ps16-1601 modification 1.pdf

Centers for Disease Control and Prevention

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

National HIV Behavioral Surveillance (NHBS)

CDC-RFA-PS16-1601

Application Due Date: 08/03/2015

Signature Date

National HIV Behavioral Surveillance (NHBS)

CDC-RFA-PS16-1601

TABLE OF CONTENTS

Part I. Overview Information

Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text

Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Required Registrations D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-PS16-1601. 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. Funding Opportunity Title:

National HIV Behavioral Surveillance (NHBS) C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by CDC. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc. gov/od/ science / integrity/ docs/cdc- policy- distinguishing- public- health- research- nonresearch. pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-PS16-1601

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.944 F. Dates:

1. Due Date for Letter of Intent (LOI): 06/10/2015

2. Due Date for Applications: 08/03/2015, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: 06/17/2015 An informational conference call will be held on Wednesday June 17, 2015 from 1:30 - 3:00 PM EDT.

Dial in number: 1-866-742-9957

Passcode: 4052267

Questions may also be directed to nhbsquestions@cdc.gov

G. Executive Summary:

1. Summary Paragraph:

According to the CDC, by the end of 2011 an estimated 1,201,100 persons aged 13 years and older were living with HIV infection in the U.S. (CDC 2014), with over 45,000 new infections occurring each year (CDC 2012). Of the estimated new infections in 2010, 63% were among men who have sex with men (MSM), 25% high-risk heterosexuals, and 8% persons who report injection drug use (IDU) (CDC 2013).

The purpose of National HIV Behavioral Surveillance (NHBS) is to continue an ongoing bio-behavioral surveillance system among high-risk populations, including MSM, IDU and heterosexuals at increased risk (referred to as NHBS-MSM, NHBS-IDU and NHBS-HET respectively). NHBS conducts rotating cycles of surveillance and anonymous HIV testing over time among these different populations in Metropolitan Statistical Areas (MSAs) with the highest HIV prevalence in the United States. This FOA will fund awardees for several required Core NHBS strategies and activities related to preparing for and conducting annual recruitment and data collection, data management and dissemination, quality assurance, and collaboration. If funds are available, applicants may be funded to conduct up to two additional optional NHBS activities (anonymous hepatitis testing during NHBS-IDU cycles and anonymous STI testing during https://foa.grantsolutions.gov/announcementmodule/www.grants.gov https://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov mailto:nhbsquestions@cdc.gov

NHBS-MSM and NHBS-HET cycles) and to conduct NHBS with up to two additional optional populations (NHBS among young men who have sex with men (YMSM) and NHBS among transgender women). The short-term aim of this 5-year project is for NHBS data to be used by state and local partners to measure testing, treatment, and prevention efforts; to guide the development and strengthening of these efforts; and to inform policy makers regarding important prevention issues. In the long-term, ongoing use of NHBS data nationally will result in improved HIV prevention, testing and treatment services for and reduced HIV incidence among populations at high risk for HIV infection.

a. Eligible Applicants: Limited

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 25 Subject to availability of funds, up to 25 awards

d. Total Project Period Funding: $76,600,000

e. Average One Year Award Amount: $550,000 For Fiscal Year 2016, $470,000 (required core NHBS), $80,000 (optional STI testing during NHBS-HET)

f. Number of Years of Award: 5

g. Estimated Award Date: 01/01/2016

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA 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 over 30 years, HIV has been an epidemic affecting millions globally. According to CDC, by the end of 2011 an estimated 1,201,100 persons aged 13 years and older were living with HIV infection in the U.S.

(CDC 2014), with over 45,000 new infections occurring each year (CDC 2012). The burden of HIV infection is disproportionately concentrated among few high-risk populations. Of the estimated new infections in 2010, 63% were among men who have sex with men (MSM), 25% high-risk heterosexuals, and 8% persons who report injection drug use (IDU) (CDC 2013). This FOA will aid in reducing HIV incidence among populations at high risk for HIV infection and improve HIV prevention, testing, and treatment services for them through the continuation of National HIV Behavioral Surveillance (NHBS) which is the nation’s only source of national data monitoring of HIV associated outcomes among populations at high risk for HIV infection.

Monitoring prevalence of HIV and other infections, awareness of infection, risk behaviors, and access to and utilization of prevention services including HIV testing and PrEP among members of high-risk populations is critical to achieving the goals of the National HIV/AIDS Strategy (NHAS) and CDC’s High Impact Prevention (HIP) approach. NHBS has previously proven effective at monitoring key outcomes among high-risk populations.

Recent publications of NHBS-MSM data show that the overall HIV prevalence among MSM has remained stable at 18% since 2008, and efforts to increase the percentage of HIV-positive MSM who are aware of their infection are having a positive effect (Wejnert, Le et al. 2013): NHBS data show that from 2008 to 2011, the percentage of MSM who reported testing in the past 12 months has increased significantly (Cooley, Oster et percentage of MSM who reported testing in the past 12 months has increased significantly (Cooley, Oster et

al. 2014). Similarly, the percentage of HIV-positive MSM who are aware of their infection has increased from 56% to 66% overall (Wejnert, Le et al. 2013). Despite these advances, NHBS data also highlight areas of need among the MSM population. For example, NHBS data have shown that among racial/ethnic MSM groups, black MSM are most likely to be infected with HIV but least likely to be aware of their infection (Wejnert, Le et al. 2013). Furthermore, a recent NHBS analysis showed that larger numbers of MSM are engaging in anal sex without a condom than in previous years (Paz-Bailey, Hall et al. 2013).

A 2012 analysis of NHBS data presented the first national estimate of HIV prevalence among IDU in over 10 years. The estimated prevalence, 9%, was approximately one half that estimated previously and suggested substantial progress in the fight against HIV among the IDU population (CDC 2012). However, NHBS-IDU data also show that additional effort is needed to reduce the large numbers of IDU who continue to engage in sexual and drug-use behaviors that increase their risk of infection (Broz, Pham et al. 2014).

NHBS data among heterosexuals at increased risk for HIV infection (NHBS-HET) have shown prevalence among low SES, urban heterosexuals to be 2.3%, five times the 0.45% estimated for persons aged ≥13 years in the U.S. (Miles, Le et al. 2013). Further, NHBS data have shown that HIV prevention strategies that address socioeconomic factors can help maximize the effectiveness of the public health response to the HIV epidemic among African American women (Ivy, Miles et al. 2013).

NHBS is a strong surveillance platform that allows CDC to monitor emerging infections among high-risk populations such as sexually transmitted infections (STI) and hepatitis viruses. Other high-risk groups such as young MSM (YMSM) and transgender women (persons born male who identify as female or anything other than male) have also been surveyed through NHBS.

b. Statutory Authorities

This program is authorized under Sections 317(k) (2) and 318 (c) of the Public Health Service Act [42 U.S.C.

Sections 247b (k) (2) and 247c (c)], as amended.

c. Healthy People 2020

This program specifically addresses or contributes to the following Healthy People 2020 objectives:

HIV-14.2: (Measureable) Increase the proportion of men who have sex with men (MSM) who report having been tested for HIV in the past 12 months.

HIV-18: (Measureable) Reduce the proportion of men who have sex with men (MSM) who reported unprotected anal intercourse with a partner of discordant or unknown status during their last sexual encounter.

For additional details on the Healthy People 2020 objectives listed above, visit http://www.healthypeople.gov /2020/topicsobjectives2020/objectiveslist.aspx?topicId=22.

d. Other National Public Health Priorities and Strategies

This program specifically addresses or contributes to the following National HIV/AIDS Strategy (NHAS) goals:

Reducing new HIV infections Increasing access to care and improving health outcomes for people living with HIV Reducing HIV-related disparities and health inequities

For additional details on the NHAS goals listed above, visit https://www.whitehouse.gov/administration/eop /onap/nhas/ http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=22 http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=22 https://www.whitehouse.gov/administration/eop/onap/nhas/ https://www.whitehouse.gov/administration/eop/onap/nhas/

e. Relevant Work

This new FOA builds upon the work of the three previous National HIV Behavioral Surveillance (NHBS) FOAs (PA 04-017, PS08-001 and PS11-001). NHBS is CDC's comprehensive system for conducting behavioral surveillance among persons at highest risk for HIV infection in the US. The overall strategy for NHBS involves conducting rotating cycles of surveillance and anonymous HIV testing over time among different populations at high risk for HIV in Metropolitan Statistical Areas (MSAs) with the highest HIV prevalence in the United States. The findings from NHBS will be 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. In particular, the prevalence of HIV infection and the percent of HIV-positive individuals who are unaware of their HIV-positive status can be used to target testing, treatment and other preventions 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 http://www.cdc.gov/hiv/statistics/systems/nhbs/

The following logic model depicts the main activities and resulting outputs that constitute the strategies the awardee is to undertake, and the outcomes expected in the short-term as a result of these efforts, and the mid-term outcomes and the long-term public health achievements to which these short-term outcomes will contribute.

i. Purpose

The purpose of the NHBS program is to continue an ongoing bio-behavioral surveillance system to monitor the HIV epidemic, to detect changes over time in HIV-risk behaviors and HIV prevalence among populations at high risk for HIV infection and to inform and evaluate HIV prevention activities. NHBS collects about 10,000 surveys annually. The data from NHBS are used to improve HIV prevention, testing and treatment services (by identifying sub-groups with sub-optimal treatment utilization) for and to reduce HIV incidence among populations at high risk for HIV infection.

ii. Outcomes

As depicted in the logic model (in italics), the awardee will be expected to show progress on the following outputs:

Effective implementation of NHBS Data meet all data security requirements and are reported into the national system Improved ability to measure prevalence of HIV-related behaviors, use of services, HIV infection, and other relevant infections (e.g. hepatitis, STIs) High-quality locally and nationally relevant data for resource allocation and evaluation of HIV prevention, testing and treatment efforts Increased dissemination of data to key stakeholders Improved information on methods to reach populations at high risk for HIV infection Enhanced collaboration among federal and local partners responsible for HIV prevention, testing and treatment

The awardee will also be expected to show progress on the following short-term outcome:

Ongoing use of NHBS data by state and local partners to measure testing, treatment and prevention efforts; to guide the development and strengthening of these efforts; and to inform policy makers regarding important prevention issues.

iii. Strategies and Activities

As depicted in the logic model, there are 5 required strategies (see logic model) awardees are expected to undertake each year of the FOA in order to conduct required Core NHBS in rotating data collection cycles among men who have sex with men (MSM), persons who report injection drug use (IDU) and heterosexuals at increased risk for HIV infection (referred to as NHBS-MSM, NHBS-IDU and NHBS-HET respectively).

As part of NHBS, eligible applicants may apply for up to 2 optional activities which will be awarded if funds are available: anonymous hepatitis testing during NHBS-IDU and anonymous STI testing during NHBS-MSM and NHBS-HET. In addition, eligible applicants may also apply to conduct the NHBS strategies with up to 2 optional populations: young MSM (YMSM) and transgender women, which will be awarded if funds are available.

The activities encompassed by the 5 required strategies to conduct Core NHBS will result in seven powerful outputs for which the awardee will be expected to show progress during the project period (as depicted in the logic model in italics). If funds are available, the 2 optional NHBS activities and the activities encompassed by conducting NHBS strategies among the 2 optional populations will also contribute to the same seven outputs:

Effective implementation of NHBS Data meet all data security requirements and are reported into the national system Improved ability to measure prevalence of HIV risk behaviors, HIV infection, and other relevant infections (e.g. hepatitis, STIs) High-quality locally and nationally relevant data for resource allocation and evaluation of HIV prevention, testing and treatment efforts Increased dissemination of data to key stakeholders Improved information on methods to reach populations at high-risk for HIV infection Enhanced collaboration among federal and local partners responsible for HIV prevention, testing and treatment

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.

Required Core NHBS: NHBS-MSM, NHBS-IDU and NHBS-HET:

The following required strategies and activities will be conducted each year of the FOA as part of Core NHBS among MSM, IDU and heterosexuals at increased risk for HIV infection:

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 Core NHBS activities under surveillance authority, or approvals to waive written consent. Develop standard operating procedures for management of adverse events, safeguards to preserve participant anonymity and 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 at high risk for HIV infection: Collect bio-behavioral surveillance data in rotating data collection cycles among MSM, IDU, and heterosexuals 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 at high risk for HIV infection.

Conduct standardized surveys: Complete standardized in-person surveys with eligible participants to meet the annual sample size.

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 referred to HIV care. Oral specimens can be collected under circumstances in which blood specimens cannot be obtained from participants. Standard HIV testing can be conducted under circumstances in which rapid HIV testing cannot be administered.

Collect and store blood specimens for future testing: Collect dried blood spots, plasma or other blood specimens for testing to detect antibodies and virus including assays that determine recent infection, viral load and antiretroviral drug resistance.

Send specimens to CDC or CDC designated laboratories: Prepare frequent shipments of specimens to the CDC or CDC designated 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 http://www.cdc.gov/nchhstp/programintegrat ion/docs/PCSIDataSecurityGuidelines.pdf . Conduct annual data security and confidentiality trainings.

Submit Certification Statement annually.

Manage and submit data: Manage all data locally and submit data to the CDC Data Coordinating Center according to CDC-approved guidance and timelines, including but not limited to interview, HIV test results, recruitment and other 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 Core NHBS population, produce at least one report (fact http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf

Analyze and disseminate data: For each 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 treatment and prevention activities. Report on annual data use and dissemination activities accomplished to CDC. Contribute to national data collection outcomes such as surveillance reports and other publications by reviewing 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 awardee 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 Core NHBS strategies and methods: Conduct ongoing formative assessment each data collection cycle to improve operational procedures. Conduct evaluations of Core NHBS, its recruitment strategies and data collection methods as necessary to ensure that the system is meeting its goals. Awardees are expected to make recommendations for improving the quality, efficiency and usefulness of NHBS both locally and nationally.

5) Collaboration:

Collaborate with partners and stakeholders to conduct Core NHBS and evaluations: Collaborate on Core NHBS survey development, strategies, methods and implementation with community partners and stakeholders. Academic or public health partners with expertise in qualitative and quantitative methods may strengthen the planning and implementation of bio-behavioral surveillance activities and evaluation.

Collaborate with partners and stakeholders to disseminate findings/promote data uses: Disseminate and present Core NHBS 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 social and health services and linking participants to HIV, hepatitis and STI care.

Optional NHBS Activities:

The following 2 optional NHBS activities will be awarded if funds are available. These optional activities shall be conducted in conjunction with the NHBS platform and in accordance with CDC-approved guidance.

Optional NHBS activities for which eligible applicants may apply include:

Optional activity #1: Conduct anonymous hepatitis testing during NHBS-IDU:

As part of the NHBS platform and in accordance with CDC-approved guidance and procedures, up to 10 awardees will be funded (if funds are available) for this optional activity to offer anonymous hepatitis testing to participants of the NHBS-IDU data collection cycle in accordance with CDC-approved guidance and procedures. Based on availability of funds, awardees may be funded to conduct Hepatitis B testing, Hepatitis C testing or both:

Offer anonymous Hepatitis B testing: Offer anonymous testing for Hepatitis B to participants in order to assess Hepatitis B seroprevalence. Hepatitis B test results shall be made available to participants and those with positive test results shall be referred to care.

Offer anonymous Hepatitis C testing: Offer anonymous testing for Hepatitis C to participants in order to assess Hepatitis C seroprevalence. Hepatitis C results shall be made available to participants and those with positive test results shall be referred to care.

Collect and store blood specimens: Collect blood specimens for laboratory and confirmatory testing according to CDC-approved methods and guidance.

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

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.

Manage and submit test result data: Manage all test result data locally and submit data to the CDC Data Coordinating Center 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.

Optional activity #2: Conduct anonymous STI testing during NHBS-MSM and NHBS-HET:

As part of the NHBS platform and in accordance with CDC-approved guidance and procedures, up to 5 awardees will be funded (if funds are available) for this optional activity to offer anonymous STI testing to female participants of the NHBS-HET data collection cycles or to participants of the NHBS-MSM data collection cycles or to both populations during the specified cycles in accordance with CDC-approved guidance and procedures. Testing among female heterosexuals will be limited to participants 30 years of age and younger. Applicants can apply to conduct this optional activity in one or both populations, which will be awarded based on the availability of funds.

Offer anonymous testing for both gonorrhea and chlamydia: Offer both anonymous gonorrhea and chlamydia testing to participants. Test results shall be made available to participants and those with positive test results shall be referred to care. Self-collected vaginal swab specimens shall be collected for female heterosexuals up to the 30 years of age and younger and self-collected pharyngeal and rectal swab specimens shall be collected from MSM.

Collect specimens: Collect swabs for laboratory testing according to CDC-approved methods and guidance. Specimen collection may include innovative strategies such as the provision of kits for home collection.

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

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.

Manage and submit test result data: Manage all test result data locally and submit data to the CDC Data Coordinating Center 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.

Optional NHBS Populations:

If funds are available, awardees will be funded to conduct NHBS strategies with the following 2 optional populations at high risk for HIV infection: young MSM (YMSM) and transgender women. NHBS with these 2 optional populations shall be conducted in accordance with CDC-approved guidance. Optional NHBS populations for which eligible applicants may apply include:

Optional population #1: Conduct NHBS among YMSM (NHBS-YMSM):

In accordance with CDC-approved guidance and procedures, up to 10 awardees will be funded (if funds are available) to conduct NHBS among young men who have sex with men (YMSM) ages 13-17, inclusive by performing the NHBS activities listed below. As NHBS does not routinely conduct bio-behavioral surveillance among this population, NHBS-YMSM may require start-up, extensive formative assessment and data collection phases with a total duration of up to 3 years. It is anticipated that start-up activities will begin in Year 2 pending clearances:

Start-up:

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 YMSM 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.

Extensive formative assessment:

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 based on CDC-approved guidance.

Collaborate with partners and stakeholders to conduct NHBS-YMSM and evaluations: Collaborate on survey development, methods and implementation with community partners and stakeholders.

Academic or other public health partners with expertise in qualitative and quantitative methods to survey YMSM will strengthen the planning and implementation of bio-behavioral surveillance activities and evaluation.

Collaborate with partners and stakeholders to ensure participant referrals: Collaborate with community partners and stakeholders to plan optimal methods for referring participants to social services, other specialized services, and linking participants to HIV care.

Conduct pre-implementation activities: Obtain regulatory approvals to conduct NHBS-YMSM activities as required locally, including, but not limited to Institutional Review Board approval, approval to conduct NHBS-YMSM under surveillance authority, or approvals to waive written consent and approvals to waive parental consent. Develop standard operating procedures for management of adverse events, safeguards to preserve participant anonymity and 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 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.

Data collection:

Recruit YMSM ages 13-17, inclusive: Collect behavioral surveillance data using recruitment strategies that include respondent-driven sampling (RDS), Facebook Sampling (FBS) or other CDC-approved strategies to recruit YMSM.

Conduct standardized survey: Complete standardized in-person surveys with eligible participants to meet the sample size for NHBS-YMSM.

Offer blood-based HIV testing: Offer 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 referred to HIV care. Oral specimens can be collected under circumstances in which blood specimens cannot be obtained from participants. Standard HIV testing can be conducted under circumstances in which rapid HIV testing cannot administered.

Collect and store blood specimens for future testing: Collect dried blood spots, plasma or other blood specimens for testing to detect antibodies and virus including assays that determine recent infection, viral load and antiretroviral drug resistance.

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

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 http://www.cdc.gov/nchhstp/programintegrat ion/docs/PCSIDataSecurityGuidelines.pdf . Conduct data security and confidentiality trainings.

Manage and submit data: Manage all data locally and submit to the CDC Data Coordinating Center according to CDC-approved protocols and timelines, including but not limited to interview, HIV test results, recruitment and other 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-YMSM, 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. Contribute to national data collection outcomes such as surveillance reports and other publications by reviewing concept proposals, table shells and manuscript drafts 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 NHBS-YMSM strategies and methods: Conduct ongoing formative assessment to improve operating procedures. Conduct evaluations of recruitment strategies and data collection methods to reach YMSM ages 13-17, inclusive.

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.

Optional population #2: Conduct NHBS among transgender women:

In accordance with CDC-approved guidance and procedures, up to 10 awardees 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 up to 3 years. It is anticipated that start-up activities will begin in Year 2 pending clearances:

Start-up:

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.

Extensive formative assessment:

Conduct extensive formative assessment: Conduct observations, key informant interviews, focus

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 and evaluations: Collaborate on survey development, methods and implementation with community partners and stakeholders. Academic or other public health partners with expertise in qualitative and quantitative methods to survey transgender women will strengthen the planning and implementation of bio-behavioral surveillance activities and evaluation.

Collaborate with partners and stakeholders to ensure participant referrals: Collaborate with community partners and stakeholders to plan optimal methods for referring participants to social services, other specialized services, and linking participants to HIV care.

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 anonymity and 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.

Data collection:

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

Conduct standardized survey: Complete standardized in-person surveys with eligible participants to meet the sample size for NHBS among transgender women.

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 referred to HIV care. Oral specimens can be collected under circumstances in which blood specimens cannot be obtained from participants. Standard HIV testing can be conducted under circumstances in which rapid HIV testing cannot administered.

Collect and store blood specimens for future testing: Collect dried blood spots, plasma or other blood specimens for testing to detect antibodies and virus including assays that determine recent infection, viral load and antiretroviral drug resistance.

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

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 http://www.cdc.gov/nchhstp/programintegrat ion/docs/PCSIDataSecurityGuidelines.pdf . Conduct data security and confidentiality trainings.

Manage and submit data: Manage all data locally and submit to the CDC Data Coordinating Center according to CDC-approved protocols and timelines, including but not limited to interview, HIV test results, recruitment and other 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 (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 activities among transgender women. Contribute to national data collection outcomes such as surveillance reports and other publications by reviewing concept proposals, table shells and manuscript drafts 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.

1.Collaborations

a. With CDC-funded programs:

Awardees are required to collaboratively partner with CDC. Awardees shall maintain local collaborations with HIV prevention program staff, HIV case surveillance staff, CDC-funded health department program staff, and other CDC-funded surveillance or prevention program staff, as appropriate for the successful implementation of the required Core NHBS strategies during NHBS-MSM, NHBS-IDU and NHBS-HET data collection cycles. Awardees funded to conduct optional anonymous hepatitis testing during NHBS-IDU and anonymous STI testing during NHBS-MSM and NHBS-HET and awardees funded to conduct NHBS among the optional populations of YMSM and transgender women (if applicable) shall also maintain local collaborations for these activities.

b. With organizations external to CDC:

Awardees are required to build or maintain collaborations with community partners and stakeholders when performing required NHBS strategies and activities. Community partners and stakeholders may include but are not limited to CBOs and HIV-related service and care organizations that serve MSM, IDU, heterosexuals at increased risk for HIV infection and other populations at high risk of HIV infection. As part of these collaborations, awardees shall incorporate feedback from community partners and stakeholders into activities, shall plan for optimal service referrals and linkage to HIV care, and shall plan for optimal dissemination of data for prevention planning. Awardees have the option to collaborate with academic and public health partners with expertise in qualitative and quantitative methods to conduct behavioral surveillance activities and evaluation. Awardees will be required to collaborate with public health or private laboratories to conduct anonymous HIV testing. Where applicable, awardees shall work with local health departments to carry out program strategies and activities. Awardees may convene community advisory boards to assist with planning NHBS activities (optional).

Awardees funded (if funds are available) to conduct any of the 2 optional activities as part of the NHBS platform will be required to build or maintain additional collaborations with community partners and stakeholders:

Optional anonymous hepatitis testing during NHBS-IDU:

For the anonymous hepatitis testing during NHBS-IDU optional activity, awardees will be required to collaborate with CBOs and other public health partners to plan for optimal service referrals and linkage to hepatitis care. Awardees will also be required to collaborate with public health or private laboratories to conduct hepatitis testing activities. Awardees will be required to collaborate with local prevention partners to disseminate the data to inform hepatitis prevention strategies among the population surveyed.

Optional anonymous STI testing during NHBS-MSM and NHBS-HET:

For the anonymous STI testing during NHBS-MSM and NHBS-HET optional activity, awardees will be required to collaborate with CBOs and other public health partners to plan for optimal service referrals and linkage to STI care. Awardees will also be required to collaborate with public health or private laboratories to conduct STI testing activities. Awardees will be required to collaborate with local prevention partners to disseminate the data to inform STI prevention strategies among the populations surveyed.

Awardees funded (if funds are available) to conduct NHBS among any of the 2 optional populations will also be required to build or maintain additional collaborations with community partners and stakeholders:

Optional NHBS among YMSM:

For the optional NHBS- YMSM population, awardees will be required to collaborate with CBOs, service providers and academic or public health partners who have expertise in working with YMSM ages 17 and younger and with prevention partners who serve this population.

Optional NHBS among transgender women:

For the optional NHBS among transgender women population, awardees will be required to collaborate with CBOs, service providers and academic or public health partners who have expertise in working with transgender women and with prevention partners who serve this population.

2. Target Populations

Individuals at risk of acquiring HIV infection including: 1) sexually-active men who have sex with men (MSM); 2) persons who report active injection drug use (IDU); 3) sexually-active heterosexuals at increased risk for HIV infection; 4) young MSM ages 13-17, inclusive (optional); and 5) transgender women (optional).

a. Inclusion

Required Core NHBS:

Persons aged 18 or older who reside in a funded MSA and meet the CDC definition of sexually active MSM, persons who report active injection drug use (IDU), and heterosexuals at increased risk for HIV infection, as defined in CDC-approved NHBS guidance documents. The heterosexual target population includes only men and women who do not have a history of male-male sex or injection drug use. Each of the 5 required strategies is to be conducted with each of these 3 Core NHBS target populations.

Optional NHBS Activities:

The target population for the optional anonymous hepatitis testing activity includes only participants in the NHBS-IDU data collection cycle. The target population for the optional anonymous STI testing activity includes all participants in the NHBS-MSM data collection cycles and female participants 30 years of age and younger in the NHBS-HET data collection cycles. Targeting of these optional strategies reflects the relative burden of hepatitis and STIs among the Core NHBS target populations and is consistent with current CDC screening recommendations for hepatitis and bacterial STIs among the Core NHBS target populations.

Optional NHBS Populations:

The optional NHBS-YMSM will be conducted with MSM ages 13-17, inclusive (the age criterion for Core NHBS does not apply).

The optional NHBS among transgender women will be conducted among persons aged 18 or older who are born male and identify as female or anything other than male.

iv. Funding Strategy (for multi-component FOAs only)

N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

CDC will work with awardees to develop a feasible scheme for measurement and evaluation that ensures successful monitoring of the implementation of the strategies and activities (process evaluation and measures) and assesses progress in achieving the project period outcomes and/or understanding of the barriers to such progress (outcome evaluation and measures).

Required Core NHBS: NHBS-MSM, NHBS-IDU and NHBS-HET:

Awardees must meet the following benchmarks yearly in order to achieve the required strategies and activities and meet outcomes for Core NHBS:

1) Preparation:

Conduct formative assessment:

If locally required, submit paperwork for regulatory approvals to conduct formative assessment within 4 weeks after receipt of CDC-approved guidance documents.

Submit formative…