Technology Translation and Transfer of Effective HIV Prevention Interventions; Notice of Availability of Funds

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement 98098]

Technology Translation and Transfer of Effective HIV Prevention

Interventions; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1998 funds for a cooperative agreement

program for the technology translation and transfer of effective HIV

prevention interventions. This program addresses the ``Healthy People

2000'' priority area of Human Immunodeficiency Virus (HIV) Infection.

In order to slow the spread of HIV/AIDS, researchers have developed

and tested prevention interventions that aim to reduce sex-related and

drug-related

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risk behaviors. As a result of these studies, a number of interventions

with credible evidence of effectiveness have been identified. This

project will be a case study of the translation and transfer of an

effective intervention in a non-research setting.

The purpose of this project is to enhance access to and use of

effective interventions by service providers nationwide. Recipients

will develop prevention packages that are readily useable by service

providers. Recipients will develop prevention packages and refine them

as they are piloted in the field setting. This will serve as a case

study of the technology transfer process.

The specific purposes of this program are to: (1) Translate an

individual or small group HIV prevention intervention (especially those

targeted to persons at increased risk of HIV infection) with credible

evidence of effectiveness, i.e., an effective intervention. This first

activity is to be done in collaboration with health departments,

community-based organizations, or other service delivery providers who

can provide feedback and advice; (2) Develop a prevention package that

includes training materials and technical assistance protocols as well

as the intervention itself; and (3) Study the process of technology

transfer, using the prevention package in a field setting.

B. Eligible Applicants

Applications may be submitted by public and private nonprofit and

for-profit organizations and governments and their agencies. Thus,

universities, colleges, research institutions, hospitals, other public

and private organizations, State and local health departments or their

bona fide agents, federally recognized Indian tribal governments,

Indian tribes or Indian tribal organizations.

However, since the purpose of this technology translation and

transfer project is to build on successful research projects,

applicants must clearly demonstrate that their intervention has been

tested under rigorous study design criteria (including the use of a

control or comparison group) and found to be effective with significant

positive results for changing HIV risk behavior. The applicant must

have evidence that a report on this effective intervention has been

submitted for publication or has been published in a peer-reviewed

journal.

Note: Public Law 104-65 states that an organization described in

section 501(c)(4) of the Internal Revenue Code of 1986 that engages

in lobbying activities is not eligible to receive Federal funds

constituting an award, grant, cooperative agreement, contract, loan,

or any other form.

C. Availability of Funds

Approximately $400,000 is available in FY 1998 to fund

approximately 2 awards. It is expected that the average award will be

$190,000, ranging from $180,000 to $200,000. It is expected that the

awards will begin on or about September 30, 1998, and will be made for

a 12-month budget period within a project period of 2 years. Funding

estimates may vary and are subject to change based on availability of

funds. An application requesting greater than $200,000 will not be

considered for review and will be returned to the applicant.

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. Continued funding for year 2 will be

dependent on the completion of required activities for year 1.

Applicants should anticipate that a portion of year 2 funding may be

used in the field setting (approximately $20,000) as needed to

implement the program.

Use of Funds

Collection of new or supplemental intervention research data, data

entry and analysis, purchase of furniture or computers, and rental of

facilities will not be funded under this program.

D. Program Requirements

In conducting activities to achieve the purpose of this

announcement, the recipient will be responsible for the activities

under 1, Recipient Activities, and CDC will be responsible for the

activities listed under 2, CDC Activities.

1. Recipient Activities

a. Develop the intervention portion of the prevention package.

(1) The recipient will develop the package in collaboration with

representatives of HIV prevention service delivery programs, e.g.,

health departments, community-based organizations (CBOs).

(2) Prevention packages should include:

(a) Language and format that are understandable and attractive to

service providers who are nonresearchers.

(b) A full description of the intervention, including the

background and the target population.

(c) A list and description of the core elements for the pre-

implementation, implementation, and maintenance phases.

(d) Protocols for implementing the intervention and ensuring its

quality and consistency.

(e) Specific guidelines for overcoming barriers to implementation.

(f) A list of all staff, facility, and material resources needed to

conduct the intervention, including level of staff skill and time

commitment, and cost breakdowns.

(g) A time line of specific steps for setting up the intervention.

(h) A bibliography of publications based on the intervention.

b. Develop the training and technical assistance portion of the

prevention package.

(1) The recipient should develop training materials that can be

used in preparing providers to use the prevention package. These

materials will assist the user with pre-implementation and

implementation tasks necessary to undertake the intervention during

year 2. The materials should emphasize experiential learning and other

active methods associated with skill building.

(2) The recipient should develop an outline for providing technical

assistance which identifies the likely technical assistance requests

that users may make and an appropriate response for each request.

c. Produce a limited number of draft prevention packages.

The recipient will produce draft packages using less costly

materials than those to be used in the final product, but without

changing the overall effect, e.g., less heavy stock paper for binding

covers but with same logo or design, notebook rather than bound.

d. Identify an organization or field setting for case study.

(1) Compile a list of HIV prevention service agencies in the

recipient's state or within close proximity to the recipient's city

which target populations for whom the intervention is appropriate (for

this announcement, such agencies will be referred to as potential

users);

(2) Create approaches to establish linkages with the potential

users and strategies to market the prevention package to them.

(3) Select ways to inform potential users who express interest

about the availability of a case study experience.

(4) Develop a written agreement with the organization selected for

the case study (for this announcement, such organization will be

referred to as the user).

e. Develop the evaluation plan.

(1) Data should be both quantitative and qualitative and should

include

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observations and reports that permit assessment of the fit between the:

(a) core elements specified in the prevention package and the

content of the implementation.

(b) methods specified in the prevention package and the delivery of

the intervention, but no behavioral or health outcomes data should be

collected.

(2) Process data should include observations and reports of:

(a) barriers to implementation and how they impacted the case study

(b) solutions to barriers

(c) cost containment strategies.

During the second year, the recipient will complete the development

of training materials, technical assistance outlines, and process

evaluation protocols necessary to initiate the case study. Data

collection will take place throughout the case study or for

approximately 6 months (based on an estimated delivery of one program

per week). The final three months of the project will be used to

analyze the process data and refine the prevention package.

2. CDC Activities.

a. Host a meeting with the successful applicants within 60 days of

the notice of grant award to discuss implementation of the project.

b. Provide technical assistance in the general operation of this

HIV prevention project.

c. Consult on the choice of user for a case study with the

prevention package.

d. Monitor and evaluate scientific and operational accomplishments

of this project through frequent telephone contact and review of

technical reports and interim data analyses.

e. Conduct site visits to assess program progress and mutually

solve problems, as needed.

f. At the end of the two year project, CDC, in addition to the

authors, may distribute the package.

E. Application Content

Develop applications in accordance with PHS Form 5161-1 (OMB Number

0937-0189) and the instructions and format provided below.

Submit the original and two copies of PHS Form 5161-1 (OMB Number

0937-0189) and the original and two copies of the application. The

application may not exceed 20 double-spaced pages, excluding abstract,

index, and appendices. Submit the original and each copy of the

application UNSTAPLED and UNBOUND. Print all material double-spaced, in

a 12-point or larger font size on 8\1/2\'' by 11'' paper, with at least

1'' margins, and printed on one side only. Provide a one-page abstract

of the proposal and a complete index to the application and its

appendices. Beginning with the first page of text, number all pages

clearly and sequentially. Number each page of the appendices also,

e.g., for Appendix #1, the pages should be numbered: A1-1, A1-2, A1-3.

Replace double-sided article reprints with a one-sided copy.

Include a general introduction, followed by one narrative

subsection for each of the numbered content elements per application,

in the order in which the elements appear below. Label each narrative

subsection with the element title and include all the information

needed to evaluate that element of the application (except for

curriculum vitae, references, and letters of support, which are

appropriate for the appendices). The application content elements are:

1. Effective intervention

a. Identify the principal investigator(s) and name and location of

the agency(ies) that originally developed, conducted, and evaluated the

small group or individual level intervention research.

b. Provide written permission from the original developers of the

intervention to develop and market materials that may be original or

derived for the prevention package.

c. Describe the study's positive results on behavioral or health

outcomes, including how these results are both statistically and

practically significant.

d. Include in the appendix, a copy of any reports that describe the

study design and the positive behavioral or health outcomes of a small

group or individual level intervention that have been submitted for

publication or published in peer reviewed journals. This portion of the

appendix should be labeled as ``Intervention Study Design and

Results.''

e. Substantiate the need for a prevention package in terms of risk

of target population and potential for generalizability to other target

groups.

f. Describe the feasibility of implementation by other

organizations, particularly those with limited resources.

2. Prevention package

a. Describe the prevention package. Include descriptions of:

(1) Target populations for whom the intervention would be

appropriate;

(2) Pre-implementation phase, including specific steps for setting

up the intervention, necessary collaborators, necessary materials,

other resources, staff commitment (numbers and time) and skills for

conducting the intervention, and training materials;

(3) Implementation phase, including protocols for implementing the

intervention and ensuring quality and consistency and providing

technical assistance, identification of barriers to implementation and

how they may be overcome, and process evaluation methods; and

(4) Maintenance phase, including how to deal with issues of staff

turnover and retraining.

b. Explain how staff from HIV prevention programs (e.g., health

departments and CBOs) within the applicant's state or within close

proximity to the applicant's home city will be involved in the

development of the package. Describe the planned procedures for how

these collaborators will be identified.

c. Present a time line for developing the prevention package.

3. Field site for implementation of the package in year two (2)

a. Discuss a plan to identify and recruit potential users within

your state or within close proximity to your home city and indicate any

which already have shown interest in or may be interested in

implementing this intervention.

b. Elaborate on the criteria and mechanism for selecting the

user(s) who will implement the package.

Note: The agency that originally conducted the intervention is

excluded from consideration as a potential user, as is any agency

that currently or previously implemented the intervention.

4. Strategy to assist implementation

a. Describe the strategy to facilitate implementation of the

package, including provision of training and direct technical

assistance from the recipient to the selected user(s).

b. Discuss procedures to involve user(s) in implementing the

package, including use of user's existing staff and resources, and to

identify barriers to implementation and how to overcome them.

Feasibility and sustainability of the intervention with existing

resources are important for the successful adoption and maintenance of

the package.

5. Plan to evaluate the implementation process

Describe the plan for evaluating the process of implementing the

prevention package. The plan should address (unless not applicable):

(1) methods, (2) quality assurance monitoring of intervention delivery

including documentation of intervention episodes, (3) employee

recruitment and retention, (4) participant recruitment, (5) accuracy

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and completeness of record keeping, and (6) costs of intervention

delivery.

6. Capacity

a. Demonstrate capacity to conduct the proposed activities

including the process evaluation.

b. Describe the proposed staffing, show percentages of each staff

member's commitment to this and other projects, and division of duties

and responsibilities for this project; include brief position

descriptions for existing and proposed personnel.

c. Demonstrate that the staff have the expertise to complete this

project, including ability to produce the intervention product(s).

Demonstration of this capability would include examples of previously

developed fact sheets, web sites, or samples from other intervention

packages.

d. Name the staff members who are key to the completion of the

project. Provide a brief description of the strengths each brings to

this project. Include their curriculum vitae in the appendix.

e. Describe access to graphics expertise for production and editing

of the intervention package.

f. Describe equipment and facilities to be used for the proposed

activities.

7. Budget

Provide a detailed, line-item budget for the project; justify each

line-item, including the need for any proposed consultants and

contractors. Plan for at least two trips to Atlanta to meet with CDC

representatives.

F. Submission and Deadline

Submit the original and two copies of PHS 5161-1 (OMB Number 0937-

0189). Forms are in the application kit. On or before August 17, 1998,

submit the application to: Maggie Slay Warren, Grants Management

Specialist, Grants Management Branch, Procurement and Grants Office,

Announcement 98098, Centers for Disease Control and Prevention (CDC),

Room 300, 255 East Paces Ferry Road, NE., M/S E-15, Atlanta, Georgia

30305-2209.

If your application does not arrive in time for submission to the

independent review group, it will not be considered in the current

competition unless you can provide proof that you mailed it on or

before the deadline (i.e., receipt from U.S. Postal Service or a

commercial carrier; private metered postmarks are not acceptable).

G. Evaluation Criteria

Each application will be evaluated individually against the

following criteria by an independent review group appointed by CDC.

1. Behavioral Intervention (20 percent)

The applicant must clearly demonstrate the effectiveness of the

proposed small-group or individual-level intervention in a report that

has been submitted for publication or has been published in a peer-

reviewed journal. This is an absolute criterion. If this evidence is

not present, score as zero.

a. The intervention is directed to small groups or individuals,

especially persons at increased risk of infection.

b. The applicant provides justification if proposing to conduct the

intervention with any groups other than the initial target population.

c. The applicant addresses the feasibility of implementing the

prevention package by organizations with limited resources.

2. Prevention Package (15 percent)

Level of detail in the description or outline of the proposed

package, including materials, protocols, and guidelines. Clarity of

described format and concepts; intended audiences; and objectives.

Justification of the appropriateness of the package's objectives,

format, and concepts to the intended users' needs and capabilities.

Adequacy of input from HIV prevention programs into the development of

the package. Adequacy of planned materials' review, pretesting, and

revision of materials as needed. Adequacy of time scheduled for

completing the proposed steps of the package's development.

3. Plan to Identify Field Site(s) to Implement the Package (10 percent)

Quality of plan to identify appropriate and eligible intended users

and interest them in adopting the package during year 2 of the project.

Selection of proactive methods to identify and solicit intended users.

Adequacy of criteria and mechanism for selecting the users for

implementing the package in year 2, including match of the

intervention's target population with the user's community planning

priorities. Recognition that the agency that originally conducted the

intervention is excluded from implementing the package.

4. Strategy to Assist Implementation (15 percent)

Clarity of the strategy to assist selected users in adopting and

implementing the behavioral intervention. Understanding of barriers to

implementation and how to overcome them. Plan to assist selected users

in implementing the intervention by using their existing resources and

staff, including provision of on-call technical assistance. Plan to

help selected users find additional funds for implementing the package,

if relevant.

5. Plan to Evaluate Implementation Process (15 percent)

Feasibility and appropriateness of the applicant's plan to evaluate

the selected user's implementation of the intervention as specified in

the replication package. Thorough and realistic selection of process

measures to evaluate.

6. Demonstrated Capacity (15 percent)

Overall ability of the applicant to perform the proposed activities

as reflected in their staff's and consultants' qualifications and

availability. The extent to which the applicant's demonstrates that

proposed staff have experience with material development and

dissemination and demonstrated familiarity with HIV behavioral

interventions, in general, and the intervention to be publicized, in

particular. The nature and extent of any partnership between

researchers and HIV prevention programs. Adequacy of existing support

staff, equipment, and facilities.

7. The degree to which the applicant has met the CDC Policy

requirements regarding the inclusion of women, ethnic, and racial

groups in the proposed research (10 percent)

This includes:

a. The proposed plan for the inclusion of both women and racial and

ethnic minority populations for appropriate representation.

b. The proposed justification when representation is limited or

absent.

c. A statement as to whether the design of the study is adequate to

measure differences when warranted.

d. A statement as to whether the plans for recruitment and outreach

for study participants include the process of establishing partnerships

with communities and recognition of mutual benefits.

8. Does the application adequately address the requirements of Title 45

CFR Part 46 for the protection of human subjects?

______YES

______No

Comments:____________________

9. Budget (not scored)

Extent to which the budget is reasonable, itemized, clearly

justified,

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and consistent with the intended use of the funds. Extent to which the

budget includes itemizations, justifications, scope, and deliverables

for consultants or contractors.

H. Other Requirements

Technical Reporting Requirements

An original and two copies of semi-annual progress reports are

required. Timelines for the semi-annual reports will be established at

the time of award. Final financial status and performance reports are

required no later than 90 days after the end of the project period. All

reports are submitted to the Grants Management Branch, CDC.

At the completion of 2 years of funding, recipients will be

expected to share prevention packages with representatives of the

original agencies that conducted the interventions on which the

products are based, if different from those of the recipient.

The following additional requirements are applicable to this

program. For a complete description of each, see Attachments.

AR98-1 Human Subjects Requirements

AR98-2 Requirements for Inclusion of Women, Racial and Ethnic

Minorities in Research

AR98-4 HIV/AIDS Confidentiality Provisions

AR98-5 HIV Program Review Panel Requirements

AR98-7 Executive Order 12373 Review

AR98-8 Public Health System Reporting Requirements

AR98-9 Paperwork Reduction Act Requirements

AR98-10 Smoke-Free Workplace Requirements

AR98-11 Healthy People 2000

AR98-12 Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 301 and 317(k), of the

Public Health Service Act [42 U.S.C. 241 and 247b], as amended. The

Catalog of Federal Domestic Assistance number is 93.941.

J. Where to Obtain Additional Information

To receive additional written information, call (888) 472-6874. You

will be asked to leave your name, address, and telephone number. Please

refer to Program Announcement 98098 when you request information. For a

complete program description, information on application procedures, an

application package, and business management technical assistance,

contact: Maggie Slay Warren, Grants Management Specialist, Grants

Management Branch, Procurement and Grants Office Announcement 98098,

Centers for Disease Control and Prevention (CDC), Room 300, 255 East

Paces Ferry Road, NE., M/S E-15, Atlanta, GA 30305-2209 telephone (404)

842-6797. Email address http://www[email protected]

See also the CDC home page on the Internet: http://www.cdc.gov

For program technical assistance, contact: Robert Kohmescher,

Division of HIV/AIDS Prevention, National Center for HIV/STD/TB

Prevention, Centers for Disease Control and Prevention (CDC), 1600

Clifton Road, NE., Mailstop E-44, Atlanta, GA 30333 telephone (404)

639-8302 email: [email protected]">[email protected]

Please refer to Announcement number 98098 when requesting

information and submitting an application.

Dated: July 6, 1998.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98-18389 Filed 7-9-98; 8:45 am]

BILLING CODE 4163-18-P