Supporting Statement B

Local Effectiveness Assessment Project (LEAP): A Case Study of a Local Jurisdiction Providing HIV Services to MSM

Sub-Collection request under Generic 0920-0840

Section B: Supporting Statement

January 30, 2021

CONTACT

James Carey, PhD, MPH
Contracting Officer’s Representative

Centers for Disease Control and Prevention
Division of HIV/AIDS Prevention, PRB
1600 Clifton Road, NE, Mailstop E-37
Atlanta, GA 30329-4027

Phone: 404-639-1903
Fax: 404-639-1950
E-mail: jcarey@cdc.gov

TABLE OF CONTENTS

1. Respondent Universe and Sampling Methods 1

2. Procedures for the Collection of Information 3

3. Methods to Maximize Response Rates and Deal with No Response 5

4. Tests of Procedures or Methods to Be Undertaken 5

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 5

EXHIBITS

Exhibit B1.1. Key Participant Interviewee Categories

Exhibit B1.2. Philadelphia Proposed Sample

Exhibit B5.1. Statistical Consultants

1. Respondent Universe and Sampling Methods

Modified Social Ecological Model (MSEM)

In order to best describe the local HIV prevention and care efforts, activities and context within the selected jurisdiction, we will utilize Modified Social Ecological Model (MSEM) to guide the case study design. According to the MSEM, several levels of risk contribute to the disease across HIV epidemic, public policy, community, social and sexual networks, and individual factors (Baral, Logie, Grosso, Wirtz, & Beyrer, 2013). This model is based on the premise that individual factors alone do not comprise the full risk of HIV but rather it suggests that there are higher order social and structural levels that represent risk factors outside the control of a given individual and can be used collectively to contextualize HIV transmission risk among MSM in a single jurisdiction. As part of our approach, the contracting team will implement two sampling plans to conduct key participant interviews (KPIs).

Key Participant Interview Sampling

To select individuals for the KPI, the contracting team will implement a two-phase sampling approach in the Philadelphia, PA: (1) in collaboration with CDC, identify and recruit 15 individuals across all categories and MSEM levels; and (2) based on preliminary analysis of the interviews in phase 1, refine the selection of the second group of individuals. When selecting individuals for participation, the contracting team will consider MSEM level and category, as well as their level of involvement in activities or programs for MSM. Although not entirely mutually exclusive, we have identified the following categories mapped to the MSEM levels Exhibit B1.1. Age will be confirmed by asking participants “Are you over 18 years old?” as part of the recruitment and consent process.

Exhibit B1.1 _{Key Participant Interviewee Categories}

Socio-ecological Level	Key Participant Interviewee Categories
Public Policy Level	HIV and STD control program staff from the local and state health departments Staff from other governmental agencies that provide other HIV support services to MSM (e.g., non-HIV healthcare facilities, social services)
Community Level	Provider staff involved with HIV clinical care Non-governmental healthcare providers (including mental health and drug treatment providers) Staff from community-based organizations and Advocacy groups who work with MSM MSM advocacy groups; and diverse representatives of leaders in the gay community population residing in the jurisdiction, including persons with different racial and ethnic, age, socioeconomic, etc. Local researchers who study MSM and HIV-related prevention and care issues in the community; Members of community planning groups with an interest in public health issues
Individual/Social and Sexual Networks	Community Leaders vocal about HIV –related prevention, care and treatment issues MSM (including HIV+, HIV- and individuals whose HIV status is unknown)

The contracting team will seek to maintain excellent relationships with participants by being respectful of their time and work. For each interview scheduled, they will make every effort to be on time and manage the time allotted for the interview. If an individual is unavailable during the previously scheduled time, they will make an effort to reschedule with the individual but after two cancellations, they will seek to identify and interview a replacement individual with similar expertise or background. This process will ensure that individuals get a fair opportunity to participate and also ensure the study stays on schedule.

The contracting team will select a diverse pool of participants within the selected jurisdiction and aim to maintain this diversity across MSEM levels and categories. Exhibit B1.2. shows a detailed sample distribution for each level, with a total of nine KPIs for the Public Policy level (five KPIs in phase 1 and four KPIs in phase 2); 15 KPIs for the Community level (eight KPIs in phase 1 and seven KPIs in phase 2); and six KPIs for the Individual/Network levels (two KPIs in phase 1 and four KPIs in phase 2). This sample is proposed with an understanding that (a) participants can belong to more than one level; and (b) the contracting team will continuously assess the need for changes in the sample based on information gathered during the interviews and CDC feedback. The contracting team will identify potential participants by collaborating with CDC and the Philadelphia AIDS Activities Coordinating Office, and through internet searches.

_{Exhibit B1.2. Philadelphia Proposed Sample}

Category	Phase 1	Phase 2	Sub-Total Across Phases
	No. of KPIs	No. of KPIs
Public Policy (n= 9)
City of Philadelphia Health Department / AACO	3	2	5
Social Service Agencies	1	2	3
Department of Corrections	1	0	1
Sub-total	5	4	9
Community (n=15)
HIV Clinical Care Providers	1	1	2
Non-Governmental Social Service Organizations	1	2	3
CBOs – MSM focused	2	2	4
Community Planning Groups	1	1	2
MSM Advocacy Groups	2	1	3
Local Researchers	1	0	1
Sub-total	8	7	15
Individual/Network (n=6)
Leaders in the Gay Community	1	2	3
MSM	1	2	3
Sub-total	2	4	6
Total	15	15	30

2. Procedures for the Collection of Information

This project will use qualitative data collection methods. For all data sources, Atlas will conduct the site visits in Philadelphia, PA. Data will be collected using encrypted and password-protected laptops, and audio-recorders that will not be connected to a server or the Internet. Atlas and Abt Associates staff will transport the data collection equipment back to their office location following the site visit. Data will be transferred via encrypted flash drives.

Key Participant interview data will be collected by Atlas and Abt using the Key Participant Interview Guide in Attachment 2a-2c. One hour interviews will be conducted with each Key Participant in a private setting (e.g. participant’s office in the Philadelphia Department of Public Health). All interview data will be recorded by Atlas and Abt using an encrypted digital audio-recorder (not video-tape) with the consent of interview participants. Upon completion of the site visit, a member from the Atlas team (both Atlas Research and Abt) will upload interview recordings on password protected/encrypted non-network laptops. Notes will also be taken using encrypted laptops in MS Word. Participants will be reminded by the interviewer not to use full names or identifying information during the discussion. Atlas will perform the transcription of all audio-recordings. Any reference to full name or other identifying information that arises unintentionally during the discussion will be redacted from the transcripts by Atlas, and reviewed for quality assurance by Abt staff. All qualitative analyses will be conducted by Atlas and Abt using the redacted interview data on NVivo 10 (stand-alone version). All transcripts and NVivo datasets will be stored on encrypted and password-protected laptops that will not be connected to a server or the internet. At the end of the contract, redacted interview data and coded NVivo dataset will be delivered to CDC via an encrypted flash drive, and Atlas and Abt will destroy the interview recordings.

Eligibility

Key participants will be selected as eligible for participation if they are identified as belonging in one of the three categories listed in Exhibit B1.1, recommended for inclusion by the Philadelphia Health Department liaison, and currently residing within the Philadelphia jurisdiction. In addition, the contracting team will include language proficiency as an eligibility criterion in order to conduct the face-to-face interview. Respondents must be able to understand English.

Respondents must be over 18 years of age to be eligible for the study; minors will be excluded. Inclusion of minors may lead to mandatory reporting (e.g., relationships between a minor and an adult over 18 years of age), which would in turn require releasing of private information. In order to minimize any scenario in which a respondent’s private information must legally and ethically be released, we have restricted our respondent pool to individuals 18 years of age or older. Age will be confirmed by asking participants “Are you over 18 years old?” as part of the recruitment and consent process.

Recruitment of Respondents

The contracting team will work with the Philadelphia Department of Public Health (PDPH) to identify the Key Participants. Recruitment will be contacted first by phone followed by email and invited to participate in the study (See attachment 5 for Key Participant recruitment script.).

Study procedures will include a semi-structured interview regarding HIV prevention and treatment efforts for MSM and structured response questions. Atlas and Abt Associates staff will work with each Key Participant to identify a mutually convenient time for the interview. If a Key Participant is unavailable during the previously scheduled time, the contracting team will reschedule at the participant’s convenience. Atlas and Abt Associates staff will accept two cancellations from a Key Participant, before scheduling the interview with another Key Participant with similar background. This process will ensure that Key Participants are given a fair opportunity to participate but also that the study stays on schedule. Semi-structured interviews will be completed at the organization location in a quiet area where others cannot overhear the interview (to maintain privacy) or alternate location if preferred or requested by the Key Participant.

3. Methods to Maximize Response Rates and Deal with No Response

We will use the following procedures to maximize cooperation and to achieve the desired high response rate:

• Key participants will be identified through past and existing partnerships with Philadelphia Department of Public Health (PDPH).

• A token of appreciation of a $40 gift card, will be provided to key participants upon completion of the interview.

• All recruitment materials indicate the voluntary nature of the study and high participation is due in part to interest in the study and participation from key participants.

4. Tests of Procedures or Methods to Be Undertaken

The contracting team includes experts with the Health departments, CBOs, and MSM populations and qualitative research, including screening and interview development and testing. The contracting team will conduct pretesting of the screening tool and interviews on three to five qualified respondents to assess question wording, skip patterns, question sensitivity, and overall flow of the interview and screener.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Exhibit B5.1 below lists the project team members who were consulted on the aspects of research design and those who will be collecting and analyzing the data. Please note: The CDC Project Officer/Contracting Officer’s Representative (COR) and Technical Monitors are primarily responsible for providing technical assistance in the design and implementation of the research; assisting in the development of the research protocol and data collection instruments for CDC Project Determination and local IRB reviews (Abt Associates); working with investigators to facilitate appropriate research activities; and analyzing data and presenting findings at meetings and in publications. The CDC Project Officer/COR and Technical Monitors will neither collect data from nor interact with research participants. Data will be collected by members of contractor project staff listed below in Exhibit B5.1 (Abt Associates and ATLAS). No individual identifiers will be linkable to collected data, and no individually identifiable private information will be shared with or accessible by CDC staff.

Exhibit B5.1. Statistical Consultants

Atlas Team Staff	Roles and Responsibilities
Senior Project Investigator (Atlas) Jamie Hart, PhD, MPH	Provide overall contract management Serve as a liaison between Atlas and CDC Assure adequate resources Oversee subcontracting agreement Provide overall quality assurance and performance improvement tracking and guidance Complete task order assignments (e.g., facilitate interviews, lead development of data collection plan)
Project Manager Dianne Fragueiro, MPH	Organize activities and manage Atlas and subcontractor staff Manage all project tasks Develop and maintain budget Develop weekly meeting agendas and facilitate weekly calls Develop monthly reports Complete task order assignments (e.g., co-facilitate interviews and lead development of interview protocols and report)
Recruitment and Data Collection Analysts (Atlas) Clarke Erickson, MHA Theresa Spitzer, PhDc	Development of the document review data collection instrument and provide comments on additional data collection instruments. Participate in data collection activities (i.e. consent participants, conduct interviews, administer provider questionnaire, conduct observations and document review) in jurisdiction determined by CDC. Participate in data analysis activities (i.e. develop codebook, qualitative data coding, quantitative statistical analysis). Contribute to final report.
Recruitment and Data Collection (Abt Associates) Angela Cheung Alex Mijares, MPH Alex Orr, MPH
Senior Qualitative Research Advisor (Abt Associates) Cynthia Klein, PhD	Provide subcontract management Serve as a liaison between Abt and Atlas Review subcontract deliverables for quality Complete task order assignments (e.g., lead development of the sampling plan and research design
CDC, NCHSTP, DHAP, Prevention Research Branch	Roles and Responsibilities
James W. Carey, MPH PhD, Project Officer/Contracting Officer Representative (COR) Deborah Gelaude, MA, Technical Monitor Aisha Wilkes, MPH, CDC Consultant Damian Denson, MPH, PhD, Technical Monitor	The CDC Project Officer/COR and Technical Monitors are primarily responsible for providing guidance in the design and implementation of the research; assisting in the development of the research protocol and data collection instruments for CDC Project Determination and local IRB review; working with investigators to facilitate appropriate research activities; and analyzing data and presenting findings at meetings and in publications.  The CDC Project Officer/COR and Technical Monitors will neither collect data from nor interact with research participants.  Data will be collected by Contractor staff.  No individual or organization identifiers will be linked to collected data, and no individually identifiable private information will be shared with or accessible by CDC staff. All datasets will be provided to CDC with individual participant study ID and Organization ID.