SOLICITATION No. 2011-N-13271 - PwP.docx

2011-N-13271

PAGES

)SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 78

2. CONTRACT NO.

3. SOLICITATION NO.

2011-N-13271

03/28/2011

6. REQUISITION/PURCHASE NO.

HCVJC5X4-2011-94134

Centers for Disease Control and Prevention (PGO) Acquisition and Assistance Branch 1 2920 Brandywine Road, MS E-15 Atlanta, GA 30341-5539

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 6 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if (Date) (Hour) ) handcarried, in the depository located in Section L.9 until 10 am local time July 6, 2011 CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Jerry W. Outley

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2831

C. E-MAIL ADDRESS

jmo4@cdc.gov

11. TABLE OF CONTENTS

PAGE(S)

SEC.

SEC.

PAGE(S)

)(x)

DESCRIPTION

(x)

DESCRIPTION

X ( K

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

)13. DISCOUNT FOR PROMPT PAYMENT

15A.

NAME

AND

ADDRESS

OF

OFFEROR

(Type or Print)

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

18. OFFER DATE

AWARD (To be completed by Government)

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

Centers for Disease Control and Prevention (PGO) Acquisition and Assistance Branch 1 2920 Brandywine Road, MS E-15 Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-498-4050 Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

Base Period

(NON-SEVERABLE CLIN)

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Date of Award through 12 months thereafter

Section B - Supplies Or Services And Prices/Costs

B.2 Option Prices

a. Unless the Government exercises its option pursuant to the optional clause referenced in Section I, Contract Clauses, this contract consists only of CLIN 0001 specified in the Statement of Work as defined in Section C, for the price set forth in CLIN 0001 of this contract.

b. Pursuant to FAR Clause 52.217-9 set forth in Section I, Contract Clauses, of this contract, the Government may, by unilateral contract modification, require the Contactor to perform the Optional Task(s) specified in the Statement of Work as defined in Section C of this contract. If the Government exercises this/these option(s), notice must be given before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the Option Provision Article in Section I, Contract Clauses, of this contract.

c. Upon the delivery and acceptance of the Optional Item(s)/Service(s) described in Section C of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the estimated costs as set forth below:

Option Period (s):

Option Period 1:

Option Period 1

(NON-SEVERABLE CLIN)

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 0001 through 12 months thereafter

Option Period 2:

Option Period 2

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 1001 through 12 months thereafter

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 1001 through 12 months thereafter

(NON-SEVERABLE CLIN)

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 1001 through 12 months thereafter

Option Period 3:

Option Period 3

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 2001 through 12 months thereafter

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 2002 through 12 months thereafter

(NON-SEVERABLE CLIN)

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 2003 through 12 months thereafter

Option Period 4:

Option Period 4

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 3001 through 12 months thereafter

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 3002 through 12 months thereafter

(NON-SEVERABLE CLIN)

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 3003 through 12 months thereafter

(NON-SEVERABLE CLIN)

Professional Services for the project entitled, “Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics” in accordance with the Statement of Work (SOW) as set forth.

Performance Period: Completion of CLIN 3001 through 12 months thereafter

B.3 FAR 52.216-1 Type of Contract (Apr 1984)

The Government contemplates award of a Cost Reimbursement Contract resulting from this solicitation.

(End of Provision)

Section C - Description/Specification/Work Statement

TITLE: Implementation and Evaluation of a Comprehensive Prevention with Positives Intervention at HIV Clinics

C.1 Background and Need

Approximately half of all new HIV infections in the United States stem from sexual risk behaviors of HIV-positive persons who are aware of their seropositive status.1 Approximately two-thirds of these HIV+/aware persons enter medical care within a year of being diagnosed.2 The HIV medical care setting is thus an ideal location for delivering a sustainable behavioral intervention to large numbers of HIV-positive persons, with the goal of improving patients’ health and reducing the potential for transmission of HIV infection. To reach this goal, a comprehensive intervention is needed that not only addresses sexual and drug risk behaviors directly, but also attempts to improve patients’ retention in medical care and their adherence to treatment regimens.

Observational studies indicate that approximately 40-50% of HIV+/aware persons who have been seen by HIV medical providers are not stable in care (i.e., they miss scheduled appointments or have large gaps between care visits).3,4 Patients who “feel well” or are not on antiretroviral therapy (ART) may exhibit a higher level of inconsistent attendance for medical care compared with their counterparts.5 Other studies have shown that for every 100 cells/mm3 increase in CD4 count, there was a 20% increase in the probability of discontinuing primary HIV care within the first 6 months of care entry.6

Improving the regularity with which HIV patients attend clinic may facilitate adherence to ART which may lead to medical and prevention benefits. Patients on ART who saw their medical providers regularly were more likely to have suppressed viral load than those who saw their providers’ irregularly.7 Importantly, those with suppressed viral load are less infectious and thus less likely to transmit HIV infection through risk behaviors.8,9

Current treatment guidelines10 recommend that ART be initiated when patients’ CD4 counts drop below 350 cells/mm3. Those guidelines also indicate that there may be longer-term medical benefits to patients11 and reduced risk of HIV transmission to others when patients are offered ART at earlier stages of disease (CD4 counts >350 cells/mm3). While there are potential risks of early ART (e.g., drug toxicities, development of drug resistance), early ART leading to suppressed viral load may play an important role in reducing HIV transmission, especially among those with on-going risk behaviors.

To improve HIV patients’ health and reduce transmission of HIV infection there is a need for a comprehensive prevention-with-positives intervention that gives attention to sexual and drug risk behaviors, retention in care, adherence to treatment regimen, and provision of ART at earlier stages of disease.

C.2 Project Objective and Scope

The objective of this contract is (1) to obtain a plan for integrating a comprehensive HIV prevention intervention into an HIV clinic; (2) to obtain a study operations manual, local IRB approval, and results of pilot testing; and (3) implement and oversee the HIV prevention intervention at the HIV clinic, collect data that will be used to evaluate the intervention, conduct quality control activities, and transmit the data to CDC. The contractor will also conduct a survey/interview study involving a sample of patients and their primary sex partners (dyads) to examine behavioral, attitudinal, and interpersonal variables that may influence prevention activities within primary relationships.

The intervention components will be developed by CDC and the National Institute of Mental Health [NIMH]). The intervention aims to increase safer sexual behaviors, reduce acquisition of new sexually transmitted diseases, increase patient retention in care and adherence to treatment regimen, and lower viral load of patients, which reduces infectiousness and the likelihood of transmitting HIV to others. Another component of the intervention pertains to antiretroviral therapy (ART). The most recent ART treatment guidelines recommend that patients begin therapy at earlier stages of disease (higher CD4 levels) than previously recommended. This can benefit the patient medically, reduce viral load and infectiousness, and reduce the risk of infecting others. Providers will have full discretion in deciding to whom they offer early ART. The cost of ART is not part of this contract.

C.3 Minimum Patient Sample Size and the Clinic Site’s Minimum Qualification

The contractor’s HIV clinic must currently serve at least 900 unduplicated HIV+ patients who have attended the clinic for HIV primary medical care in the most current 12-month period preceding submission of the award. The minimum acceptable count of 900 unduplicated HIV+ primary care patients must all be served by a single, physical clinic location (satellite and part-time remote clinics must not be included in the count).

C.4 General Requirements

The contractor shall implement the following intervention components:

Intervention Components

Primary care providers shall deliver brief messages about safer sex, adherence, and clinic attendance to patients when they present for primary care exams. Patients shall be re-engaged with prevention messages when they return for primary care visits.

The contractor shall develop and implement a plan to integrate the delivery of a computerized intervention into the routine care of patients such that all patients receive the intervention at least once a year. Some patients with persistent risks may need multiple exposures to the computerized intervention. The plan shall include a strategy to accommodate several patients simultaneously using multiple computer stations dedicated to delivery of the intervention. The computerized intervention will contain modules on adherence, retention in care, and safer sex.

To identify higher-risk patients who may need more intensive intervention, a brief behavioral screener (developed by CDC and NIMH) shall be administered either by clinic staff or by computer/electronic device to all patients each time they present for primary care exams (but not more often than on a quarterly basis). The information will help identify the specific prevention needs of patients and to identify patients who need more intensive targeted interventions for sexual risk, sub-optimal adherence, or missed clinic appointments.

Patients who do not have an undetectable viral load shall be identified for the purpose of targeted intervention to improve adherence, retention in care, or both, as needed.

The contractor shall develop and implement a plan to administer face-to-face intervention (e.g., using a prevention specialist) with patients who exhibit persistent risk (e.g., not following their treatment plan, continuing to engage in unsafe sexual behaviors) after multiple exposures to the computerized intervention. The prevention specialist may need to ask some patients to identify a support person (e.g., family member, friend) who will play a role in helping the patient stay adherent to ART and attend clinic as recommended by their medical provider.

Referrals to case managers, social workers, or psychologists shall be made when necessary to assist patients with unmet needs regarding transportation, housing, substance use, mental health, etc. The Medical Director at the clinic will be asked to discuss with clinical staff the current ART treatment guidelines and encourage clinicians to seriously consider using early ART with patients who can benefit medically and to help prevent transmission of HIV infection.

Providers will receive information (prepared by CDC) about the current ART treatment guidelines.

Patients will receive a brochure (developed by CDC) that includes messages about prevention behaviors, including early ART and its benefits and risks.

Other materials (developed by CDC) to be used in the intervention include prevention posters that shall be displayed in all exam rooms and the waiting room.

Documentation of delivery of all aspects of the intervention (screening, brief messages, targeted interventions, discussions with clinicians about early ART) including time spent on these activities is required. This information will be used by CDC to conduct a cost-effectiveness analysis of the intervention components.

Study Implementation and Outcome Data

The intervention will be implemented and tested at six HIV primary care clinics. It will be evaluated with (1) data collected from a cohort of patients followed across time and (2) data from clinic databases containing information on all patients in the clinic.

Prior to the onset of the intervention, all six clinics will enroll a cohort of 250 sexually active patients and obtain baseline outcome measures described below. The full cohort shall be enrolled in the first 4 months of Phase 3. Eligible cohort patients shall be randomly selected from among patients presenting at the clinic and shall represent the gender, sexual orientation, and racial/ethnic distribution of patients at the clinic.

Three clinics (Panel A clinics) will begin the intervention immediately after cohort enrollment and baseline data are collected. The other three clinics (Panel B clinics) will delay onset of the intervention for 12 months and thus serve as a control group for between-panel comparisons during that time. The design also enables pre-post comparisons within clinics. See design schematic below.

Clinics will be selected for Panel A or Panel B based on matching and then random assignment. For example, the six clinics will be rank ordered on a key background variable (e.g., percent of patients at the clinic that has an undetectable viral load). Of the two clinics with the highest and second highest percentage, one clinic will be randomly selected for Panel A and the other clinic will be in Panel B. The same procedure will be used for the two clinics that have intermediate levels of patients who have undetectable viral load and for the two clinics with the lowest levels.

Phase 3:

(Months 25-60) 25-28 30 37 42 48 54 60

T = Intervention training activities at clinic

The contractor shall obtain and transmit to CDC the following baseline and follow-up outcome data during the entire Phase 3 periods. Data for each patient shall be identified with a unique study identification number.

Baseline outcome data (from clinic databases) for all clinic patients:

· Individual-level clinic attendance for primary care during the 12 months immediately preceding cohort enrollment

· Individual-level HIV clinical data during the 12 months immediately preceding cohort enrollment, including CD4 cell counts, viral load levels, whether patient is on ART, and STI diagnoses.

Baseline outcome data from cohort members only:

· Computer-administered behavioral questionnaire at time of enrollment.

Follow-up outcome data (from clinic databases) for all clinic patients during reporting periods:

· Individual-level attendance for primary care

· Individual-level HIV clinical variables including CD4 cell counts, viral load levels, whether patient is on ART, and STI diagnoses.

Follow-up outcome data for cohort members only:

· Computer-administered behavioral questionnaire administered in 6-month intervals throughout Phase 3.

Patient Exit Interviews and Periodic Provider Surveys

To confirm the delivery and fidelity of the intervention, patients and medical care providers are to be surveyed quarterly during Phase 3 (at least one survey before the intervention starts and then quarterly thereafter). CDC will develop these surveys. Patients are to be surveyed at the clinic after they exit their primary care exam. The patient surveys will include items on whether prevention messages were delivered during the exam, patient’s attitudes about ART, as well as other issues. The provider surveys will include questions on providers’ attitudes and practices regarding early ART as well as questions about whether they are delivering prevention messages to their patients. Specific information about the administration of these surveys can be found in Task 3.13 (Phase 3).

Patient-Partner Survey/Interview Study (All six clinics)

A patient-partner survey/interview study is to be performed as part of Phase 3. All six clinics will participate in this survey/interview study. The contractor shall enroll 50 patients at the clinic (the number of men and women enrollees being proportionate to their distribution at the clinic) who are in a primary sexual relationship (at least six months duration) and are able to participate along with their partner in a survey and semi-structured interview. The contractor shall enroll both seroconcordant and serodiscordant partnerships. Patients in the cohort enrolled in Phase 3 are not eligible for enrollment in the patient-partner study. The intent of this patient-partner survey is to assess support for ART adherence and clinic attendance, barriers, risk-reduction strategies, behavioral changes after starting ART (among those who recently started therapy), communication dynamics, prevention attitudes, and knowledge and attitudes about super infection (if the partner is HIV-positive).

C.5 Technical Requirements

The contractor shall as an independent organization and not as part of the Government, furnish all necessary services, facilities, equipment, qualified personnel, and material (except for those to be furnished by the Centers for Disease Control and Prevention (CDC) as specified elsewhere in this solicitation) to perform the work required by the Statement of Work as set forth below:

a. Phase 1 – Base Period: PLAN FOR INTEGRATING PROTOCOL AT CLINIC SITE (Date of Award through 12 months thereafter).

Task 1.1 Investigators Meeting. Within 60 days of the award, the contractor shall meet with CDC COTR and other CDC project staff to discuss the clinic-specific issues in integrating the study into the clinic setting, clarify the scope of work and delivery schedule, further delineate roles and responsibilities, and to establish communication protocols. This meeting shall take place at CDC Atlanta, GA. Duration: 2-day meeting. The meeting shall be attended by the CDC COTR, other CDC staff, and two contractor key personnel.

Task 1.2 Conference Calls. The contractor shall coordinate and participate in bi-weekly telephone conference calls with the CDC COTR to communicate progress in the plans/project for integrating the protocol into its specific clinic setting.

Task 1.3 Feedback and Written Revisions to Draft Study Protocol. The CDC COTR will provide a draft protocol to the contractor at the investigators meeting. Within 20 days of the meeting, the contractor shall independently prepare written comments regarding clinic-specific issues in integrating all aspects of the protocol into their clinic setting and send to the CDC COTR in a Microsoft Word (either 2003 or 2007 compatible) document identified by date and version number. The CDC COTR will review the contractor’s written comments and request additional or clarifying information as needed. The contractor shall address all of the CDC COTR’s queries within 20 days and submit written responses to the CDC COTR in a Word document including date and the new version number. Following CDC COTR’s acceptance of the draft revision, the contractor shall submit the final draft within 20 days that contains any modifications directed by the CDC COTR.

Task 1.4 Feedback and Written Revisions to the Cohort Questionnaire. The CDC COTR will provide a draft of the cohort questionnaire to the contractor following the investigators meeting. The contractor shall independently prepare written comments regarding the questions, response alternatives, and formats in the questionnaire and send to the CDC COTR in a Microsoft Word (either 2003 or 2007 compatible) document identified by date and version number within 20 days of receiving the draft from CDC.

Task 1.5 Program Review Panel. The contractor shall submit a signed copy of the Program Review Panel document attesting to the Panel’s review of intervention materials. CDC COTR will provide the form.

Task 1.6 Patient Attendance Tracking System. The contractor’s selected site’s electronic attendance tracking capability shall provide individual-level data on patient attendance for primary care including date appointment was made, date of appointment, and disposition of the visit (kept, cancelled, no show without cancelling). If the contractor’s selected site does not have a reliable electronic attendance tracking capability (as determined by CDC), the contractor’s selected site must make necessary upgrades to assure the accuracy of those data. The tracking system shall provide individual-level data on attendance of all patients during the 12-month period before the cohort is enrolled and must track forward in time until the end of Phase 3, if exercised by the Government. Each patient shall be identified by a unique study identification number, not clinic medical identification number.

Task 1.7 Medical Records Database. The contractor’s selected site’s electronic medical records database(s) shall contain HIV clinical variables on all patients. If site does not have a reliable electronic medical records database (as determined by CDC), the contractor’s selected site must make necessary upgrades to assure the accuracy of those data. The medical records database shall provide individual-level HIV clinical data on all patients during the 12-month period before the cohort is enrolled and must track forward in time until the end of Phase 3, if exercised by the Government. Each patient shall be identified by a unique study identification number, not clinic medical identification number.

b. Phase 2 - Option Period 1: IRB APPROVAL, STUDY OPERATIONS MANUAL, PILOTING

All activities in Phase 2 pertain to both Panel A and B clinics. CDC anticipates that there will be fewer activities during this task because CDC will be waiting for OMB approval. CDC will be developing the OMB package.

Task 2.1 Local IRB Submission and Approval. The contractor shall receive the CDC-approved protocol and modify its format according to the required format for submission to the local-site IRB. Following local-site 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 2.2 Investigators Meeting. Within 60 days of the start of Phase 2, the contractor shall meet with CDC COTR and other CDC project staff to discuss their final site preparation for integrating the study into the clinic setting and delineation of roles and responsibilities. This meeting shall take place at CDC Atlanta, GA. Duration: 2-day meeting. The meeting shall be attended by the CDC COTR, other CDC staff, and two Contractor key personnel.

Sub-Task 2.3 Conference Calls. The contractor shall coordinate and participate in bi-weekly telephone conference calls with the CDC COTR to communicate progress in Phase 2.

Sub-Task 2.4 Written Comments on Study Operations Manual. The CDC COTR will provide a draft of the study operations manual to the contractor. Within 20 days after receiving the draft, the contractor shall independently prepare written comments regarding the specific descriptions of how all aspects of the study have been integrated into the clinic setting and send to the CDC COTR in a Microsoft Word (either 2003 or 2007 compatible) document identified by date and version number. The CDC COTR will review the contractor’s written comments and request additional or clarifying information as needed. The contractor shall address all of the CDC COTR’s queries within 20 days and submit written responses to the CDC COTR in a Word document including date and the new version number. Following CDC COTR’s acceptance of the draft revision, the Contractor shall submit the final draft within 20 days that contains any modifications directed by the CDC COTR.

Task 2.5 Pilot Test the Cohort Questionnaire and Provide Written Comments. The CDC COTR will provide the contractor with the cohort questionnaire to be pilot tested. The contractor shall select six patients at the HIV clinic to pilot test the questionnaire and provide written feedback to the CDC COTR on refinements that need to be made within 14 days of the final pilot-test patient. The six pilot patients shall represent at least two racial-ethnic backgrounds; include gay or bisexual men, heterosexual men, and women.

c. Phase 3 – Option Periods 2, 3 and 4: COHORT ENROLLMENT, IMPLEMENTATION OF INTERVENTION, DATA COLLECTION AND TRANSMITTAL OF DATA TO CDC

Clinics will be randomly assigned into Panel A and Panel B clinics according to procedures described in the Statement of Work. The randomization will occur during Phase 2 in order to determine which clinics will start intervention immediately (Panel A) and which will delay intervention (Panel B). Panel A will initiate the intervention portion during Phase 3 by performing the tasks under CLIN 2002, which is immediately upon the commencement of work under Option Period 2. Panel B will delay initiation of the intervention portion 12-months later in Phase 3 under CLIN 3002 in Option Period 3. Both Panel A and Panel B clinics will perform intervention in Option Period 4 under CLIN 4002.

Additionally, both Panel A and Panel B clinics will conduct a Patient/Partner survey and transmit data to CDC. This work will be in the last 12 months of Phase 3 and will begin in Option Period 4 under CLIN 4004. See Tasks 3.17, 3.18 and 3.19 below.

Task 3.1 Investigator Meeting. There will be three investigators meetings during Phase 3. The first will occur within 60 days of the start of Phase 3 - Option Period 2, the second meeting will occur within 60 days of the start of Phase 3 - Option Period 3, and the third will occur within 60 days of the start of Phase 3 - Option Period 4. At these meetings, the contractor shall meet with CDC COTR and other CDC project staff to discuss plans for achieving all aspects of Phase 3 and report progress in attaining task requirements during the exercised period. Each meeting will take place at CDC Atlanta, GA. Duration: 2-day meeting. The meeting shall be attended by the CDC COTR, other CDC staff, and two contractor key personnel.

Task 3.2 Conference calls. The contractor shall continue to participate in bi-weekly conference calls.

Task 3.3 Cohort Enrollment. Identify and enroll a cohort of 250 sexually active patients (men who have sex with men, heterosexual men, and women) at the clinic during the first 3-4 months of Phase 3. Sexually active is defined as any oral, anal, or vaginal sex in the past three months. Eligible cohort patients shall be randomly selected from among patients presenting at the clinic and represent the gender, sexual orientation, and racial/ethnic distribution of patients at the clinic.

Task 3.4 Administer Baseline Questionnaire to Each Cohort Member. The baseline cohort questionnaire, provided by CDC, shall be administered at the time a cohort member is enrolled.

Task 3.5 Transmit Baseline Questionnaire Data to CDC. The contractor shall transmit the data on a quarterly basis using a secure data network (SDN) established by CDC.

Task 3.6 Administer Follow-Up Questionnaires to Each Cohort Member. The content of the follow-up questionnaires will be determined by CDC. Each cohort member is to receive 5 follow-up questionnaires during Phase 3. For each cohort member, the follow-up questionnaire shall be administered approximately 6 months after the prior questionnaire was administered.

Task 3.7 Transmit Follow-Up Questionnaire Data to CDC. The contractor shall transmit the follow-up questionnaire data on a quarterly basis using the SDN.

Task 3.8 Transmit HIV Clinical Data. The contractor shall obtain and transmit to CDC, individual patient records (each patient identified by a unique study identification number) of HIV clinical data for all patients (not just cohort participants) who received care at the clinic during the 12-month period before the start of Phase 3 and during each funded period of Phase 3. The minimum content of HIV clinical data shall include individual-level data on CD4 cell counts, viral load levels, whether patient is on ART, and STI diagnoses.

The HIV clinical data reflecting the 12-month period before the start of Phase 3 shall be transmitted to CDC through the SDN no later than month 6 after the start of Phase 3. The HIV clinical data during the Phase 3 period shall be transmitted to CDC through the SDN on a quarterly basis throughout the Phase 3 periods.

Task 3.9 Transmit Patient Clinic Attendance Data For Primary Care. The contractor shall obtain and transmit to CDC, individual patient records (identified by a unique study identification number) of primary care appointments and attendance for all clinic patients (not just cohort participants) who received care at the clinic during the 12-month period before the start of Phase 3 and during each CLIN under Phase 3, if exercised by Government. The minimum content shall include dates of primary care appointments, status of the appointments (kept, cancelled by patient, no-show without cancellation), dates of walk-in appointments for primary care. The attendance data reflecting the 12-month period before the start of Phase 3 shall be transmitted to CDC through the SDN no later than 6 months after the start of Phase 3. The data reflecting patient attendance during the Phase 3 periods shall be transmitted to CDC through the SDN on a quarterly basis throughout the Phase 3 periods.

Task 3.10 Quality Control Data. The contractor shall perform quality control procedures to assure that there is at least 95% accuracy of all data transmitted to CDC. The contractor shall provide quality control data to CDC on a quarterly basis. On each submission, CDC COTR will inspect the data to ensure that the 95% accuracy threshold has been met and require the contractor to correct mistakes to achieve the 95% accuracy level within 14 days of learning about the deficiency from CDC.

Task 3.11 Intervention Training. Approximately one month before the onset of the intervention in Panels A and B, the contractor’s clinic staff (physicians, nurse practitioners, physician assistants, nurses, prevention specialist, social workers, case managers, receptionists) shall be properly trained in a four-hour group intervention training at the clinic site involving a series of adult learning activities including role playing. There will be a two-hour booster training at the clinic approximately two months after the initial training. The contractor shall be required to provide a room at the clinic or medical center for these group trainings, an LCD projector, and assure that all clinic staff attends the trainings.

There will be one other additional training activity: the interventionist (e.g., prevention specialist) at the clinic who will be administering the targeted interventions to higher-risk patients shall participate in a two-day training meeting in Atlanta, GA. NOTE: The intervention training will be conducted by a separately funded mechanism.

Task 3.12 Deliver and Supervise Intervention. The contractor shall supervise and deliver the intervention components (e.g., identification of patients that do not have undetectable viral loads, behavioral screening of patients, delivery of computerized intervention to patients, and face-to-face intervention (e.g. with a prevention specialist) among patients who need additional attention according to the intervention content and clinic integration plan determined in the final study protocol (Task 1).

Task 3.13 Conduct Patient Exit Surveys. CDC will provide the contractor with these surveys. Patients shall be randomly selected after their primary care exams (but not after urgent care visits) and asked if they would be willing to answer a few questions verbally about topics (but not personal information) discussed with their provider. These patients may be part of the 250 cohort members or not. 50 patients (10 per day, Monday through Friday) are to be surveyed two weeks before the onset of the intervention. After onset of the intervention, 50 patients (10 per day, Monday through Friday) shall be surveyed every three months during each CLIN under Phase 3. Patients are eligible to participate in the survey at more than one quarterly period. No identification code is needed for linking a patient’s surveys across time.

Task 3.14 Transmit Patient Exit Survey Data to CDC. The contractor shall mail copies of completed batches of surveys to CDC using a courier service (3-day delivery) no later than 14 days after completing the batch of surveys.

Task 3.15 Conduct Provider Surveys. CDC will provide the contractor with these surveys. Medical providers (physicians, nurse practitioners, physician assistants, nurses) shall be surveyed two weeks before the onset of the intervention to assess whether they talked with patients about prevention topics. After onset of the intervention, providers shall be surveyed every three months. An identification code shall be developed to link a provider’s surveys across time.

Task 3.16 Transmit Provider Survey Data to CDC. The contractor shall mail copies of completed batches of surveys to CDC using a courier service (3-day delivery) no later than 14 days after completing a batch of surveys.

Task 3.17 Pilot tests the patient-partner survey and interview questions (CLIN 4004) The CDC COTR will provide the contractor with the survey and interview questions. The contractor shall recruit three patients at the clinic who have a primary sexual partner of at least six months. These three patients (but not their sexual partners) will pilot test the survey and interview questions. The contractor shall provide written feedback to the CDC COTR on refinements that need to be made to the survey and interview questions within 14 days of the final pilot-test patient. Of the three pilot patients, one shall by a gay or bisexual man, one heterosexual man (if available), and one woman. There is no ethnicity requirement for this piloting.

Task 3.18 Patient-partner survey/interview study (CLIN 4004). This survey/interview study shall be conducted during of the last 12 months of Phase 3. The contractor shall enroll 50 patients at the clinic (the number of men and women enrollees being proportionate to their distribution at the clinic) who are in a primary sexual relationship (at least six months duration) and are able to participate along with their partner in a survey and semi-structured interview. The contractor shall enroll both seroconcordant and serodiscordant partnerships. The contractor shall administer the survey and interview to patients and partners. Cohort participants are not eligible for enrollment in the patient-partner study.

Task 3.19 Transmit Patient-Partner Survey/Interview Data to CDC (CLIN 4004). The contractor shall prepare an electronic dataset of the data collected in the patient-partner study. The dataset shall include variable names from the survey, coded responses, as well as text reflecting open-ended verbal responses to interview questions. The data shall be transmitted quarterly to CDC through the SDN. The dataset of the 50 patient-partner surveys/interviews shall be delivered to CDC no later than 30 days after the final participant has completed the survey/interview. The final dataset, including CDC COTR recommendations, shall be delivered two weeks prior to the end of the performance period.

C.6 Reporting Schedule

a. Work Plan

(1) Original Work Plan. The Contractor shall submit a copy of the Work Plan to the Contracting Officer as part of the contractor’s proposal. The Work Plan shall consist of the following:

(i) A narrative statement reflecting the methods and technical approach to be used by the Contractor in achieving the objectives and requirements set forth in the contract.

(ii) A program schedule (milestones, tasks, activities, events) in adequate detail to provide reasonable measurement of the technical accomplishments which can be summarized to the cost reporting level of the Statement of Work (SOW).

(iii) Graphs reflecting cumulative estimated costs (exclusive of fee) and man-hours by months for the total contract effort.

(iv) The contractor shall address any anticipated copyright requests, and any claims of "Limited Rights" or "Restricted Rights".

(2) Revisions to Work Plan. The Contractor shall submit revisions to the Work Plan described above:

(i) when required by the Statement of Work; and

(ii) when directed by the CDC Contracting Officer pursuant to the Change clause; and

(iii) whenever the contract requirements are changed by appropriate contract modification. The Contractor may submit recommended revisions to the Work Plan when the Contractor believes such revision is deemed desirable for optimum achievement of contract objectives. Every revision to the Work Plan shall be approved by the Contracting Officer prior to implementation by the Contractor.

b. Quality Assurance (QA) / Quality Control (QC) Plan

One copy of the contractor’s Quality Control Plan and quality assurance processes shall be provided to the Contracting Officer as part of the contractor’s proposal. This will include incorporating quality control and quality assurance processes for each of the task areas for which the contract is responsible for supporting. An updated copy if needed must be provided to the Contracting Officer on the contract start date and as changes occur. All aspects of quality control/quality assurance shall include performance standards and measures for which contract performance will be gauged in meeting contract requirements.

Records of quality inspections shall be kept and made available to the Government throughout the performance period and for the period after contract completion until final settlement of any claims under this contract.

A description of the site specific quality control inspection plan shall be provided with the offeror’s proposal. The plan shall include: (1) cohort recruitment and enrollment; (2) development and implementation of plans in accordance with the Statement of Work (e.g. inspections performed for completion of tasks, data collection, and transmittal of data; and (3) corrective or preventive actions that will be taken to meet quality standards.

Any proposed modifications to the QA/QC Plan, including SOPs, shall be submitted to the Contracting Officer for review and approval prior to implementation.

c. Quarterly Progress Reports

By the last week of each quarterly report period, the Contractor shall submit an electronic copy of a report of work performed in the quarter. Each quarterly report shall consist of:

(a) Contract number and title;

(b) Period of performance being reported;

(c) Author(s); and

(d) Date of submission.

(e) Information shall include a brief summary of the work performed during the reporting period including the following:

(1) Project personnel in place during the quarter (Name and title)

(2) Changes in personnel or major duties that occurred during the quarter

(3) Data collected and submitted by type and shipment date

(4) Number of patients screened for enrollment

(5) Number of participants enrolled

(6) Description of work completed and plans for next quarter including anticipated travel and estimated funds remaining.

(7) Description of current technical or administrative problems encountered, and their resolution or proposed corrective actions.

d. Final Report

This report is to include a summation of the work performed by the entire contract period of performance. The Final Report should be submitted in accordance with the deliverable schedule. One copy of the report will go to the CDC COTR and one copy of the report to the Contracting Officer.

C.7 Special Considerations

All data generated under this project is the property of CDC.

C.8 Government Furnished Materials

CDC will provide a final study protocol, forms, behavior screeners, and manual for conducting the various components of the study.

C.9 References

1. Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the United States. AIDS, 2006;20:1447-1450.

2. Centers for Disease Control and Prevention. Surveillance Report. www.cdc.gov/hiv/topics/surveillance/resources/reports/2005supp_vol11no2.

3. Gardner L, Metsch L, Anderson-Mahoney P, Loughlin A, del Rio C, Strathdee S, Sansom S, Siegal A et al. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS 2005; 19: 423-431.

4. Kazi S, Boroumand S. Assessing quality of primary care provided to the HIV-infected Ryan White population in the Baltimore eligible metropolitan area. Am J Med Qual 2008,23:484-491.

5. Craw JA, Gardner LI, Marks G, Rapp RC, Bosshart J, Duffus WA, Rossman A, Coughlin SL, Gruber D, Safford LA, Overton, J, Schmitt K. Brief strengths-based case management promotes entry into HIV medical care: results of the Antiretroviral Treatment Access Study-II (ARTAS-II). JAIDS, 2008;47:597-606.

6. Samet J, Freedberg K, Savetsky J, Padmanabhan L and Stein M. Discontinuation from HIV medical care: squandering treatment opportunities. Journal of Health Care for the Poor and Underserved 2003;14:244-255.

7. Giordano TP, Gifford AL, White AC, Suarez-Almazor ME, Rabeneck L, Hartment C, et al. Retention in care: a challenge to survival with HIV infection. Clin Infect Dis 2007;44:1493-1499.

8. Quinn TC, Wawer MJ, Sewankambo N, Servadda D, Chuanjun L, Wabwire-Mangen F, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. N Engl J Med 2000;342:921-929.

9. Tovanabutra S, Robison V, Wongtrakul J, Sennum S, Suriyanon V, Kingkeow D, et al. Male viral load and heterosexual transmission of HIV-1 subtype E in northern Thailand. J Acquir Immune Defic Syndr 2002;29:275-283.

10. Guidelines for the Use of AntiretroviralAgents in HIV-1-Infected Adults and Adolescents.

Developed by the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents – A Working Group of the Office of AIDS Research Advisory Council (OARAC), December, 2009.

11. Gras L, Kesselring AM, Griffin JT, et al. CD4 cell counts of 800 cells/mm3 or greater after 7 years of highly active antiretroviral therapy are feasible in most patients starting with 350 cells/mm3 or greater. J Acquir Immune Defic Syndr 2007;45:183-92 .

C.10 CDC Point of Contact

Jerry Outley,…