PS15-002 Amend 1.pdf

Centers for Disease Control and Prevention

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Extramural Research Program Office

Mobile Messaging Intervention to Present New HIV Prevention Options for MSM

RFA-PS-15-002

Application Due Date: 03/16/2015

Mobile Messaging Intervention to Present New HIV Prevention Options for MSM

RFA-PS-15-002

TABLE OF CONTENTS

Part 1. Overview Information

Key Dates Required Application Instructions Executive Summary

Part 2. Full Text

Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Extramural Research Program Office (NCHHSTP ERPO) National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Office of Public Health Scientific Services (OPHSS) Funding Opportunity Announcement (FOA) Title Mobile Messaging Intervention to Present New HIV Prevention Options for MSM Activity Code Applications in response to this FOA will be funded using the U01 activity code.

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-PS-15-002

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.941 Category of Funding Activity:

Health FOA Purpose Amendment I. A Summary of the Conference Call held on Tuesday, January 13, 2015 with Potential Applicants for Funding Opportunity Announcement (FOA): PS15-002 “Mobile Messaging Intervention to Present New HIV Prevention Options for MSM” and Answers to Questions from Potential Applicants has been added as an amendment to the FOA in Section VIII. "Other Information" on pages 41-44. Changes made to this FOA to clarify questions from potential applicants has been added in red text on pages 2, 3, 4, 6, 10, 11, 12, 14, 15, 19 and 28.

The purpose of this funding opportunity is to develop and test a mobile messaging (e.g., texting, App) HIV prevention intervention for sexually-active (i.e., had sex with a man in the prior 12 months) gay, bisexual and other men who have sex with men (MSM). The intervention will consist of brief, multi-component messages about new and emerging HIV risk reduction information (e.g., pre-exposure prophylaxis [PrEP] for HIV prevention, post-exposure prophylaxis [PEP], partner benefit of antiretroviral therapy [ART] use, condom effectiveness during use for anal sex, encouragement of periodic HIV testing, importance of ART adherence for optimal benefit). Brief messages will be presented over a 3-month period of time and will target three population groups: 1) HIV-positive MSM, 2) high-risk HIV-negative MSM (i.e., recent anal sex without condoms with a non-primary or HIV-discordant primary partner in the past 3 months), and 3) lower-risk HIV-negative MSM. The prospective grantee will develop a research project that includes Metropolitan Statistical Areas (MSA) from three of the four geographical regions in the United States. One, and only one, location must be in the South (Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia) and one, and only one location must be in the Northeast (Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, or Vermont). The remaining MSA location will be chosen from the two remaining nationally-designated geographical regions (Midwest or West). The grantee will partner with appropriate agencies in each MSA location in order to

(Midwest or West). The grantee will partner with appropriate agencies in each MSA location in order to access the target population and to implement study activities. The multi-site project will be conducted in two phases. Phase 1 (n=90) involves conducting formative research to develop intervention content, including custom messages, delivery technology and approach. Phase 2 (n=1206) involves testing the mobile messaging intervention for efficacy in changing HIV prevention behavior in a randomized two (2)-group trial (intervention and delayed intervention arms). Assessments will occur simultaneously for both arms at three-month intervals starting with a common baseline through six-month post-intervention follow-up; an immediate post-intervention assessment will also be given to the delayed intervention arm. For the intervention arm: the intervention will occur between baseline and the first 3 month assessment and assessments will occur at 3, 6, and 9 months post baseline (also referred to in the table as intervention arm immediate post-test, and 3 and 6-month post-intervention follow-up assessments, respectively). For the delayed intervention arm: the intervention will occur between the 9 and 12 month post baseline period (i.e., immediately following the intervention arm 6-month follow-up assessment);

assessments for this arm will occur at 3, 6, 9 and 12 months post baseline. The end point of the RCT 2-arm comparison is at the 6-month post-intervention follow-up assessment for the intervention arm (i.e., 9 months post baseline). The immediate post-test for the delayed intervention arm (i.e., 12 months post baseline) provides a secondary analysis for within-group change for the delayed intervention arm.

Novel, scientifically sound research designs (e.g., partial baseline sample data collection with data imputation) are encouraged.

Key Dates Publication Date: To receive notification of any changes to RFA-PS-15-002, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 02/16/2015

Application Due Date: 03/16/2015 90 days after the publication date, by 5:00 PM U.S. Eastern Time. On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., no error correction window).

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 05/07/2015

Secondary Review: 06/12/2015

Estimated Start Date: 09/01/2015

Expiration Date: 03/17/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where http://www.grants.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose. The purpose of this funding opportunity is to develop and test a mobile messaging (e.g., texting, App) HIV prevention intervention for sexually-active (i.e., had sex with a man in the prior 12 months) gay, bisexual and other men who have sex with men (MSM). The intervention will consist of brief, multi-component messages about new and emerging risk reduction information (e.g., pre-exposure prophylaxis [PrEP] for HIV infection. Message components that will include, but will not be limited to pre-exposure prophylaxis [PrEP] for HIV infection, post-exposure prophylaxis [PEP], partner benefit of antiretroviral therapy [ART] use, condom effectiveness during use for anal sex, encouragement of HIV testing, importance of ART adherence for optimal benefit). Proposed messaging content, format, frequency, and delivery should reflect the state of the scientific literature at the time of application submission.

Intervention messages will be presented to study participants over a three-month period of time and target three MSM population groups: 1) HIV-positive MSM, 2) high-risk HIV-negative MSM (i.e., self-reported recent anal sex without condoms with a non-primary partner or an HIV serodiscordant primary partner), and 3) lower-risk HIV-negative MSM (i.e., no self-reported recent anal sex without condoms with a non-primary partner or an HIV serodiscordant primary partner). The prospective grantee will develop a three-region project within Metropolitan Statistical Areas (MSAs)[1] with populations of 500,000 or more and located in the four US regions of residence defined by the U.S. Census Bureau[2]. So that additional data can be obtained to validate recent trends in HIV incidence in the southern and northeastern US, each research application must identify one, but no more than one, MSA performance site from within the Southern region (Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia) and one, and but no more than one MSA performance site from the Northeastern region (Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, or Vermont). The applicant will identify one remaining MSA performance site from the two remaining geographical regions in the US (Midwest or West). The grantee will partner with appropriate agencies within each MSA to improve access to the target population and to implement study activities. The three-region project will be conducted in two phases. Phase 1 (n=90) will involve conducting formative research to develop intervention content, including custom messages and delivery technology whereas Phase 2 (n=1206) will involve testing the mobile messaging intervention for efficacy in changing HIV prevention behavior in a randomized 2-group trial (intervention and delayed intervention arms). Assessments will occur simultaneously for both arms at three-month intervals starting with a common baseline through six-month post-intervention follow-up; an immediate post-intervention assessment will also be given to the delayed intervention arm.

The prospective grantee will develop mobile technology for message delivery and data collection, as well as preliminary messages using message presentation and delivery approach identified from http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf file://cdc/project/NCHHSTP_ERPO/Peer%20Reviews/FY15%20Peer%20Review/NCHHSTP%20(PS)/PS15-002/FOA/PS15-002_Mobile%20Messaging%20Intervention_Research%20FOA%20%2010-10-14%20CM%20GS%20version%202%20DL%2010_21_14%20CM.docx file://cdc/project/NCHHSTP_ERPO/Peer%20Reviews/FY15%20Peer%20Review/NCHHSTP%20(PS)/PS15-002/FOA/PS15-002_Mobile%20Messaging%20Intervention_Research%20FOA%20%2010-10-14%20CM%20GS%20version%202%20DL%2010_21_14%20CM.docx

Phase 1 and based on the state of public health communication research at the time of application.

Phase 1 (n=90 total, n=30 per site) formative research will include a combination of focus groups (n=45 total, n=15 per site) and participant interviews (n=45 total, n=15 per site). Participant feedback will be used to determine acceptability and appropriateness of message content as well as feasibility of delivery technology and messaging approach for the three-month intervention trial.

The Phase 2 study design will be a randomized 2-group trial (intervention and delayed intervention arms) with both study arms receiving the brief mobile messaging HIV prevention intervention plus provision of standard-of-care services. The intervention group will receive three-month intervention messaging immediately following baseline assessment, and the delayed intervention group will receive the three-month intervention immediately following final assessment at 6 months. Again, assessments will occur simultaneously for both arms at three-month intervals starting with a common baseline through six-month post-intervention follow-up; an immediate post-intervention assessment will also be given to the delayed intervention arm.

Standard-of-care services for HIV-negative MSM, regardless of risk level, includes provision of an HIV test (based on the local HIV testing standard procedure) as described below. Standard-of-care services for HIV-positive MSM include provision of linkage to HIV care services based on the standard-of-care services offered in the local project site community.

A sample size of approximately 1206 MSM (603 per study arm) will include 402 men recruited in each of three MSAs with one, but no more than one, MSA site located in the South (Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia) and one, but no more than one MSA site located in the Northeast (Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, or Vermont).

The remaining MSA location will be chosen from the two remaining nationally-designated geographical regions (Midwest or West). Within each MSA site, equal proportions (134/134/134) of the study participants will be HIV-positive, HIV-negative high-risk and HIV-negative lower-risk MSM. Baseline HIV status will be measured by self-report (including self-perceived status for men who have not been tested). Given that HIV testing will be included in intervention message content and is also an outcome of interest, providing testing for HIV-negative/unknown status participants at study baseline would be expected to bias data on self-initiated HIV testing behavior. Therefore, all HIV-negative/unknown status men will be provided access to HIV testing resources at the six-month post-intervention follow up assessment or study endpoint. Importantly, participants are expected to continue normal healthcare activities during the course of the study and to be offered HIV testing referral information and perhaps even on-site testing through existing service providers.

Primary study outcomes of interest will include participant behavior data after exposure to HIV risk reduction and prevention messaging (e.g., HIV testing, condom use, PrEP, PEP or ART use) as assessed at baseline, and at three- and six-months post-intervention follow-up. Multiple HIV prevention messages will be presented daily via mobile technology (e.g., texting, App) over a 3-month time period. The messages will be tailored for each of the three targeted MSM populations and self-reported baseline prevention behaviors (e.g., self-reported PrEP use among high-risk MSM, ART use and viral suppression among HIV-positive MSM). HIV testing will be offered to all HIV-negative and HIV-unknown status participants at the six-month follow-up.

[1] MSA areas with populations of 500,000 or more according to the OMB Bulletin 10-02. http://www.white house.gov/sites/default/files/omb/assets/bulletins/b10-02.pdf . Published December 1, 2009.and as indicated in CDC’s 2011 HIV Surveillenace Report Table 23 and 24 http://www.cdc.gov/hiv/pdf/statistics_2011_HIV_ Surveillance_Report_vol_23.pdf file://cdc/project/NCHHSTP_ERPO/Peer%20Reviews/FY15%20Peer%20Review/NCHHSTP%20(PS)/PS15-002/FOA/PS15-002_Mobile%20Messaging%20Intervention_Research%20FOA%20%2010-10-14%20CM%20GS%20version%202%20DL%2010_21_14%20CM.docx http://www.whitehouse.gov/sites/default/files/omb/assets/bulletins/b10-02.pdf http://www.whitehouse.gov/sites/default/files/omb/assets/bulletins/b10-02.pdf http://www.cdc.gov/hiv/pdf/statistics_2011_HIV_Surveillance_Report_vol_23.pdf

[2] Four US regions as defined by the US Census: https://www.census.gov/geo/maps-data/maps/pdfs/refer ence/us_regdiv.pdf

Mechanism of Support. Cooperative agreement.

Funds Available and Anticipated Number of Awards. Estimated total funding available, to include direct and indirect costs for the entire project period, is $3,800,000. The project period will be four years. There will be one award. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. The total amount awarded will depend on the number, quality, duration and cost of the applications received.

Budget and Project Period. The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $600,000. The estimated total funding (direct and indirect) for the second year (12-month budget period) will be $600,000, the third year (12-month budget period) will be $1,300,000, and the fourth year (12-month budget period) will be $1,300,000. The project period will run from 09/01/2015 to 08/31/2019.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III. 1. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI for this project. Co-investigators can be identified from local partnering agencies/project sites.

Number of Applications. The eligible applicant institution may submit only one application.

Application Type. New

Special Date(s). A potential applicant conference call will be held on Tuesday, January 13, 2015 from 1:00 pm to 2:00 pm Eastern Time. The bridgeline number is 1-866-662-8986; passcode 8378091.

Application Materials. See Section IV.1 for application materials.

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

(770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

Sections 301 and 318 of the Public Health Service Act (42 U.S.C. Sections 241 and 247(c)), as amended.

file://cdc/project/NCHHSTP_ERPO/Peer%20Reviews/FY15%20Peer%20Review/NCHHSTP%20(PS)/PS15-002/FOA/PS15-002_Mobile%20Messaging%20Intervention_Research%20FOA%20%2010-10-14%20CM%20GS%20version%202%20DL%2010_21_14%20CM.docx https://www.census.gov/geo/maps-data/maps/pdfs/reference/us_regdiv.pdf https://www.census.gov/geo/maps-data/maps/pdfs/reference/us_regdiv.pdf

1. Background and Purpose

CDC announces a cooperative agreement funding opportunity announcement titled “Mobile Messaging Intervention to Present New HIV Prevention Options for MSM” to develop and systematically evaluate a brief mobile messaging HIV prevention intervention for reducing HIV-related risk behaviors among HIV-positive and HIV-negative gay, bisexual and other men who have sex with men (MSM).

Sexual risk behavior among MSM in the U.S. increased from 2005-2011 among subgroups of men who have sex with men (MSM), a group already disproportionally affected by HIV (1). At the same time, messaging on the range and complexity of HIV risk reduction options is becoming increasingly challenging. As new information about prevention options continues to emerge from the scientific community, this information must be translated clearly and concisely to populations at highest risk for HIV infection, such as MSM. New and complex scientific information about pre-exposure prophylaxis (PrEP) for HIV prevention, post-exposure prophylaxis (PEP), condom efficacy during anal sex, ART adherence benefit for non-infected partners, and lack of HIV testing among some MSM, and other prevention-relevant information, needs to be combined to present multi-component messaging in effective ways to 1) HIV-positive MSM, 2) high-risk HIV-negative MSM (i.e., self-reported recent anal sex without condoms with a non-primary partner or an HIV serodiscordant primary partner) and 3) lower-risk HIV-negative MSM (i.e., no self-reported recent anal sex without condoms with a non-primary partner or an HIV serodiscordant primary partner). Importantly, these three target groups are distinct from each other with respect to the prevention messages that will be most appropriate for them. For example, ART medication adherence is important for HIV-positive MSM, and PrEP/PEP are viable HIV prevention methods for high-risk HIV-negative MSM but not lower-risk MSM. Research has demonstrated that mobile messaging is a promising approach to brief intervention messaging for HIV risk reduction strategies and medication adherence in MSM target groups.

The purpose of this FOA is to develop and test a brief mobile messaging (e.g., texting, App) HIV prevention intervention for sexually-active (i.e., had sex with a man in the prior 12 months) gay, bisexual and other men who have sex with men and will consist of multi-component messages about new and emerging HIV risk-reduction information delivered over a three-month period of time.

Proposed messaging content, format, frequency, and delivery technologies used in this study are expected to reflect the state of the scientific literature at the time of application submission. The FOA study will consist of formative research and experimental Randomized Control Trial (RCT) phases conducted in three geographically diverse US MSAs with one, but no more than one MSA located in the Southern region (Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia) and one, but no more than one MSA located in the Northeastern region (Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, or Vermont). The remaining MSA location will be chosen from the two remaining nationally-designated geographical regions (Midwest or West). The 2-arm RCT will include randomization of participants to intervention or delayed intervention arms. Assessments will occur simultaneously for both arms at three-month intervals starting with a common baseline through six-month post-intervention follow-up; an immediate post-intervention assessment will also be given to the delayed intervention arm.

References

1) Centers for Disease Control and Prevention. HIV Testing and Risk Behaviors Among Gay, Bisexual, and Other Men Who Have Sex with Men — United States. MMWR 2013a; 62(47);

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6247a4.htm

958-962. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6247a4.htm . Accessed 9/29/2014.

2) CDC. Diagnoses of HIV infection in the United States and dependent areas, 2011. HIV surveillance report. Vol. 23. Atlanta, GA: US Department of Health and Human Services, CDC;

2013. Available at: http://www.cdc.gov/hiv/library/reports/surveillance/2011/surveillance_report_vol_23 .html or http://www.cdc.gov/hiv/pdf/statistics_2011_HIV_Surveillance_Report_vol_23.pdf Accessed 9/29/2014.

3) Centers for Disease Control and Prevention. HIV Surveillance Report, 2011; vol. 23. http://www .cdc.gov/hiv/topics/surveillance/resources/reports/.Published February 2013. Accessed 9/29/2014.

Research Objectives: Applications submitted under this FOA must address all of the following research objectives (Additional details are provided in Part 2, Section I.2: Approach). Applicants will:

Identify three MSAs from separate and distinct geographical regions within the US with one of these MSAs located in the US Southern region (Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia) and one, but no more than one MSA located in the Northeastern region (Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, or Vermont). The remaining MSA location will be chosen from the two remaining nationally-designated geographical regions (Midwest or West).

1.

Partner with HIV prevention service organizations (including, but not limited to, local health departments, community-based organizations, community health centers, and other agencies) that serve gay, bisexual and other MSM target populations whose sociodemographics (e.g., race/ethnicity and socioeconomic status) are representative of each of the three proposed regional MSA sites with populations of 500,000 or more.

2.

Develop a mobile, brief messaging (e.g., texting, App) HIV behavioral intervention about new and emerging HIV prevention methods through relevant formative research (Phase 1) in HIV-positive and HIV-negative (high-risk, lower-risk) MSM.

3.

Evaluate the efficacy of a mobile, brief messaging HIV behavioral intervention delivered over a three-month period to reduce risk behaviors (e.g., number of anal sex partners) and increase protective behaviors for HIV-negative (e.g., condom use, PrEP/PEP use, HIV testing) and HIV-positive (e.g., condom use, ART use and adherence, viral load testing) MSM (Phase 2).

4.

Scientific knowledge to be achieved:

The extent to which a brief mobile messaging (e.g., texting, App) HIV behavioral intervention can successfully change behaviors and attitudes of MSM.

1.

The important components and feasibility of implementing a brief mobile messaging (e.g., texting, App) HIV behavioral intervention among HIV-positive, high-risk HIV-negative (i.e., self-reported recent anal sex without condoms with a non-primary partner or a serodiscordant primary partner) and lower-risk HIV-negative MSM (i.e., no self-reported recent anal sex without condoms with a non-primary partner or a serodiscordant primary partner).

2.

Health Equity. The program supports efforts to improve the health of populations disproportionately affected by HIV/AIDS, viral hepatitis, STDs and TB by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with the National HIV/AIDS Strategy available at http://www.whitehouse.gov/administration/eop/onap/nhas .

Health disparity is a particular type of health difference that is closely linked with social or economic http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6247a4.htm http://www.cdc.gov/hiv/library/reports/surveillance/2011/surveillance_report_vol_23.html http://www.cdc.gov/hiv/library/reports/surveillance/2011/surveillance_report_vol_23.html http://www.cdc.gov/hiv/pdf/statistics_2011_HIV_Surveillance_Report_vol_23.pdf http://www.cdc.gov/hiv/topics/surveillance/resources/reports/ http://www.cdc.gov/hiv/topics/surveillance/resources/reports/ http://www.whitehouse.gov/administration/eop/onap/nhas

Health disparity is a particular type of health difference that is closely linked with social or economic disadvantage based on their racial or ethnic group, religion, socioeconomic status, gender, mental health, cognitive, sensory, or physical disability, sexual orientation, geographic location, or other characteristics historically linked to discrimination or exclusion [HP 2020-http://www.healthypeople.gov/2020/topics-objec tives/topic/hiv]. Health disparities in HIV, viral hepatitis, STDs, and TB are inextricably linked to a complex blend of social determinants that influence which populations are most severely affected by these diseases.

Social determinants are the economic and social conditions that influence the health of individuals, communities and jurisdictions and include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic disadvantage. It requires:

Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and Continuous efforts to maintain a desired state of equity after particular health disparities are eliminated.

Programs should use data, including social determinants data, to identify communities within their jurisdiction that are disproportionately affected by HIV, viral hepatitis, STDs and TB and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, programs should consider social determinants of health in the development, implementation, and evaluation of program specific efforts and use culturally appropriate interventions that are tailored for the communities for which they are intended.

Healthy People 2020 and other National Strategic Priorities

The NCHHSTP of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020" and measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This FOA addresses the “Healthy People 2020” priority area of HIV and is in alignment with: 1) performance goal HIV-1 (developmental) to reduce new HIV diagnoses among adolescents and adults; 2) performance goal HIV-2 to reduce new (incident) HIV infections among adolescents and adults; performance goal HIV-10 to increase the proportion of HIV-infected adolescents and adults who receive HIV care and treatment consistent with current standards by 2020; performance goal HIV-14.2 (developmental) to increase the proportion of MSM who have been tested for HIV in the past 12 months; and HIV-18 (developmental) to reduce the proportion of MSM who reported unprotected anal sex in the past 12 months. For more information, please see http://www.healthypeople.gov/2020/topics-objectives /topic/hiv

The National HIV/AIDS Strategy (NHAS) has also set goals and this proposed study supports goal 1 to prevent new HIV infections, goal 2 to increase access to care and improve health outcomes for people living with HIV, and goal 3 to reduce HIV-related health disparities. For more information, please see http://aids .gov/federal-resources/national-hiv-aids-strategy/overview/index.html

Also related to NHAS, this study is in support of the White House’s HIV Care Continuum Initiative which calls for coordinated action to increase the number of people living with HIV in the United States who have achieved the treatment goal of controlling the HIV virus. For more information, please see http://aids.gov /federal-resources/policies/care-continuum/

CDC’s Winnable Battles: This FOA addresses one of CDC’s Winnable Battle goals by:

Intensifying HIV prevention efforts in communities where HIV is most heavily concentrated.

Expanding targeted efforts to prevent HIV infection using a combination of effective, evidence-based approaches for persons living with HIV and those at high risk of infection.

Maximizing the proportion of people with HIV who have suppressed viral load by improving http://www.healthypeople.gov/2020/topics-objectives/topic/hiv http://www.healthypeople.gov/2020/topics-objectives/topic/hiv http://www.healthypeople.gov/2020/topics-objectives/topic/hiv http://www.healthypeople.gov/2020/topics-objectives/topic/hiv http://aids.gov/federal-resources/national-hiv-aids-strategy/overview/index.html http://aids.gov/federal-resources/national-hiv-aids-strategy/overview/index.html http://aids.gov/federal-resources/policies/care-continuum/ http://aids.gov/federal-resources/policies/care-continuum/ diagnosis, linkage and retention in care, and antiretroviral provision and adherence.

Improving data monitoring, dissemination, and feedback.

Educating Americans about the threat of HIV and how to prevent it.

Public Health Impact

Gay, bisexual and other MSM continue to be at disproportionate risk for HIV infection compared to others in the United States at a time when new scientific information is emerging about new HIV prevention options. This project will develop and test the efficacy of a brief mobile messaging HIV prevention intervention delivered over a three-month period to HIV-positive MSM, and high- and lower-risk HIV-negative MSM. The ultimate goal is to develop a cost efficient and scalable intervention that incorporates the most current information about options for reducing risk for HIV transmission among MSM.

Relevant Work

Centers for Disease Control and Prevention. HIV Testing and Risk Behaviors Among Gay, Bisexual, and Other Men Who Have Sex with Men — United States. MMWR 2013a; 62(47);958-962.

CDC’s 2011 HIV Surveillance Report: Centers for Disease Control and Prevention. HIV Surveillance Report, 2011; vol. 23. Published February 2013b. Accessed July, 29, 2014. http://www.cdc.gov/hiv/topic s/surveillance/resources/reports/.

PRS Efficacy Criteria for Best-Evidence (Tier I) Risk Reduction (RR) Individual-level, Group-level, and Couple-level Interventions (ILIs/GLIs/CPLs). Last Updated April, 2014. Accessed October 4, 2014. http://www.cdc.gov/hiv/dhap/prb/prs/efficacy/rr/criteria/bestEvidence_ILIs_GLIs.html The Health Communicator’s Social Media Toolkit. Last Updated July 2011. Accessed October 10, 2014. http://www.cdc.gov/healthcommunication/toolstemplates/socialmediatoolkit_bm.pdf

2. Approach

CDC is proposing the Mobile Messaging Intervention to Present New HIV Prevention Options for MSM FOA for the development and testing of an HIV prevention intervention for sexually-active (i.e., had sex with a man in the prior 12 months) HIV-positive, high-risk (i.e., recent anal sex without condoms with a non-primary or HIV-discordant primary partner in the past three months) HIV-negative and lower-risk HIV-negative gay, bisexual and other men who have sex with men. After award, CDC will collaborate with one grantee to develop a trial protocol. Although some details of the randomized 2-group trial will be determined after award, the intended core activities and study outcomes are presented in this FOA.

The grantee will oversee formative research (Phase 1) to develop the brief mobile messaging HIV prevention intervention for targeted groups of HIV-positive and HIV-negative MSM. Messages may be tailored to baseline prevention method utilization of individual participants (e.g., self-reported use of PrEP, PEP, ART and condoms). The grantee will oversee implementation of the randomized controlled trial in three MSA project sites with populations of 500,000 or more from three of the four US geographic regions as identified by the US Census and in Table 23 of CDC’s 2011 HIV Surveillance Report. See: http://www.cdc.gov/hiv/pdf/statistics_2011_HIV_Surveillance_Report_vol_23 .pdf . One, but no more than one, location will be in the US South (Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia) and one, but no more than http://www.cdc.gov/hiv/topics/surveillance/resources/reports/ http://www.cdc.gov/hiv/topics/surveillance/resources/reports/ http://www.cdc.gov/hiv/dhap/prb/prs/efficacy/rr/criteria/bestEvidence_ILIs_GLIs.html http://www.cdc.gov/healthcommunication/toolstemplates/socialmediatoolkit_bm.pdf one location will be in the Northeast (Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, or Vermont). The remaining MSA location will be chosen from the two remaining nationally-designated geographical regions (Midwest or West) due to high HIV incidence or diagnoses in these regions (see Relevant work, CDC 2013b).

Applicants will select and establish partnerships with relevant agencies (e.g., health departments, community-based organizations, HIV/STD care clinics, community health centers) in each of the three proposed MSA project sites (one must be located in the US South and one site must be located in the US Northeast) to establish a credible presence in the community and facilitate successful completion of the proposed project activities. Partner agencies must serve gay, bisexual and other MSM to satisfy the minimum sample size specified in this FOA. Applicants should include in their application letters of support for the research from partners and a description of how and why the collaborating agencies were selected.

Letters of support should include:

A statement of the collaborating agency’s role in the project;

Estimates of the total number of HIV-positive and HIV-negative MSM that have received HIV prevention services annually during the past three years and the applicant’s ability to recruit and retain large samples of MSM in randomized trial studies, including 1) HIV-positive MSM, 2) high–risk HIV negative MSM (recent anal sex without a condom) and 3) lower-risk HIV negative MSM (no recent anal sex without a condom) as required by this study;

Statement of their resources and commitment to the success of the study, including any skills or experiences that may make them uniquely qualified to serve as a study partner;

Intent to enter into formal agreements for participation (e.g., Memoranda of Understanding, Contracts) for the entire four (4) years of the project period.

During Phase 1 of the study, each MSA project site will recruit and enroll a minimum of 30 MSM (n=90 combined) – including 30 HIV-positive, 30 high-risk HIV-negative MSM, and 30 lower-risk HIV-negative MSM – for the formative research (see Table 1). During Phase 2, each project site will recruit and enroll 402 MSM (n=1206 combined) for the behavioral intervention randomized trial (see Table 2), with approximately one-third in each of the three messaging target groups. A common assessment tool must be developed and employed across the three project sites. Given the importance of a sexual partner’s role in prevention option decisions (e.g., ART and PrEP/PEP use, viral load monitoring) and the different social contexts of sexual decision-making for primary and non-primary partners, each site will assess behavior with both primary and non-primary partners.

Formative Research (Phase 1). The purpose of Phase 1 is to assist in developing multi-component brief messages that will be presented to MSM study participants via mobile messaging technology over a three-month intervention period and further test efficacy in Phase 2 of the study. Phase 1 of the study (three-to-six months) will consist of both focus groups and individual interviews to develop a brief assessment tool to measure collective risk reduction and overall individual perceived protective value (i.e., potential combined benefit of using multiple prevention options over time, such as condoms, HIV testing, ART, PrEP, PEP, etc.) and pilot-test intervention message content, presentation (approach), and mobile messaging technology (e.g., texting, App). The minimum sample size per MSA project site will be 30 MSM (total sample of 90 across all three sites; see Table 1), with half assessed through focus groups and half through individual interviews.

Table 1. Target sample size by subgroup for formative research (Phase 1)

Table 1. Target sample size by subgroup for formative research (Phase 1) HIV-negative

HIV-positive High-risk* Lower-risk Combined

Site 1 10 10 10 30 Site 2 10 10 10 30 Site 3 10 10 10 30 _ 30 30 30 90 *Anal sex without condoms with a non-primary or HIV-discordant primary partner in the past three months.

Behavioral Intervention Trial (Phase 2). Phase 2 will encompass a 24-month phase of the study which involves implementation of a randomized trial to test the efficacy of the multi-component HIV prevention messaging intervention developed in Phase 1. Novel scientifically sound research designs (e.g., partial baseline sample data collection with data imputation) are strongly encouraged but must include the following components and study design elements: eligibility screening, informed consent, study arm randomization, and exposure to three-month intervention messaging. Study assessments will measure behavior change and multiple prevention method usage over time in a randomized 2-group trial. Assessments for the intervention arm will occur at baseline (immediately following study enrollment), and at three and six months post-baseline intervention. Assessments will occur simultaneously for both arms at three-month intervals starting with a common baseline through six-month post-intervention follow-up (see Table 3); an immediate post-intervention assessment will also be given to the delayed intervention arm. Rapid HIV testing will be directly provided to all interested HIV-negative participants at the study endpoint, and referrals to HIV testing and care services will be provided to all participants at any time point during the study.

The brief assessment tool developed during Phase 1 will measure collective risk reduction and overall individual perceived protective value (i.e., potential combined benefit of using multiple prevention options over time, such as condoms, HIV testing, ART, PrEP, PEP, etc.) during Phase 2.

Post-intervention outcomes (see “Objective and Outcomes” in Section I.2 below for more detail) will consist of self-reported sexual risk behaviors risk reduction method usage, and overall individual HIV risk reduction across prevention options for primary and non-primary partners by target group (HIV-positive, and high- and lower-risk HIV-negative MSM).

Table 2. Target sample size by subgroup for the behavioral intervention trial (Phase 2) HIV-negative

HIV-positive High-risk* Lower-risk Combined

Interv(a) Delay(b) Interv Delay Interv Delay Interv Delay Total

Site 1 67 67 67 67 67 67 201 201 402 Site 2 67 67 67 67 67 67 201 201 402 Site 3 67 67 67 67 67 67 201 201 402 201 201 201 201 201 201 603 603 1206

* Anal sex without condoms with a non-primary or HIV-discordant primary partner in the past three months.

a Intervention group b Delayed intervention group

Table 3. Behavioral intervention trial study design

Baseline Intervention Occurs

Intervention Post-test

3-month Follow Up

6-month Follow Up

Intervention Occurs

Delayed Intervention Post-test

Timeline 0 months 3 months 6 months 9 months 12 months

Intervention Arm

A XXXXXXX A A A

Delayed Intervention Arm

A A A A XXXXXXX A

A = assessment X = intervention Proposal Design and Analysis. The applicant must submit a plan for the design of the proposed evaluation of intervention outcomes that meets published standards or criteria for providing “best evidence” of intervention efficacy in reducing HIV risk behaviors. These standards from the scientific literature have been summarized and are discussed in greater detail online at http://www.cdc .gov/hiv/dhap/prb/prs/efficacy/rr/criteria/bestEvidence_ILIs_GLIs.html .

To satisfy the design criteria for providing “best evidence” of intervention efficacy, the design for the proposed evaluation must include the following elements

Prospective design; that is, collection of assessment data at baseline (prior to delivering the intervention) and at one or more points after the intervention has been delivered (see details below);

A concurrent comparison / delayed intervention group;

Random assignment to intervention and delayed intervention groups;

Informed consent, study arm randomization, and exposure to three-month intervention messaging groups - assessments will occur simultaneously for both arms at three-month intervals starting with a common baseline through six-month post-intervention follow-up (see Table 3) - an immediate post-intervention assessment will also be given to the delayed intervention arm;

A strategy to retain at least 80 percent of participants in the intervention and delayed intervention groups for data collection at all planned follow-up assessments;

The measurement of relevant outcomes (see “Objective and Outcomes” section below for more details) such as behaviors that directly impact risk of HIV infection.

The applicant must submit a plan for analysis of evaluation results that includes the following elements:

A comparison of the intervention group and the delayed intervention group on relevant outcomes;

A comparison of groups as originally assigned; that is, regardless of the amount of intervention exposure (i.e., intention-to-treat analysis);

Use of appropriate cluster-level analyses, if participants are assigned to intervention and comparison conditions by cluster or group (e.g., study site);

http://www.cdc.gov/hiv/dhap/prb/prs/efficacy/rr/criteria/bestEvidence_ILIs_GLIs.html http://www.cdc.gov/hiv/dhap/prb/prs/efficacy/rr/criteria/bestEvidence_ILIs_GLIs.html

Analyses based on pre-/post-intervention changes in measures (if pre-/post-intervention changes are used in analyses, outcome measures must be identical, including the recall period);

Alpha = 0.05 and 2-sided statistical test.

In addition, the design for the proposed evaluation during Phase 2 must include:

A sample that includes a minimum of 603 participants in the intervention group and a minimum of 603 participants in the concurrent comparison delayed intervention group.

Objectives/Outcomes

The objective and desired outcome of this FOA is to develop a mobile technology messaging intervention (including prevention messages and delivery system) for MSM that is tested for behavior change efficacy in a randomized 2-group trial. Prevention messages are to be tailored for and tested among three target groups: HIV-positive, and high- and lower-risk HIV negative MSM.

Outcomes include change in use of HIV prevention methods (from baseline to follow-up) that are the subject matter of multiple messages delivered over a three-month period.

Primary outcomes are behaviors based on the content of the prevention messages, which are to be determined by the HIV serostatus/risk-level group including, but not limited to, the following:

HIV-negative MSM (both high-risk and lower-risk):

Overall number of (a) insertive and (b) receptive non-primary anal sex partners with whom a condom was not used (past three months);

Percentage of anal sex acts with condom use with non-primary partners (past three months);

Percentage of anal sex acts with condom use with HIV discordant primary partners (past three months);

HIV testing behavior (past three months);

STD testing behavior (past three months).

High-risk HIV-negative MSM (i.e., recent anal sex without condoms with a non-primary or HIV-discordant primary partner in the past three months):

PrEP/PEP uptake and adherence (past three months).

HIV-positive MSM:

Overall number of non-primary anal sex partners (past three months);

Overall number of (a) insertive and (b) receptive non-primary anal sex partners with whom a condom was not used (past three months);

Percentage of anal sex acts with condom use with non-primary partners (past three months);

Percentage of anal sex acts with condom use with discordant primary partners (past three months);

ART uptake and adherence (past three months);

Viral load testing behavior and results (past three months);

STD testing behavior (past three months).

Secondary outcomes are behavioral intentions to use, knowledge of and beliefs about the content of the prevention messages by HIV serostatus group. For example:

HIV-negative MSM (both high-risk and lower-risk):

Intent to reduce number of anal sex partners (next three months);

Intent to reduce overall number of (a) insertive and (b) receptive non-primary anal sex partners with whom a condom was not used (past three months);

Intent to use condoms during anal sex with non-primary partners (next three months);

Intent to use condoms during anal sex with discordant primary partners (next three months);

Intent to get an HIV test (next three months);

Intent to get tested for STDs (next three months).

High-risk HIV-negative MSM (i.e., recent anal sex without condoms with a non-primary or HIV-discordant primary partner in the past three months):

Intent to uptake and adhere to PrEP/PEP regimens (next three months).

HIV-positive MSM:

Intent to reduce number of anal sex partners (next three months);

Intent to reduce overall number of (a) insertive and (b) receptive non-primary anal sex partners with whom a condom was not used (past three months);

Intent to use condoms during anal sex with non-primary partners (next three months);

Intent to use condoms during anal sex with discordant primary partners (next three months);

Intent to uptake and adherence to ART regimens (next three months);

Intent to get a viral load test, and/or reduce or maintain low viral load (next three months);

Intent to get tested for…