Page 14, 29 Corrected Appendix PDF File Limit to 10

Amendment I (12.12.11):

Page 14, 29 – Corrected appendix PDF file limit to 10.
Pages 29-31 - Added Questions and Answers from the conference call held on December 2, 2011.

Part 1. Overview Information
Part 2. Full Text of the Announcement

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 (CDC)

Components of Participating Organizations

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

Funding Opportunity Title

/ Formative Research on Use of Mobile Applications (“app”) to Increase HIV Testing Behavior and HIV Prevention with Positive Persons

Mechanism of Support

/ U01 Research Project Cooperative Agreements

Announcement Type

/ New

Funding Opportunity Announcement (FOA) Number

/ RFA-PS-12-001

Catalog of Federal Domestics Assistance (CFDA) Number(s)

/ 93.941; HIV Demonstration, Research, Public and Professional Education Projects

Category of Funding Activity

/ Health

FOA Purpose

/ The purpose of this funding announcement is to fund one applicant to conduct formative research to understand the needs, barriers, and facilitators of using mobile phone applications (‘apps’) for HIV prevention. Findings from this project will be used by the CDC to develop future HIV prevention mobile apps to support public health.

Key Dates

Publication Date

/ November 10, 2011
To receive notification of any changes to RFA-PS-12-001, return to the synopsis page of this announcement at click on the “Send Me Change Notification Emails” link An email address is needed for this service.

Letter of Intent Due Date

/ Not Applicable

Application Due Date

/ January 6, 2012, 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., error correction window).

Scientific Merit Review

/ February, 2012

Secondary Review

/ April, 2012

Start Date

/ July 1, 2012

Expiration Date

/ January 7, 2012

Due Dates for E.O. 12372

/ Due no later than 60 days after the application receipt date.

Required Application Instructions

It is critical that applicants follow the instructions in theSF 424 (R&R) Application Guideexcept where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance toall 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.

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

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

Part 2. Full Text

Section I. Funding Opportunity Description

Statutory Authority

Sections 318 and 319 of the Public Health Service Act 42 U.S.C. Sections 247(b)(k)(2) and 247c(b), as amended.

Background

Formative research will be conducted in the United States to explore the need for two different HIV prevention mobile phone applications (“apps”):

(1) an app for meeting the HIV prevention and health care needs of persons living with HIV, including adherence to HIV medications, retention in care, and treatment management, and

(2) an app encouraging HIV testing by identifying testing sites and providing periodic reminders for testing among high risk men who have sex with men (MSM).

The two apps will be stand alone applications, and should be considered independently during the research planning.

Qualitative ethnographic methods and user-centered human-computer interaction research methods will be used to identify the mobile technology needs of users, mobile app design preferences, as well as the barriers and facilitators that prohibit or encourage the uptake and sustained use of mobile apps for HIV prevention. Findings will identify technology preferences and features, HIV related content requirements, design specifications, and issues related to long term appeal and maintenance of apps in at-risk or affected populations.

Future HIV prevention apps for Smartphones (such as the iPhone and Android phones) and other new media technologies for HIV prevention will be developed using the findings from this project. This funding opportunity is not for the development of the mobile applications.

Tools developed using this research have the potential to extend the impact and reach of HIV testing programs for high-risk MSM and HIV prevention and health care for persons living with HIV.

The purpose of the program is toconduct formative research to understand the needs, barriers, and facilitators of using mobile phone applications (‘apps’) for HIV prevention. This program addresses the “Healthy People 2020” focus area(s) of HIV testing and HIV care and treatment.

Through this announcement, the CDC intends to fund applications that have the potential to yield high impact research results by reducing burden and improving population health on a large scale.

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

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- 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.

Objectives:

The applicant must respond to ALL objectives 1 and 2 below:

1.Conduct formative research with HIV seropositive persons and HIV care providers to identify acceptable and appropriate features for a mobile app designed to provide up-to-date HIV prevention and health care information, HIV treatment management and adherence assistance, support for staying in care, and linkage with AIDS service providers, healthcare systems, and social support. Applicants must:

a.Recruit a sample of persons living with HIV and a sample of staff from agencies serving the needs of HIV seropositive clients for formative research.

i.Recruit a minimum of 50 people living with HIV.

1.HIV seropositive participants should be representative of persons with the greatest burden of HIV infection in the US, including racial and ethnic minorities and MSM.

2.Participants should include persons familiar with Smartphones, as well as persons unfamiliar with this technology.

3.The sample should include persons currently in HIV treatment, as well as those out of treatment or who experience difficulty maintaining treatment schedules.

4.Participants should include persons who are recently and previously diagnosed with HIV.

ii.Recruit a sample of at least 25 staff and professionals from AIDS service providers, clinics, and pharmacies with experience managing the HIV prevention and treatment needs of persons living with HIV.

1.Agencies and organizations should serve communities most affected by HIV infection in the US, including racial and ethnic minorities and MSM.

2.Participants should include persons familiar with Smartphones, as well as persons unfamiliar with this technology.

b.Use rapid qualitative needs assessment or rapid ethnographic methods, including interviews, focus groups, and surveys to identify the needs, barriers and facilitators of mobile app use in the target population.

c.Conduct user-centered research and analysis to inform the development of a Design Document. The Design Document provides the functional requirements and user case scenarios for the mobile design. Methods may include review of best practices, focus groups, user surveys (both online and/or telephone), and usability assessment.

d.Obtain all local and federal regulatory approvals prior to beginning data collection, as required (including OMB, IRB).

e.Collect qualitative and quantitative data to:

i.Identify the HIV prevention, treatment, and management needs of HIV seropositive persons for a mobile app.

ii.Identify the barriers and facilitators for using mobile apps for HIV prevention with HIV seropositive persons.

iii.Identify app preferences (including platform and design requirements, navigational features, and marketing preferences) of HIV seropositive persons, including:

1.What information and other content is preferred.

2.How to integrate local resources.

3.How to interface with health care providers and health systems.

4.What are the preferred options for linking with care providers.

5.How to integrate with social support systems.

6.How to address privacy and confidentiality concerns.

7.How to support treatment adherence.

8.How to manage treatment schedules.

9.What are the preferences and requirements for a companion Website, including content and mobile Web access.

f.Provide a plan to disseminate findings for use by CDC and other public health practitioners for the future development of mobile apps for prevention with HIV seropositive persons.

2.Conduct formative qualitative research with MSM at high risk for HIV infection to identify acceptable and appropriate features for a mobile app intended to locate nearby HIV testing sites, encourage HIV testing, reminders to get regular HIV tests, and provide up-to-date local HIV prevention resources.

a.Recruit a diverse sample of a minimum of 50 MSM at high risk for HIV infection.

i.Participants should be representative of communities with the greatest burden of HIV infection in the US, including racial and ethnic minorities and young MSM (aged 13-29).

ii.Participants should include persons familiar with Smartphones, as well as persons unfamiliar with this technology.

b.Use rapid qualitative needs assessment or rapid ethnographic methods, including interviews, focus groups, and surveys to identify the needs, barriers and facilitators of app use in the target population.

d.Obtain all local and federal regulatory approvals prior to beginning data collection, as required (OMB, IRB).

e.Collect qualitative and quantitative data to:

i.Identify needs of MSM at high risk for HIV for a mobile testing app.

ii.Identify the barriers and facilitators to using a mobile HIV testing app for MSM at high risk for HIV.

iii.Identify app preferences (including platform and design requirements, navigational features, and marketing preferences) of MSM at high risk for HIV, including:

1.What HIV prevention, testing, and other content are preferred.

2.What HIV prevention messages should be integrated into the testing app.

3.How local HIV testing resources can be integrated.

4.How nearby HIV testing site locations can be accessed.

5.How to integrate with social networking Internet sites.

6.How to address privacy and confidentiality concerns.

7.What are the preferences for a supporting Website, including content and mobile web access preferences.

8.How to integrate the testing app into existing HIV prevention campaigns for MSM.

f.Provide a plan to disseminate findings for use by CDC and other public health practitioners in future development of HIV testing apps for MSM at high risk of HIV infection.

In addition, applicants must demonstrate:

1.Partnerships with HIV healthcare providers and agencies serving HIV seropositive persons (for objective 1, formative research for the HIV prevention, treatment, and adherence app):

a.Partnerships/collaborations should be established with AIDS Service Organizations, CBOs, physicians, clinics, healthcare systems, pharmacies, and local HIV prevention and treatment resources.

i.Partnerships/collaborations should be established with organizations such as AIDS Service Organizations, CBOs, clinics, healthcare systems, and pharmacies to: a) provide access to sufficient numbers of the target population for the proposed research activities, and b) consult on appropriate resources for features required for the app, such as prescription refill and medication reminders, appointment scheduling, support groups, and linkages to other needed services or testing resources.

ii.Collaborations and partnerships should be established with agencies serving HIV seropositive persons in communities most affected by HIV/AIDS.

iii.Evidence can include letters of support or memoranda of agreement (MOA) with all proposed partners and collaborators and reports of volume of clients served by proposed partners and collaborators.

2.That the sample is drawn from a jurisdiction in the United States with high HIV/AIDS burden.

3.Experience conducting qualitative research in HIV prevention or a comparable public health area, including use of rapid assessment procedures and methods, and analyzing and reporting qualitative data. Evidence can include publications and previous research as history documented in CVs of key personnel.

4.Experience in user-centered analysis, usability methodologies, and the development of Design Documents for mobile applications, Websites, or other media in public health or a related field. Evidence can include publications, products (software, websites, etc.) and previous research history as documented in CVs of key personnel.

5.Experience disseminating findings tailored to the needs of audiences and stakeholders. Evidence can include publications, products (software, websites, etc.) as documented in CVs of key personnel.

Assessing and Reporting the Intervention Translatability of the Research

Applicants must include a plan to estimate and report the potential translatability and public health impact of the research.

Section II. Award Information

Funding Instrument

/ Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

/ New

Funds Available and Anticipated Number of Awards

/ Year 1: $250,000
Anticipated number of awards: 1
Estimated total funding available for first year: $250,000
Estimated total funding for entire project period: $250,000
Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Ceiling and Floor of Individual Award Range

/ Applicants may not exceed the ceiling amount of $250,000 for the budget or project period or the application will not be reviewed.

Project Period Length

/ The project period will be 1 year.

Potential Applicant Conference Call

/ A conference call with all potential applicants will be held on Friday, December 2, 2011 at 01:00 PM E.T.
Phone Number: 1-866-620-0420 Passcode: 8943360

HHS/CDC grants policies as described in the HHS Grants Policy Statement( will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

Nonprofits (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other