FOREWORD

I am grateful to the United States Agency for International Development (USAID) and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) for supporting this work.

I thank co-author Sarah Hileman, of the USAID- and PEPFAR-funded MEASURE Evaluation project at the University of North Carolina at Chapel Hill (UNC), for her patience and willingness to work with me on this material for the past five years. She has been gracious through all the changes and rewriting. I also thank MEASURE Evaluation co-authors Jessie K. Edwards, Becky Wilkes, Grace Mulholland, Zahra Reynolds, Michael Herce, Marcia Hobbs, Lauren Zalla, Whitney Ewing, , Kate Muessig, and Sabrina Zadrozny, as well as William Miller, Jean Lambert Chalachala, and Katherine Lancaster for their technical contributions and overall support. I thank those in other countries who have contributed so meaningfully to the new PLACE manuals through careful implementation and priceless feedback and insights. Among those who have contributed the most are Dr. Peter J. Figueroa, of Jamaica, and team members Lovette Byfield, Jackie Duncan, Marion Scott, and Carol Jones Cooper; Dr. Freddie Ssengooba, of Uganda, and team members Susan Babirye, Steven Ssendagire, Florence Nankya, Dr. Lynn Atuyambe, Dr. Simon Kasese, and Milly Nattimba; Dr. Fatou Maria Drame, of Senegal, and her colleague Dr. Diouda Diouf; Diane Mpinganzima and her team in Burundi; Nyanyiwe Mbeye, of Malawi, and colleagues Blackson Matatiyo, Shawn Aldridge, Agatha Bula, Innocent Mofolo, Victor Gama, and Melchiade Ruberintwari; and Baurzhan Zhussupov, of Kazakhstan, and colleagues on the USAID-funded Linkages across the Continuum of HIV Services for Key Populations Affected by HIV (LINKAGES) project.

Acknowledgment goes to Clare Barrington, Julie Nelson, Myron Cohen, and Irving Hoffman at UNC for their support and guidance. A shout-out is due to Krista Stewart and Joseph Mwangi, of USAID, who played a key role in that agency’s recognition of the PLACE method. I thank my colleagues in the Measurement & Surveillance of HIV Epidemics (MeSH) consortium (especially Stef Baral, Liz Fearon, Brian Rice, James Hargreaves, and Anita Rao); at the Joint United Nations Programme on HIV/AIDS (especially Keith Sabin, Mary Mahy, and Peter Ghys); Txema Calleja, at the World Health Organization; Jinkou Jhou, at the Global Fund to Fight AIDS, Tuberculosis and Malaria; David Wilson, at the World Bank; and J. Ties Boerma, Jamie Blanchard, Faran Emmanuel, Shajy Issac, and Paranita Bhattacharjee, at the University of Manitoba.

Thanks to MEASURE Evaluation’s knowledge management team for editorial, design, and production services.

Sharon S. Weir

Senior Technical Advisor for Key Populations

MEASURE Evaluation, University of North Carolina at Chapel Hill

Suggested citation for the tool kit as a whole:

MEASURE Evaluation. (2019). Priorities for Local AIDS Control Efforts (PLACE) Tool Kit. Chapel Hill, NC, USA: MEASURE Evaluation, University of North Carolina.

Suggested citation for this document:

MEASURE Evaluation. (2019). Priorities for Local AIDS Control Efforts (PLACE): Sample Protocol. Chapel Hill, NC, USA: MEASURE Evaluation, University of North Carolina.

CONTENTS

Figures and Tables	7

Abbreviations	8

Definitions	9

How to Use This Manual	10

Sample Place Protocol	11

1. Study Summary and Time Frame	11

2. Aim, Rationale, and Specific Objectives	14

3. Engagement, Organizational Structure, and Ethical Review	15

4. Selecting and Mapping Study Areas	17

5. Readiness Assessments: Key Populations and Service Delivery Providers	18

6. Study Design and Survey Populations, Recruitment, and Informed Consent	19

7. HIV Testing and Viral Load Estimates	23

8. Quality Assurance, Safety, and Training	23

9. Sampling and Sample Size	23

10. Key Indicators: Venue Profiles and Biobehavioral Indicators	27

11. Statistical Analysis and Population Size Estimates	29

12. District Reports and Data Use Workshops	31

Appendix A. Informed Consent Fact Sheets	33

Appendix B. Place Survey Questionnaires (Form A, Form B, and Form C)	37

Form A	38

Form B	42

Form C	56

FIGURES

Figure 1. PLACE organizational structure	16

Figure 2. Fieldwork: Five-step fieldwork protocol	19

Figure 3. Survey populations	20

Figure 4. High- and low-priority districts sampled	23

Figure 5. Venue profile	27

Figure 6. Biobehavioral indicators	28

Figure 7. Example of a district summary of PLACE fieldwork	31

Figure 8. Example of a map showing PPAs	31

TABLES

Table 1. Study summary	11

Table 2. Sampling and sample size summary	26

ABBREVIATIONS

ANC	antenatal care
ART	antiretroviral therapy
CBO	community-based organization
FSW	female sex worker
GIS	geographic information system
GPS	global positioning system
M&E	monitoring and evaluation
MSM	men who have sex with men
NA	not applicable
PEPFAR	United States President’s Emergency Plan for AIDS Relief
PLACE	Priorities for Local AIDS Control Efforts
PMTCT	prevention of mother-to-child transmission
POC	point of care
PPA	priority prevention area
PrEP	pre-exposure prophylaxis
PWID	people who inject drugs
SOP	standard operating procedure
STI	sexually transmitted infection
UNAIDS	Joint United Nations Programme on HIV/AIDS
USAID	United States Agency for International Development
WHO	World Health Organization

DEFINITIONS

HIV prevention cascade: Those who need services to prevent HIV acquisition, those who have access to the service (or services), and those using the service consistently

HIV treatment cascade: The number of people infected, the number of those on treatment, and the number on treatment who have achieved viral suppression

Key population: Populations most at risk of acquiring and transmitting HIV either by sex or needle sharing, generally defined as men who have sex with men, female sex workers, people who inject drugs, and transgender women

Priority population: A term often used along with the term “key populations,” priority populations are all other groups identified at a national or subnational level who are at increased risk of HIV transmission. Examples are fisher folk, truck drivers, and those in uniformed services.

Priority prevention areas (PPAs): Geographic areas expected based on epidemiological data and contextual information to have higher incidence of HIV infection

Stakeholder: Anyone who could be affected by a Priorities for Local AIDS Control Efforts (PLACE) study or who could benefit from the findings. Stakeholder consultations should include engagement with healthcare workers, politicians, national AIDS control committees, health ministry leaders, key populations, police, epidemiologists, and academics.

HOW TO USE THIS MANUAL

Please consult Priorities for Local AIDS Control Efforts (PLACE): Overview of the Toolkit and the Method It Supports (https://www.measureevaluation.org/resources/tools/hiv-aids/place) for orientation to this package of resources as a whole.

This Sample PLACE Protocol is a template that can be adapted to support studies using the PLACE method in a variety of contexts. The protocol assumes a typical application of the PLACE method. It has sections on study rationale, objectives, methods, and data analysis. It is available for download in Word here: https://www.measureevaluation.org/resources/tools/hiv-aids/place.

See Priorities for Local AIDS Control Efforts (PLACE): Protocol Decisions Manual (https://www.measureevaluation.org/resources/tools/hiv-aids/place) for guidance on using the template to create a protocol for your own study.

SAMPLE PLACE PROTOCOL

This sample protocol is a template that can be used to adapt PLACE to other settings. An editable version of this protocol can be downloaded here: https://www.measureevaluation.org/resources/tools/hiv-aids/place.

Guidance and resources for adapting the protocol are available in the Protocol Decisions and Methods section, which follows this sample protocol.

This sample protocol is set in a fictitious country called Carolina, comprising 100 districts.

In this sample illustrative protocol for Carolina, protocol decisions have been made. The Protocol Decisions and Methods section describes the options and methods for each decision in more detail and steers users to protocol tools.

The University of North Carolina at Chapel Hill provides technical assistance (TA) for implementing PLACE. Please visit www.measureprogram.org and contact us for trainings and TA.

1. Study Summary and Time Frame

The study summary describes the aim, methods, participants, and outputs.

Table 1. Study summary

Study Title	The 2019 PLACE Study in Carolina
Aim	To increase local capacity to understand the drivers of local HIV epidemics, identify gaps in services among those most likely to acquire and transmit HIV, and provide evidence to support tailored interventions to reduce HIV transmission and improve access to treatment
Objectives	Analyze available evidence to identify geographic areas called “priority prevention areas” (PPAs): geographic areas that are likely to contain influential HIV transmission networks. Identify public venues in PPAs where people in HIV transmission networks could be reached with services. Map, describe, and assess the availability of HIV services at these venues. Provide an epidemic profile of men and women at these venues and engage with local stakeholders to use the data to improve programs.
Study Areas	<Insert list of 30 selected districts>
Study Design: The 5 Steps of Fieldwork	District launch and identification of PPAs Venue identification Venue verification, profiling, and mapping Biobehavioral survey Feedback and data use workshop
Methods	Stakeholder input Community informant interviews Programmatic mapping Biobehavioral surveys HIV testing and viral load estimation Data use workshops
Participants per district	10–50 district stakeholders 300 community informants 300 venue informants 90 venue workers 600 venue patrons
Total expected number of members of key populations	1,500 female sex workers 600 men who have sex with men 100 people who inject drugs 50 transgender women
Outputs in each district	PPAs identified Complete list of public venues where people meet new sexual partners Complete list of public venues where people who inject drugs can be reached Venue maps and profiles Action plans based on the data
Key coverage and biobehavioral indicators provided	HIV prevalence Population size Sexual partnership rate Condom use Access to services HIV prevention cascade 90-90-90 treatment cascades
Leadership and Funding
National level	The PLACE National Steering Committee, chaired by: Name, organization, address, contact details, telephone, email
Local level	The District Steering Committee in districts where PLACE is implemented
Implementation	Name, organization, address, contact details, telephone, email
Other	Organizations, their addresses, contact details, telephone, email
Funding	Organization

Time Frame

The preparation phase requires three to six months, depending on the scale of the study. Funding should have been secured prior to the preparation phase.

Preparation phase (six months)

Establishment of National Steering Committee (month 1)

Identification of national stakeholders (month 1)

Synthesis of available HIV strategic information (months 1 and 2)

Protocol decisions (month 3)

PLACE readiness assessments (month 4)

Ethical review and any approvals (month 5)

Logistics planning (month 6)

Fieldwork phase (six to eight weeks per district, depending on the size of the fieldwork team and logistics issues)

Initial training and logistics planning (week 1)

District launch meeting and identification of PPAs (week 2)

Community informant interviews (week 2)

Venue informant interviews and mapping (weeks 3 and 4)

Patron and worker interviews (weeks 5 and 6)

Data use workshop (week 8, after time to analyze results)

Supplemental analysis (after all districts are completed)

Coordinating data use and dissemination

Identifying supplemental analyses

2. Aim, Rationale, and Specific Objectives

Aim

The aim of PLACE is to increase local capacity to understand the drivers of local HIV epidemics, identify gaps in services among those most likely to acquire and transmit HIV, and provide evidence to support tailored interventions to reduce HIV transmission.

Rationale

The rationale for PLACE is based on the four pillars of PLACE:

Epidemiological theory and evidence

Evidence-based local response

Scientific rigor

Ethics and engagement

Our understanding of the local HIV epidemics in our country is limited. PLACE will address the following gaps in strategic information that limit our understanding of how best to respond to the epidemic:

Lack of information on the geographic distribution of HIV in our country

Lack of information on the location and characteristics of PPAs likely to have high HIV incidence

Lack of information on who is most likely to transmit HIV (We do not know the prevalence of HIV among those with the highest rates of new sexual partnerships in our country.)

Lack of information on the number and characteristics of people who inject drugs

Lack of information on HIV prevalence among key populations, whether or not those who have the virus are on treatment, and whether or not they have achieved viral suppression

Our resources are limited. We need to focus on an evidence-based response at the local level. The PLACE method engages local stakeholders to obtain information that can be used locally. The method provides maps that can be used for outreach. HIV prevention and treatment programs can use the data to tailor interventions.

We need indicators that are based on well-established, standard survey methods and training materials. The PLACE method will provide valid information for the following purposes:

Identify where to reach people most likely to acquire and transmit HIV

Estimate the size of key populations

Estimate program coverage for key populations

Estimate HIV prevention cascades

Estimate HIV treatment cascades

Inform prevention strategies for young people.

The PLACE method engages key population groups, national stakeholders, and district-level stakeholders using a collaborative approach that provides meaningful engagement with key and priority populations (all other groups identified at a national or subnational level who are at increased risk of HIV transmission, such as fisher folk, truck drivers, and those in uniformed services).

Specific Objectives

These are the specific objectives of PLACE:

Analyze available evidence to identify PPAs (geographic areas that are likely to contain influential HIV transmission networks).

Identify public venues in PPAs where people in HIV transmission networks go to socialize and meet new sexual (and/or needle-sharing) partners and could be reached with services.

Visit, describe, map, and assess the availability of HIV prevention services at these venues.

Measure key indicators of HIV infection status, population size, transmission risk, and access to HIV prevention and treatment services among key and priority populations at venues.

Estimate HIV prevention and treatment cascades for key and priority populations.

Engage with local stakeholders to use the data to improve programs.

3. Engagement, Organizational Structure, and Ethical Review

The National Steering Committee, established in collaboration with government, funding organizations, and stakeholders, identified the districts where PLACE will be implemented (see Section 4 below).

Engagement included consultation with the following:

Government offices of HIV strategic information, epidemiology, monitoring and evaluation (M&E), and geographic information system (GIS) mapping to understand the HIV epidemic, align indicators with national strategies, select areas for PLACE implementation, and take advantage of national GIS expertise and systems

Key and priority population groups to operationalize definitions of key populations, identify a typology of venues where people meet new sexual partners or where people who inject drugs can be reached, identify barriers to access HIV services, to assess the potential for risks arising from PLACE implementation, and to identify strategies for reducing risks, maintaining the safety of participants and field workers, and increasing participation by key populations during the implementation phase

Service delivery providers, including HIV testing and counseling offices, to specify any standard national packages of HIV prevention services, to align testing with national guidelines, to align coverage indicators from PLACE with national indicators, and to specify coverage maps

Ethical review committees to review the protocol regarding participant and study personnel safety, informed consent, and strategies to safeguard data so that the confidentiality of participants can be protected

Methods for engagement consisted of meetings convened by the steering committee, visits to stakeholder offices, and sharing versions of the protocol for comment and feedback. Guided focus group discussions, called readiness assessments, were held with key populations and service delivery providers. See Section 5 for a fuller description of the methods and content of these assessments.

The National Steering Committee will guide the design of the protocol and its ethical review and the design, implementation, and dissemination of PLACE findings. Implementation will not begin until the required ethical approval has been obtained. Implementation will be led by a Core Implementation Team supported by district fieldwork teams hired within each district.

In each district, a steering committee will convene a meeting of stakeholders to identify the subdistrict areas where PLACE will be implemented, provide support for implementation and guidance during implementation, and lead the process to use the findings.

Figure 1. PLACE organizational structure

4. Selecting and Mapping Study Areas

The PLACE National Steering Committee led the process of selecting the districts. The process was informed by the following:

A synthesis of available district-level data: HIV prevalence, demographic, program, and contextual data

Stakeholder consultation with stakeholders knowledgeable about the epidemiology of HIV in the country, GIS data experts, key population groups, and service delivery providers

Development of district priority scores based on the consultations

The National Steering Committee scored each of the 100 districts on the following criteria (1 point per criterion met):

HIV prevalence among antenatal care (ANC) patients is greater than the average district HIV prevalence among ANC patients in the country

A population of adults ages 15 to 49 over 1 million

Three or more fishing villages

Cross-border area on an international trucking route.

The 50 districts with a score of 1 or more were classified as high-priority districts. The remaining 50 districts were classified as low-priority districts. The committee ultimately selected 30 districts for PLACE implementation:

A random sample of 20 high-priority districts (40% of high-priority districts)

A random sample of 10 low-priority districts (20% of low-priority districts)

5. Readiness Assessments: Key Populations and Service Delivery Providers

Readiness Assessment for Key Populations

The readiness assessment for key populations asked stakeholders from the key population community to provide the following support:

Describe the legal environment for each key population as well as any police harassment

Assess the acceptability of the protocol among key populations

Review the terminology in the protocol for each key population and improve the terminology where warranted

Assess the risks of implementation and advise on strategies to reduce risk and ensure safety

Encourage engagement of key populations in the design and implementation of the study

Review, adapt, and improve the generic venue typology to reflect the country setting.

The readiness assessment involved focus group discussions with key population groups. If the PLACE readiness assessment had found that key populations opposed the study or that the study could not be implemented safely, then the study would have been discontinued.

Readiness Assessment for Service Delivery Providers

The readiness assessment for service delivery providers asked those stakeholders to provide the following support:

Describe the standard package of HIV prevention interventions

Describe outreach efforts to high-risk venues

Describe condom promotion strategies, educational programs, and peer education

Describe any efforts to estimate the size of key populations from routine data

Describe the most important program coverage indicators

Identify how they will use the findings from PLACE to improve HIV prevention and treatment programs

Describe any division of the country among donors for key population programming

Describe their efforts to engage key populations in programming efforts

Describe their efforts to reduce police interference

The study protocol was adapted in response to the findings from the readiness assessments and submitted to the appropriate ethical review committee in the country for review and approval.

6. Study Design and Survey Populations, Recruitment, and Informed Consent

This section describes the study design, the survey populations, their recruitment, the informed consent process and survey content.

Study Design: The Five Steps of PLACE

The study design is a venue-based set of three sequential cross-sectional surveys in selected geographic areas to identify and characterize populations who visit or work at venues patronized by people at increased risk of acquiring and transmitting HIV. Data from each survey phase are used to build the sampling frame for the next phase. The process provides a data set of behavioral interviews and HIV testing of a probability sample of venue informants, venue patrons, and venue workers. The design supports estimation of sampling weights, population size estimates, and key HIV biobehavioral surveillance indicators.

The PLACE method will be implemented in each selected district following a series of five steps (Figure 2).

Step 1: During the district launch meeting, the PLACE District Steering Committee will solicit input and support from district stakeholders to guide the identification of PPAs in the district in which fieldwork will be focused.

Step 2: District Fieldwork Teams will interview community informants to identify all public venues in each PPA where people meet new sexual partners or where people who inject drugs can be reached. A master list of venues will be created to serve as a sampling frame for venues in Steps 3 and 4. A venue is a public physical venue, event, or website where people go to meet new sexual partners or where people who inject drugs socialize and can be reached by a program. Private venues (e.g., private homes) are excluded.

Figure 2. Fieldwork: Five-step fieldwork protocol Step 3: Interviewers will visit all venues identified by community informants in Step 2 and will interview a venue informant at each venue about the characteristics of the venue and any HIV prevention outreach conducted at the venue.

Step 4: District Fieldwork Teams will interview and test a probability sample of men and women at a random sample of 30 venues selected from the master list of venues.

Step 5: A feedback and data use workshop will be conducted to provide results to the district-level stakeholders and offer an opportunity to develop a district action plan based on the findings.

Definition of a Venue and the Venue Typology

A venue is a public physical location, building, or event where people meet new sexual partners or where people who inject drugs could be reached by health workers. Venues can be outdoors, such as parks or streets. Private events and private locations are not eligible for a PLACE study. In some cases, key populations may recommend meeting the study team at a private location, but these exceptions are made to ensure safety. Private locations are not listed, described, or mapped. The reason for limiting the study to public locations is because the locations should be places where outreach teams could bring services. In addition, mapping private locations could cause unanticipated harm to people at the venue.

A venue typology was developed with input from stakeholders during the readiness assessments. The venue typology is used to describe venues when they are reported by community informants.

Survey Populations Overview

There are three survey populations, as shown below.

Figure 3. Survey populations

Survey Populations: Level 1 Community Informants (Interviewed during Step 2)

Definition: Community informants are adults knowledgeable about their community who know where people go locally to meet new sexual partners and/or where people who inject drugs can be reached. Examples of community informants are taxi drivers, shopkeepers, street cleaners, and security guards.

Inclusion criteria: Men and women ages 18 and older who provide informed consent are eligible.

Exclusion criteria: There is no exclusion based on race, gender, or ethnicity and pregnant women are not excluded.

Recruitment: Community informants are recruited by interviewers based on targets set during field work that aim to recruit a variety of informants across the entire district. No incentive payment is provided to community informants.

Protecting privacy: No identifying information is collected from community informants. No questions are asked regarding individual behaviors. There is minimal risk to participants and exceptional privacy measures are not needed.

Informed consent: Participation is voluntary. Potential community informants are offered a Community Informant Fact Sheet (Appendix A) that describes the study and provides the name and contact information of the principal investigators. Potential respondents are asked if they have any questions and to voluntarily participate. Interviewers use the language most familiar to the respondent. Those who decline to participate are thanked for their willingness to consider participation. The informed consent process has been approved by an appropriate ethical review committee.

Fieldwork step: Community informants are interviewed during Fieldwork Step 2.

Survey content: Form A (Appendix B) collects information on the names and locations of places where people meet new sexual partners or where people who inject drugs can be reached. Information from community informants is used to develop a complete list of public venues where people meet new sexual partners or where people who inject drugs can be reached.

Survey Populations: Level 2 Venue Informants (Interviewed during Step 3)

Definition: A venue informant is an adult age 18 and older who is at the venue when the PLACE District Fieldwork Team visits. This person could be a patron, a key population member socializing at the site, a security guard, the venue owner, or a manager. One general venue informant is selected per venue based on his/her ability to provide information about what occurs at the venue, the people who visit the venue, and any HIV prevention activities that occur at the venue. Venues are physical places, events, and websites.

Inclusion criteria: Men and women ages 18 and older who provide informed consent are eligible.

Exclusion criteria: There is no exclusion based on race, gender, or ethnicity and pregnant women are not excluded.

Recruitment: Venue informants are recruited by interviewers during their visit to a sample of venues. The interviewers look for someone who is knowledgeable about the venue, such as a manager. No incentive payment is provided to venue informants.

Protecting privacy: No identifying information is collected from venue informants. No questions are asked regarding individual behaviors. There is minimal risk to participants and exceptional privacy measures are not needed.

Informed consent: Participation is voluntary. Potential venue informants are offered a Venue Informant Fact Sheet (see Appendix A) that describes the study and provides the name and contact information of the principal investigators. Potential respondents are asked if they have any questions and to voluntarily participate. Interviewers use the language most familiar to the respondent. Those who decline to participate are thanked for their willingness to consider participation. The informed consent process has been approved by an appropriate ethical review committee.

Fieldwork Step: Venue informants are interviewed during Fieldwork Step 3.

Survey content: Form B (Appendix B) collects information about the characteristics of the venue.

Survey Populations: Level 3 Venue Patrons and Workers (Interviewed during Step 4)

Definition: Workers and patrons at venues during a busy time (Fieldwork Step 4) are adults ages 15 and older. Workers are anyone employed by the venue or self-employed at the venue. Patrons are people socializing or interacting with other patrons or workers at the venue.

Inclusion criteria: All workers and patrons ages 18 and older at venues selected for the biobehavioral survey are eligible to participate. Workers and patrons ages 15 to 17 are eligible if they are at the venue autonomously and independent of their family. Anyone who does not meet these criteria is ineligible and may not complete the informed consent process.

Exclusion criteria: There is no exclusion based on race, gender, or ethnicity and pregnant women are not excluded.

Recruitment: All workers meeting the inclusion criteria are recruited. A random sample of patrons is recruited. The sampling method may vary based on the physical layout of the venue. Usually the supervisor puts pencil marks on the floor to identify the specific location where each interviewer will recruit participants. Interviewers sequentially recruit the patron closest to his or her mark on the floor. All recruitment occurs at the venue. Interviewers offer a Patron and Worker Fact Sheet (Appendix A), request participation in a 30-minute survey, and ask for permission to do an HIV test. No incentive payment is provided to workers and patrons.

Protecting privacy: Patrons and workers at venues will be interviewed and tested at the venue. The interview asks about personal behaviors. Because the venues are public, the interviewer will ask that the respondent move to a private place specifically set up by the study team within or outside the venue that ensures privacy (specifically, that prevents anyone else from hearing or seeing the responses). No identifying information will be collected by the interviewer. For the HIV testing and counseling part of the study, participants will be tested in private areas. After post-test counseling, those who are HIV-positive will be asked for contact information according to national treatment guidelines that will be shared with HIV/AIDS treatment providers. This contact information will not be entered in the study database.

Informed consent: Participation is voluntary. Potential participants are offered a Patron and Worker Fact Sheet (Appendix A) that describes the study and provides the name and contact information of the principal investigators. Potential respondents are asked if they have any questions and to voluntarily participate. Interviewers use the language most familiar to the respondent. Those who decline to participate are thanked for their willingness to consider participation. The informed consent process has been approved by an appropriate ethical review committee.

Survey content: Form C (Appendix B) collects information about demographic characteristics, sexual behavior, and access to and use of HIV prevention and treatment services. There is an offer for an HIV test and a request for a dried blood spot from people with a positive test result so that the viral load of HIV-positive respondents can be used to estimate the HIV treatment cascade.

7. HIV Testing and Viral Load Estimates

HIV testing is required for participation in the survey. Those who refuse to test are not eligible for participation. HIV counseling and testing will be performed by trained HIV counselors and testers who work in the local public health clinic and agree to conduct outreach testing for the PLACE study. They are provided some reimbursement for their time and travel. They receive training on the content and purpose of the study as well as the process for recording HIV test results on the tablets they are given for that purpose (see Section 8) and separately recording HIV test results for official reporting.

Those who receive a positive HIV antibody test result will be asked to provide a set of dried blood spots for analysis by the Carolina Lab to estimate viral load and determine which participants have achieved viral suppression. Information will be provided to participants about how to obtain treatment for HIV and how to obtain the result of the viral load test. The HIV counselor will offer the respondent the services of a treatment navigator and give the respondent the choice of contacting the navigator or being contacted or both.

8. Quality Assurance, Safety, and Training

Supervisors and interviewers will be trained in ethics, interviewing techniques, safety and security policies, and the importance of data security. A full pilot will be conducted in order to ensure that each person on the team understands his or her role and how to implement the survey. Training will be held immediately prior to fieldwork. Each step in the fieldwork will be documented using fieldwork Forms A, B, and C. Interview data will be entered in Excel (Form A) and by tablet (Forms B and C). Tablets will be password-protected. At last once a week, supervisors will upload the data to a secure server where data quality checks will be performed—also at least once a week. Errors will be reported to the supervisor so that the interviewer can be informed about them, in order to reduce their occurrence in the future. Information about the identity of those who test positive will be seen only by those administering the HIV test, who will report the information to the public health authorities so that treatment can be provided to the respondent.

9. Sampling and Sample Size

Figure 4. High- and low-priority districts sampled Selection of Districts

Thirty of 100 districts were sampled for the study using a probability sampling method: 20 randomly sampled from 50 high-priority districts and 10 randomly sampled from 50 low-priority districts. Districts were defined as high or low priority based on a scoring system approved by the PLACE National Steering Committee.

Selection of Community Informants

A total of 9,000 community informants will be interviewed in the 30 districts, allocated proportionally based on the size of the district population ages 15–49. Community informants will be interviewed in each of the identified PPAs to identify public venues where people meet new sexual partners and/or where people who inject drugs can be reached. Informants are interviewed until no new venues are named.

Selection of Venue Informants

We expect that 9,000 venues will be identified across the 30 districts. PLACE interviewing teams will attempt to visit each identified venue and interview one venue informant at each of the 9,000 venues. The venue informant will be a person age 18 or older who is knowledgeable about the venue.

Selection of Patrons and Workers

The study design for the biobehavioral survey of patrons and workers is a stratified probability sample of patrons and workers from a sample of venue clusters. Thirty venues will be randomly selected from the list of verified venues in each district. A complete sample of workers at these venues (approximately 90 per district) and a probability sample of patrons (approximately 600 per district) will be selected (Table 2).

The table below summarizes the sampling method and sample sizes for community informants, venue informants and patrons and workers in the 30 selected districts.

Sample Size Justification

The sample size is large enough to estimate HIV prevalence in each district among patrons (prevalence expected to be 6.5%) with a +/- 3 percent margin of error, assuming at least 600 patrons are interviewed in 30 venues and the design effect is 2. Statistical power is enhanced when the district data are combined. For the 30 districts, the precision of the estimate improves to approximately +/- 0.5 percent. The design effect of 2 was calculated from previous surveys. The free online statistical program “OpenEpi” (http://web1.sph.emory.edu/users/cdckms/samplesize%20icc%20deff2.html), from Emory University, was initially used to assess the precision of the estimate (Dean, Sullivan, & Soe, 2013). The program can be accessed at www.OpenEpi.com, updated 2013/04/06, accessed 2019/04/03). Precision was also confirmed with Statcalc, a tool that is included in the EpiInfo program developed by the United States Centers for Disease Control and Prevention.

Table 2. Sampling and sample size summary

Population	Sampling method	Description	Sample size target
Community informants	Quota assigned for each type of informant in the district	30 community informants interviewed per population of 20,000 people ages 15–49 in selected districts	9,000 allocated across the 30 districts based on district population
The total population in selected districts is 6 million
Venue informants	First stage: Take-all sampling Second stage: Quota sampling	All venues named by community informants are visited Upon arrival, interviewers ask for the most knowledgeable person at the venue	9,000 venue informants interviewed, assuming that 9,000 venues are identified
Venue workers	First stage: Stratified random sample of 30 venues in each district Second stage: Take-all sample of workers	Venues are stratified into high-priority and low- priority. High-priority venues are oversampled. All workers at selected venues are chosen	2,700 workers: 90 workers per district in 30 districts
Venue patrons	First stage: Stratified random sample of 30 venues in each district Second stage: A random sample of male patrons and a random sample of female patrons	Venues are stratified into high-priority and low- priority. High-priority venues are oversampled. Separate samples of male and female patrons are selected, with the number interviewed at each venue proportional to the number present at the time of the interview.	18,000 male and female patrons: 600 per district in 30 districts. The sample of 600 allocated across the selected venues is proportional to the size of the venue.

10. Key Indicators: Venue Profiles and Biobehavioral Indicators

Venue Profiles & Indicators

A venue is a public, physical place, event, or website where people go to meet new sexual partners or where people who inject drugs socialize and can be reached by a program. Private venues (e.g., private homes) are excluded.

Venue profiles will be constructed that describe the characteristics of each venue (Figure 5).

Figure 5. Venue profile

Biobehavioral Indicators

Biobehavioral profiles will be provided for the following:

Venue workers and patrons

Key populations

See Figure 6 for a list of indicators.

The data for the indicators will be obtained using Form C (Appendix A). Appropriate statistical analysis will be conducted using the appropriate weights. See the section on Statistical Analysis.

Figure 6. Biobehavioral indicators

11. Statistical Analysis and Population Size Estimates

Statistical Analysis

District Stratification and Venue Weights

Simple unweighted description of the venues will be presented separately for the 20 high-priority and 10 low-priority districts as well as for each district. Venue data from high- and low-priority districts will be combined for national descriptions using the appropriate weights based on the probability of selection of the district.

Note that each high-priority district has a weight of 2.5 (1/40%) and each low-priority district has a weight of 5 (1/20%). (High-priority districts were twice as likely to be included in the sample than low- priority districts (40% vs 20%) and thus have a weight half that of low-priority districts (2.5 vs 5).) Because all venues that were identified were visited, there is no further adjustment of venue weights to reflect any sampling of venues within a district.

Patron and worker data

Sampling weights will be estimated as the inverse of the probability that the individual was sampled for an interview. Sampling weights account for known differences in sampling probabilities among respondents. If necessary, inverse probability weights will be employed to account for missing data owing to refusals of the HIV and viral load tests (Seaman & White, 2013). (See an example regarding the use of inverse probability weights with PLACE data in Edwards, et al., 2019). Weighted data represent the distribution of characteristics among male patrons, female patrons, and female workers at public venues identified as places where people meet new sexual partners.

Standard errors will be estimated in SAS using Taylor series linearization to account for the complex survey design (Binder, 1983). Specifically, the SAS procedure called Proc SURVEYFREQ will be used to analyze data accounting for district stratum and venue cluster and to estimate population totals, proportions, standard errors, and confidence intervals. (See also PROC Surveyfreq in the SAS/STAT manual: https://support.sas.com/documentation/cdl/en/statug/63033/PDF/default/statug.pdf .)

Population Size Estimates and Their Use

The following populations sizes will be estimated:

Venue-level crude size estimates of selected key populations at each venue during a busy time. Each estimate comes directly from Form B, where the venue informant is asked about the number of people who come to the venue at a busy time.

District-level crude size estimate of key and priority populations in each district. This estimate is the sum of the number of key and priority populations at the venue on Saturday night between 8 pm and 11 pm, as reported at each venue on Form B. By limiting the reporting to a specific time across all venues, there is no need to account for people visiting multiple venues per night. The estimate will miss people who do not go out on Saturday night.

District-level size estimates of the number of key and priority populations at venues during a busy time. This estimate is based on the weighted sum of each key and priority population, with the weights reflecting the inverse of each individual’s probability of selection for a Form C interview, taking into account the sampling design.

District-level size estimates of the number of key and priority populations that could be reached in a month at venues. This estimate adjusts the Form C estimate above, by taking into account information provided by the respondent on frequency of attendance at the venue during a month and visits to other venues.

Figure 7. Example of a district summary of PLACE fieldwork 12. District Reports and Data Use Workshops

The focus of data analysis is the preparation of a PLACE district report. The PLACE district report describes the fieldwork and the main findings. (The PLACE district reports for Uganda, cited earlier, are useful examples: https://www.measureevaluation.org/resources/tools/hiv-aids/place/uganda.) In addition, district data will be merged to produce a combined national report patterned after the district report. Here is an example of the one compiled for Uganda: https://www.measureevaluation.org/resources/publications/fs-18-322z/.

District reports will summarize the fieldwork in the district: the number of stakeholders engaged, the number of venues identified, the number of people tested for HIV, and the number with a positive HIV test, as shown in Figure 6.

Stakeholders and researchers will use MEASURE Evaluation’s QGIS PLACE Mapping Tool (available here https://www.measureevaluation.org/resources/tools/hiv-aids/place/place-method/the-place-mapping-tool-a-plug-in-for-gis) to make maps of the PPA identified in the district and the location of venues within each PPA (see Figure 8).

Figure 8. Example of a map showing PPAs

The report will also describe the biobehavioral characteristics of male and female patrons of the venues, the women who work at the venue, and the women who live at the venue. It will provide size estimates for key populations and HIV prevention and treatment cascades for key and priority populations. And it will highlight gaps in HIV prevention and treatment, including maps showing venues that have not received outreach services and the characteristics of people who have not received services.

A data use workshop will be held to review the findings and make recommendations to improve HIV prevention and treatment programs based on the findings. District stakeholders and service providers will use the QGIS PLACE Mapping Tool to design and make custom coverage maps.

appendix a. informed consent fact sheets

<IMPLEMENTING AGENCY LETTERHEAD>

<Project Director Name, Address, and Telephone Number>

Form A: Fact Sheet for Informed Consent by a Community Informant

Who is conducting this study?

<Name of implementing agency> in to improve health programs in this area with funding from <name of funding collaboration with <collaborating organizations> is conducting a survey of people ages 18 and older sources>.

What is this study about?

The study is part of an outreach program to populations at risk of health problems, such as infectious diseases—especially HIV. This survey has been approved by <organizations providing ethical review>. We will ask you a few questions to get some information to develop and monitor HIV and AIDS programs. The knowledge obtained from the study will help identify where better programs are needed in this area.

Why is this study important?

The results will be used to strengthen HIV programs and to improve people’s access to services.

What will the survey cover?

If you participate in this study, we will ask you questions about your knowledge of this particular area or location, and about venues or events where people go to meet new sexual partners around here. None of the questions will be about your behavior specifically. The interview will last 10 to 20 minutes.

Can I refuse?

Participation is voluntary. You have the right to refuse to participate, or you can refuse to answer any question in the survey. If you change your mind about participating during the interview, you have the right to withdraw and end your participation at any time.

Who will have access to my survey answers?

Answers from your survey will not be shared outside the team working on this study. We will not ask or record your name or other information about your identity, so your responses will remain anonymous. The questionnaires will be kept in a locked cabinet. When describing the findings from the survey, we will use only summary information and never any information about you specifically.

What if I have questions?

The study is being conducted by <agency> in collaboration with <groups, including official groups>. If you have any questions you can contact <project director or principal investigator name and telephone number>. This study has been approved by <name of institutional review board>, which can be reached at <telephone number>.

<IMPLEMENTING AGENCY LETTERHEAD>

<Project Director Name, Address and Telephone Number>

Form B: Fact Sheet for Informed Consent by a Venue Informant

Who is conducting this study?

<Name of implementing agency> in collaboration with <collaborating organizations> is conducting a survey of people ages 18 and older to improve health programs in this area with funding from <name of funding sources>.

What is this study about?

The study is part of an outreach program to populations at risk of health problems such as infectious diseases—especially HIV/AIDS. This survey has been approved by <organizations providing ethical review>. We will ask you a few questions to get some information to develop and monitor HIV and AIDS programs. The knowledge obtained from the study will help identify where better programs are needed in this area.

Why is this study important?

The results will be used to improve HIV programs and improve people’s access to services.

What will the survey cover?

If you participate in this study, we will ask you questions about this place. Some questions are related to sexual partnerships. None of the questions will be about your behavior specifically. The interview will last 15 to 30 minutes.

Can I refuse?

Participation is voluntary. You have the right to refuse to participate, or you can refuse to answer any question in the survey. If you change your mind about participating during the interview, you have the right to withdraw and end your participation at any time.

Who will have access to my survey answers?

Answers from your survey will not be shared outside the team working on this study. We will not ask or record your name or other information about your identity, so your responses will remain anonymous. The questionnaires will be kept in a locked cabinet. When describing the findings from the survey, we will use only summary information and never any information about you specifically.

What if I have questions?

The study is being conducted by <agency> in collaboration with <groups including official groups>. If you have any questions you can contact <project director principal investigator name and telephone number>. This study has been approved by <name of institutional review board>, which can be reached at <telephone number>.

<IMPLEMENTING AGENCY LETTERHEAD>

<Project Director Name, Address, and Telephone Number>

Form C: Fact Sheet and Consent Form for Participation in the PLACE Study Patron/Worker Interview

IRB Study #

Title of Study: Priorities for Local AIDS Control Efforts (PLACE)

Principal Investigators:

<Name>

<Phone Number>

Sponsor:
Introduction:

This study has been approved by < > and the < > .

Your participation in this study is voluntary, and you may end your participation in the study at any time. Refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled, and you may discontinue participation at any time without penalty or loss of benefits.

This study involves research. The purpose of the research is to identify ways to improve HIV prevention and treatment programs to prevent more people from acquiring HIV. I would like to ask you a few questions to get some information necessary to develop and monitor the programs. I would like to ask you some questions about your behavior, including your sexual behavior. The interview should take 30 minutes of your time, and a rapid HIV test will take up to another 30–45 minutes. Your name will not appear anywhere on the survey and I will not ask your name, but the person who tests you for HIV may ask for your name in case you need follow-up medical care. You must agree both to the interview and the HIV test in order to participate.

Testing:

If you agree to the interview and testing, the testing will be done by trained people working with the County or District Health Team or other organizations committed to HIV testing and counseling. The County or District Health Team will not be able to link your name to this survey.

Testing is a benefit for you, because you might have HIV but not show any signs or symptoms of the infection. If you want to be tested, the tester will need to prick your finger for a drop of blood. One drop will be used for the HIV test. The counselor will give you your results today, after the interview. The counselor will refer you to services and treatment if you need it. If you have a positive HIV test, you will be asked to provide an additional five drops of blood that will be sent to the lab to determine your level of infection. You can call the number on your participant card to get the results of that test if you would like.

Possible risks and benefits:

When trained medical personnel prick your finger, sterile equipment will be used to minimize discomfort or infection, but you may experience minor discomfort and bruising. Learning your HIV status may make you feel uncomfortable. Your test results will be provided by a trained counselor.

Some people feel anxious or embarrassed when asked questions about their behavior. Your participation is completely voluntary and you may decline to answer any specific question or completely refuse to participate. We would greatly appreciate your help in responding to these questions, even though we are not able to pay you anything.

Learning your HIV status is a personal benefit and your community will benefit from the results of this study, which will inform health programs here.

Confidentiality:

All data obtained through the interview will be stored in a manner such that the information about individual respondents is kept strictly confidential. Your name will never be used in connection with your interview responses and your name will not appear in any report. The only people who will see the questionnaire are people working on this study. Your HIV test results will not be shared with anyone but you.

Any information that links you to a specific venue or that could be used to ascertain your identity will be kept strictly confidential by the study team. Once information that may link you to a specific venue or that could be used to identify you has been removed, the remaining information you provide may be shared publicly or with third parties, without additional informed consent from you or your legal representative.

If you have any questions about this research study, you can contact <name> at telephone number < > .

VOLUNTEER AGREEMENT: PATRON/WORKER

By marking an X in this box, I certify that the nature and purpose, the potential benefits, and possible risks associated with participating in this survey have been explained to me.

Put X in box:

Signature of Interviewer: ______________________________

Date: _________________________

Appendix b. place survey questionnaires (form a, form b, and form c)

Editable versions of Forms A, B, and C in Microsoft Word are in the PLACE Tool Kit, here: https://www.measureevaluation.org/resources/tools/hiv-aids/place.

form a

form B

Level 2: Interview with a Venue Informant

form C

Level 3: Interview with a Patron or Worker