[Federal Register Volume 73, Number 248 (Wednesday, December 24, 2008)]
[Notices]
[Pages 79134-79135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30675]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

    In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to OMB under the Paperwork Reduction Act 
of 1995. To request more information on the proposed project or to 
obtain a copy of the data collection plans and draft instruments, e-
mail [email protected] or call the HRSA Reports Clearance Officer on 
(301) 443-1129.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed Project: Intervention Trials To Retain HIV-Positive Patients 
in Medical Care (NEW)

    The purpose of this project is to develop, implement, and test the 
efficacy of an intervention designed to increase client appointment 
attendance among patients at risk of missing scheduled appointments at 
HIV clinics. This project is a collaboration between the Centers for 
Disease Control and Prevention (CDC), the Health Resources and Services 
Administration (HRSA), and six university-affiliated HIV clinics in the 
United States. The proposed intervention will be implemented in two 
phases. Phase 1 is a clinic-wide intervention that includes the 
following components: a theme slogan for the intervention, brochures, 
posters with messages to patients, brief verbal retention in care 
messages from providers to patients, buttons printed with the theme of 
the intervention worn by providers, and appointment reminder cards with 
information on how to cancel appointments. All clinic patients will 
receive the Phase 1 intervention. Phase 2 of the project is a two-arm 
randomized trial in which 300 patients will be enrolled and randomly 
assigned to one of two study arms. In Arm 1 (control arm), patients 
(n=100) will receive the clinic-wide intervention only. Patients 
(n=200) assigned to Arm 2 (intervention arm) will continue to receive 
the clinic-wide intervention plus a client-centered intervention from 
two trained interventionists.
    The efficacy of the intervention will be assessed through data 
collection efforts tailored to each phase of the intervention. Phase 1 
uses a pre-post comparison of clinic attendance rates before and during 
a clinic-wide intervention. Specifically, in Phase 1, the attendance 
rate for HIV primary care is currently being assessed via electronic 
medical records during the 12-month period before the clinic-wide 
intervention begins. This pre-intervention assessment is being 
collected for all patients who had at least one HIV primary care visit 
at the clinic during the preceding 12 months. This cohort of patients 
will be reassessed via electronic medical records during the 12-month 
intervention period. In addition, provider surveys will be administered 
quarterly during Phase 1 and semi-annually during Phase 2 to obtain 
information from primary care providers (MD, DO, nurse practitioner, 
physician assistant) about whether they talked to their patients about 
the importance of regular care.
    In Phase 2, participants will be enrolled over a period of 4-9-
months to allow flexibility for faster or slower enrollment in the 
clinics. It is anticipated that most clinics will complete their 
enrollment in approximately 6 months. On a daily basis, clinic staff or 
the study coordinator will generate a list of patients who meet 
eligibility criteria based on attendance history. The list will be 
given to the study coordinator who will approach patients to ask about 
their interest in being screened for eligibility in the study. When 
patients agree to be screened for eligibility, the study coordinator 
will administer an eligibility screener. Patients who are found to be 
eligible will be enrolled in the project and all enrollees will 
complete a baseline survey (that will take approximately 30 minutes) 
before being randomized to the intervention or control arm. No follow-
up surveys will be collected. The survey will be

[[Page 79135]]

administered in a private setting at the clinic using Audio Computer-
Assisted Self-Interview (ACASI) in which respondents can read and 
listen via earphones to survey questions presented on the computer 
screen and respond directly into the computer.
    Participants randomly assigned into the intervention arm will 
receive interventional services from two trained interventionists. The 
intervention will be delivered in face-to-face encounters as well as 
over the telephone and the first dose of the intervention will be 
delivered on the day the participant is enrolled into study. During 
this first face-to-face encounter, an interventionist will administer a 
retention risk screener. This screener is a clinical tool that will 
help identify attitudes, barriers, and unmet needs that might prevent a 
patient from staying in care. The screener contains three sections: (1) 
Attitudes and beliefs about HIV care and treatment, (2) barriers to 
consistent clinic attendance (e.g., transportation, child care, housing 
instability, scheduling problems, and lack of social support), and (3) 
recent drug/alcohol use and mental health. The information obtained 
from the risk screener will be used to tailor the intervention to each 
individual patient's needs. Because a patient's situation or needs may 
change over time, the screener will be re-administered to intervention 
arm participants at a minimum every 3-4 months during a clinic visit or 
other arranged face-to-face meetings outside of the clinic. In 
addition, the study coordinator will obtain contact/locator information 
for all participants enrolled in the intervention arm. Contact 
information will be updated as necessary by the intervention staff.
    The response burden for grantees is estimated as:

                                        Estimated Annualized Burden Hours
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                                                     Number of                    Average burden
      Type of form by phase          Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)      (in hours)
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Phase 1 Provider Survey.........             150               4             600           0.167             100
Phase 2 Provider Survey.........             150               2             300           0.167              50
Patient Eligibility Screener *..           3,000               1           3,000           0.083             249
Patient Baseline Survey *.......           1,800               1           1,800           0.50              900
Retention Risk Screener.........           1,200               4           4,800           0.25            1,200
Contact/locator information.....           1,200               4           4,800           0.083             398
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    Total Burden................           3,150  ..............          15,300  ..............           2,897
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* Only administered one time during the entire project period.

    E-mail comments to [email protected] or mail the HRSA Reports 
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, 
Rockville, MD 20857. Written comments should be received within 60 days 
of this notice.

    Dated: December 18, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E8-30675 Filed 12-23-08; 8:45 am]
BILLING CODE 4165-15-P