CDC-RFA-PS22-2201.pdf

PDF 2 MB Posted May 10, 2021

Attached to: National HIV Behavioral Surveillance (NHBS)
Opportunity number: CDC-RFA-PS22-2201
Issued by: Department of Health and Human Services Centers for Disease Control and Prevention

About this file

From the source

CDC-RFA-PS22-2201.pdf

View the file

On GovTribe

Work with this file

Download the original file
Contacts named in this file
Similar government files
Ask GovTribe AI about this file

Try for free Login

Text version

The file's text, extracted by GovTribe without its formatting.

Centers for Disease Control and Prevention

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STDS AND TB PREVENTION

National HIV Behavioral Surveillance (NHBS)

CDC-RFA-PS22-2201

08/02/2021

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Required Registrations

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- PS22-2201. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) B. Notice of Funding Opportunity (NOFO) Title:

National HIV Behavioral Surveillance (NHBS) C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52- 2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr- 46/index.html (See section 45 CFR 46.102(d)).

New

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS22-2201

E. Assistance Listings Number:

93.944 F. Dates:

1. Due Date for Letter of Intent (LOI):

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

https://www.grants.gov/ https://www.grants.gov/ https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

Recommended but not Required The purpose of an LOI is to allow CDC program staff to estimate the number of and plan for the review of submitted applications. An LOI is requested from eligible applicants for either Component 1 or Component 2 with no previous experience conducting NHBS.

LOI must be sent via email to:

Kathryn Lee, Project Officer Centers for Disease Control and Prevention Email: NHBS@cdc.gov

2. Due Date for Applications:

08/02/2021 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

June 09, 2021 An informational conference call will be held from 1:30p-3:00p EDT. Please refer to https://www.cdc.gov/hiv/funding/announcements/ps22-2201/index.html for additional information about the call.

To join ZoomGov Meeting:

https://cdc.zoomgov.com/j/1606950276?pwd=TXpiSjRTSThkeG5pZGUySlhQZTRuZz09

Dial by your location +1 669 254 5252 US (San Jose) +1 646 828 7666 US (New York) Meeting ID: 160 695 0276 Passcode: 31489099

Questions can also be directed to NHBS@cdc.gov.

F. Executive Summary:

Summary Paragraph The purpose of National HIV Behavioral Surveillance (NHBS) is to conduct bio-behavioral surveillance among populations overburdened by HIV infections. In Component 1, surveillance will be conducted in rotating cycles among three populations: men who have sex with men (MSM), persons who inject drugs (PWID), and heterosexually active persons at increased risk (referred to as NHBS-MSM, NHBS-PWID, and NHBS-HET, respectively). Surveillance will be conducted in a specified metropolitan statistical area (MSA). In Component 2, surveillance will be conducted through Brief HIV Bio-behavioral Assessments (BHBAs). Funded applicants for Component 2 will conduct at least two mixed-methods assessments in at least two priority populations in specified geographic areas of interest per year across the state.

Applicants may only apply for either Component 1 or Component 2.

This NOFO will fund recipients for required NHBS strategies and activities related to recruitment and data collection, data management and dissemination, quality assurance, and collaboration.

mailto:NHBS@cdc.gov https://www.grants.gov/ https://www.cdc.gov/hiv/funding/announcements/ps22-2201/index.html https://cdc.zoomgov.com/j/1606950276?pwd=TXpiSjRTSThkeG5pZGUySlhQZTRuZz09

The short-term aim is for state and local partners to use NHBS data to measure prevention, testing, and treatment, to guide the development and strengthening of these efforts, and to inform prevention policy. The long-term use of NHBS data will improve HIV prevention, response, and testing and treatment services for and reduce HIV incidence among populations overburdened by HIV infections.

a. Eligible Applicants:

Open Competition

b. NOFO Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards Subject to the availability of funds, up to 30 awards:

Up to 25 awards for Component 1 (Core NHBS) Up to 5 awards for Component 2 (NHBS BHBAs)

d. Total Period of Performance Funding:

$ 97,750,000

e. Average One Year Award Amount:

$ 0

Component 1 (Core NHBS):

o REQUIRED: $470,000 (NHBS-PWID) o OPTIONAL: $150,000 (Viral hepatitis testing in NHBS-PWID), $250,000

(NHBS among Transgender Women), $250,000 (NHBS among Women who Exchange Sex)

Component 2 (NHBS BHBAs): $450,000

f. Total Period of Performance Length:

g. Estimated Award Date:

January 01, 2022

h. Cost Sharing and / or Matching Requirements:

No Cost sharing or matching funds are not required for this program.

Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview

For almost 40 years, HIV has been affecting millions globally. According to CDC, by the end of 2018 an estimated 1.2 million persons aged 13 years and older were living with diagnosed or undiagnosed HIV infection in the U.S. with an estimated 36,400 new infections each year. [1] The burden of HIV infection is disproportionately concentrated among a few populations. Of HIV infections diagnosed in 2018 and reported to CDC, 66% were attributed to male-to-male sexual contact, 24% were attributed to heterosexual contact, and 7% were attributed to injection drug use. [2] This NOFO will improve HIV prevention, response, testing, and treatment services and ultimately aid in reducing HIV incidence among populations overburdened by HIV infections through essential data obtained in continuation of NHBS. NHBS is the nation’s only source of national data monitoring HIV-related behaviors among populations overburdened by HIV infections.

Monitoring key indicators among members of populations overburdened by HIV infections is critical to achieving the goals of the Ending the HIV Epidemic: A Plan for America initiative and CDC’s High Impact Prevention (HIP) approach. [3, 4] NHBS has previously proven effective at monitoring key indicators such as risk behaviors, HIV testing and linkage to care, access to and use of prevention interventions including pre-exposure prophylaxis (PrEP) and syringe services programs (SSPs), and prevalence of HIV and other infections.

In Component 1, bio-behavioral surveillance, including anonymous HIV testing, will be conducted in rotating cycles among three populations: men who have sex with men (MSM), persons who inject drugs (PWID), and heterosexually active persons at increased risk (referred to as NHBS-MSM, NHBS-PWID, and NHBS-HET, respectively). Surveillance will be conducted in a specified MSA. In Component 2, surveillance will be conducted through Brief HIV Bio-behavioral Assessments (BHBAs). Funded applicants for Component 2 will conduct at least two mixed-methods assessments in at least two priority populations overburdened by HIV infections in specified geographic areas of interest per year across the state.

In addition to required strategies and activities, some additional activities may be funded under each Component.

Component 1 only: If funds are available, recipients may be funded to conduct surveillance in up to two additional Optional Populations: transgender women (NHBS-Trans) and women who exchange sex (NHBS-WES).

Components 1 and 2: Funds may also be available to conduct up to two Optional Activities:

anonymous sexually transmitted infections (STI) testing and anonymous viral hepatitis testing.

Applicants shall describe their interest in including any Optional Populations or Optional Activities in their Project Narrative to be considered for additional funding, if funds are available.

NHBS is a robust surveillance platform that allows CDC to monitor progress towards decreased prevalence of HIV-related risk behaviors and other relevant infections such as sexually transmitted infections (STIs) and hepatitis viruses. NHBS methods have been adapted to reach new populations overburdened by HIV infections in geographic areas of interest. [5] Groups such as transgender women (persons assigned male at birth who identify at least in part as women or transgender women) and women who exchange sex have also been surveyed through

NHBS.

b. Statutory Authorities This program is authorized under Section 318(c) of the Public Health Service Act [42 U.S.C.

Section 247c(c)], as amended.

c. Healthy People 2030 This NOFO aligns with the following Healthy People 2030 objectives for HIV prevention:

Reduce the number of HIV infections (HIV-01) Increase knowledge of HIV status (HIV-02) Reduce the number of new HIV diagnoses (HIV-03) Increase linkage to HIV medical care (HIV-04)

The topic area of Sexually Transmitted Infections will also be supported.

d. Other National Public Health Priorities and Strategies Ending the HIV Epidemic: A Plan for America National HIV/AIDS Strategy: Update 2020 CDC Division of HIV/AIDS Prevention Strategic Plan 2017-2020 CDC National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan Through 2020

e. Relevant Work This NOFO builds upon the work of four previous National HIV Behavioral Surveillance (NHBS) NOFOs (PA 04-017, PS08-001, PS11-001 and PS16-1601).

Findings from NHBS are used to guide local and national HIV prevention programs and to evaluate existing programs and services by assessing exposure to and use of prevention services over time, and to determine gaps in provision of, access to or use of HIV prevention services.

The prevalence of HIV-related behaviors can be used to target testing, response, treatment and other prevention efforts and to evaluate uptake of current HIV testing and other prevention guidelines. Additional information can be found at http://www.cdc.gov/hiv/statistics/systems/nhbs.

2. CDC Project Description

a. Approach Bold indicates period of performance outcome.

Strategies and Activities Short-Term

Outcomes Intermediate

Outcomes Long-Term

Outcomes Component 1: Core NHBS (Required cycles: men who have sex with men

(MSM), persons who inject drugs

(PWID), heterosexually active persons at increased risk for HIV (HET);

Improved ability to measure prevalence of

HIV-related behaviors, use of services, HIV infection, and other relevant health

Improved monitoring of HIV-related behaviors through an ongoing and adaptable HIV bio-

Improved HIV prevention, response, testing and treatment services for populations overburdened by HIV infections https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections/reduce-number-new-hiv-infections-hiv-01 https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections/increase-knowledge-hiv-status-hiv-02 https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections/reduce-number-new-hiv-diagnoses-hiv-03 https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections/increase-linkage-hiv-medical-care-hiv-04 https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/national-hiv-aids-strategy/nhas-update https://www.cdc.gov/hiv/pdf/dhap/cdc-hiv-dhap-external-strategic-plan.pdf https://www.cdc.gov/nchhstp/strategicpriorities/docs/nchhstp-strategic-plan-through-2020-508.pdf https://www.cdc.gov/nchhstp/strategicpriorities/docs/nchhstp-strategic-plan-through-2020-508.pdf http://www.cdc.gov/hiv/statistics/systems/nhbs

Optional Populations: transgender women, women who exchange sex)

1) Preparation: Conduct formative assessment and pre-implementation activities

2) Recruitment and Data Collection:

Recruit populations overburdened by HIV infections; conduct standardized surveys;

and offer anonymous blood-based HIV testing.

3) Data Management and

Dissemination: Ensure HIV data security and confidentiality and manage, submit, analyze and disseminate data.

4) Quality Assurance: Conduct quality assurance activities and evaluate NHBS strategies and methods

5) Collaboration: Collaborate with partners and stakeholders to conduct

NHBS; share findings and promote data use; and ensure participant referrals to prevention, health, and social services

Core NHBS Optional Activities:

Conduct anonymous sexually transmitted infections (STI) testing and/or anonymous viral hepatitis testing outcomes

High-quality locally and nationally relevant data for resource allocation and evaluation of HIV prevention, testing and treatment efforts

Increased dissemination of data and recipient-developed recommendations to key stakeholders

Improved information on methods to reach populations overburdened by HIV infections

New or enhanced collaboration among federal, state and local partners responsible for

HIV prevention, response, testing and treatment behavioral surveillance system

Improved ability to detect changes over time in HIV risk behaviors among populations overburdened by HIV infections

Increased use of data to develop effective

HIV prevention, response, testing and treatment activities

Increased use of data to evaluate HIV prevention, response, testing and treatment activities

Improved ability to reach populations overburdened by HIV

Reduced HIV incidence among populations overburdened by HIV infections

Component 2: NHBS Brief HIV Bio-behavioral Assessments (BHBA, Brief mixed-methods needs-based assessments across state)

1) Preparation: Conduct statewide assessment and establish community partnerships to support project

2) Pre-Implementation Activities: Hire and train local staff; collaborate with stakeholders on project development and participant referrals to prevention, health, and social services; and conduct and analyze formative assessment

3) Data Collection: Collect quantitative bio-behavioral data through brief standardized surveys and anonymous blood-based HIV testing and conduct rapid qualitative assessments

4) Analysis, Interpretation, and

Dissemination: Analyze and triangulate quantitative and qualitative data;

collaborate with stakeholders to disseminate findings; and update statewide assessment of data as needed

5) Data Management and Quality

Assurance: Ensure HIV data security and confidentiality; manage and submit data;

conduct quality assurance and control activities; and evaluate BHBA strategies

NHBS BHBA Optional Activities:

Conduct anonymous STI testing and/or anonymous viral hepatitis testing infections

i. Purpose The purpose of this NOFO is to support ongoing national bio-behavioral surveillance to monitor HIV-related behaviors, detect changes over time in HIV risk behaviors among populations overburdened by HIV infections, and to inform and evaluate HIV prevention activities. This NOFO also aims to fill gaps in knowledge regarding HIV prevention priorities among populations in geographic areas where current data are limited. Data from NHBS will be used to improve HIV prevention, response, and testing and treatment services, and to reduce HIV incidence among populations overburdened by HIV infections.

ii. Outcomes Recipients are expected to demonstrate measurable progress toward addressing short-term and intermediate outcomes that appear bolded in the logic model. A listing of these outcomes is provided below.

Improved ability to measure prevalence of HIV-related behaviors, use of services, HIV infection, and other relevant health outcomes

High-quality locally and nationally relevant data for resource allocation and evaluation of HIV prevention, testing, and treatment efforts

Increased dissemination of data and recipient-developed recommendations to key stakeholders

Improved information on methods to reach populations overburdened by HIV infections New or enhanced collaboration among federal, state, and local partners responsible for

HIV prevention, response, testing and treatment Improved monitoring of HIV through an ongoing and adaptable HIV bio-behavioral surveillance system

iii. Strategies and Activities As depicted in the logic model, there are 5 required strategies each for Component 1 and Component 2. Applicants may seek funding for only one component: either Component 1 or Component 2. Throughout the entire 5-year period of performance, all recipients will be required to implement all activities for the selected program component as delineated below.

Note that all activities shall be implemented according to CDC-approved guidance and procedures, including the provision of participant incentives for recruitment and data collection activities when indicated.

Component 1: Core NHBS In Component 1, recipients are expected to undertake the strategies and activities listed below each year of the NOFO to conduct the required rotating data collection cycles among men who have sex with men (MSM), persons who inject drugs (PWID), and heterosexually active persons at increased risk for HIV (referred to as NHBS-MSM, NHBS-PWID, and NHBS-HET respectively). Project years 1 and 3 will be NHBS-PWID cycles, project years 2 and 5 will be NHBS-MSM cycles, and project year 4 will be an NHBS-HET cycle.

As part of Component 1, eligible applicants may apply to conduct NHBS strategies with up to two Optional Populations: transgender women (NHBS-Trans) and/or women who exchange sex (NHBS-WES), which will be awarded if funds are available. Strategies and activities for these Optional Populations will include start-up, extensive formative assessment, and data collection phases over multiple project years, as described below. NHBS strategies and activities among these two Optional Populations are independent of required activities and will be conducted in parallel with the required data collection cycles.

Eligible applicants may also apply for Optional Activities which will be awarded if funds are available:

anonymous STI testing during NHBS-MSM, NHBS-HET, NHBS-Trans, and/or NHBS- WES cycles anonymous viral hepatitis testing during NHBS-PWID, NHBS-Trans, and/or NHBS- WES cycles.

Component 1: Required Core NHBS (NHBS-MSM, NHBS-PWID, NHBS-HET)

1) Preparation

Conduct formative assessment: Obtain regulatory approvals, if locally required, to collect primary data for formative assessment. In accordance with CDC-approved guidance, conduct review of secondary data sources, observations, key informant interviews, focus groups and other activities to inform best operational procedures and to identify interview locations. Write and submit reports and other required documents summarizing findings from the formative assessment per CDC-approved guidance.

Conduct pre-implementation activities: Conduct all pre-implementation activities according to CDC-approved timelines in order to initiate recruitment and data collection in time to meet annual sample size. Obtain regulatory approvals to conduct NHBS activities as required locally, including, but not limited to Institutional Review Board approval, approval to conduct NHBS activities under surveillance authority, or approvals to waive written consent. Develop standard operating procedures for management of adverse events, safeguards to preserve participant data confidentiality, and activities to address urgent needs identified during contact with participants such as linkage to HIV care. Hire and train required staff needed to recruit participants, collect data, conduct anonymous blood-based HIV testing and conduct other activities. Set up interview locations and obtain all required equipment, supplies and other materials to conduct all activities. Provide input on all national operational documents and data collection instruments, including, but not limited to formative assessment manuals, operations manuals, questionnaires, interviewer guides, data management manuals and other documentation of standard operating procedures. Complete and submit checklists documenting pre-implementation activities and operational procedures (Operations Checklist).

2) Recruitment and Data Collection

Recruit populations overburdened by HIV infections: Collect bio-behavioral surveillance data in rotating data collection cycles among MSM, PWID, and heterosexually active persons at increased risk for HIV infection. According to CDC-approved guidance and timelines, implement recruitment strategies that include venue based, time-space sampling (VBS), respondent-driven sampling (RDS), and other CDC-approved strategies to recruit populations overburdened by HIV infections.

Conduct standardized surveys: Complete standardized in-person surveys with eligible participants to meet the annual sample size using the CDC-provided comprehensive data collection instrument.

Offer anonymous blood-based HIV testing: Offer anonymous blood-based rapid testing and supplemental testing for HIV infection to participants in order to assess HIV seroprevalence per CDC-approved guidance and procedures. HIV screening results shall be made available to participants. Participants with preliminary positive test results shall be linked to HIV care.

Collect and store blood specimens for future testing: Collect dried blood spots, plasma or other blood specimens for additional testing such as the detection of antibodies or virus that determine recent HIV infection, viral load, or antiretroviral drug resistance, as well as the presence of antiretroviral drugs (including PrEP) or fentanyl and fentanyl analogs.

Send specimens to CDC or participating laboratories: Prepare frequent shipments of specimens to CDC or participating laboratories in compliance with CDC-approved guidance and timelines.

3) Data Management and Dissemination

Ensure HIV data security and confidentiality: Adhere to all local and national guidelines for maintaining HIV data security and confidentiality, including but not limited to the Centers for Disease Control and Prevention’s Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action available at https://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf. C onduct annual data security and confidentiality trainings.

Manage and submit data: Manage all data locally and submit data to CDC according to CDC-approved guidance and timelines, including but not limited to interview, HIV test results, and recruitment data. Conduct data cleaning activities according to CDC timelines including reconciliation, reviewing and responding to error reports, and other activities as needed to maintain data quality.

Analyze and disseminate data: For each Required Core NHBS population, produce at least one report (fact sheets, epidemiologic profiles, surveillance reports, peer-reviewed manuscripts or other formats as appropriate) and conduct at least one presentation to community partners and stakeholders. Efforts shall be made to customize data dissemination activities to inform key decisions regarding budgeting, planning, and evaluation of HIV prevention and health services. Report on annual data use and dissemination activities to CDC. Contribute to national data collection outcomes such as surveillance reports and other publications by reviewing analysis notifications, concept proposals, table shells and manuscript drafts within specified timelines and participating in discussions during monthly conference calls and annual meetings. Work with local officials to participate in data sharing through national restricted use datasets.

4) Quality Assurance

Attend relevant trainings and meetings: Attend all trainings required by CDC to include field operations and data management trainings. Attend all required meetings including but not limited to the annual recipient meeting. Attend all site visits, webinars and conference calls.

Conduct quality assurance activities: Conduct all required data quality assurance activities, including but not limited to field staff evaluations, as described in CDC-approved guidance documents.

Evaluate Required Core NHBS strategies and methods: Conduct ongoing formative assessment each data collection cycle to improve operational procedures. Conduct evaluations of Required Core NHBS, its recruitment strategies, and data collection methods as necessary to ensure that the system is meeting its goals. Recipients are expected to make recommendations for improving the quality, efficiency and usefulness of NHBS both locally and nationally.

https://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf

5) Collaboration

Collaborate with partners and stakeholders to conduct activities and evaluations:

Collaborate on survey development, strategies, methods and implementation with community partners and stakeholders. Collaborators may include academic or public health partners with expertise in qualitative and quantitative methods who can strengthen the planning and implementation of bio-behavioral surveillance activities and evaluation.

Collaborate with partners and stakeholders to share findings/promote data use: Work with partners and stakeholders to understand topics of local relevance, the data needs of the community, and how NHBS can meet these needs. Disseminate and present findings to health departments, Community Based Organizations (CBOs), and other community partners to inform HIV prevention and services planning and decision-making.

Collaborate with partners and stakeholders to ensure participant referrals: Collaborate with community partners and stakeholders to plan optimal methods and sources for referring participants to prevention, health, and social services and linking participants to HIV, viral hepatitis and STI care.

Component 1, Optional Population 1: NHBS among transgender women (NHBS-Trans) In accordance with CDC-approved guidance and procedures, recipients will be funded (if funds are available) to conduct NHBS among transgender women by performing the NHBS activities listed below. As NHBS does not routinely conduct bio-behavioral surveillance among this population, NHBS among transgender women may require start-up, extensive formative assessment and data collection phases with a total duration of about 2 years. It is anticipated that start-up activities will begin in Year 1 pending approvals. Activities for this Optional Population shall be conducted in accordance with CDC-approved guidance.

1) Start-up (Year 1 of NHBS-Trans)

Conduct start-up activities: Apply for regulatory approvals, if locally required, to conduct extensive formative assessment. Begin to engage community partners and to garner community support. Review available data on transgender women and write and submit reports summarizing findings.

Collaborate with CDC on development of operational documents: Provide input on all national operational documents and data collection instruments. Attend relevant conference calls.

2) Extensive formative assessment (Year 1 of NHBS-Trans)

Conduct extensive formative assessment: Conduct observations, key informant interviews, focus groups and other activities to inform best operational procedures and to identify interview locations. Write and submit reports and other required documents summarizing findings from the formative assessment.

Collaborate with partners and stakeholders to conduct NHBS among transgender women:

Collaborate on survey development, methods and implementation with community partners and stakeholders. Collaborators may include academic or other public health partners with expertise in qualitative and quantitative methods to survey transgender women. These collaborations will strengthen the planning and implementation of bio-behavioral surveillance activities.

Conduct pre-implementation activities: Obtain regulatory approvals to conduct activities with transgender women as required locally, including, but not limited to Institutional Review Board approval, approval to conduct activities under surveillance authority, or approvals to waive written consent. Develop standard operating procedures for management of adverse events, safeguards to preserve participant data confidentiality, and strategies to address urgent needs identified during contact with participants such as linkage to HIV care and referral to specialized services. Begin to hire and train required staff needed to recruit participants, collect data, conduct anonymous blood-based HIV testing and conduct other activities. Set up interview locations and obtain all required equipment, supplies and other materials to conduct all activities. Complete checklist documenting pre-implementation activities and operational procedures.

3) Data collection (Year 2 of NHBS-Trans)

Recruit transgender women: Collect bio-behavioral surveillance data using recruitment strategies that include respondent-driven sampling (RDS) or other CDC-approved strategies to recruit transgender women.

Conduct standardized surveys: Complete standardized in-person surveys with eligible participants to meet the target sample size for NHBS among transgender women using the CDC-provided comprehensive data collection instrument.

Offer anonymous blood-based HIV testing: Offer anonymous blood-based rapid testing and supplemental testing for HIV infection to participants in order to assess HIV seroprevalence. HIV screening results shall be made available to participants. Participants with preliminary positive test results shall be linked to HIV care.

Collect and store blood specimens for future testing: Collect dried blood spots, plasma, or other blood specimens for additional testing such as the detection of antibodies or virus that determine recent HIV infection, viral load, or antiretroviral drug resistance, as well as the presence of antiretroviral drugs (including PrEP) or fentanyl and fentanyl analogs.

Send specimens to CDC or participating laboratories: Prepare frequent shipments of specimens to CDC or participating laboratories in compliance with CDC-approved guidance and timelines.

Manage and submit data: Manage all data locally and submit to CDC according to CDC-approved protocols and timelines, including but not limited to interview, HIV test results, and recruitment data. Conduct data cleaning activities according to CDC timelines including reconciliation, reviewing and responding to error reports, and other activities as needed to maintain data quality.

Analyze and disseminate data: For NHBS among transgender women, produce at least one report (factsheets, epidemiologic profiles, surveillance reports, peer-reviewed manuscripts or other formats as appropriate) and conduct at least one presentation to community partners and stakeholders. Efforts shall be made to customize data dissemination activities to inform key decisions regarding budgeting, planning, and evaluation of HIV prevention activities among transgender women. Contribute to national data collection outcomes such as surveillance reports and other publications by reviewing materials disseminated by CDC within specified timelines and participating in discussions during monthly conference calls and annual meetings.

Attend relevant trainings and meetings: Attend all required trainings, meetings, site visits, webinars and conference calls.

Conduct quality assurance activities: Conduct all required data quality assurance activities, including but not limited to field staff evaluations, as described in CDC-approved guidance documents.

Evaluate strategies and methods: Conduct ongoing formative assessment to improve operating procedures. Conduct evaluations of recruitment strategies and data collection methods to reach transgender women.

Collaborate with partners and stakeholders to disseminate findings/promote data uses:

Disseminate and present findings to health departments, CBOs, and other community partners to inform HIV prevention and services planning and decision-making.

Component 1, Optional Population 2: NHBS among women who exchange sex (NHBS-

WES)

In accordance with CDC-approved guidance and procedures, recipients will be funded (if funds are available) to conduct NHBS among women who exchange sex by performing the NHBS activities listed below. As NHBS does not routinely conduct bio-behavioral surveillance among this population, NHBS among women who exchange sex may require start-up, extensive formative assessment and data collection phases with a total duration of about 3 years. It is anticipated that start-up activities will begin in Year 1 pending approvals. Activities for this Optional Population shall be conducted in accordance with CDC-approved guidance.

1) Start-up (Year 1 of NHBS-WES)

Conduct start-up activities: Apply for regulatory approvals, if locally required, to conduct extensive formative assessment. Begin to engage community partners and to garner community support. Review available data on women who exchange sex and write and submit reports summarizing findings.

Collaborate with CDC on development of operational documents: Provide input on all national operational documents and data collection instruments. Attend relevant conference calls.

2) Extensive formative assessment (Year 2 of NHBS-WES)

Collaborate with partners and stakeholders to conduct NHBS among women who exchange sex: Collaborate on survey development, methods and implementation with community partners and stakeholders. Collaborators may include academic or other public health partners with expertise in qualitative and quantitative methods to survey women who exchange sex. These collaborations will strengthen the planning and implementation of bio-behavioral surveillance activities.

Conduct pre-implementation activities: Obtain regulatory approvals to conduct activities with women who exchange sex as required locally, including, but not limited to Institutional Review Board approval, approval to conduct activities under surveillance authority, or approvals to waive written consent. Develop standard operating procedures for management of adverse events, safeguards to preserve participant data confidentiality, and strategies to address urgent needs identified during contact with participants such as linkage to HIV care and referral to specialized services. Begin to hire and train required staff needed to recruit participants, collect data, conduct anonymous blood-based HIV testing and conduct other activities. Set up interview locations and obtain all required equipment, supplies and other materials to conduct all activities. Complete checklist documenting pre-implementation activities and operational procedures.

3) Data collection (Year 3 of NHBS-WES)

Recruit women who exchange sex: Collect bio-behavioral surveillance data using recruitment strategies that include respondent-driven sampling (RDS) or other CDC-approved strategies to recruit women who exchange sex.

Conduct standardized surveys: Complete standardized in-person surveys with eligible participants to meet the sample size for NHBS among women who exchange sex using the CDC-provided comprehensive data collection instrument.

Offer anonymous blood-based HIV testing: Offer anonymous blood-based rapid testing and supplemental testing for HIV infection to participants in order to assess HIV seroprevalence. HIV screening results shall be made available to participants. Participants with preliminary positive test results shall be linked to HIV care.

Send specimens to CDC or participating laboratories: Prepare frequent shipments of specimens to CDC or participating laboratories in compliance with CDC-approved guidance and timelines.

Conduct data security and confidentiality trainings.

Analyze and disseminate data: For NHBS among women who exchange sex, produce at least one report (factsheets, epidemiologic profiles, surveillance reports, peer-reviewed manuscripts or other formats as appropriate) and conduct at least one presentation to community partners and stakeholders. Efforts shall be made to customize data dissemination activities to inform key decisions regarding budgeting, planning, and evaluation of HIV prevention activities among women who exchange sex. Contribute to national data collection outcomes such as surveillance reports and other publications by reviewing materials disseminated by CDC within specified timelines and participating in discussions during monthly conference calls and annual meetings.

Attend relevant trainings and meetings: Attend all required trainings, meetings, site visits, webinars and conference calls.

Conduct quality assurance activities: Conduct all required data quality assurance activities, including but not limited to field staff evaluations, as described in CDC-approved guidance documents.

Collaborate with partners and stakeholders to disseminate findings/promote data use:

Disseminate and present findings to health departments, CBOs, and other community partners to inform HIV prevention and services planning and decision-making.

Component 1, Optional Activity 1: Conduct anonymous STI testing during NHBS-MSM, NHBS-HET, NHBS-Trans and/or NHBS-WES As part of the NHBS platform and in accordance with CDC-approved guidance and procedures, recipients will be funded (if funds are available) for this Optional Activity to offer anonymous STI testing to participants of NHBS-HET, NHBS-MSM, NHBS-Trans and/or NHBS-WES data collection cycles. Applicants can elect to apply for this Optional Activity for each of the data collection cycles listed or any subset of these cycles. Based on availability of funds during the NHBS-HET data collection cycles, recipients may be funded to conduct STI testing for men, women, or both.

Offer and conduct anonymous testing for gonorrhea and chlamydia: Offer anonymous gonorrhea and chlamydia testing to participants. Collect specimens from multiple anatomic sites for laboratory testing according to CDC-approved methods and guidance.

Specimens may include pharyngeal, rectal, and/or urogenital specimens.

Send specimens to participating laboratories: Prepare frequent shipments of specimens to participating laboratories in compliance with CDC-approved guidance and timelines.

Provide test results and linkage to care: Test results shall be made available to participants in a timely fashion and those with positive test results shall be linked to care and treatment.

Ensure data security and confidentiality: Adhere to all local and national guidelines for maintaining data security and confidentiality, including but not limited to the Centers for Disease Control and Prevention’s Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action available at https://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf.

Manage and submit data: Manage all test results and return of results data locally and submit data to CDC according to CDC-approved guidance and timelines. Conduct data cleaning activities according to CDC timelines including reconciliation, reviewing and responding to error reports and other activities as needed to maintain data quality.

Component 1, Optional Activity 2: Conduct anonymous viral hepatitis testing during NHBS-PWID, NHBS-Trans and/or NHBS-WES As part of the NHBS platform and in accordance with CDC-approved guidance and procedures, recipients will be funded (if funds are available) for this Optional Activity to offer anonymous viral hepatitis testing to participants of the NHBS-PWID, NHBS-Trans and/or NHBS-WES data collection cycles. Applicants can elect to apply for this Optional Activity for each of the data collection cycles listed or any subset of these cycles. Based on availability of funds, recipients may be funded to conduct Hepatitis B testing, Hepatitis C testing or both.

Offer and conduct anonymous testing for Hepatitis B and Hepatitis C: Offer anonymous Hepatitis B and Hepatitis C testing to participants in order to assess prevalence of infection. Collect blood specimens for laboratory and confirmatory testing according to CDC-approved methods and guidance.

Send specimens to participating laboratories: Prepare frequent shipments of blood specimens to participating laboratories in compliance with CDC-approved guidance and timelines.

Provide test results and linkage to care: Test results shall be made available to participants in a timely fashion and those with positive test results shall be linked to care and treatment.

Component 2: NHBS Brief HIV Bio-behavioral Assessments (BHBAs) In Component 2, recipients are expected to undertake the strategies and activities listed below for Year 1 of the NOFO including all required preparatory work, conducting a statewide assessment to identify at least two priority populations in specified geographic areas of interest, collaborating with CDC on operational documents, establishing community partnerships, and developing a data management plan. In Year 2, recipients will conduct mixed-methods BHBAs for the identified priority populations. Strategies and activities are described below including:

engaging local staff and community members, conducting standardized bio-behavioral surveys and testing, conducting a rapid qualitative assessment, and analyzing and disseminating project findings. Year 2 strategies and activities will repeat for Years 3-5, in the same or different priority populations, based on need. Subject to approvals, activities may shift during the performance period.

Eligible applicants may also apply for up to two Optional Activities which will be awarded if funds are available: anonymous STI testing and anonymous viral hepatitis testing.

Component 2: Required NHBS BHBAs

1) Preparation (Year 1)

Prepare for project activities: Conduct all Year 1 pre-implementation activities according to CDC-approved timelines. Hire and train core BHBA staff, including traveling field staff. Obtain all required equipment, supplies and other materials to conduct project activities. Obtain regulatory approvals to conduct Component 2 activities as required locally, including, but not limited to Institutional Review Board approval, approval to conduct formative assessment, quantitative assessment, and qualitative assessment activities under surveillance authority, or approvals to waive written consent.

Conduct statewide assessment to identify at least two priority populations in geographic areas of interest: Identify comprehensive list of existing data sources to assess HIV prevention priorities. Triangulate information from multiple existing data sources, including HIV surveillance, to determine current HIV prevalence and priorities.

Collaborate with CDC to develop a process for identifying and confirming at least two priority populations in specified geographic areas of interest to conduct BHBAs in Year 2.

Collaborate with CDC on development of operational documents and procedures:

Provide input on standard operational documents and data collection instruments.

Develop standard operating procedures for management of adverse events, safeguards to preserve participant data confidentiality, and activities to address urgent needs identified during contact with participants such as linkage to HIV care.

Establish community partnerships to support project: Identify stakeholders and develop a core advisory group (e.g., state health department officials, members of HIV planning boards, community advocates, university partners, faith-based organizations) that will provide their individual, expert opinion to State and local officials on project activities.

Conduct a project kickoff meeting with core advisory group to create a community connection.

Develop a data management plan: In collaboration with CDC, develop a data management plan. Obtain required software/hardware for project activities. Train data management staff and/or attend data management training on use of required software to conduct project activities. Conduct annual data security and confidentiality trainings.

In Component 2, recipients are expected to undertake the strategies and activities listed below in each year of the NOFO during years 2 through 5. These activities will occur for each BHBA that the recipient conducts.

2) Pre-Implementation Activities

Establish community partnerships to support project: Identify ad-hoc advisory group members based on identified priority populations. Identify and engage key stakeholders (e.g., local and regional health officials, CBOs, law enforcement, service providers, community members) in each of the specified locations. Conduct initial site visits to create a community connection and additional remote or local work prior to data collection.

Hire and train staff to conduct BHBA locally: Hire and train required staff needed to recruit participants, collect data, conduct anonymous blood-based HIV testing and conduct other activities.

Collaborate with partners and stakeholders on project development and establishing participant referrals to prevention, health, and social services: Collaborate on local survey development, strategies, methods and implementation with community partners and stakeholders. Plan optimal methods and sources for referring participants to prevention, health, and social services and linking participants to HIV care.

Conduct formative assessment and analyze…

This is the start of the file's text. The full file is on GovTribe.

File details come from the government source that posted it. Updated May 11, 2021.