ATTACHMENT H.pdf

National HIV Behavioral Surveillance System:

Men Who Have Sex with Men

(NHBS-MSM2)

OPERATIONS

MANUAL

Behavioral Surveillance Team

NCHHSTP/DHAP/BCSB

Version Date: July 10, 2008

NHBS-MSM2 Operations Manual i July 10, 2008

Table of Contents

1 Introduction 1

1.1 Overview 1

1.2 Justification 1

1.3 NHBS-MSM2 Methods 1

1.4 Responsibilities 1

1.5 Pre-implementation Checklist 2

2 Staffing 3

2.1 Overview 3

2.2 Principal Investigator 3

2.3 Project Coordinator 4

2.4 Field Supervisor 5

2.5 Recruiters, Interviewers, HIV Test Counselors 7

2.5a Recruiters 7

2.5b Interviewers 7

2.5c HIV test counselors 8

2.6 Data Manager 8

2.7 Spanish-speaking Staff 9

2.8 Staff Training 9

3 Project Preparation 10

3.1 Overview 10

3.2 Study Logo and Marketing Materials 10

3.3 Supplies 10

3.3a Materials for the venue and van 10

3.3b Prevention materials and referrals 10

3.3c Binder for project forms and logs 11

3.3d Survey ID 11

3.4 Safety Guidelines 11

3.4a General principals of field safety 12

3.4b Plan ahead – local safety procedures 12

NHBS-MSM2 Operations Manual ii

3.4c Be alert 12

3.4d Use common sense 13

3.4e Dangerous/difficult situations 13

3.4f Safeguard the handheld computers 14

3.4g Field incident reporting procedures 14

4 Monthly Recruitment Calendar 15

4.1 Overview 15

4.2 VDTS Program 15

4.2a Constructing the initial sampling frame 15

4.2b Constructing subsquent sampling frames 15

4.2c Reviewing and editing a sampling frame 16

4.2d Sorting a sampling frame 16

4.2e Selecting VDTs for recruitment events 16

4.3 Constructing a Monthly Recruitment Calendar 20

4.3a Determining staff availability 20

4.3b Scheduling non-random recruitment events 20

4.3c Scheduling random recruitment events 20

4.3d Scheduling reserve venues 21

4.3e Assigning alternate venues 21

4.4 Revising a Monthly Recruitment Calendar 22

4.4a Scheduling a new date for a recruitment event 23

4.4b Selecting a new day-time period for a venue 23

4.4c Selecting another venue 23

5 Recruitment Event Preparation and Management 25

5.1 Overview 25

5.2 Assurance of Confidentiality and Field Operations 25

5.3 Scheduling Staff 25

5.4 Notify Venue Owner or Manager 26

5.5 Recruitment Event Checklist 26

5.6 Preparation for a Recruitment Event 26

5.6a Venue and alternate venue information 26

5.6b Interviewer ID, survey ID, venue ID, and event number 26

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5.7 Recruitment Event Setup 29

5.7a Check in with venue owner/manager 29

5.7b Pre-event meeting 29

5.7c Interview and HIV testing location 30

5.8 Alternate Venues 30

5.9 Length of Recruitment Event 31

5.10 Maximum Number of Interviews per Recruitment Event 31

5.11 Target Sample Size 32

5.12 Evaluating Staff 32

5.13 Maximizing Effectiveness During Recruitment Events 33

5.13a Supervision 33

5.13b Teamwork 34

5.13c Recruiting technique 34

6 Counting, Recruitment, and Interviewing 36

6.1 Overview 36

6.2 Counting 36

6.2a Counter 36

6.2b Who to count 37

6.2c When to count 37

6.2d Counting area 38

6.3 Recruitment 39

6.3a Intercept 39

6.3b Recruiter 40

6.3c Intercept methods 40

6.3d Intercept Form 42

6.3e Appointments 42

6.4 Interviewing 45

6.4a Screening for eligibility 45

6.4b Obtaining informed consent 46

6.4c NHBS-MSM2 survey 46

6.5 HIV Testing 47

6.6 Participant Compensation 47

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6.7 HIV Prevention Materials and Service Referrals 48

7 Recruitment Event Closeout 49

7.1 Venue and VDT Information 49

7.2 Event Notes 49

7.3 Field Staff Debriefing 49

7.4 HIV Test Results Log 50

7.5 Intercept Form 50

7.6 Staff Evaluation Forms 50

7.7 Data Corrections Log 51

7.8 Recruitment Monitoring Form 51

8 HIV and Other Laboratory Testing 52

8.1 HIV Testing 52

8.2 Other Laboratory Testing 53

8.3 Anonymity, Test Results, and Referral to Care 54

8.3a Providing laboratory test results 54

8.3b Anonymous referrals 55

8.3c Referral to care and counseling and testing by outside agencies 55

8.4 Laboratory Test Results Form 56

8.5 Specimen and Rapid Test Storage, Processing, and Shipping Procedures 58

8.6 Optional Appointment Reminder Procedures 58

9 Process Indicators 61

9.1 Overview 61

9.2 Collecting Recruitment Event Data 61

9.3 Update Data in Forms and Binders 61

9.4 Sample Size Goal 61

9.5 NHBS-MSM2 Process Indicators 62

9.5a Monthly Sampling Frame 62

9.5b Monthly Recruitment Calendar 62

9.5c Recruitment Monitoring Form 63

9.5d Sample Characteristics 63

9.6 Recruitment Monitoring Goals 63

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Appendices 65

A Pre-Implementation Checklist

B Recruitment Event Checklist

C Field Incident Report

D Monthly Recruitment Calendar

E Instructions for Selecting VDTs Manually

F Random Numbers Tables

G Field Supervisor Evaluation Form

H HIV Counseling and Testing Evaluation Form

I Interviewer Evaluation Form

J Recruiter Evaluation Form

K Intercept Form

L Intercept Form Instructions

M Strategies for Overcoming Intercept Barriers

N Strategies for Overcoming Participation Barriers

O HIV Test Results Appointment and Phone Information Cards

P HIV Test Results Log

Q Data Corrections Log

R Recruitment Monitoring Form

S Recruitment Monitoring Form Instructions

T Telephone Results Log

U Specimen Shipping Log

V Appointment Reminder Call Form

W Sample Characteristics

NHBS-MSM2 Operations Manual 1

1 Introduction

1.1 Overview

The NHBS-MSM2 VBS Operations Manual is designed to guide field staff during the implementation activities for NHBS-MSM2. All field staff should read the NHBS- MSM2 Operations Manual and the MSM2 Protocol in order to prepare for Venue-based sampling (VBS) activities. The Operations Manual should also be available during each recruitment event as well as at the project office.

The manual describes in detail activities needed to conduct venue-based sampling. This includes staffing, materials, constructing recruitment calendars, recruitment event preparation, recruitment event procedures, HIV testing and process indicators.

1.2 Justification

The primary purpose of an Operations Manual is to develop and document procedural strategies to be used in conducting NHBS-MSM2 activities. The manual is to be used to ensure the operational standardization of NHBS-MSM2 activities across all project sites.

1.3 NHBS-MSM2 Methods

NHBS-MSM2 will be conducted using venue-based sampling procedures. Venue-based sampling (VBS) is used to conduct a cross-sectional survey of men who have sex with men (MSM) who attend venues within the metropolitan statistical area (MSA). VBS sampling activities include constructing an initial “universe” of MSM-identified venues through formative research. Next, staff will use the identified universe to construct monthly sampling frames of venues and venue-specific day-time periods that are expected to produce a sufficient number of eligible men. The final stage is conducting interviews and HIV testing with MSM at venues and day-time periods that are randomly selected from constructed sampling frames. During recruitment events, staff count, approach, and interview eligible men who wish to participate in NHBS-MSM2.

1.4 Responsibilities

The CDC investigators are principally responsible for writing the Operations Manual and supporting appendices and will provide technical assistance to project sites during implementation. The local NHBS-MSM2 staff will conduct the project using the procedures described and submit necessary data to CDC in a timely manner.

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1.5 Pre-implementation Checklist

The Pre-implementation Checklist is found in Appendix A. The checklist should be completed and sent to your CDC Project Officer along with the requested attachments.

The items in the Pre-implementation Checklist and the attachments must be approved by your Project Officer prior to implementing data collection in the field. Your Project Officer will set up a conference call to review the checklist prior to implementation to ensure all components of the NHBS-MSM2 project have been addressed. Any changes in the items in the checklist (e.g. staffing) over the course of the NHBS-MSM2 cycle should be reported to your CDC Project Officer.

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2 Staffing

2.1 Overview

The careful screening and selection of staff is critical to the overall success of NHBS- MSM2. Strong leadership abilities, good communication skills, and a marked enthusiasm for the project are essential attributes for NHBS-MSM2 staff. The following is the CDC recommended staffing pattern for NHBS-MSM2. Each of these positions is described below. Participating project sites are required to tailor the information in this chapter to reflect their local staffing pattern.

2.2 Principal Investigator

The Principal Investigator will spend approximately 10% of his/her time on NHBS- MSM2. The duties and responsibilities of the Principal Investigator are to:

• Oversee administrative aspects of NHBS-MSM2 and hire and supervise NHBS-

MSM2 project staff.

• Coordinate NHBS-MSM2 among appropriate collaborating agencies (e.g., Community Based Organizations, contracting agencies and other stakeholders).

• Oversee the tailoring of local NHBS-MSM2 protocol.

• Assure compliance with the NHBS-MSM2 protocol.

o Review local NHBS-MSM2 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 NHBS-MSM2 activities.

• Oversee the transfer, analysis, dissemination, and use of NHBS-MSM2 data.

o Ensure timely submission of NHBS-MSM2 data to CDC.

o Present reports and updates and disseminate NHBS-MSM2 data.

o Use findings from NHBS-MSM2 for the development, modification, and evaluation of prevention programs.

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

MSM2 data.

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

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• 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 of procedural changes and other revisions (as applicable). Ensure that all subcontracting agencies having contact with human subjects have a federal wide assurance (FWA) number and required IRB reviews are completed. Send approval letters to CDC.

• Participate in NHBS investigator meetings and monthly NHBS conference calls.

• Participate in CDC site visits.

2.3 Project Coordinator

The Project Coordinator is critical to the success of NHBS-MSM2. The Project Coordinator will spend up to 100% of his/her time on NHBS-MSM2. 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 NHBS-MSM2 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-MSM2 is conducted, broad knowledge of HIV/AIDS, excellent leadership skills and experience, and attention to detail. In addition s/he has a basic understanding of surveillance and is familiar with computer programs such as word processing, spreadsheets, file management, and has a willingness to learn additional programs, such as the Questionnaire Development System (QDS). The duties and responsibilities of the Project Coordinator are to:

• Provide overall management of NHBS-MSM2.

• 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-MSM2 project staff on key activities such as recruitment, interviewing, and use of software.

• Act as the liaison between the NHBS-MSM2 project staff and CDC in matters that relate to NHBS-MSM2 on an ongoing basis.

• Respond to requests for input on revisions of the NHBS-MSM2 questionnaire and other data collection instruments.

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• Oversee the development of prevention and local questions.

• Manage contracts related to NHBS-MSM2 (as applicable).

• Oversee data management procedures.

o Oversee quality control of NHBS-MSM2 data.

o Establish and monitor security and confidentiality of NHBS-MSM2 data.

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

o Maintain data in QDS warehouse.

o Oversee monthly & weekly data submission; review and ensure submission to CDC through the Secure Data Network (SDN).

• Monitor interviews (10% of all NHBS-MSM2 interviews should be monitored)

• Participate in the analysis and dissemination of NHBS-MSM2 data.

o Oversee development of the local analysis plan.

o Implement policies pertaining to analysis and dissemination of local

NHBS-MSM2 data.

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

• Oversee maintenance of inventory and supplies for NHBS-MSM2. This includes handheld computers, flashcards and other necessary project supplies.

2.4 Field Supervisor

The Field Supervisor is an essential position to the success of NHBS-MSM2. NHBS– MSM2 teams should be composed of at least one full-time Field Supervisor. The Field Supervisor should be highly motivated, able and willing to work evenings and weekends, and be culturally competent. The Field Supervisor should spend up to 100% of his/her time on NHBS-MSM2 and will have primary responsibility for the day-to-day operational management of NHBS-MSM2, including management of all recruitment events. Consistent high-level supervision during all recruitment events is necessary to ensure the initial and sustained success of NHBS–MSM2.

Recruiters use different strategies and scripts for their approaches. These strategies may work better at some events than others. In addition, recruiters may have a particularly good or bad event. When multiple recruiters are used at an event, the Field Supervisor should monitor the number of individuals recruited across recruiters. The Field

NHBS-MSM2 Operations Manual 6

Supervisor uses the number of individuals recruited to assess how to increase the success of approaching men at the venue for the purpose of recruiting them into the survey.

A Field Supervisor must be present at every recruitment event; 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 s/he has a basic understanding of surveillance and is familiar with computer programs such as word processing, spreadsheets, file management, and has a willingness to learn other programs as needed.

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

• Manage the recruitment events.

o Contact venue owners prior to the event o Assigning survey IDs o Prepare and distribute participant incentives.

o Schedule monthly recruitment events o Manage all conducted recruitment events.

- Event set up, includes ensuring all proper documents are available.

- Establish count and intercept methods and start and end times.

- Evaluate performance objectives and adjusting efforts to optimize recruitment.

- Address and resolve problems with owners, patrons, and potential participants.

- Event closeout includes debriefing staff prior to departing the event.

o Based on the recruitment calendar, set the schedule for interviewer staff.

o Control flow of participants at venue locations, including mobile units.

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

• Oversee data collection procedures.

o Manage recruitment and incentives.

o Oversee and conduct interviews as necessary.

o Generate and submit process indicators to CDC (in requested format) on a weekly or monthly basis.

• Assure data quality.

o Supervise and evaluate data entry.

o Oversee editing and correction of data files as necessary.

o Ensure data security.

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• Participate in interviewer training and NHBS-MSM2 software/hardware training.

• Participate in regular conference calls with CDC Project Officer.

2.5 Recruiters, Interviewers, and HIV Test Counselors

In order to maximize staff diversity and flexibility of operations, having several staff act as recruiters, interviewers and HIV test counselors for NHBS-MSM2 is necessary. Some project sites may train interviewers to perform recruiter duties. Interviewers can also be trained to conduct HIV testing if other trained staff is not hired for HIV testing activities.

NHBS-MSM2 teams should be composed of the equivalent of three full-time recruitment/interview/HIV test counselor positions. Staff should be highly motivated, able and willing to work in the evenings and on weekends, be culturally competent, and to the extent possible, representative of the major racial/ethnic population segments of MSM. In addition, staff should be knowledgeable about HIV/AIDS and competent in conducting interviews with men of diverse backgrounds and circumstances

2.5a Recruiters Project sites may consider the use of designated recruiters to approach participants and assess their willingness to participate in NHBS-MSM2. Recruiters may be identified during formative research, such as through key informants or other members of the communities in which venues for NHBS-MSM2 are located. The main duties of recruiters would be to approach participants, briefly describe the study, and bring interested potential participants to the interviewers for eligibility screening. Recruiters should be trained on NHBS-MSM2 methods.

During recruitment events, recruiters are responsible for: (1) intercepting men in accordance with the protocol and as directed by the Counter (see section 6.2a); (2) accurately documenting all intercepts on the Intercept Form; (3) assisting other recruiters that may require help with intercept and recruitment process; (4) checking in with the Field Supervisor if intercepts are not successful; (5) monitoring individual recruitment indicators; and (6) reviewing all completed Intercept Forms at the end of each recruitment event.

2.5b Interviewers

The primary duties and responsibility of an interviewer are to assess 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. NHBS-MSM2 interviewers should be extremely familiar with the questionnaire content, flashcards and skip patterns programmed into the survey on the handheld computers. Interviews should adhere to the NHBS-MSM2 protocol, interviewer guide and local guidelines established for conducting interviews.

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2.5c HIV test counselors Project sites may also 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-MSM2 with men who agree to participate, and provide them with information about testing for HIV. HIV counselors should be trained on NHBS- MSM2 methods, clearly understand the flow of recruitment events, and ensure that the NHBS-MSM2 protocol and local guidelines are followed with respect to HIV testing.

2.6 Data Manager

A Data Manager is necessary to accomplish NHBS-MSM2 activities. The Data Manager will spend approximately 15% of his/her time on NHBS-MSM2. The overall duties and responsibilities of the Data Manager are:

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

o Enter HIV testing data into the data entry spreadsheet to be sent to CDC.

o Maintain data warehouse and HIV data log.

• Data reporting o Produce the process indicator reports used by the field team, local Principal Investigator, and CDC Project Officer to monitor recruitment and the sampling characteristics.

o Communicate with Field Supervisor and Principal Investigator regarding reports.

• Data quality control o Review data reports from CDC and document either the edit to the data needed to resolve the problem highlighted in the data report or reason the problem can not be resolved.

o Maintain integrity of data.

o Maintain a log of errors and other issues in the error tracking log.

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

• Data submission o Prepare data reports and data submissions for CDC.

o Communicate with CDC regarding data submissions.

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2.7 Spanish-speaking Staff

NHBS sites that utilize Spanish language materials will need to have Spanish-speaking project staff available for recruitment, interviewing and HIV counseling and testing. A Spanish-speaking project staff member should also be available for answering general questions about the project.

2.8 Staff Training

All interviewers must undergo several trainings for NHBS-MSM2. CDC will hold a Field Operations Training to be attended by Field Supervisors and one additional staff member.

These staff will then conduct trainings for remaining NHBS staff at the local project site.

These trainings should be listed in the Pre-implementation Checklist (Appendix A). In addition, CDC will hold several Net Meetings for interviewers, Field Supervisors, and Data Managers before and following the Field Operations Training. Staff should plan to attend each of these Net Meetings to be fully trained in NHBS-MSM2 methods and interviewing skills.

All NHBS-MSM2 staff must have had confidentiality training and signed a confidentiality agreement prior to data collection. HIV counseling and testing training is mandatory for all staff who will conduct testing and counseling. A cultural competency course is recommended for all interviewers, so that they may learn culturally sensitive skills in order to work with MSM as well as different racial and ethnic groups. 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 attends, such as safety trainings, conflict de-escalation trainings, or others should be listed in the Pre-implementation Checklist.

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3 Project Preparation

3.1 Overview

Prior to the implementation of NHBS-MSM2 there are a few project preparation tasks that should be completed. These tasks will prepare project sites for a successful NHBS- MSM2 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 and log books necessary to document and maintain the project.

3.2 Study Logo and Marketing Materials

Logos and marketing materials can be created for NHBS-MSM2 project identification.

However, sites should have logos and materials reviewed by their CDC Project Officer before printing and distributing these materials. 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 to promote project awareness.

3.3 Supplies

3.3a Materials for the venue and van

Several materials are necessary to conduct the NHBS-MSM2 survey in the field. Before going into the field all NHBS-MSM2 field staff should ensure they have the necessary materials to conduct data collection. See Appendix B for a list of project supplies. 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 in the van or venue and office:

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

• Referral agencies for MSM who are HIV-positive or in need of drug treatment.

• Supplies used to reduce HIV risk including condoms, lubricants, and hygiene kits.

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3.3c Binder for project forms and logs

To ensure successful project management and quality data collection, NHBS staff should develop a systematic plan to monitor the day-to-day operations of NHBS-MSM2 activities at the venues and in the office. Several forms and logs mentioned throughout this manual are used to collect specific information regarding different operational aspects of NHBS-MSM2. Using a binder to store these forms will help NHBS 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 staff will be responsible for reviewing, completing, and correcting forms and updating them in accordance with their local plan and the NHBS-MSM2 Protocol. Sites are encouraged to develop additional forms as they see fit to help manage NHBS-MSM2 activities. The following forms and logs should be found in your binder:

• Venue Universe

• Monthly sampling frames and calendars

• Memorandums of Understanding

• Intercept Forms

• Recruitment Monitoring Forms

• Reminder Call Forms

• Test Results Log

• Telephone Results Log

• Specimen Shipping Log

• Data Corrections Log

• Survey ID Log

• Appointment Log

3.3d Survey ID

The Survey ID is a unique 4-digit number that is assigned to a prospective participant when he is going to be screened for eligibility for NHBS-MSM2. All NHBS-MSM2 project sites must develop a system for communicating the prospective participant's Survey ID number to his interviewer. Regardless of the system developed, the Survey ID must be communicated in writing, not verbally. Please see section 5.6b for instructions on assigning survey ID numbers.

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 staff to avoid trouble by using common sense and advance planning. Staff must be alert to their own safety and to that of their co-workers at all times. A basic

NHBS-MSM2 Operations Manual 12 awareness of one’s surroundings is critical when working in the field. Generally, the Field Supervisor is responsible for crowd control and overall safety. Each of the field staff must also be responsible for maintaining a safe working environment.

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 staff members at each recruitment event.

• Keep activities on neutral ground--never enter a person’s car or residence.

3.4b Plan ahead – local safety procedures Before implementation, each project site must submit local safety procedures to their CDC project officer. 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.

The Field Supervisor must have emergency contact information for each member of the team. This information should be easily accessible whenever interviewers are in the field.

• 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 venue, storefront or van.

• 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. You might use something like the phrase “bring the red folder.” For example, if a staff member was not comfortable interviewing a participant by themselves or needed help with an uncooperative participant, they would ask one of their co-workers to bring them the “red folder” to indicate that they needed assistance.

3.4c Be alert

• Be aware of your surroundings.

• If a threatening situation arises, remove yourself from the location immediately.

Leave quickly, but do so carefully and with a "cool head."

• Use all of your senses to assess a situation. If your sixth sense tells you that this

NHBS-MSM2 Operations Manual 13 is not a safe location, then leave immediately.

• Approach every potential participant as though he is welcoming, but be cautious if you have concerns about an individual.

3.4d Use common sense

• Limit the amount of cash you carry.

• Avoid wearing or carrying articles that look valuable. Jewelry, purses, expensive watches, and cameras invite theft and attendant violence.

• Do not carry illegal weapons.

• Never leave the keys in your car or the doors unlocked.

• Do not use illegal drugs or alcohol while you are working.

• Do not make change or give donations to those asking for money while in the field.

• Do not buy or receive merchandise from clients in the field.

• Do not accept gifts from anyone while in the field.

• Do not offer rides to or accept rides from participants.

3.4e Dangerous/difficult situations

End the interview at any point if you feel threatened by the participant.

Aggressive or threatening individuals

If directly confronted by an individual, employ verbal de-escalation techniques: position yourself at an angle and allow extra space between you and the other person; do not smile; let them vent; listen to and acknowledge their concerns; avoid becoming defensive; lower your voice, tone, and tempo; and respond to valid complaints. Local safety officials (police, fire, and rescue) may be able to provide de-escalation training to project staff.

Sexual harassment

If a participant is sexually coming on to you or sexually harassing you, you have the right to terminate the interview. If you feel the participant is behaving inappropriately, you should first remind them that you are only there to interview them and that you are not interested in any sexual offers. If the participant continues, tell them that you are going to stop the interview if they cannot stay focused on the questions. If this does not work, terminate the interview.

Drunk, high, or drowsy participants

A participant may not be able to complete the interview or give accurate data for a

NHBS-MSM2 Operations Manual 14 variety of reasons. He may be unable to give coherent answers to the questions, nod off or appear to be very drowsy during an interview if he has had little sleep or has recently used alcohol or drugs.

• If you are screening someone for eligibility and they cannot give coherent answers, answer the final Eligibility Screener question “Is this person alert and able to complete the health survey in English or Spanish?” as “No”. Explain to the participant that the computer has not selected him to participate in the survey and thank him for his time. Enter the reason they were not able to complete the survey in the interviewer comments field.

• If you have begun the interview (after screening) and the participant is no longer giving coherent answers, stop the interview, thank the participant for their time, and enter a description of what happened in the interviewer comments.

3.4f Safeguard the handheld computers

Field staff must use the handheld computers in the field, and the following guidelines are written with the objective of not allowing the handhelds to put field staff in a dangerous position.

• Store your handheld computer out of view in a locked, secure place when you are not using it.

• Try to be inconspicuous when carrying and using your handheld computer. Never leave it unattended.

• Download data from your handheld computer to the central database after each recruitment event.

3.4g Field incident reporting procedures

Create incident reporting procedures prior to starting work at the field site and include them in the Pre-implementation Checklist (see Appendix A). For an example field incident report, see Appendix C. In the event that an incident occurs at your site, notify your supervisor. The supervisor or Project Coordinator will then notify CDC within 24 hours and complete a “Field Incident Report” and send it to the CDC project officer.

Work with your CDC project officer to determine if this is also an adverse event (See Chapter 9.8 of the NHBS-MSM2 Protocol).

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4 Monthly Recruitment Calendar

4.1 Overview

The purpose of this chapter is to provide guidance in creating the monthly recruitment calendar. Each month, project sites will create a recruitment calendar to schedule the upcoming month’s recruitment events. Project sites will select the venues, days, and times (VDTs) when the events will occur using the VDTS Program supplied by CDC. In the unexpected event that the VDTS Program malfunctions or is not operational, VDTs can be selected manually as described in Appendix E. The recruitment calendar for an upcoming month should be made at least one week prior to the start of that month so that CDC project officers can review the calendar and project sites can begin to contact the management of the selected venues.

4.2 VDTS Program

The VDTS Program will allow project sites to create and randomly sort a sampling frame of venues and their associated day-time periods. The program will output a list of these randomly selected VDTs that project sites, in turn, will use to construct their monthly recruitment calendars.

4.2a Constructing the initial sampling frame

To begin sampling frame construction, project sites should review the Venue Universe they created during formative research to identify those VDTs that would be suitable for conducting recruitment events. Suitable VDTs must have all the following:

● management who have agreed to allow recruitment events to be held at their venue,

● safe environments,

● spaces where it is logistically feasible to conduct recruitment, interviewing, and HIV testing (alternatively, a van can be used for interviewing and testing), and

● >75% of venue attendees who are eligible for NHBS-MSM2 (≥ 18 years old, MSA residents, and had sex with another man in the past 12 months).

Once all the suitable VDTs have been identified, they should be entered into the VDTS Program to create the first month’s sampling frame (see the VDTS Program User Guide for instructions on entering VDTs).

4.2b Constructing subsequent sampling frames

After the initial month’s sampling frame has been created, project sites can use the VDTS Program to construct the next month’s sampling frame by copying and editing the initial sampling frame. In the “Sampling Frame List” window of the VDTS Program, project

NHBS-MSM2 Operations Manual 16 sites should copy the initial sampling frame and save it with the name of the upcoming month. By editing the copied sampling frame, project sites can update the frame’s VDTs based on their ongoing formative research. As attendance patterns at venues change, day-time periods on the sampling frame should be adjusted accordingly. If new venues or day-time periods are identified, they should be added to the sampling frame. On the other hand, if venues close or certain day-time periods no longer have sufficient levels of attendance to ensure productive recruitment, they should be removed from the sampling frame.

A subsequent month’s sampling frame does not always have to be created from the initial sampling frame. Project sites can construct a subsequent month’s sampling frame by copying and editing any monthly sampling frame saved in the VDTS Program.

4.2c Reviewing and editing a sampling frame

After project sites create a monthly sampling frame, they should review it for accuracy.

The VDTS Program will allow project sites to view any sampling frame they have created, as well as print a hard copy of it. If any errors are noted, they should be corrected using the “Edit” function of the VDTS Program. It is important to ensure that a sampling frame is correct before sorting occurs because once a frame has been sorted, it cannot be changed. If errors are detected in a sampling frame that has been sorted, a new version of the frame will have to be created for editing. To do this, project sites should copy the incorrect sampling frame and save it with a new version number. The new version of the sampling frame can then be edited to correct any errors.

4.2d Sorting a sampling frame

With venue-based sampling, project sites must randomly select the venues where recruitment events will take place and the days and times when these events will occur.

The VDTS Program will automatically perform this random selection for project sites by sorting and ordering the venues and day-time periods on their monthly sampling frames.

The program first randomly sorts all the venues on the sampling frame and lists them by their selection order. The program then randomly sorts all the day-time periods available for each venue and lists them by their selection order. The final product is a line-listing of randomly sorted venues and associated day-time periods that the VDTS Program will use to select the VDTs for a project site’s monthly recruitment events (figure 4.1).

4.2e Selecting VDTs for recruitment events

To use the VDTS Program to select VDTs for an upcoming month’s recruitment events, project sites should first decide how many events they need to conduct that month.

Project sites should plan on conducting a minimum of 14 recruitment events each month to reach the target enrollment of 500 MSM. Once project sites have decided on the planned number of recruitment events, they should classify the events as either random or non-random based on how the VDTs for the events will be selected. VDTs selected for random events will be randomly chosen from the sorted sampling frame by the VDTS

NHBS-MSM2 Operations Manual 17

Figure 4.1 Sorted sampling frame produced by the VDTS Program.

Venue Venue Venue Pick Order Code Name Pick Order

1 C001 Woodfire Grill 1 TUE 11:00 AM - 2:00 PM

2 FRI 5:00 PM - 9:00 PM

3 MON 11:00 AM - 2:00 PM

2 B002 Amsterdam's 1 FRI 6:00 PM - 10:00 PM

2 THU 6:00 PM - 10:00 PM

3 B001 ESPN Zone 1 SAT 1:00 PM - 5:00 PM

2 SUN 6:00 PM - 10:00 PM

3 SUN 2:00 PM - 6:00 PM

4 D001 Club 2000 1 SAT 10:00 PM - 2:00 AM

5 F002 Fitness Factory 1 THU 4:00 PM - 8:00 PM

2 TUE 4:00 PM - 8:00 PM

6 S005 Main ST & 2nd AVE 1 WED 10:00 AM - 2:00 PM

7 P002 Piedmont Park 1 SUN 10:00 AM - 2:00 PM

2 SAT 2:00 PM - 6:00 PM

3 FRI 4:00 PM - 8:00 PM

4 SAT 10:00 AM - 2:00 PM

5 SUN 2:00 PM - 6:00 PM

8 R008 Outwrite Bookstore 1 SAT 2:00 PM - 6:00 PM

2 THU 6:00 PM - 10:00 PM

3 SUN 1:00 PM - 5:00 PM

4 FRI 6:00 PM - 10:00 PM

9 D003 Ovation 1 FRI 10:00 PM - 2:00 AM

CDC-ville

Day-Time Period

Sorted Sampling Frame June 2008

Day-Time Period

NHBS-MSM2 Operations Manual 18

Program, whereas VDTs selected for non-random events will be purposefully chosen by project sites.

Non-random events can be used to capture special events or to increase representation of important sub-populations, but they should be used sparingly. Accordingly, a maximum of 3 non-random events are permitted each month. This restriction will be relaxed, however, during the month that each project site holds its largest or main pride festival.

That month, project sites may conduct up to 2 additional non-random events at venues that are part of the main gay pride festival, for a total of 5 non-random events. Yet, to be able to conduct these extra non-random events, project sites must first gain approval from their CDC project officer by providing written justification for adding the extra events.

For example, the added non-random events may help a project site enroll an important sub-population that the project site is having difficulty reaching. Project sites are only allowed to conduct the extra non-random events at their main gay pride festival; they cannot conduct them at smaller pride festivals that target specific groups, such as a black gay pride festival or a leather festival.

Project sites will start the VDT selection process by entering the planned number of random events in the VDTS Program (see the VDTS Program User Guide for instructions on selecting VDTs). The maximum number of random events a site can select each month with the VDTS Program is 40. However, if there are fewer than 20 venues on the sampling frame, the maximum number of random events is reduced to twice the number of venues on the frame to ensure that events are not held at the same venue more than twice in a single month. The VDTS Program will also allow project sites to select a certain number of venues to serve as reserve venues. These reserve venues can, if needed, replace any venues that cannot be scheduled on the monthly recruitment calendar because of conflicts with event days or times.

After the number of random events and the number of reserve venues are entered in the VDTS Program, the program will display a table of the VDTs selected from the sorted sampling frame. The program will then give project sites the option of selecting VDTs for non-random events. In a given month, non-random events should not ordinarily be held at the same venue as a random event or another non-random event. However, under rare circumstances, project sites may repeat a non-random event at a venue if they obtain prior approval from their CDC Project Officer.

When project sites have finished choosing non-random events (or if they by-pass this process), the VDTS Program will display a final table of selected VDTs (figure 4.2). The top section of this table will list any VDTs purposefully chosen for non-random events, the middle section will contain VDTs randomly selected from the monthly sampling frame for random events, and the bottom section will list possible reserve VDTs. Project sites should print a hard copy of the table of selected VDTs that they will use to construct their monthly recruitment calendars.

NHBS-MSM2 Operations Manual 19

Figure 4.2 Table of selected VDTs produced by the VDTS Program.

Number of Pick Order Day-Time Venue Venue Periods Code Name Period

Non-random:

-- Z001 Auburn Street Fest -- SUN 12:00 PM - 5:00 PM

Random:

1 D001 Club 2000 1 SAT 10:00 PM - 2:00 AM

2 B002 Amsterdam's 1 FRI 6:00 PM - 10:00 PM

2 THU 6:00 PM - 10:00 PM

3 C001 Woodfire Grill 1 TUE 11:00 AM - 2:00 PM

2 FRI 5:00 PM - 9:00 PM

3 MON 11:00 AM - 2:00 PM

3 B001 ESPN Zone 1 SAT 1:00 PM - 5:00 PM

2 SUN 6:00 PM - 10:00 PM

3 SUN 2:00 PM - 6:00 PM

Reserve:

2 F002 Fitness Factory 1 THU 4:00 PM - 8:00 PM

2 TUE 4:00 PM - 8:00 PM

1 S005 Main ST & 2nd AVE 1 WED 10:00 AM - 2:00 PM

Selection Parameters:

CDC-ville

Day-Time Period

Selected VDTs June 2008 of Day-Time

Number of Non-random Events= 1 Number of Random Events= 4 Number of Reserve Venues= 2

NHBS-MSM2 Operations Manual 20

4.3 Constructing a Monthly Recruitment Calendar

The monthly recruitment calendar lists the venues, dates, and times when recruitment events will occur during a month. Appendix D provides an example of a monthly recruitment calendar. Project sites will create their monthly recruitment calendars by scheduling recruitment events using the VDTs they selected with the VDTS Program.

For each scheduled recruitment event, project sites will also need to identify one or two alternate venues where they could hold the event if it cannot be held at the originally scheduled venue.

4.3a Determining staff availability

Before project sites begin scheduling recruitment events on their monthly calendars, they should first determine which dates and times the field staff will not be available to conduct recruitment events because of holidays, vacations, or other planned absences.

These dates and times should then be blocked-off the calendar. Project sites should also block-off other dates and times when recruitment events cannot occur, such as weekly office hours.

To prevent burnout, project sites may want to establish work limits for their field staff.

For example, limiting the number of recruitment events that can be scheduled on consecutive days so that staff can have a day off or not scheduling a morning recruitment event the day after a night event. On the other hand, some project sites may have more than one team of field staff. In these cases, if staff are available and burnout can be avoided, project sites could conduct more frequent recruitment events (up to a maximum of two events in a single day).

4.3b Scheduling non-random recruitment events

Because non-random events have the highest priority for scheduling, project sites should place them on the monthly recruitment calendar first. VDTs available for non-random events are listed in the top section of the table of selected VDTs that is produced by the VDTS Program.

4.3c Scheduling random recruitment events

Project sites should schedule random events on the monthly recruitment calendar after any non-random events have been scheduled. VDTs available for random events are listed in the middle section of the table of selected VDTs. The venues for these VDTs are arranged in order from venues with the fewest number of day-time periods to venues with the most. Venues with the same number of day-time periods are ranked in the order that they were randomly selected by the VDTS Program. Project sites should schedule the venues for their random events in the order that they are listed on the table. By starting with venues with the fewest number of day-time periods, project sites will minimize any irreconcilable scheduling conflicts with days or times.

NHBS-MSM2 Operations Manual 21

The scheduling of random events should begin with venues with one day-time period.

Project sites can schedule these venues on any date that can accommodate their day-time periods. Once this has been completed, project sites can start scheduling those venues with more than one day-time period. Before project sites can do this, however, they must first randomly select a day-time period for each venue. To facilitate this process, the table of selected VDTs lists all the day-time periods for each venue in the order that they were randomly chosen by the VDTS Program (i.e., the first day-time period randomly selected is listed first, the second randomly selected is listed second, etc.). For each venue, project sites should therefore pick the first day-time period listed for that venue and schedule it on any date that can accommodate this day-time period. If no dates are available to schedule the first day-time period listed for a venue, project sites should choose the second day-time period listed. If a date cannot be found for this day-time period either, project sites should move down the list of the venue’s day-time periods until they find one that can be scheduled on the recruitment calendar. In some rare cases, none of a venue’s day-time periods can be scheduled. If this happens, project sites should exclude the venue and after they have finished scheduling the remaining random events, replace it with a reserve venue.

4.3d Scheduling reserve venues

Because of scheduling conflicts, a venue selected for a random event may sometimes have to be excluded and replaced with a reserve venue. Possible reserve venues are listed in the bottom section of the table of selected VDTs. The table lists both the reserve venues and their day time-periods in the order that they were randomly selected by the VDTS Program. If a venue selected for a random event must be replaced, project sites should pick the first reserve venue listed as the replacement. Project sites will then have to choose a day-time period for this venue and schedule it on the recruitment calendar.

As was described above in section 4.3c, project sites should pick the first day-time period listed for the venue and schedule it on any date that can accommodate this day-time period. If a date cannot be found for the first day-time period, the second one should be picked, and so on. If dates cannot be found to accommodate any of the venue’s day-time periods, project sites should move to the next reserve venue on the list. This process should continue until project sites are able to schedule a replacement venue on the recruitment calendar.

Note: Project sites should not schedule any reserve venues as replacements until all the venues selected for random events have been scheduled on the recruitment calendar.

4.3e Assigning alternate venues

Occasionally, a recruitment event cannot be conducted at a scheduled venue because of unforeseen circumstances like inclement weather or a lack of eligible participants.

Accordingly, project sites should schedule at least one alternate venue as a back-up for each planned recruitment event. Under most circumstances, one alternate venue is sufficient. However, because recruitment events are moved to alternate venues at the last

NHBS-MSM2 Operations Manual 22 minute, it is often prudent to also schedule a second alternate venue in case the first is not available.

Possible alternate venues should have day-time periods that begin either at the same time as the scheduled recruitment event or up to two hours later. In addition, possible alternate venues should not be the same as any venues already scheduled as the primary venue for a recruitment event nor the same as any venues already assigned as alternates.

Nevertheless, the restriction on repeating venues can be lifted if there are no other possible alternate venues available for a particular recruitment event. If project sites must repeat venues, they should repeat venues assigned as second alternates before they repeat any venues assigned as first alternates, and they should repeat venues assigned as first alternates before they repeat any primary venues. When choosing possible alternate venues, project sites should also consider potential logistical and weather problems.