Communication and Negotiation About Barrier Contraceptive Use Among Young Adults at Risk; Notice of Availability of Funds

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Federal RegisterMar 28, 2003
68 Fed. Reg. 15191 (Mar. 28, 2003)

Application Deadline: May 27, 2003.

A. Authority

This program is authorized under sections 301(a) and 317(k)(2) of the Public Health Service Act, [42 U.S.C. sections 247b(k)(2)], as amended. The Catalog of Federal Domestic Assistance number is 93.283.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year 2003 funds for a cooperative agreement for Communication and Negotiation About Barrier Contraceptive Use Among Young Adults At Risk. This program addresses the “Healthy People 2010” focus areas family planning, HIV, and sexually transmitted diseases.

The purpose of this program is to investigate the context within which sexually active young adult African American and Latino women and men (ages 18-25) communicate sexual values and negotiate about barrier contraceptive use (use of male condoms, female condoms, or the diaphragm). The program will develop, implement and evaluate case study intervention models to encourage choices and effective negotiation skills for prevention of HIV/STDs and unplanned pregnancies.

In Phase I, support will be provided for multi-method formative approaches toward understanding communication between heterosexual partners about sexual abstinence, monogamy, and barrier contraceptive use and factors influencing implicit expectations (about gender roles, reproductive ambivalence, competing contraceptive alternatives, power, cultural values, social norms, etc.) and explicit negotiation processes. This phase will culminate with the development of a plan for an intervention model.

Phase II will support implementation of case studies of community-based intervention models to facilitate communication about reproductive decision making and barrier contraceptive use among young adult women and men with their partners, using information gathered in Phase I.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP): Support prevention research to develop sustainable and transferable community-based behavioral interventions.

C. Eligible Applicants

Applications may be submitted by public and private nonprofit organizations and by governments and their agencies; that is, universities, colleges, technical schools, research institutions, hospitals, other public and private nonprofit organizations, community-based organizations, faith-based organizations, state and local governments or their bona fide agents, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau, federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations. Title 2 of the United States Code section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

D. Funding

Availability of Funds

Approximately $800,000 is available in FY 2003 to fund approximately two awards. It is expected that the average award will be $400,000, ranging from $300,000 to $450,000. It is expected that the awards will begin on or about September 1, 2003 and will be made for a 12-month budget period within a total project period of five years; the first phase will be for two-three years and the second phase will occur during the subsequent two-three years. Awards for Phase II will be subject to documented collaboration with community partner(s) and availability of funds. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Recipient Financial Participation

No matching funds are required for this program.

Funding Priority

Priority will be given to projects that demonstrate access to and propose to target young adult women and men at high risk for STDs, including HIV, and unintended pregnancies. Communities in which research is to be conducted, and interventions fielded, should be predominately African American or Latino and disproportionately affected by HIV and other STDs. Priority will be given to communities with rates of chlamydia, gonorrhea, and teen pregnancy that are above national average rates.

Funds may be awarded in such a way as to achieve geographic distribution of funded projects.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for activities listed under Recipient Activities, and CDC will be responsible for activities listed under CDC Activities.

Recipient Activities

The recipient will be responsible for conducting the research outlined in Phase I, and using the formative research collected during this Phase to develop an intervention plan and case study evaluation for Phase II. Funding for Phase II will be contingent upon satisfactory progress as evidenced by required reports, the intervention plan, the documented establishment of a formal collaboration with a community-based organization equipped to implement the intervention model, and availability of funds. A complete description of the activities required within Phase I and Phase II follows.

Phase I (Years One to Two or One to Three)

This program announcement seeks a multi-method approach toward understanding the complexity of communication between partners: To what extent does negotiation about sexual choices, including monogamy, abstinence, and explicit barrier contraceptive use take place and by whom; the nature of the actual communication processes; and the context within which they lead to different outcomes. In this initial formative phase of the project, applicants are encouraged to propose creative, innovative data collection methods that will yield information about individual, social, and cultural factors that affect contraceptive decision making and behavior that may be used in the Phase II intervention design.

Activities to be conducted are:

1. Clearly identify key research questions to be addressed including, but not limited to:

a. How do young adult men and women make decisions about abstinence, sexual initiation, and monogamy?

b. How do sexually active young adult men and women decide to use barrier contraception and how are these choices negotiated? Or if not directly negotiated, how do social roles, norms, and expectations influence these decisions?

c. How are intimacy and commitment to mutual monogamy assumed, expected, and communicated between partners, and how do couples that perceive themselves as mutually monogamous communicate about barrier methods?

d. Are power differentials between young adult men and women perceived, and if so, how are they communicated (verbally or nonverbally)?

e. What are the tacit assumptions made or the explicit negotiation strategies commonly used by young women and men and how do partners respond to each approach (what contextual factors are important)?

f. Do young adult women and men use hierarchical strategies, if they have multiple contraceptive methods available?

g. What social and cultural factors predict young adult men's receptiveness to safe sex negotiation strategies offered by a female partner? What social and cultural factors predict young adult men's ability or willingness to negotiate?

h. How does marital and childbearing motivation, including cultural expectations, ambivalence about pregnancy and perceptions of each other's desires affect communication?

i. How do young adult men communicate their reproductive values to their partners and what is the context in which this occurs?

j. How does communication about hormonal contraceptive use (e.g., oral contraceptives, implants, injectables, ring, patch) occur and what is the context in which it occurs or what prompts it to occur?

2. Conduct comprehensive literature review related to identified research questions.

3. Identify and recruit sexually active women and men, ages 18-25 from predominantly African American or Latino communities with documented HIV/STD risk characteristics (rates of chlamydia, gonorrhea, and teen pregnancy above national average rates).

4. Conduct formative research activities such as the following, but not limited to:

a. Development of vignettes or scenarios depicting communication of values and barrier negotiation strategies. Presentation of these vignettes to young adult men and women (individually or in groups), and assessment of their qualitative responses, similar experiences, and further development of the situations (for intervention planning).

b. Mixed or same sex focus groups to explore cultural/environmental influences and the role of peers in shaping attitudes toward communication about sexual values and choices, including barrier contraception. If focus groups are conducted, ensure that the appropriate privacy concerns are addressed, as information provided will be sensitive and confidential.

c. In-depth qualitative interviews with young adult men and women who are sexually active. May consider their specific experiences with barrier contraceptive use, including successful communication, avoidance of use or dissuasion of a partner, partner responses, and perceptions of partner attitudes, roles, and monogamy. May explore implicit or explicit reproductive issues along with the context of negotiating hormonal contraceptive use (including newer methods, such as the contraceptive patch, ring, and emergency contraception).

d. Observational study of cohort of sexually active young adult men and women provided with barrier contraceptives (male condom, female condom, or diaphragm), trained in use of coital diaries (possibly a software log), and interviewed at follow-up intervals to assess act-by-act experiences with negotiation and partner communication (including contextual factors).

5. Conduct analyses of data collected using, but not limited to, these methods:

a. Identify the characteristics of different negotiation/communication styles among young adult women and men.

b. Identify key influences on these negotiation and communication styles.

c. Develop or identify existing quantitative measures of key variables that could be used in Phase II and be hypothesized to predict the behavior of women and men with different communication styles.

d. Collaborate with other recipients in the development and measurement of a common core set of variables to permit comparative analyses.

6. Develop a plan for using this formative research in the design of a theory and evidence-based intervention model feasible for implementation in a community-based case study.

a. Present relevant conceptual foundation for the model.

b. Integrate the results of the research with literature on communication interventions and strategies. As part of this synthesis, thoroughly document the intervention models and strategies that already exist.

c. Based on formative research, theory and the review of the intervention research, develop state-of-the-art recommendations on intervention strategies to promote successful negotiation and communication for young adult women and men at risk. These interventions must consider the characteristics of the community and cultural contexts of the participants' lives.

d. Collaborate with other recipients during development of design and protocol.

7. Establish and document formal collaboration with a community-based organization(s) or partner qualified to carry out the work proposed in Phase II.

Phase II (Years Three to Five or Four to Five)

Case Study: Community-Based Intervention Models

Project(s) in this phase would implement and conduct a feasibility assessment of an intervention for facilitating reproductive decision-making and effective barrier contraceptive negotiation by young adult women and men based on the selected intervention plan. Proposed interventions should address the subtle strategies and interpersonal pathways to successful communication, the contextual (social normative, etc.) factors that facilitate or constrain negotiation and communication, and be designed to influence large numbers of young adult men and women in a community. Applicant activities to be conducted are:

1. Collaborate with community partners and members of the target group to plan all phases of the project.

2. Identify a community site for implementation of the case study. A comparison community may be used as part of a case study approach to evaluation that includes extensive process evaluation, documenting all aspects of program design and implementation.

3. Clearly state the objectives of the proposed intervention model.

4. Propose an intervention model that could be replicated in community-based settings (a concept and preliminary approaches proposed in this application must be fully developed based on Phase I: six a-d).

5. Develop and implement community-based intervention strategies that have the potential for broad reach and high impact.

6. The cost effectiveness of the model as a public health intervention must be addressed. Interventions that are costly and logistically difficult for implementation in public health settings, such as couples-based counseling interventions for young adults, will not be supported by this announcement.

7. Collaborate with other recipients during the development and implementation of the project evaluation.

CDC Activities

1. Host meetings each year to facilitate planning of the research program and to promote progress toward meeting national health objectives.

2. Provide technical assistance in the design and development of the formative research, scientific review and evaluation of measurement strategies and instruments, and development of operational plans for the protocols. Coordinate review of intervention plans and process evaluation strategies.

3. Coordinate plans for data management and analysis of data from Phase I and Phase II; assist with development of plan for, and participation in analysis, preparation, and reporting of results.

4. Assist with development of a research protocol for Institutional Review Board (IRB) review by all cooperating institutions participating in the research project. Perform site visits to assess program progress and to provide technical assistance.

F. Content

Letter of Intent (LOI)

A LOI is required for this program. The Program Announcement title and number must appear in the LOI. The LOI narrative should be no more than three pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point font. The LOI will be used to enable CDC to determine the level of interest in the announcement and should include the following information: Target group and site characteristics, experience collaborating with relevant community partner(s) and specific objectives to be addressed in the proposed project.

Applications

Program announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The application narrative should be no more than 25 pages single-spaced, printed on one side, with one-inch margins, and unreduced 12-point font.

The narrative should consist of a Background and Significance section, a Plan, Objectives, Methods, a Research and Intervention Capacity section, a Collaboration section, Evaluation, and Budget.

G. Submission and Deadline

Letter of Intent (LOI) Submission

On or before April 28, 2003. Submit the LOI to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application Forms

Submit the signed original and two copies of application form PHS 398. Forms are available at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

The application must be received by 4 p.m. Eastern Time May 27, 2003. Submit the application to: Technical Information Management-PA# 03037, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Rd, Atlanta, GA 30341-4146.

CDC Acknowledgement of Application Receipt

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your LOI and application.

Deadline

Letters of intent and applications shall be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their LOI or application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an LOI or application is received after closing due to (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any LOI or application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the grant or cooperative agreement. Measures of effectiveness must relate to the performance goal stated in section “B. Purpose” of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness shall be submitted with the application and shall be an element of evaluation.

An independent review group appointed by CDC will evaluate each application against the following criteria (in order of weight):

1. Methods (30 points)

The extent to which the design, methods, plans for instrument development, data collection, and analysis for Phase I are scientifically sound and capable of producing the intended results. The extent to which the research is innovative and represents a new approach by integrating new literature sources and using sophisticated methodology to identify subtle or complex communication variables. The extent to which the data synthesis process can be clearly used in a timely manner for development of the Phase II intervention plan. The extent to which the proposed intervention approaches for Phase II represent a consideration of appropriate theoretically, empirically, and programmatically justified intervention approaches which could realistically be adapted using Phase I data. The proposed intervention model should be feasible in community-based settings in which many women and men might be influenced. The extent to which the applicant describes a plan for process evaluation to be conducted during Phase II.

2. Background and Significance (15 points)

The extent to which the applicant: Describes the background leading to the application, including the theoretical or conceptual framework; critically evaluates existing knowledge; specifically identifies gaps that the Phase I project is intended to fill; and describes the target population and the potential health impact of the research and intervention.

3. Plan (15 points)

The quality of the justification for the theoretical, empirical and programmatic focus of Phase I research and the approach proposed for the Phase II intervention model (approaches and concepts considered for design of Phase II are expected in the application; the proposed intervention plan may be revised and will be fully developed at the end of Phase I).

The extent to which the applicant describes the proposed research plan for Phase I and the plan for establishing collaboration with a community-based organization/partner qualified to carry out the work proposed in Phase II. In Phase I, linkage between the research questions and the formative research activities should be clearly presented. The extent to which the applicant proposes a feasible case study plan for Phase II.

The applicant must address the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research plan. This includes:

1. The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.

2. The proposed justification when representation is limited or absent.

3. A statement as to whether the design of the study is adequate to measure differences when warranted.

4. A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

4. Objectives (10 points)

The extent to which the applicant describes the broad objectives and the specific research questions this project is intended to address in Phase I and II. The research questions must address multiple levels: individual, partner, social, cultural, and other contextual variables. The objectives must be quantifiable in terms of output and timeline.

5. Research and Intervention Capacity (10 points)

The extent to which the applicant provides an account of the research team members' studies pertinent to the application that will help establish the experience and competence of the team members to pursue both phases of the proposed project. The extent to which the applicant documents access to researchers with experience and training in analysis of qualitative data, demonstrates the capacity to obtain the participation of adequate numbers of male and female participants from the proposed sites, and describes the adequacy of the staff (in each phase) and facilities to feasibly carry out the project. Extent of experience with formative research on this topic, experience conducting community-based interventions addressing sexual risk behavior or reproductive health, and experience implementing process evaluations.

6. Collaboration (10 points)

The extent to which the applicant describes how community partners and members of the target group will be involved in Phase I and potentially Phase II, defines the responsibilities of organizations in the community on this project and highlights past involvement with community-based organizations or partners (provides letters of support).

7. Evaluation (10 points)

The methods by which the applicant proposes to measure progress in meeting goals and objectives, and presents a reasonable plan for collecting data, analyzing data, and reporting the results. Quality assurance plan must be addressed.

8. Budget (reviewed but not scored)

The extent to which the budget and justification are consistent with program objectives and purpose.

9. Human Subjects Involvement (reviewed but not scored)

The extent to which the applicant addresses the requirements of 45 CFR part 46 for the protection of human subjects. Not scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

10. Performance Goals (reviewed but not scored)

The extent to which the applicant addresses the relevant Performance goals. The relevant goals include (timeline may vary):

Year 1: Design the formative research component, including literature review, methods, sampling frame, data collection instruments, and IRB package.

Year 2: Conduct data collection and prepare a detailed analysis and publication plan.

Year 3: Analyze the data, synthesize data with review of literature on communication interventions and strategies, prepare a report and develop an intervention and evaluation plan.

Year 4: Pending approval and funds, implement the intervention and prepare an interim process evaluation report.

Year 5: Evaluate the intervention and prepare a final report summarizing results of the case study and recommendations for technology transfer.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. An interim progress report. The interim progress report will be due on the 15th of March each year through 2008. This interim progress report will serve as your non-competing continuation application. A second report is due 90 days after the end of each budget period. These reports must include the following elements:

a. A succinct description of the program accomplishments and progress made in meeting each Current Budget Period Activities Objectives during the previous six months of the budget period.

b. A succinct description of the program accomplishments/narrative and progress made in meeting each Current Budget Period Activities Objectives during the previous six months of the budget period.

c. The reason(s) for not meeting established program objectives and strategies to be implemented to achieve unmet objectives.

d. Current Budget Period Financial Progress.

e. New Budget Period Proposed Activities and Objectives.

f. Detailed Line-Item Budget and Justification.

g. For all proposed contracts, provide the name of contractor, method of selection, period of performance, scope of work, and itemized budget and budget justification. If the information is not available, please indicate “To Be Determined” until the information becomes available; it should be submitted to CDC Procurement and Grants Management Office contact identified in this program announcement.

2. Financial status report, no more than 90 days after the end of the budget period. The financial status report should include an attachment that identifies unspent balances for each program component.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement as posted on the CDC Web site.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-5 HIV Program Review Panel Requirements

AR-7 Executive Order 12372 Review

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC Web site, Internet address: http://www.cdc.gov.

Click on “Funding” then “Grants and Cooperative Agreements''.

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146, Telephone: 770-488-2700.

For business management and budget assistance, in the states, contact: LaKassa Wyatt, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone: 770-488-2728, E-mail address: Lwyatt@cdc.gov.

For business management and budget assistance in the territories, contact: Charlotte Flitcraft, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone: 770-488-2632, E-mail address: caf5@cdc.gov.

For program technical assistance, contact: Rebecca Cabral, Ph.D., Division of Reproductive Health, Centers for Disease Control and Prevention, 4770 Buford Hwy, NE., Atlanta, GA 30341, Telephone: 770-488-6399, E-mail address: Rcabral@cdc.gov.

Dated: March 24, 2003.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.

[FR Doc. 03-7452 Filed 3-27-03; 8:45 am]

BILLING CODE 4163-18-P