Loren Data's SAM Daily™

FBO DAILY ISSUE OF JUNE 06, 2007 FBO #2018
SOLICITATION NOTICE

A -- Retaining HIV Positive Patients in Medical Care: Test of Intervention Strategy for HIV Clinics

Notice Date

4/16/2007
 

Notice Type

Solicitation Notice
 

NAICS

541710 — Research and Development in the Physical, Engineering, and Life Sciences
 

Contracting Office

Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146, UNITED STATES
 

ZIP Code

30341-4146
 

Solicitation Number

2007-N-09250
 

Response Due

6/5/2007
 

Archive Date

8/1/2007
 

Point of Contact

Jerry Outley, Contract Specialist, Phone 770-488-2718, Fax 770-488-2777, - Deborah Workman, Contract Specialist, Phone 404-639-8893, Fax 404-639-8095/8155,
 

E-Mail Address

jmo4@cdc.gov, atl7@cdc.gov
 

Description

Project Objectives The procedures of the study, including the intervention, will be designed by CDC and HRSA with collaborative input from the contractors. The objective of this contract is for contractors to conduct a randomized controlled trial to examine an intervention to increase retention of HIV+ patients in primary medical care. Contractors will implement and oversee the trial, assure its quality, and supply CDC and HRSA with relevant outcome data described below. We anticipate that the intervention will increase HIV patient retention at least 30% relative to the rates before the intervention. If found to be efficacious, the government will be able to disseminate this intervention to HIV primary care clinics throughout the United States. Scope of Work • The intervention will be implemented and tested for efficacy at six HIV primary care clinics. Clinic attendance (from clinic records) is the primary outcome variable. Three clinics (Panel A clinics) will be randomly selected to implement the intervention immediately after baseline clinic data are tabulated and a cohort of patients enrolled and surveyed at each of the six sites; the other three clinics (Panel B clinics) will delay implementation of the intervention for approximately 12 months and will serve as a control group for evaluating the efficacy of the intervention as delivered by Panel A clinics during the prior year. The first follow-up tabulation of attendance will occur at each clinic after this 12-month intervention period. Panel B clinics will then implement the intervention for 12 months (and Panel A clinics will continue implementing the intervention). Follow-up tabulation of attendance will be made at each of the six clinics. Basic design of the study is shown below Year 2 3 4 5 ---------------------------------------------------------------------------------------------------------------------------- Oa Oa Oa Oa Oa Oa Oa Oa Oa Oa Oa Oa Oa Oa Oa Oa Oa Omc Omc Omc Omc Omc Omc Omc Os Os Os Panel A Enroll [Intervention begins…………………………………………………] cohort Panel B Enroll [Intervention begins…………………..] cohort -------------------------------------------------------------------------------------------------------------------- Oa = quarterly clinic attendance data (clinic wide and cohort specific) Omc = semiannual medical chart data from cohort participants Os = annual survey from cohort participants • The period of performance for this contract shall be “Date of Award” through five years thereafter. The work shall be complete in five phases as follows:  Phase 1-Protocol Development (Date of award through 12 months thereafter)  Phase 2-Pre-OMB Approval: (12 months from date of award through 24 months from date of award)  Phase 3 Intervention Implementation Panel A (24 months from date of award through 36 months from date of award)  Phase 4: Intervention Implementation Panel B & Continue Panel A (36 months from date of award through 48 months from date of award)  Phase 5: Intervention Continues and Final Follow-up Survey (48 months from the date of the award through 60 months from date of the award). • The place of performance shall be the contractor’s facility. Technical Requirements Project Tasks and Activities The following are the specific tasks, activities and personnel requirements by phase of the project: 1. PHASE 1--PROTOCOL DEVELOPMENT (Date of Award through 12 months thereafter). Unless otherwise specified all activities pertain to both Panel A and B clinics. Task 1.1 Investigators Meetings. Attend a two-day investigators meeting at CDC in Atlanta to establish contractor and CDC roles, contractor and CDC responsibilities and study timelines. Task 1.2 Protocol Development The contractor shall participate in bi-weekly telephone conference calls with CDC and the other contractors to prepare the study protocol including the design of the intervention, development of survey instrument, clinic-level variables and a consent form for participants who will complete the survey. Task 1.3 Feedback and Written Revisions. CDC will provide a draft protocol. The contractor shall prepare written comments and revisions to be placed inside a Microsoft Word formatted draft protocol and survey questionnaires. The protocol will be circulated by CDC to the contractors several times during Phase 1. The protocol will include all the intervention procedures. Task 1.4 Program Review Panel. The contractor shall submit a signed copy of the Program Review Panel document (CDC form 0.1113, To be provided in the Solicitation) attesting to the Panel’s review of educational pamphlets, fact sheets and intervention materials. Task 1.5 OMB Package. The CDC will provide a draft of the OMB documents. The contractor shall provide written comments and suggestions (inside a Microsoft Word document) concerning CDC’s OMB packet Task 1.6 Make Improvements to Attendance Tracking System. The contractor shall make improvements necessary to their site’s attendance tracking capability. If site does not have a reliable electronic attendance tracking capability (as determined by CDC), they must purchase new software to permit reliable tracking (into the future) of all patients’ attendance at primary medical care visits. Task 1.7 Create Attendance Database. The contractor shall create a clinic-wide database on attendance using clinic records. The database shall track forward in time all clinic patients’ attendance at primary medical care visits, using patient identifiers. Task 1.8 Data Manager Training. The contractor shall participate in a two-day data manager training at CDC, during the first 12 months of project. This training will supply to the contractors the format and software for medical record abstraction, and clinic attendance data submissions. Quality control procedures, (e.g., double checking of data values) will be included in the training. Task 1.9 Local IRB Submission and Approval. The contractor shall submit the CDC-approved protocol for local-site IRB approval. Following approval, contractor shall deliver to CDC the IRB approval letter and a copy of the IRB-approved consent form with approval and date indicated. . Task 1.10 Patient Contact Instruments. The contractor shall develop instruments that capture Case Manager and Outreach worker documentation of patient contacts. These instruments will produce the data that will document the consistency with which the intervention is delivered across time. The minimum format will be specified at the Data Manager Training (Task 1.8).. Task 1.11 Quarterly Reports. Submit quarterly progress reports to CDC. The minimum content of the quarterly reports shall be: project personnel in place (by name) during the quarter; changes in personnel or major duties that occurred during the quarter; data collected and submitted by type and shipment date; number of subjects screened; number of subjects enrolled; number of medical chart abstractions. ESTIMATED LEVEL OF EFFORT FOR PHASE 1 Based on 2080 hours per year. Principal Investigator: 416 hours Study Coordinator: 624 hours Data Manager/Analyst: 624 hours 2. PHASE 2—PRE-OMB APPROVAL: (12 months from date of award through 24 months from date of award). Unless otherwise specified all activities pertain to both Panel A and B clinics. We anticipate that there will be minimal activities in Phase 2 because we will be waiting for OMB approval. Staffing should reflect the reduced workload. Task 2.1 Investigators Meetings: The contractor shall attend a two-day investigators meeting at CDC to refine intervention responsiblities of clinic staff, refine the intervention timeline, plan for the intervention training, and participate in bi-weekly conference calls during the year. Task 2.2 Study Collaboration and Manual: The contractor shall continue to work towards preparing to put study in the field. Contractor shall prepare sections of the intervention training manual that are to be used by study staff members and providers in his clinic. The manual shall include how clinic patients are being approached and recruited into the measurement cohort; the plans for delivering the intervention and oversight of the intervention; and plans for submitting data. Task 2.3 Attendance Database: The contractor shall make quarterly transmissions to CDC in Atlanta of the clinic-wide database on patient attendance. See Task 1.7 for database requirements. Task 2.4 Quarterly Reports: The contractor shall submit quarterly progress reports to CDC. See task 1.11 for required content. ESTIMATED LEVEL OF EFFORT FOR PHASE 2 Principal Investigator: 416 hours Study Coordinator: 624 hours Data Manager/Analyst: 624 hours 3. PHASE 3—COHORT ENROLLMENT AND INTERVENTION IMPLEMENTATATION (24 months from date of award through 36 months from date of award). Unless otherwise specified all activities pertain to both Panel A and B clinics. After contract award, CDC will determine which clinics will be randomly assigned to implement the intervention immediately (Panel A clinics) and which will delay implementation for approximately one year (Panel B clinics). Phase 3 therefore is presented in 2 options, and the offerors’ proposal must include both options. Option 3A—Panel A clinics will implement the intervention during Phase 3,and should therefore include appropriate staffing. Option 3B—Panel B clinics, the control group clinics, will enroll their cohort during phase 3 but will not implement the intervention during phase 3. Requirements for study-specific case management and peer outreach should not be included. Appropriate staffing is to be included by Panel B clinics. Task 3.1 Investigators Meeting: The contractor shall attend a two-day investigators meeting at CDC to finalize intervention procedures, and revise timelines. The contractor shall continue to participate in bi-weekly conference calls. Task 3.2 Cohort Enrollment: Identify and enroll a cohort of at least 250 patients during a 4 to 6-month period from the clinic-wide data base. This cohort should include sufficient numbers of patients who have attended clinic inconsistently. Attempts should be made to enroll all new patients during the patient enrollment period. Task 3.3 Administer Questionnaires. These are to be administered to the minimum of 250 cohort members. Task 3.4 Medical chart Abstraction . Contractor shall perform medical chart abstractions of each cohort member, using the methodology given at the Data Manager Training at CDC (Phase 1). The minimum content for the abstractions shall include CD4+ Tcell counts, HIV viral load, AIDS-defining conditions, and therapeutic regimens. What is entailed in the Chart Review process? Task 3.5 Quality Control . Contractor shall perform quality control procedures of data collection. Quality control procedure will be specified in detail by CDC at the Data Manager Training (Phase 1, Task 1.8). Task 3.6 Attendance Data: The contractor shall tabulate patient clinic attendance before and after the intervention using clinic attendance records. This shall include attendance data for the clinic-wide population as well as the cohort. The format for that part of the attendance data to be transmitted to CDC will be specified at the Data Manager Training (Phase 1, Task 1.8). Task 3.7 Transmitting Data. Transmit attendance, medical chart data, survey (questionnaire) and patient contact data to the CDC over the secure data network. Task 3.8 Intervention Training-Panel A. The contractor’s clinic staff shall participate in a four-hour intervention training at the clinic site (Panel A clinics). The intervention training is to be conducted by a separately funded training contractor, and will require clinic staff to participate in a series of adult learning activities (e.g., written exercises, role playing). Task 3.9 Identify Patients at Risk-Panel A. Implement a method to identify patients at risk of falling out of medical care (Panel A clinics), using the methods in the finalized study protocol from Phase 1. Task 3.10 Begin Referrals-Panel A. Refer patients at risk of falling out of care to a case manager and peer outreach worker as appropriate (Panel A clinics) within one week of screening for this risk. Task 3.11 Begin Intervention delivery-Panel A. Contractors shall begin delivering the intervention (Panel A clinics) according to the intervention content determined at the time the study protocol is finalized in Phase 1. Task 3.12 Supervise Intervention Delivery-Panel A: Supervise delivery of the intervention by medical providers, case manager and peer outreach personnel, and address problems or issues that arise (Panel A clinics). Problems and their solution shall be included in the quarterly reports. Task 3.13 Quarterly Progress Reports. Submit quarterly progress reports to the CDC. See task 1.11 for required content. The intervention will target those at risk of missing scheduled clinic appointments as determined by past clinic attendance records and other information. The intervention will be given to those enrolled in the cohort as well as to other clinic patients deemed at risk of missing appointments. The intervention will have multiple components including individual- and systems-level components such as:  messages given to patients by providers about the importance of staying in care.  brochures and posters (developed under a separate Intervention Trainer contract ).  case managers to work with patients in a client-centered manner and conduct outreach to patients who have not been seen at clinic during a specific time period.  peers who will help teach and advise patients how to successfully navigate within a complex medical setting and perform outreach to patients who have missed clinic appointments.  structural changes in the clinic to make it easier for patients to attend clinic and stay in care. ESTIMATED LEVEL OF EFFORT FOR PHASE 3 Option 3A--Panel A Clinics Principal Investigator: 416 hours Study Coordinator: 2080 hours Data Manager/Analyst: 832 hours Peer Outreach Worker: 2080 hours Case Manager : 2080 hours Option 3B--Panel B Clinics Principal Investigator: 416 hours Study Coordinator: 2080 hours Data Manager/Analyst: 832 hours PHASE 4—INTERVENTION IMPLEMENTATION PANEL B & CONTINUE PANEL A (36 months from date of award through 48 months from date of award). Unless otherwise specified all activities pertain to both Panel A and B clinics. Task 4.1 Investigators Meeting: Contractor shall attend a two-day investigators meeting at CDC tracking progress of the study, and participate in bi-weekly conference calls to ensure quality control. Task 4.2 Medical Chart Abstractions: Contractor shall conduct medical chart abstractions of each cohort member, using the methodology given at the Data Manager Training at CDC (Phase 1). The minimum content for the abstractions shall include CD4+ Tcell counts, HIV viral load, AIDS-defining conditions, and therapeutic regimens. Task 4.3 First Follow-up Questionnaire: Contractor shall administer first follow-up questionnaire to the study cohort. The content and format of the questionnaire will be specified in the study protocol, as the questionnaire is an attachment to the study protocol. Task 4.4 Quality Control: Contractor shall perform quality control of survey, medical record, case manager/outreach worker patient contact data collection using agreed-upon methods established in phase 1 and phase 2. Refer to phase 1, Task 1.8 for specifications. Task 4.5 Tabulate attendance data: Contractor shall tabulate clinic attendance data (for entire clinic and cohort) using clinic records. The minimum specifications for the attendance database will be given at the Data Manager Training. The format for that part of the attendance data to be transmitted to CDC will also be specified at the Data Manager Training (Phase 1, Task 1.8). Task 4.6 Transmitting data. Transmit attendance, medical chart data ,survey (questionnaire) and patient contact data to the CDC over the secure data network. Task 4.7 Intervention Training-Panel B: The contractor’s clinic staff shall participate in a four-hour intervention training at the clinic site (Panel B clinics). The intervention training is to be conducted by a separately funded training contractor, and will require clinic staff to participate in a series of adult learning activities (e.g., written exercises, role playing). Task 4.8 Identify Patients at Risk-Panel B: Contractor shall implement a method to identify patients at risk of falling out of medical care (Panel B clinics.), using the methods in the finalized study protocol from Phase 1 Task 4.9 Begin Referrals-Panel B: Contractor shall begin referring patients at risk of falling out of care to a case manager and peer outreach worker as appropriate (Panel B clinics), within one week of screening for this risk. Task 4.10 Begin Intervention Delivery-Panel B: Contractor shall begin delivering the intervention as described in Phase 3. (Panel B clinics), according to the intervention content determined at the time the study protocol is finalized in Phase 1. Task 4.11 Supervise Intervention Delivery-Panel B: Contractor shall begin supervising delivery of the intervention by medical providers, case manager and peer outreach personnel, and address problems or issues that arise. Problems and their solution shall be included in the quarterly reports. Task 4.12 Continue delivering the intervention (Panel A clinics), as it was implemented in Phase 3 Task 4.13 Quarterly Reports: Submit quarterly progress reports to the CDC. See task 1.11 for required content. ESTIMATED LEVEL OF EFFORT FOR PHASE 4 Applies to both Panel A and B Clinics. Principal Investigator: 416 hours Study Coordinator: 2080 hours Peer Outreach Worker: 2080 hours Case Manager : 2080 hours Data Manager/Analyst: 832 hours PHASE 5 INTERVENTION CONTINUES AND FINAL FOLLOW-UP SURVEY (48 months from the date of the award through 60 months from date of the award). Unless otherwise specified all activities pertain to both Panel A and B clinics. Task 5.1 Investigators Meeting: Attend a two-day investigators meeting at CDC and participate in bi-weekly conference calls. Task 5.2. Intervention Continues. Continue delivering and supervising the intervention., as it was implemented in phases 3 and 4. Task 5.3. Second Follow-up Questionnaire. Administer second follow-up questionnaire to the study cohort, using method of administering given in Data Manager Training and questions specified in the questionnaire that was included as part of the study protocol. Task 5.4 Medical Chart Abstractions. Conduct medical chart abstractions of each cohort member, using the methodology given at the Data Manager Training at CDC (Phase 1). The minimum content for the abstractions shall include CD4+ Tcell counts, HIV viral load, AIDS-defining conditions, and therapeutic regimens. Task 5.5: Quality Control. Perform quality control of data collection. Quality control procedures will be specified in detail by CDC at the Data Manager Training (Phase 1, Task 1.8). Task 5.6: Attendance data collection Continues. Tabulate clinic attendance data (for entire clinic and cohort) using clinic records, as was done in phases 2, 3 and 4. Task 5.7: Transmitting data. Transmit attendance, medical chart data, survey (questionnaire) data, and patient contact data to the CDC over the secure data network. Task 5.8: Progress Reports. Submit quarterly and final progress reports to the CDC. See task 1.11 for required content. ESTIMATED LEVEL OF EFFORT FOR PHASE 5 Principal Investigator: 416 hours Study Coordinator: 2080 hours Peer Outreach Worker: 2080 hours Case Manager : 2080 hours Data Manager/Analyst: 832 hours G.2 MINIMUM CONTRACTOR QUALIFICATIONS Qualified offerors must meet each of the following six technical requirements. Documentation substantiating how you met these requirements should be placed in an Appendix. These requirements may be examined in a pre-decisional site visit: 1) Contractor must demonstrate that they meet one or both of the following criteria: 1. 1 Demonstration (with supporting data) that 25% or more of the HIV patients at the clinic missed two or more scheduled clinic appointments for medical care with physician, nurse-practitioner, physician assistant during the 12-month period prior to the submission of the application. Do not include appointments for which patients notified the clinic in advance to cancel or re-schedule the appointment. OR 1.2 Demonstration (with supporting data) that at least 25% of your HIV patients were not seen in clinic for primary medical care in at least two of four quarters of the 12 month period before you submitted your proposal. Patients must have been seen at least once in this 12-month period to be eligible to be counted in this criterion. 2) Demonstrate that the clinic attendance data is collected at the patient-level, with linkable identifiers. 3) Demonstration that 50% or more of the HIV clinic patient population is of African ancestry (including African-American, African, Caribbean peoples). 4) Demonstration that the HIV clinic is still accepting new patients (i.e., does not have a “capped” enrollment). 5) Demonstration that the HIV clinic currently serves at least 1000 unduplicated HIV+ patients presenting at clinic for HIV primary care in the most current 12-month period preceding submission of the application for award. The minimum acceptable count of 1000 unduplicated HIV+ patients must all be served by a single, physical clinic location (satellite and part-time remote clinics must not be included in the count). 6) Demonstration that the clinic currently serves a minimum of 15% female patients from the most current 12-month period. Offeror must use the same methodology for demonstrating an unduplicated count as used in requirement #5 above. If your response does not demonstrate that you meet each of the criteria outlined in this section, your submission will not be entered into the review process. You will be notified that your proposal did not meet all of the submission requirements. POint Of Contact is Jerry W. Outley 404-639-6053 Email: jmo4@cdc.gov. Fax 404-639-2200 1. Letter of Intent We encourage Potential Offerors to send a letter or email indicating their intent to respond to this research opportunity. The letter well help HHS/CDC in its planning effort, and is not binding on the institution sending the letter. Please send these letters, emails or faxes no later than [April 30, 2007] to: Jerry Outley, Contracts Specialist CDC; Procurement and Grants Office; Mail stop E-15 2920 Branddywine Rd. Atlanta, GA 30333 Telephone: (404) 639-6053 Fax: (404) 639- Email: JOutley@cdc.gov NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (16-APR-2007). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 04-JUN-2007, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/CDCP/PGOA/2007-N-09250/listing.html)
 

Place of Performance

Address: The Clinic of the Sucessful Offeror

Zip Code: 30329-2013

Country: UNITED STATES
 

Record

SN01310097-F 20070606/070604221520 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |