week before planned data collection. Project sites may also want to send draft sections of the checklist to their CDC Project Officer as they are completed.

The CDC Project Officer will set up a conference call to review the checklist prior to implementation to ensure all components of the NHBS-HET2 project have been addressed. Once these materials are reviewed and approved by the CDC Project Officer, project sites will receive confirmation via email that project activities may begin.

Project sites should revise the checklist when there are changes over the course of the

NHBS-HET2 data collection cycle (e.g., new staff, change in the number of coupons distributed, etc.), and each revised version of the checklist should be sent to the CDC

Project Officer.

NHBS-HET2 Operations Manual 2-1

2 Staffing

2.1 Overview

The careful screening and selection of project staff is critical to the overall success of

NHBS-HET2. Strong leadership abilities, good communication skills, and a marked enthusiasm for the project are essential attributes. The following is the CDC-recommended staffing pattern for NHBS-HET2. Each of these positions is described below. Participating project sites should tailor this chapter to reflect their local staffing patterns and attach it to their Pre-implementation Checklist (see Appendix A).

2.2 Principal Investigator

The Principal Investigator (PI) provides local scientific oversight for NHBS-HET2. PIs will spend approximately 10% of their time on NHBS-HET2. Projects sites that hire a contractor for project activities may have a PI in the contracting agency, but it is the ultimate responsibility of the directly funded Health Department PI to ensure the success of the project. The duties and responsibilities of the PI(s) are to:

• Oversee administrative aspects of NHBS-HET2 and hire and supervise NHBS project staff.

• Coordinate the project among appropriate collaborating agencies (e.g., community-based organizations, contracting agencies and other stakeholders).

• Oversee the development of the local NHBS-HET2 Model Surveillance Protocol.

• Assure compliance with the NHBS-HET2 Model Surveillance Protocol.

o Review local protocol and see that it is properly implemented.

o Oversee the development and selection of local prevention questions.

o Oversee the development and selection of other local questions.

o Monitor all project activities.

o Send all field incident reports and report adverse events to the CDC Project

Officer and local Institutional Review Boards (IRBs).

• Oversee the transfer, analysis, dissemination, and use of NHBS-HET2 data.

o Ensure timely submission of NHBS-HET2 data to CDC.

o Oversee analysis of local NHBS-HET2 data.

o Present reports and updates and disseminate NHBS-HET2 data.

o Use findings from NHBS-HET2 for the development, modification, and evaluation of prevention programs.

NHBS-HET2 Operations Manual 2-2 o Develop policies pertaining to analysis and dissemination of local NHBS-

HET2 data.

o Make certain data is released in accordance to local policy and data use agreements.

• Review, monitor, and assure compliance with established Notice of Grant Award

(NGA) guidelines to provide fiscal administration and management of federal funds. This includes administrative supervision to investigate and report any financial irregularity.

• Oversee the preparation and submission of annual cooperative agreement reports, including interim or annual progress reports and financial status reports, to CDC’s

Procurement and Grants Office (PGO).

• Apply for and obtain Institutional Review Board (IRB) approvals, inform IRB(s) of procedural changes and other revisions (as applicable). Ensure that all subcontracting agencies having contact with human subjects have a Federalwide

Assurance (FWA) number and complete required IRB reviews. Send IRB approval letters to CDC.

• Evaluate NHBS project staff, including Field Supervisor, Coupon Manager, interviewers, and HIV test counselors.

• Participate in CDC site visits, NHBS investigator meetings, and monthly NHBS conference calls. Participate in (or have a designee participate in) regular conference calls with the CDC Project Officer.

2.3 Project Coordinator

The Project Coordinator is critical to the success of the project. Project Coordinators will spend up to 100% of their time on NHBS-HET2. Generally, the Project Coordinator and

Field Supervisor positions together comprise 1.5-2.0 FTEs. The Project Coordinator will have primary responsibility for the day-to-day management of the project including at least partial control of key administrative functions (e.g., hiring, evaluating, and firing staff). A successful Project Coordinator has considerable knowledge of the communities in which NHBS-HET2 is conducted, broad knowledge of HIV/AIDS, excellent leadership skills and experience, and attention to detail. In addition, a Project Coordinator should have a basic understanding of surveillance, be familiar with computer programs such as word processing, spreadsheets, file management, and have a willingness to learn additional programs, such as the Questionnaire Development System (QDS™) and RDS

Coupon Manager (RDSCM). The duties and responsibilities of the Project Coordinator are to:

• Provide overall management of the project.

NHBS-HET2 Operations Manual 2-3

• Assist PI with IRB-related activities.

• Participate in CDC site visits, training programs, workshops, monthly NHBS conference calls, and regular conference calls with CDC Project Officer.

• Train and supervise NHBS project staff on key data collection activities such as recruitment, interviewing, and use of software.

• Act as the primary point of contact between the NHBS project staff and CDC in matters that relate to the project on an ongoing basis.

• Respond to requests for input on revisions of the NHBS-HET2 questionnaire and other data collection instruments.

• Coordinate the development of prevention and local questions.

• Manage contracts related to the project (as applicable).

• Oversee data management procedures.

o Oversee quality control of NHBS-HET2 data.

o Establish and monitor security and confidentiality of NHBS-HET2 data.

o Ensure that data are entered and validated appropriately in RDSCM.

o Oversee the transfer of data from handheld computer to desktop computer.

o Maintain data in QDS™ Warehouse.

o Oversee weekly data submission; review and ensure submission to CDC through the Data Coordinating Center (DCC) Data Portal.

• Evaluate interviewers (10% of all NHBS-HET2 interviews should be monitored) as well as the activities of other field staff (e.g., Field Supervisor, HIV test counselors) as described in section 2.10.

• Participate in the analysis and dissemination of NHBS-HET2 data.

o Oversee development of the local analysis plan.

o Implement policies pertaining to analysis and dissemination of local NHBS-

HET2 data.

• Prepare annual cooperative agreement reports, including interim or annual progress reports and financial status reports.

• Oversee maintenance of inventory and supplies for NHBS-HET2. This includes handheld computers, flashcards, HIV testing supplies, and other necessary project supplies.

• Compile and submit all field incident and adverse event reports to the PI.

NHBS-HET2 Operations Manual 2-4

2.4 Field Supervisor

The Field Supervisor is an essential position to the success of NHBS-HET2; there should be at least one full-time Field Supervisor. The Field Supervisor should be highly motivated and culturally competent. Field Supervisors should spend up to 100% of their time on NHBS-HET2 and will have primary responsibility for the day-to-day operational management of the project, including management of all field sites. Consistent high-level supervision at all field sites is necessary to ensure the initial and sustained success of the project.

A Field Supervisor must be present at every field site during operating hours; project sites often find it useful to have more than one part-time Field Supervisor or at least one person trained to be a back up supervisor. The Field Supervisor handles the intricate details of the project operations. A successful Field Supervisor has broad knowledge of

HIV/AIDS, excellent leadership skills and experience, and attention to detail. In addition a Field Supervisor should have a basic understanding of surveillance, be familiar with computer programs such as word processing, spreadsheets, file management, and have a willingness to learn other programs as needed.

The overall duties and responsibilities of the Field Supervisor are to:

• Oversee project procedures.

o Facilitate seed recruitment process.

o Prepare and distribute participant incentives.

• Manage the field site(s).

o Schedule project operations (e.g., days of week, times of day, and location within city) and be on site at all times.

o Schedule participant appointments (if applicable) and record them in the appointment book or log.

o Set the schedule for interviewer staff.

o Schedule appointments for recruiter reimbursement, if necessary.

o Control flow of participants at field site(s).

o Ensure safety and security of all staff and study-related materials.

• Oversee data collection procedures.

o Oversee and conduct interviews as necessary.

• Assure data quality.

o Monitor interviews.

o Supervise and evaluate data entry.

o Oversee editing and correction of RDSCM records as necessary.

o Oversee the completion of Data Corrections Log and review errors with interviewers.

NHBS-HET2 Operations Manual 2-5 o Ensure that data from the HIV Test Results Log and Data Corrections Log are entered into the DCC Data Portal’s online databases on a daily basis.

o Ensure data security.

• Participate in training of local staff on topics such as recruitment, interviewing and use of NHBS software/hardware.

• Participate in CDC site visits, CDC trainings, and regular conference calls with

CDC Project Officer.

• Evaluate interviewers (10% of all NHBS-HET2 interviews should be monitored) as well as the activities of other field staff (e.g. Coupon Manager, HIV test counselors) as described in section 2.10.

• Monitor interviewers and other field staff to identify all human subjects violations, and report all potential incidents to the Project Coordinator and/or PI.

2.5 Interviewers and HIV Test Counselors

In order to maximize staff diversity and flexibility of operations, having several project staff serve as interviewers and HIV test counselors for NHBS-HET2 is necessary. Some project sites may have interviewers conduct HIV testing as well as recruiter training duties (see Chapter 7 of this manual); teams should be composed of the equivalent of three full-time interviewer/HIV test counselor positions. Project staff should be highly motivated, culturally competent, and able to work during the hours of field site operation.

In addition, project staff should be knowledgeable about HIV/AIDS and competent in conducting interviews with individuals of diverse backgrounds and circumstances.

2.5a Interviewers

The primary duties of an interviewer are to screen for eligibility, obtain informed consent and conduct interviews using handheld computers. Interviewers are responsible for providing appropriate referrals to participants after the completion of the survey.

Interviewers should be extremely familiar with the NHBS-HET2 questionnaire content, flashcards and skip patterns programmed into the survey on the handheld computers.

Interviewers should adhere to the NHBS-HET2 Model Surveillance Protocol, NHBS

Interviewer Guide, and local guidelines established for conducting interviews.

2.5b HIV test counselors

Project sites may have staff hired specifically to conduct HIV testing and counseling. The main duties and responsibilities of HIV test counselors are to conduct the HIV testing component of NHBS-HET2 with individuals who complete the survey and have provided their consent for testing. HIV test counselors should be trained on NHBS-HET2 methods, clearly understand the participant flow at the field site(s), and ensure that the NHBS-

NHBS-HET2 Operations Manual 2-6

HET2 Model Surveillance Protocol and local guidelines are followed with respect to HIV testing. All HIV test counselors should be trained per local regulations on all testing modalities used by the project site (e.g. rapid HIV tests, phlebotomy, collection of oral and fingerstick specimens). Please see Chapter 9 of this manual for more information.

2.6 Coupon Manager

Project sites may consider the use of a designated Coupon Manager to collect and distribute coupons and monitor these activities through the use of a specific computer program, RDSCM. The Coupon Manager is responsible for participant check-in/out (see

Chapter 7 of this manual). The Field Supervisor can also serve as the Coupon Manager, although this is not recommended as the Field Supervisor’s main duties are to oversee the field site and all project staff.

2.7 Data Manager

A Data Manager is necessary to accomplish project activities. Data managers will spend approximately 15% of their time on NHBS-HET2. Data managers will work with the

DCC regarding data submissions and corrections. The overall duties and responsibilities of the Data Manager are:

• Data file management o Upload and track data files from electronic data collection instrument and laboratory test forms.

o Enter HIV Test Results Log data into DCC Data Portal’s online database on a daily basis (see the DCC Data Management Manual).

o Maintain QDS™ Warehouse.

• Data quality control o Maintain integrity of data.

o Update the Data Corrections Log into DCC Data Portal’s online database on a daily basis (see the DCC Data Management Manual).

o Communicate with Field Supervisor on a regular basis regarding irregularities in data.

• Data submission o Submit required weekly and monthly data files to CDC through the DCC Data

Portal in a timely manner.

o Review data reports from DCC and document either the edit to the data needed to resolve the problem highlighted in the data report or reason the problem cannot be resolved.

o Communicate with DCC and CDC Project Officer regarding data submissions.

NHBS-HET2 Operations Manual 2-7

2.8 Spanish-speaking Staff

NHBS project sites that utilize Spanish language materials will need to have Spanish-speaking project staff available for interviewing and HIV counseling and testing. A

Spanish-speaking project staff member should also be available for answering general questions about the project.

2.9 Staff Training

All interviewers must undergo several trainings for NHBS-HET2. CDC will hold a Field

Operations Training to be attended by Field Supervisors and one additional project staff member. These staff will then conduct trainings for remaining NHBS staff at the local project site. All trainings should be listed in the Pre-implementation Checklist (see

Appendix A). In addition, the DCC will be training data managers on best practices for

NHBS data management and data processing procedures during an in-person training.

All NHBS project staff must have had confidentiality training and signed a confidentiality agreement prior to data collection. HIV counseling and testing training is mandatory for all project staff who will conduct testing and counseling. A cultural competency course is recommended for all interviewers, so that they may learn how to work with diverse sub-populations of heterosexuals at increased risk of HIV. Project staff may find such courses offered at local universities, through state health departments, medical schools, or through companies that specialize in diversity training. Any additional training that project staff attend, such as safety trainings, conflict de-escalation trainings, or others, should be listed in the Pre-implementation Checklist.

2.10 Staff Evaluations

All project staff must be evaluated on a regular basis. Evaluation forms that project sites can tailor to their specific needs are provided in Appendices B thru E for this purpose.

Project Coordinators should determine when project staff will be evaluated, which skills will be evaluated and who will do the evaluation. Persons conducting evaluations should be familiar with RDS, the NHBS-HET2 Model Surveillance Protocol and NHBS-HET2

Operations Manual, and the duties assigned to the person being evaluated. Each person being evaluated should be familiar with the criteria by which they are being evaluated, and should receive feedback after each evaluation. If the evaluation involves the observation of an interview or HIV testing procedure, permission must first be obtained from the participant. The interviewer should follow a locally developed script to explain the monitoring process to the participant, and the evaluator should interrupt the interview only for major issues (such as issues related to consent or miscoding that leads to an entire section of the survey being skipped), be discreet when doing so, and direct any questions to the interviewer (not the participant). Table 2.1 lists the type of project staff

NHBS-HET2 Operations Manual 2-8 who should be evaluated, the title of the project manager who should evaluate them, and the frequency of evaluation. Because the Field Supervisor will often be busy with their oversight responsibilities, the Project Coordinator or PI should conduct most evaluations.

If NHBS-HET2 project activities are conducted in more than one field site, it is important that evaluation occur in all field sites.

Evaluation forms (Appendices B-E) should be used to guide evaluation. Evaluation forms should be kept on file and available for review during CDC site visits.

Table 2.1: Project staff evaluation schedule (see Appendices B - E)

Appendix Project staff: Evaluation by: Frequency:

B Field Supervisors Project Coordinator or

Principal Investigator

For first 3 weeks, once per week, and then once per month

C HIV test counselors Field Supervisor, Project Coordinator, or

Principal Investigator

For first 3 weeks, once per month

D Interviewers Field Supervisor, Project Coordinator, or

Principal Investigator

For first 3 interviews, and then every 10 th interview.

Also, at least 3 practice interviews should be conducted and evaluated prior to the start of data collection

E Coupon Manager Field Supervisor, Project Coordinator, or

Principal Investigator

For first 3 weeks, once per month

2.11 Interviewer Improvement Report

To assist project sites with providing feedback to interviewers to improve their interview techniques, the DCC will produce a report showing the mean, median, and range in length of the eligibility screener, the consent process, and the interview itself by interviewer ID (Appendix F). Project sites should review this report regularly with their field staff to identify and discuss unusually short or long times for any of these components.

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3 Project Preparation

3.1 Overview

Prior to the implementation of NHBS-HET2, there are several project preparation tasks that must be completed. These tasks will prepare project sites for a successful NHBS-

HET2 cycle. The purpose of this chapter is to describe the use of a study logo and marketing materials, as well as describe the project supplies, log books, and computer programs necessary to document and maintain the project.

3.2 Study Logo and Marketing Materials

Logos and marketing materials can be created for NHBS-HET2 project identification.

However, project sites should have logos and materials reviewed by their CDC Project

Officer before printing and distributing. Formative research should guide the creation of these materials, and members of the community should be asked about the types of logos and marketing that would be appealing to potential participants. The purpose of having these materials is for project recognition. Materials should be used in a limited manner, as NHBS-HET2 will rely on peer recruitment rather than recruitment by project staff.

Due to the nature of RDS and the use of coupons for recruitment, marketing materials may not be necessary to encourage participation and could, in fact, hinder project recruitment by advertising the project to the wrong target population, contributing to a large influx of ineligible and self-referred individuals at the field site(s). Marketing materials can be used, however, to garner community support through communicating the goals and objectives of NHBS-HET2 to local stakeholders.

3.3 Supplies

3.3a Materials for the field site(s)

Several materials are necessary to conduct NHBS-HET2 activities at the field site(s).

Before field site operation begins all NHBS-HET2 project staff should ensure they have the necessary materials to conduct data collection. See Appendix G for a model list of project supplies. Project sites may need to modify the list in order to meet local needs.

3.3b Prevention materials and referrals

The following are suggested prevention materials to have readily available at the field site(s):

• Information pamphlets on the following subjects: HIV, STD, hepatitis, and strategies for preventing HIV infection through sex and drug use.

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• Referral agencies for participants who are HIV-positive to enter into care. Also referrals to health care and social service agencies relevant to the target population.

• Supplies used to reduce HIV risk, such as condoms and lubricants.

3.3c Binder for project forms and logs

To ensure successful project management and quality data collection, NHBS project staff should develop a systematic plan to monitor the day-to-day operations of NHBS-HET2 activities at the field site(s). Several forms and logs mentioned throughout this manual are used to collect specific information regarding different operational aspects of NHBS-

HET2. Using a binder to store these forms will help NHBS project staff organize important project-related materials in a central and easily referenced location. Forms that contain confidential information (i.e., reminder call forms, test results log, and telephone results log) should be kept in a locked file cabinet. The Field Supervisor and project staff will be responsible for reviewing, completing, and correcting forms and updating them in accordance with their local plan and the NHBS-HET2 Model Surveillance Protocol.

Project sites are encouraged to develop additional forms as they see fit to help manage

NHBS-HET2 activities. The following forms and logs should be found in your binder:

• Appointment Book or Log

• RDSCM Hardcopy Log

• Reminder Call Forms (if applicable)

• HIV Test Results Log*

• Telephone Results Log (if applicable)

• Specimen Shipping Log

• Data Corrections Log*

• Memorandums of Understanding

*Templates of the HIV Test Results Log and Data Corrections Log can be found in the

Data Coordinating Center (DCC) Data Management Manual.

3.3d Survey software

HAPI™ version 2.4 must be installed on all handheld computers. The survey control file will not run properly (i.e., skip patterns may not function appropriately) if HAPI™ version 2.5 is used. To manage the survey data, project sites should have QDS™

Warehouse version 2.4 or 2.5.

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All surveys must be conducted using the handheld computers. Paper surveys are not allowed. Project staff should ensure that all handhelds are charged and working properly before each day of field site operation. It is recommended to have one or two backup handheld computers available if possible. Interviewers should check the date and time displayed on the handheld computer before conducting the first survey of each day of field site operation. It is recommended that interviewers check the date and time periodically throughout the day.

3.4 Safety Guidelines

The objective of these guidelines is to provide a general overview of safety issues.

Project sites must develop local safety procedures, document these procedures in the Pre-implementation Checklist (Appendix A) and train field staff on those procedures.

It is important for project staff to prevent problems by using common sense and advance planning. Project staff must be alert to their own safety and to that of their co-workers at all times. A basic awareness of one’s surroundings is critical when working at the field site(s). Generally, the Field Supervisor is responsible for crowd control and overall safety. Each of the project staff must also be responsible for maintaining a safe working environment. Project sites should consider the following steps for field safety:

3.4a General principals of field safety

• Call 911 without hesitation if danger is present.

• Always carry project or health department identification card.

• Plan ahead, be alert, and use common sense.

• Always have at least 3 project staff members at each field site during the hours of operation.

3.4b Local safety procedures

Before implementation, project sites must submit local safety procedures to their CDC

Project Officers. These procedures must outline a communication plan for alerting field staff to a general threat, alerting others to a threat to a specific field staff, and plans for dealing with these situations. Project sites should periodically review local safety procedures with project staff to ensure they stay current on what to do in case of an emergency.

The Field Supervisor must have emergency contact information for each project staff member. This information should be easily accessible during the field site(s) hours of operation.

Described below are example local safety procedures:

Note

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Plan ahead

• Have an emergency action plan.

o Know what you are going to do ahead of time in case things go wrong.

o Know who to contact in case of emergency.

o Always know the location of all exits from any point in the field site(s).

• During interviews, always position yourself closest to the door; you do not want an unruly participant between you and the exit.

• Consider developing a code word to call for assistance from a co-worker.