[Federal Register Volume 65, Number 99 (Monday, May 22, 2000)]
[Notices]
[Pages 32101-32105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 00080]


Optimizing Strategies To Provide Sexually Transmitted Disease 
(STD) Partner Services; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2000 funds for a cooperative agreement 
research program for Optimizing Strategies to Provide STD Partner 
Services. CDC is committed to achieving the health promotion and 
disease prevention objective of ``Healthy People 2010'', a national 
activity to reduce morbidity and mortality and improve the quality of 
life. This announcement is related to the focus area(s) of Sexually 
Transmitted Diseases. For the conference copy of ``Healthy People 
2010'', visit the Internet site: http://www.health.gov/healthypeople. 
The goal of this cooperative agreement research program is to develop 
and evaluate the delivery of cost-effective, innovative, and 
confidential approaches to providing effective partner services within 
a time frame that interrupts the chain of STD transmission. Partner 
services (PS) are a critical component of STD control and prevention in 
public health practice.
    Initially, this process was named ``contact tracing,'' but was 
renamed ``partner notification'' in the past two decades. Three primary 
strategies for partner notification are described in the literature, 
although other variations are also employed. The most common strategies 
are patient referral (patients are encouraged to notify sexual 
partners); provider referral, (health care staff, traditionally in the 
health department, notify partners); or contract referral (a time limit 
is agreed upon for patient referral, after which provider referral is 
initiated). In this program announcement, ``partner services'' is used 
to describe the constellation of services that should be provided to 
the sexual partners of individuals in whom a sexually transmitted 
disease has been detected and treated.
    The purpose of PS is to break the chain of infection and re-
infection that can occur when a STD is treated in only a part of a 
sexual dyad or network. STDs are often asymptomatic, many infected 
individuals are unaware of their infection, thus symptom-driven patient 
presentation for diagnosis and treatment fails to reach many people 
with STDs. PS may shorten the duration of infection in many additional 
individuals by identifying, treating, and counseling the sex partners 
of patients with STDs. Furthermore, PS offers a unique opportunity to 
assist at-risk, infected and uninfected people to adopt safer behaviors 
that will enable them to remain STD-free and is a key component of 
public health practice. The objectives of partner services include 
identifying, locating, notifying, testing, treating, and providing 
counseling to reduce STD risk for the sex partners of an individual 
diagnosed with chlamydia, gonorrhea, syphilis, trichomoniasis, herpes, 
or human immunodeficiency virus (HIV).
    Despite the importance of partner services in public health 
practice, relatively little scientific information is available on the 
impact on disease transmission or cost effectiveness of various 
approaches, particularly for STDs that are treated in the private 
sector. Another limitation of the current science base is that existing 
data on partner services has been generated from federal, state, and 
local public health programs that have a legal responsibility to 
provide PS. This information does not reflect partner services in other 
clinical settings where the majority of STD diagnosis and treatment 
take place. At least half of STD care is sought from private providers. 
Therefore, further research across the full spectrum of STD treatment 
providers with respect to PS is clearly needed. Current data from a 
national survey of providers suggests that the most common method of 
notification in the private sector is patient referral, although the 
rate of new infections uncovered in the private sector from this method 
is not known. Fewer than 5 percent of providers reported engaging in 
provider referral and less than 50 percent consistently reported 
patients' names to health departments after a diagnosis of chlamydia, 
gonorrhea, syphilis, or HIV infection. Case reporting from providers 
and from laboratories enables the local health department to provide 
partner services. However, providers may also diagnose and treat 
presumptively without performing a laboratory test, and relatively 
little is known about case reporting or partner services following 
presumptive treatment.
    Provider-perceived barriers to offering partner services include 
concerns about negative effects on relationships with patients and 
their partners, lack of training and time for these activities, and 
lack of reimbursement.
    Nevertheless, providers agreed that PS could promote appropriate 
behavior and attitude change, and reduce (re)infection rates. In 
summary, this survey confirmed that the effectiveness of PS in the 
private sector is unknown and reporting of names to agencies that 
conduct PS is limited.
    Current methods of PS require substantial time and effort from 
public health staff, although data estimating the magnitude of the 
reduction in STD incidence or prevalence within communities that is 
attributable to PS are currently lacking. Recent advances in STD 
detection and treatment, information system hardware and software, and 
behavioral interventions offer an unprecedented opportunity to:
    (1) Design and evaluate innovative strategies that increase the 
effectiveness of partner elicitation;

[[Page 32102]]

    (2) Improve the timely connection of partners with appropriate 
detection, treatment, and counseling services;
    (3) Intervene to lower STD risk among sex partners; and
    (4) Evaluate the cost-effectiveness of new methods in comparison to 
current strategies.
    This is likely to require complex evaluation that moves from the 
index patient to the patient-partner dyad, to sexual networks, and to 
community levels of evaluation.
    CDC envisions that data from this research program will be used to 
design cost-effective strategies that
    (a) Augment the effectiveness of PS in the public and private 
sectors;
    (b) Reduce the incidence and the prevalence of curable STDs; and
    (c) Utilize the opportunities inherent in partner services to lower 
partners' risk behaviors.
    Incidence and prevalence reductions should be demonstrably 
attributable to innovations in PS.
    This program has four general objectives:
    1. To develop, apply, and evaluate confidential and innovative 
partner services across a variety of practice settings using new 
techniques or technologies and to assess their effectiveness and 
acceptability in comparison with current PS methods;
    2. To develop and assess the feasibility of policy level 
interventions that may be needed to make innovative strategies 
feasible;
    3. To assess the cost-effectiveness of proposed alternatives in 
comparison with current methods of partner services; and
    4. To develop mathematical models that assess the impact of current 
and alternative partner service approaches on rates of incident and 
prevalent infections.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for-profit organizations; governments and their agencies; that is, 
universities, colleges, research institutions, managed care 
organizations, hospitals; State and local governments or their bona 
fide agents; and federally recognized Indian tribal governments, Indian 
tribes, or Indian tribal organizations. Eligible applicants should 
collaborate with their local or state health department because this 
linkage is critical to the successful conduct of this research.


    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 $750,000 is available in FY 2000 to fund the first 
year of approximately 2-3 awards. It is expected that the average award 
will be $250,000, ranging from $100,000 to $350,000. It is expected 
that the awards will begin by September 30, 2000 and will be made for a 
12-month budget period for a maximum project period of four years. 
Funding estimates may change. Continuation awards within an approved 
project period will be based on satisfactory progress as evidenced by 
required reports and on the availability of funds.

Funding Preferences

    Funding preference will be given:
    1. To applicants with access to subjects in public and private 
settings where STDs are diagnosed and treated;
    2. To achieve geographic distribution;
    3. To applications that address more than one STD;
    4. To applications that involve collaboration with health 
departments; and
    5. To applications that incorporate a mix of provider settings 
where chlamydia, gonorrhea, syphilis, trichomoniasis, herpes, or human 
immunodeficiency virus (HIV) are detected and treated.
    Collaborative partnerships are strongly encouraged with managed 
care organizations, private practice settings, family planning clinics, 
or community and migrant health centers in addition to traditional 
public STD clinics.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
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. Design and conduct research to address the study question(s) as 
listed below. Applicants may address one or more of the study questions 
listed and are encouraged to address at least two.
Study Questions
    (1) In comparison to current strategies, what innovative methods 
can be developed and evaluated to increase the timeliness, 
effectiveness, and cost-effectiveness of partner services across a 
variety of practice settings?
    PS interventions should be tailored to patient, partner, or 
provider characteristics, to specific STDs, and to different practice 
settings in order to produce the most effective partner services. It is 
also important to assess methods that increase patient's cooperation, 
recall, and accuracy with respect to (a) providing names and locating 
information for partners or (b) following through with patient 
referral. Evaluation of the barriers that inhibit patients from naming 
partners or delivering patient referral in conjunction with 
interventions that overcome those barriers and increase the proportion 
of partners who receive medical evaluation, treatment, and counseling 
are encouraged. Development and evaluation of strategies that promote 
the timely and appropriate delivery of partner services are encouraged. 
There is also interest in identifying methods for delivering partner 
services that promote changes in partners' risk behaviors and how this 
may vary by whether or not the exposed partner had acquired an STD.
    For new strategies, techniques, or technologies, identify how they 
can be implemented in public and private health care settings. 
Evaluations should address to what extent and how the use of the new 
technologies or techniques increase the productivity of staff and 
reduce the barriers to timely and effective partner services for staff, 
patients, and partners.
    Finally, there is programmatic interest in assessing the cost-
effectiveness of innovative strategies, new techniques, and new 
technologies. Such interest includes accurately determining the 
incremental cost of identifying and locating partners and infections 
using innovative strategies and their comparison with the cost of 
current strategies. Cost-effectiveness measures should include 
research, training, and program costs separately so that implementation 
can be examined independently of research costs.
    Applications that combine some or all of the above elements are 
encouraged. Preference will be given to applications that:
    (a) Propose the development, implementation, and evaluation of 
innovative strategies;
    (b) Present a detailed plan for measuring and evaluating outcomes;
    (c) Will be able to identify which elements of a proposed strategy 
account for its effectiveness;
    (d) Make the incremental value of the strategy visible; and
    (e) Incorporate technology transfer to settings where STDs are 
diagnosed and treated.
    (f) Compare proposed innovative strategies with traditional methods 
of partner services and clarify whether

[[Page 32103]]

these new techniques or technologies offer any added value to current 
partner service activities.
    (2) What policy level interventions can be developed, implemented, 
and evaluated to promote partner services across a broad spectrum of 
health care settings?
    This may include identification of the policy sources, their policy 
function (advisory, regulatory, implementation), and the introduction 
and evaluation of policy-level changes that promote the improved 
delivery of partner services. There is interest in funding 
interventions that can produce the necessary policy changes, including 
linking the process of such interventions with specific outcomes (e.g., 
policy changes in health care plans that make partner services 
reimbursable).
    (3) Apply mathematical models to assess the impact of current and 
alternative partner service approaches on rates of incident and 
prevalent infections?
    The application of mathematical models to assess which current 
strategies and proposed alternatives may be most valuable in increasing 
the timeliness and effectiveness of partner services are also 
encouraged. Consideration will be given to the use of existing 
databases. The use of cost-effectiveness data as part of a model (or 
series of models) is encouraged.
    b. Evaluate and analyze the research data.
    c. Disseminate study findings through presentations at scientific 
meetings and publications in peer-reviewed journals.

2. CDC Activities

    A cooperative agreement reflects an assistance relationship between 
the Federal Government and the recipient in which substantial 
programmatic involvement is anticipated about the scientific or 
technical management of an activity during its performance. The CDC 
program office will:
    a. Provide up-to date scientific information, technical assistance, 
and guidance in the design and conduct of the research.
    b. As needed, assist in the development of a research protocol for 
local IRB review at cooperating institutions participating in the 
research project. The CDC IRB will review and approve the protocol 
initially and on at least an annual basis until the research project is 
completed.
    c. As needed, assist in data analysis and the preparation of 
manuscripts.
    d. Convene meetings of all grantees for the exchange of 
information.

E. Application Content

    Applications must be developed in accordance with the information 
contained in this program announcement, the PHS 398 Grant Application, 
and the instructions provided in this section. Your application will be 
evaluated on the criteria listed, so it is important to follow them in 
laying out your program plan.

Instructions

    The program narrative for sections 1-5 below should be no more than 
25 single-spaced pages, printed on one side, with one-inch margins, and 
10 or 12 cpi typeface. All pages, including appendices, should be 
numbered sequentially. The narrative must contain the following 
sections in the order presented below:
    1. Abstract: Provide a brief abstract of the project. The abstract 
must reflect the project's focus and the length of the project period 
(maximum is 4 years) for which assistance is being requested (see 
``Availability of Funds'' for additional information).
    2. Specific Aims: List the broad, long-term objectives and what the 
specific research proposed in this application is intended to 
accomplish. State the hypotheses to be tested. One page is recommended.
    3. Background and Significance: Briefly sketch the background 
leading to the present application, critically evaluate existing 
knowledge, and specifically identify the gaps which the project is 
intended to fill. State concisely the importance and health relevance 
of the research described in this application by relating the specific 
aims to the broad, long-term objections. Two to three pages are 
recommended.
    4. Preliminary Studies: Use this section to provide an account of 
the principal investigator/program director's preliminary studies 
pertinent to the application information that will help to establish 
the experience and competence of the investigator to pursue the 
proposed project. The complete references to appropriate publications 
and manuscripts submitted or accepted for publication may be listed and 
are not part of the page limitations. Five collated sets of no more 
than 10 such items of background material may be submitted in an 
appendix. Six to eight pages are recommended for the narrative portion 
of the Preliminary Studies section.
    5. Research Design and Methods: Describe the research design and 
the procedures to be used to accomplish the specific aims of the 
project. Include how the data will be collected, analyzed, and 
interpreted. Describe any new methodology and its advantage over 
existing methodologies. Discuss the potential difficulties and 
limitations of the proposed procedures and alternative approaches to 
achieve the aims. As part of this section, provide a tentative sequence 
or timetable for the project. Describe specific study protocols or 
plans for the development of study protocols. Describe the nature and 
extent of collaboration with CDC and/or others during various phases of 
the project. Describe in detail a plan for evaluating study results and 
for evaluating progress toward achieving project objectives.
    6. Inclusion of Racial and Ethnic Populations: Describe the degree 
to which applicant will meet requirements regarding the inclusion of 
women, and members of minority groups in the proposed study.
    7. Human Subject Involvement: Describe procedures that will provide 
for the protection of human subjects. Address how these procedures are 
in compliance with Federal regulations.

F. Submission and Deadline

Letter of Intent (LOI)

    For planning purposes, a letter of intent to apply is requested and 
needed to staff the review panels, but not required, from potential 
applicants. Your letter of intent should include the following 
information: Program Announcement Number [00080], name and address of 
institution; name address, and telephone number of contact person; and 
specific objectives to be addressed by the proposed project.
    The letter of intent must be submitted on or before June 12, 2000 
to the Grants Management Specialist identified in the ``Where to Obtain 
Additional Information'' section of this announcement.

Application

    Applicants should submit five copies of PHS-398 (OMB Number 0925-
0001) and adhere to the instructions on the Errata Instruction Sheet 
for PHS 398.
    Forms are available at the following Internet address: 
www.cdc.gov/...Forms, or in the application kit. On or before July 14, 
2000 submit the application to the Grants Management Specialist 
identified in the ``Where to Obtain Additional Information'' section of 
this announcement.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    (a) Received on or before the deadline date; or

[[Page 32104]]

    (b) Sent on or before the deadline date and received in time for 
distribution to the review panel. (Applicants must request a legibly 
dated U.S. Postal Service postmark or obtain a legibly dated receipt 
from a commercial carrier or U.S. Postal Service. Private metered 
postmarks shall not be acceptable as proof of timely mailing.)
    Late Applications: Applications, which do not meet the criteria in 
(a) or (b) above, are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

    Upon receipt, applications will be reviewed by CDC for completeness 
and responsiveness to the purpose of this request for applications 
(RFA) (as described in Section A), and as outlined under Eligible 
Applicants and Program Requirements (Items A to B). Incomplete 
applications and applications that are not responsive will be returned 
to the applicant without further consideration. It is important that 
the applicant's abstract reflects the project's focus, because the 
abstract will be used to help determine the responsiveness of the 
application.
    All proposals will be independently reviewed for scientific merit 
by no less than three reviewers with appropriate expertise using 
current National Institutes of Health (NIH) review criteria to evaluate 
the methods and scientific quality of the proposal. Factors to be 
considered will include:
    1. The specific aims of the research project, i.e., the intended 
accomplishment of the specific research proposal, and the hypothesis to 
be tested. (5 percent)
    2. The background of the proposal, i.e., the basis for the present 
proposal, the critical evaluation of existing knowledge, and 
identification of specific knowledge gaps which the proposal is 
intended to fill. (10 percent)
    3. The significance and innovation from scientific and programmatic 
standpoints of the proposed research, including the adequacy of the 
theoretical and conceptual framework for the research. (20 percent)
    4. The adequacy of the proposed research design, approaches, and 
methodology to carry out the research, including quality assurance 
procedures, plan for data management, statistical analysis plan, and 
evaluation plan. (40 percent)
    5. The extent to which the research will lead to feasible, cost-
effective interventions. (10 percent)
    6. Qualifications and appropriateness of the proposed personnel to 
accomplish the proposed activities as well as the degree of commitment 
and cooperation of proposed collaborators and organizations (as 
evidenced by letters detailing the nature and extent of the 
involvement). (10 percent)
    7. Research Capacity--adequacy of existing and proposed facilities 
and resources. (5 percent)
    8. Gender and minority issues. Does the application include:
    a. The proposed plan for the inclusion of both sexes 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 community(ies) and recognition of mutual benefits.
    9. Human Subjects--What are the strategies for the recruitment and 
retention of human subjects? Are the procedures proposed adequate for 
the protection of human subjects and are they fully documented? Are all 
procedures in compliance with applicable published regulations and 45 
CFR 46?
    10. The reasonableness of the proposed budget to the proposed 
research and demonstration program. Applications that propose to 
address more than one of the study questions described in Section D: 
Program Requirements should include a separate budget breakdown for 
each study question to be addressed.
    Final awards will be determined by the Director of the Division of 
STD Prevention (DSTD) based on priority scores assigned by the 
independent review group appointed by CDC, consultation with DSTD 
senior staff, the match between the proposal and the program 
announcement, the relevance and balance of proposed research relative 
to DSTD priorities, and the availability of funds.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of:
    1. Progress reports annually, no later than 90 days after the end 
of the budget period;
    2. Financial status report, no later than 90 days after the end of 
the budget period; and
    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 in the 
application kit.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-7  Executive Order 12372 Review
AR-8  Public Health System Reporting Requirements
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-14  Accounting System Requirements
AR-21  Small, Minority, And Women-owned Business

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 318 of the Public Health 
Service Act, [42 U.S.C. Section 247c, as amended. The Catalog of 
Federal Domestic Assistance Number is 93.978.

J. Where To Obtain Additional Information

    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888 472-6874). You will be asked 
to leave you name and address and will be instructed to identify the 
Announcement number of interest.
    To obtain additional information, contact: Kang W. Lee, Grants 
Management Specialist, Procurement and Grants Office, Grants Management 
Branch, Centers for Disease Control and Prevention, Room 3000, 2920 
Brandywine Road, Atlanta, GA 30341-4146; Telephone number (770) 488-
2733; FAX number (770) 488-2847; Email address <a href="/cdn-cgi/l/email-protection#fc979590c4bc9f989fd29b938a"><span class="__cf_email__" data-cfemail="3952505501795a5d5a175e564f">[email protected]</span></a>.
    See also the CDC home page on the Internet: http://www.cdc.gov.
    For program technical assistance, contact: Janet S. St. Lawrence, 
Division of STD Prevention, Centers for Disease Control and Prevention 
(CDC), Mail Stop E44, 1600 Clifton Road NE, Atlanta, GA 30333, (404) 
639-8298; FAX: (404) 639-8622; Email address: <a href="/cdn-cgi/l/email-protection#bed0c4cd8afedddadd90d9d1c8"><span class="__cf_email__" data-cfemail="620c181156220106014c050d14">[email protected]</span></a>.


[[Page 32105]]


    Dated: May 16, 2000.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 00-12742 Filed 5-17-00; 8:45 am]
BILLING CODE 4163-18-P


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