HOPS SOW draft 4-30-20.docx

Statement of Work

Title: The HIV Outpatient Study (HOPS): Activity to Abstract Data from Persons Receiving Ambulatory Care for HIV in the United States

SECTION 1 – BACKGROUND

The U.S. Centers for Disease Control and Prevention (CDC) estimate that approximately 1.1 million Americans are living with HIV and approximately 40,000 are newly diagnosed with HIV each year. Studies of HIV infection in ambulatory persons receiving regular outpatient medical care have been critical to the formulation of guidelines for treatment as well as for secondary prevention and treatment of conditions related to HIV/AIDS. This type of research has formed the backbone of many treatment and prevention guidelines published by the U.S. Public Health Service, the CDC, National Institutes of Health (NIH), and professional medical societies. These guidelines include recommendations regarding the initiation, use, and appropriate modifications of treatment with combination antiretroviral therapy (cART), the treatment and prevention of opportunistic illnesses, and the treatment and prevention of complications and comorbidities related to HIV infection, the use of cART, and aging of HIV-infected patients, whose survival has significantly improved over the past 25 years. In the State of the Union Address on February 5, 2019, the White House announced this administration’s goal to end the HIV epidemic in the United States within 10 years. A critical pillar of the Ending the HIV Epidemic initiative includes effective treatment and engagement in care for sustained viral suppression for people living with HIV. The HIV Outpatient Study (HOPS) addresses this area by generating knowledge to improve comprehensive HIV care, with in turn allows patients to achieve best possible health with HIV viral suppression, and to avoid morbidity, mortality and transmission of HIV to their sexual partners.

The HOPS project was established by the CDC in 1993 at U.S. medical practice settings. Since its inception, this research study has encompassed complete standardized and confidential medical chart abstraction from adults with HIV receiving routine HIV-related outpatient care. The results from the study have been widely disseminated (over 80 publications to date) and presented at international and national conferences. The proposed 5-year contract, “The HIV Outpatient Study (HOPS) Activity to Abstract Data from Persons Receiving Ambulatory Care for HIV Infection in the United States”, is a continuation of medical data abstraction and behavioral survey data collection from the previous contract. Newly collected data shall be combined with multi-year medical chart abstraction and behavioral survey data obtained during the prior HOPS project contracts to enable longitudinal data analyses.

The data abstracted from eight active clinics form the largest and most comprehensive set of information of its kind in the United States, providing uniquely valuable insights regarding the treatment and prevention of HIV infection in Americans. The CDC intends to continue this data abstraction activity at these eight clinics, which will enable the CDC to carry out a central component of its public health mission, namely, gathering and analyzing data to develop guidelines and recommendations for clinicians, public health departments, and other partners participating in the prevention and treatment of HIV infection. The HOPS data collection contributes to the knowledge base and is aligned with the key strategy for “Ending the HIV Epidemic; A Plan for America”, namely: Treat the infection rapidly and effectively to achieve sustained viral suppression.

SECTION 2 – PURPOSE

The purpose of the HIV Outpatient Study is to generate research and actionable solutions to optimize the health for Americans living with HIV, and describe factors associated with clinical, immunologic and virologic success, and any new problems associated with long-term chronic HIV infection and its treatment. HOPS contributes to the Ending the HIV Epidemic initiative chiefly by producing data on how to treat HIV infection effectively to achieve sustained viral suppression and reduce long term morbidity and mortality. The HOPS is a complete standardized and confidential medical chart abstraction from HIV-infected patients receiving routine HIV-related ambulatory care. The HOPS collaborates with and contributes de-identified data to the North American AIDS Cohorts Collaboration on Research & Design (NA-ACCORD).

Among a cohort of HIV-infected persons receiving care at eight HIV-specialty ambulatory clinics. The datasets shall include the entirety of patient medical record while at the HOPS clinic for the following variables:

a. Demographics

b. Social and behavioral characteristics

c. Medical diagnoses

d. Treatments and procedures

e. Laboratory values

f. Payor or insurance type

g. Causes of death or withdrawal of enrollees from the study

The Contractor shall support the ongoing behavioral survey data collection for HOPS participants and, in each option year, perform two additional surveys/enhanced data collection tasks relevant to the prevention and treatment of HIV infection within the cohort of enrolled patients to address questions that emerge during the course of the study and that result from the evolving knowledge of HIV/AIDS.

SECTION 3 – SCOPE OF WORK

A cohort of HIV-infected adult patients receiving care at eight HIV-specialty outpatient clinics (incorporated herein as Attachment J.1) has been assembled. All participating patients have signed informed consent forms that have been cleared by local and CDC Institutional Review Boards (IRBs). The administration of the HOPS project is subject to review and approval by the Office of Management and Budget (OMB).

This data abstraction project takes advantage of participating patients’ routine clinical care visits to collect data. The Contractor shall perform the requested tasks at the eight sites listed in Attachment J.1. The data is abstracted from the medical records on an ongoing basis to provide a continuous record of the patient experience at each participating HOPS site. A brief behavioral survey is administered, to patients via Telephone Audio- Computer Assisted Self-Interview (T-ACASI) or a Web based Computer Assisted Self-Interview (W-CASI) at sites listed in Attachment J.1. In addition to quarterly transfer of datasets to the CDC, data is also submitted annually to NA-ACCORD data management center..

Throughout the contract, the Contractor provides management of data collection and maintain quality control and data integrity. The Contractor conducts basic and advanced statistical data analyses, including complex longitudinal regression analyses, of data collected under this contract and participates in the interpretation and public dissemination of findings. The Contractor assists in planning and collecting data for two additional surveys/enhanced data collection tasks per year. Planning occurs during the annual two-day program review noted in subtask 4C. Data collection activities are conducted at designated study sites in conjunction with routine data entry.

The contractor provides and executes a transition/continuity plan for shift from the previous HOPS contract to ensure continuity and integrity of the existing and newly collected medical chart abstraction and behavioral survey data for the patients currently enrolled in the study at the participating HOPS clinic sites (Attachment J.1). It is essential to the success of this project and value of its data to maximize the length and continuity of follow-up among the enrolled HOPS patients.

The Contractor , as an independent organization and not as an agent of the Government, furnishes all of the necessary services, qualified personnel, material, equipment, and facilities to perform the following contract requirements.

SECTION 4 – TASKS TO BE PERFORMED

The Contractor shall administer the HOPS project by collecting and managing data from the HIV specialty clinics currently participating in the HIV Outpatient Study and replacement clinics should current participants be removed or elect to discontinue participation and their physician(s), hiring, training and supervising all data abstraction and analysis staff, ensuring compliance at each clinic with local Institutional Review Board approvals and procedures and adherence to CDC Information Technology data confidentiality and security requirements. Participating HIV-specialty clinics (Attachment J.1) may only be added, removed or replaced by the contracting officer. The Contractor shall collect data from physician-patient interactions including demographics, social-behavioral characteristics, medical diagnoses, treatments, and laboratory values, and death records. As part of this data collection activity, the Contractor shall administer a brief confidential behavioral survey, to be completed by patients either by phone (T-ACASI) or through a secure website (W-CASI). This data abstraction activity shall also include, conducting up to two additional surveys/enhanced data collection tasks per year to collect additional clinically relevant data. The Contractor shall maintain chart abstraction across HOPS medical practices for a minimum of 2,700 active patients, with active defined as having made at least one visit to a participating HOPS medical practice within 18 months of the beginning of the relevant option period of the project. Abstraction at any individual HOPS medical clinic site shall include no fewer than 50 active patients. The confidential behavioral survey shall be offered once per year to active HOPS patients.

Task 1: Preparation Subtask 1A: The Contractor shall collect data from the HIV specialty clinic sites (see Attachment J.1) collecting data from medical records and behavioral survey data for the HOPS .

Subtask 1B: The Contractor shall ensure that the contractor and all HOPS clinic sites where data collection shall take place (listed in Attachment J.1) have obtained a current FWA number (Federal Wide Assurance) before performing any work under the current contract.

Subtask 1C: The Contractor shall ensure that each HOPS clinic site maintains local institutional review board (IRB) approval with annual renewals in keeping with the schedule established and maintained by each local IRB. The Contractor shall ensure the annual approval by its local IRB of the study protocol, all interval protocol amendments, and any other study-related documentation that requires human subjects research oversight The Contractor shall report any study protocol deviations to the CDC project officer within 24 hours of its occurrence and shall provide written documentation detailing the deviation and its resolution within 48 hours of occurrence. The Contractor shall ensure that the CDC COR and Project Officer(s) receive copies of all communications with each site’s IRB, including copies of annual letters of approval to continue the study. The Contractor shall provide copies of all written communications between each local site and its respective local IRB to the CDC COR and Project Officer(s) within 14 business days of the date such communication takes place.

Subtask 1D: Contractor shall provide assistance to COR/PO to ensure CDC IRB and OMB approval. The Contractor shall ensure that the CDC COR and PO receive copies of screenshots of all data collection tools associated with the HOPS project. The contractor shall provide copies of data collection tool screen shots and all necessary documentation within 14 business days of the information request.

Subtask 1E: The Contractor shall provide all necessary information to CDC information security/IT office, for ongoing maintenance of the Authority to Operate (ATO) as outlined in Section 12 Information Security. This shall include performance of scans for data collection software vulnerabilities and resolution of such vulnerabilities.

Subtask 1F: The Contractor shall ensure that all investigators and study personnel, who will have patient contact, complete the Office for Human Research Protection (OHRP) on-line human subjects protection training. Written documentation of local IRB approvals and of staff who have completed the OHRP training shall be provided to the CDC COR and Project Officer(s) within 4 business days after request has been made. The Contractor shall train all study personnel in administering informed consent to patients before enrolling them in the HOPS, and ensuring that consent forms are stored in a private and secure manner not accessible to persons not authorized to view them.

Subtask 1G: It is essential that ongoing data are collected on the patients from the same sites (same ‘catchment area’) so that the CDC can evaluate long-term outcomes of HIV disease and its treatments among the individual HOPS patients enrolled in the HOPS. The Contractor shall provide and execute a finalized detailed transition/continuity plan to seamlessly transition and maintain continuity and integrity of existing and newly collected longitudinal HIV medical abstraction data, by engaging existing HOPS clinic sites (listed in Attachment J.1).

Subtask 1H: The Contractor shall hire and train all persons employed to abstract, enter, and update medical records abstraction data under this contract (these persons are also referred to as “Research Consultants or “data abstractors”). Contractor shall provide the CDC COR with a revised organizational chart within 30 calendar days of the departure or addition of key personnel. The hired study personnel shall be trained in using data collection hardware and software to be provided by the Contractor, which is compliant with CDC’s Information Technology Security Certification and Accreditation requirements, and in data security implementation. Because of the complexity and specialized nature of the medical records documentation for HIV-infected adults, and because of the need for highly accurate and complete data to preserve the epidemiological value of the HOPS longitudinal data collection, it is expected that persons performing data abstraction and entry shall have nursing, public health research or other healthcare backgrounds, and have at least 12 months of experience in chart abstraction of data from HIV-infected patients or equivalent. The Contractor shall establish through discussion with the CDC COR and Project Officer(s) the parameters for data abstractor training during a meeting prior to execution of activities awarded under this contract. The parameters for training of data abstractors shall be discussed and reviewed by the Contractor, CDC COR and CDC Project Officer(s) on an annual basis.

Subtask 1I: The Contractor shall identify and train designated project personnel at each site in Attachment J.1 in administering the T-ACASI/W-CASI survey (Attachment J.2), including the systematic offering of the survey to all eligible patients to maximize survey participation rates. The training shall be conducted to specifically include tracking mechanisms with the aim that each patient enrolled in this research study is offered the opportunity to participate in T-ACASI/ W-CASI survey at least once per year.

Subtask 1J: The Contractor shall develop a Manual of Standard Operating Procedures (SOPs) for all requirements of work to be performed by the contractor, including training of site study personnel in administering informed consent and enrolling patients in the study, and the requirements for data abstraction, entry and corrections by local site personnel, and data quality assurances activities to be performed by the Contractor to fulfill the requirement. The initial and subsequent updated manual shall be provided to the CDC COR and Project Officer(s) within the first 90 calendar days of contract performance period, and updated annually.

Task 2: Data Collection

Subtask 2A: The Contractor shall provide training and technical support to all software users in order to perform the contract requirements.

Subtask 2B: Within 14 calendar days of the start of the base period of the award, the contractor shall have in place all necessary services, qualified personnel, material, equipment, and facilities to perform the contract requirements, including hardware, software and processes for data collection, to include medical chart abstraction and telephone and web-based behavioral survey. The contractor shall abstract, enter, store and maintain all data from participating HOPS patients’ medical records for this contract The Contractor shall perform abstraction of data items at study sites incorporated herein as Attachment J.1. Data specified in the HIV Outpatient Study data dictionary (Attachment J.2) shall be abstracted from no fewer than 2,700 active patients across all participating sites (active defined as patients who have made at least one visit to the clinic within 18 months of the start of each option period of the contract) and no fewer than 50 active patients from each individual site. Data to be collected by the Contractor specified in the data dictionary include the following: patient demographics, patient social and behavioral characteristics relevant to the risk for HIV acquisition and transmission as well as the treatment of HIV infection, recorded at each visit, medical diagnoses made at each visit, payor or insurance type at each visit, results of all laboratory or clinical testing performed at each visit, a full record of every treatment provided at each visit (including medication dosage), as well as date of withdrawal from study and cause of death for patients who die. In addition to abstracting data from every clinical encounter the patient has with the clinic, the Contractor shall abstract any relevant data (as outlined above) that may be present in other accessible sources (e.g., reports from visits to other providers, hospital discharge summaries, and death certificates or publicly available databases of death records) as allowed by the protocol and patient consent. Particular attention shall be paid to completeness of cause of death information. The data elements collected for each individual patient shall be linked by HOPS patient identification number using an exact (deterministic) link, to enable summarizing data for each participant at each particular medical visit and over calendar time since 1993 or since the beginning of HOPS data collection for that HOPS participant, whichever came later.

Subtask 2C: All medical chart abstraction data from participating HOPS sites listed in Attachment J.1 shall be entered into (OpenClinica®) or an industry comparable standard web-based medical record abstraction application, either manually or by automatic transfer from clinic sites’ existing electronic medical records (EMRs). The Contractor shall provide technical support for the software, and shall monitor and ensure modifications of the software as necessary, and provide technical support to all users of the hardware and software required for data entry. The Contractor shall incorporate software updates (e.g., adding new diagnoses, treatments, laboratory values, etc.) and execute all necessary related software modifications as requested by the CDC COR and Project Officer (s). Maintaining stable variable definitions and coding system for HOPS Study data already collected since 1993 and additional data to be collected during the new contract period is critical for ensuring the validity of these data for longitudinal analyses and for overall value of this project.

Subtask 2D: The Contractor shall compile the data collected from HOPS participants at participating HOPS sites listed in Attachment J.1. The data shall be compiled into datasets with data dictionaries using commercially available SAS Institute Inc. (SAS) © software. The datasets shall be delivered to the CDC COR and Project Officer(s) within 45 calendar days after the end of each calendar quarter, using a secure method of data transfer consistent with CDC Information Technology Security protocols, as specified in Deliverables/Reporting Schedule in SECTION 9. The datasets shall combine, using a unique HOPS patient identification number, the newly collected data together with the data obtained from HOPS participants under the previous HOPS contracts, in order to maintain continuity and integrity of longitudinal data collection for HOPS participants since 1993.

Subtask 2E: Within 30 calendar days of the start of the base period of the award the contractor shall conduct behavioral survey (Attachment J.2) data collection via Telephone Audio-Computer Assisted Self-Interview (T-ACASI) and a Web based Computer Assisted Self-Interview (W-CASI) survey among patients participating in this study at the Attachment J.1 sites. The information collected shall include age, sex at birth, current gender, use of alcohol and drugs, cigarette smoking, opioid use, mental health, adherence to antiretroviral medications, types of sexual intercourse, condom use, and disclosure of HIV status to partners, and PrEP use among partners. All patients enrolled in this research protocol are to be offered participation in the T-ACASI/W-CASI survey annually. Patients are to complete the survey by logging into a secure and encrypted website or by dialing a 1-800 number from a private location in the clinic or from home. The Contractor shall provide technical support for the software to all users, and shall monitor and ensure modifications of the software as necessary, including adding or correcting response options to the existing survey items, or potentially adding new survey questions. The Contractor shall, at a centralized location, receive, download, merge, manage, and clean all data collected via T-ACASI/W-CASI surveys from the clinics. The contractor shall provide a weekly report of ACASI activity to include the total number of complete and incomplete surveys by site from the previous week. The data shall be compiled into datasets with data dictionaries using commercially available SAS Institute Inc. (SAS) © software. The contractor shall clean and combine T-ACASI/W-CASI survey data collected under the contract with the pre-existing T-ACASI/W-ACSI data, which the data collected under this contract extend. The Contractor shall provide a database of all T-ACASI/ W-CASI survey results collected to date to the CDC COR and Project Officer within 45 calendar days after the end of each quarter, using a secure method of data transfer consistent with CDC Information Technology Security protocols, as specified in Deliverables/Reporting Schedule in SECTION 9 and as described in subtask 2D.

Subtask 2F: The Contractor shall participate in conducting up to two additional surveys/enhanced data collection tasks per year to collect enhanced or additional clinically relevant data required for analyses of new and existing medical conditions and behaviors from HOPS participants, as permitted by the HOPS protocol. This task is to be performed as part of the duties of the HOPS study site personnel performing medical records abstraction. The Contractor shall establish through discussions with the CDC COR and Project Officer(s) the content and format of these additional surveys/enhanced data collection tasks prior to execution of activities awarded under this contract.

Task 3: Data Management and Quality Assurance

Subtask 3A: The Contractor shall assure the quality and integrity of data abstracted from participating HOPS sites in Attachment J.1. The Contractor shall, at a centralized location, receive, download, merge, manage, and clean all data collected from the clinics. The existing HOPS data to date has been captured using open source data collection and management software OpenClinica®. The Contractor shall continue to capture HOPS data using (OpenClinica®) or an industry comparable standard web-based medical record abstraction application a single secure electronic database. During HOPS conduct, most data collection has been done using a custom coding system (not ICD-9 or ICD-10 code based) tailored to requirements of this contract for collecting medical chart abstraction data on all the diagnoses, treatments, laboratory values, and types of medical patient visits and other encounters and events (hospitalizations, deaths) relevant to the HOPS. Maintaining stable variable definitions and coding system for HOPS Study data already collected since 1993 and additional data to be collected during the new contract period is critical for ensuring the validity of these data for longitudinal analyses and for overall value of the HOPS project.. The contractor shall provide a detailed data management plan for the HIV Outpatient Study. Additionally, the Contractor shall provide a detailed transition/continuity plan for the phase in of the project described in Subtask 1G.

Subtask 3B: The Contractor shall perform ongoing reviews and resolve data errors to ensure complete and accurate datasets on a quarterly basis, and shall also maintain and execute automated programming to identify errors or gaps in data collection. The contractor shall prioritize in discussion with the CDC COR and Project Officer(s) the gaps and errors that require re-review of medical records and ensure resolution of all prioritized errors or gaps within 90 to 180 calendar days of their identification. Such errors or gaps include missing date for start of HIV treatment, lack of medical encounter in the past 18 months, and date of HIV diagnosis being later than date of starting antiretroviral treatment, or missing or inconsistent diagnosis or treatment start and end dates.

Subtask 3C: The contractor shall securely maintain, manage and transmit data outlined in subtask 2D and 2E using a secure method of data transfer consistent with CDC Information Technology Security protocols, as specified in Deliverables/Reporting Schedule in SECTION 9.

Subtask 3D: The contractor shall submit upon request, de-identified data outlined in subtask 2D to the North American AIDS Cohort Collaboration on Research & Design (NA-ACCORD) as part of its collaboration with the HIV Outpatient Study (HOPS). The global data transfer is requested by NA-ACCORD once per year and typically requested between May and September, and shall be delivered within 60 calendar days of a request. The HOPS data shall be formatted according to the specifications of NA-ACCORD data center, which are updated each year. An example of data transfer protocol is found in Attachment J.3.

Subtask 3E: The Contractor shall ensure and verify that among active HOPS patients (defined as having made at least one visit to the medical practice during the relevant option of the project), at least 90% of patients have ever been offered T-ACASI or W-CASI and at least 80% of active patients (patients who have had a visit within the previous 12 months), who do not have a documented refusal, have been offered T-ACASI or W-CASI each year. This performance shall be documented in reports as per Subtask 4E.

Subtask 3F: The Contractor shall provide quarterly and annual summary reports of the data collected under the current contract together with pre-existing HOPS study data. These reports shall include summaries of patient demographics, diagnoses, treatments, laboratory values, hospitalization, deaths and behavioral data collected by TACASI/W-CASI as outlined in Task 2. The annual summary shall contribute toward a combined site visit Report Summary Data deliverable and shall be delivered 45 calendar days of the end of the fiscal year. The content of the Quarterly Summary will be abbreviated and established through discussions with the CDC COR and Project Officer(s), shall be delivered in a Microsoft Power Point presentation together with datasets specified in Subtask 3C within 45 calendar days of the end of the quarter.

Task 4: Performance Management

Subtask 4A: The Contractor shall review site performance and data quality by making at least one annual site visit (of at least one day duration) to each participating HOPS clinic to ensure adherence to all applicable study policies as described in Manual of Standard Operating Procedures (SOPs) and OHRP human subject research requirements. At the annual site visit, the Contractor shall verify the presence of signed informed consent forms for this research protocol and review records from no fewer than 10 randomly selected patients from each of the participating sites incorporated herein as Attachment J.1. If any informed consent forms are found to be incomplete or missing, the Contractor shall notify the CDC COR and Project Officers, and the site investigator, within one business day of the date such finding takes place.

Subtask 4B: During the annual HOPS clinic site visits, the Contractor shall have a formal meeting with the HOPS Principal Investigator (i.e. clinic physician) to review site progress and status, including any concerns related to staffing, completeness and timeliness of HOPS data entry and administration, status of T-ACASI/W-ACASI implementation. The Contractor and the Principal Investigator of each HOPS clinic shall jointly devise an action plan to ameliorate any problems encountered. The Contractor shall submit a site visit report of 600 to 1000 words including any action plans to the CDC COR and Project Officer(s) within 14 calendar days of the completion of the site visit, and forward a copy to the Principal Investigator. The site report shall include, but not be limited to the following: (1) number of current HOPS participants without a clinic visit in the past 12 months;(2) number of patients newly enrolled into HOPS in the past 12 months; (3) number of outstanding HOPS data entry queries; (4) number of patients offered T-ACASI/W-CASI in the past 12 months; (5) number of active patients who have never completed T-ACASI/W-ACASI at the site (excluding patients who actively refused the survey), (6) any protocol or IRB consent deviations discovered during the audit, (7) specific difficulties or barriers to data entry and offer of T-ACASI/W-CASI as reported by site study personnel or Principal Investigator and proposed solutions to these problems, and (8) site accomplishments in the prior year, as well as any other logistical, administrative, financial, hiring and other considerations that affect performance of the HOPS project at the site.

Subtask 4C: The Contractor shall review combined site performance and data quality by organizing and conducting an annual two-day program review among active HOPS sites to include at least one representative from each participating HOPS clinics. The program review shall occur at a host HOPS site in one of the metropolitan areas where there are existing HOPS study sites (Attachment J.1) or at the Centers for Disease Control and Prevention in Atlanta, GA or virtually. The annual program review shall be conducted during the second quarter of the calendar year, unless otherwise directed by the CDC COR and Project Officer(s). The annual program review shall be attended by (1) the CDC COR, (2) the CDC Project Officer(s), (3) the Contractor staff assigned to this project (including data managers, analysts and statisticians), (4) the Principal Investigators, or approved site designee from each of the participating HOPS sites and (5) the data abstractors from each HOPS clinic study site. The purpose of the annual program review is to collectively review and update as necessary adherence to all applicable study policies as described in Manual of Standard Operating Procedures (SOPs) and OHRP human subject research requirements including recruitment and enrollment, data collection and medical chart abstraction and review of combined HOPS clinic practice profiles. The Contractor and HOPS site representatives shall jointly discuss project progress, study and contract related issues and devise action plans to ameliorate any problems encountered. Additional activities shall include reviewing study progress, present findings from the preceding year, and plan future data collection, research and analytic activities. The review of site and study progress shall include measures relevant to tracking the goals for Ending the HIV Epidemic initiative to include: CD4 cell counts at the start of HIV antiretroviral therapy, the initial and sustained viral load suppression, and retention in HIV care. The activities at each of the HOPS study sites (Attachment J.1) related to Ending the HIV Epidemic, such as patient programs and interventions to support timely provision of HIV treatment, adherence to HIV care, linkage to services and continuity of care (with the number of HOPS patients served through each activity) shall be summarized and presented. The Contractor shall assist site investigators in presenting specific individual or group site analytics performed under the term of this contract during each option period and obtain epidemiologic, statistical, and clinical inputs for analytic improvements from all the participants. The Contractor staff shall also lead the discussion of additional variables to be added to the database, any updates to the codes used (e.g., for recently approved HIV medications or laboratory tests). Contractor staff shall also review site-aggregated data on new patient enrollments and losses to follow-up in the previous year, and most common data entry errors and inconsistencies with the goal of improving overall data quality. The CDC COR and Project Officer(s) in consultation with the Contractor will specify the dates and location of the annual program review, the list of attendees, the content of documents, and the agenda. Specific Contractor duties for the annual program review shall include the following:

· Identify and secure a hotel with adequate room space to accommodate comfortably all persons anticipated to attend from all participating HOPS sites.

· Identify and procure all audio/visual needs.

· coordinate the attendance by all non-federal anticipated attendees from each of the participating HOPS sites.

· Pay for production of and distribute any necessary documents.

Subtask 4D: The Contractor shall also deliver to the CDC COR and Project Officer(s) a summary of data collection quality assurance activities executed under Subtask 3B. This summary shall be delivered quarterly together with the datasets under Subtask 2E.

Subtask 4E: On a quarterly basis, the Contractor shall prepare a brief tabular summary of data entry progress for each individual site, including number of new patients, diagnoses, treatments, laboratory values, and clinical encounters entered during the last calendar quarter. The summary shall also include the number and types of outstanding HOPS data queries, and the number of T-ACASI/W-CASI surveys completed in the prior quarter. The summary shall present data for all HOPS enrolled and active HOPS participants, with active defined as having made at least one visit to the participating HOPS medical clinics within 18 months of the base year and each option year of the contract. The summary shall be aggregate data for patients collected during the current Contract combined with previously collected HOPS data collected. The Contractor shall establish through discussions with the CDC COR and Project Officer(s) the content and format of this data summary prior to execution of activities awarded under this contract. The Contractor shall prepare this summary across all HOPS sites, and specific summaries for each participating HOPS site, and provide these to the CDC COR and HOPS Project Officer(s) within 45 calendar days after the end of each quarter.

Subtask 4F: During the annual site visit, and by periodic phone-calls and on-line meetings, the Contractor shall assess each abstractor’s performance and provide refresher training for the data abstractors as needed to meet the Contractor’s obligations under Tasks 2 and 3. The Contractor shall specifically address the performance of abstracting and collecting data, entering data, and completing data management duties under Tasks 2 and 3. The Contractor shall host a monthly telephone conference designated for data abstractors that shall be used for the purpose of reviewing and updating progress with data abstraction and as a forum for shared discussion of issues relevant to continuing and improving data abstraction and other data collection issues and topics related to this contract. The contractor shall prepare a summary of the call discussion and provide the call summary to the CDC and all data abstractors within 7 business days of the conference call.

Subtask 4G: The Contractor shall coordinate and schedule bi-monthly telephone conference calls among the HOPS site investigators to review scientific progress with project administration and data collection. Audio-visual support for presentation of Power Point slides or webinar format is expected. The contractor shall provide a summary of the call discussion within 7 business days of the conference call to the COR and POs for review and upon COR and POs acceptance distribute to the HOPS site investigators and the CDC.

Subtask 4H: The contractor shall coordinate and schedule bi-weekly conference calls with the CDC COR and project officer(s) to review issues relevant to project administration and shall provide a meeting summary including action items to be addressed. The meeting summary shall be provided to the CDC COR and the project officer(s) within 5 business days after the conference call.

Subtask 4I: The contractor shall attend leadership-level data management and analytics calls with NA-ACCORD data group, CDC COR and HOPS Project Officer(s), once per calendar quarter, to discuss updates to HOPS data submission requirements for annual NA-ACCORD data submissions, quality assurance procedures or other issues or concerns as they may arise.

Task 5: Statistical Data Analysis

Subtask 5A: During this contract, the Contractor shall analyze data collected under the contract together with pre- existing data for HOPS patients, which the data collected under this contract extend, to produce scientific research that informs the prevention and treatment of HIV infection. . During each option period, the Contractor shall provide statistical support for new and separate scientific analyses of the data specified above, and contribute to preparation of four separate scientific manuscripts for CDC Clearance. The Contractor shall develop, modify and finalize analysis plans in consultation with HOPS Site Investigators and per guidance of the CDC COR and Project Officer(s). The contractor shall have a demonstrated proficiency with a published record of longitudinal epidemiologic and health services data analyses, proven expertise in cohort, cross-sectional or case-control study designs, and a variety of techniques for regression modeling of repeated measures data, accounting for confounding and statistical interaction. The Contractor shall conduct analyses of longitudinal data from medical chart abstraction and behavioral survey data with methodological rigor and clear and transparent documentation outlined in the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE), see http://www.strobe-statement.org/. For each separate analysis, an analytic plan and results shall be delivered to CDC COR and Project Officer(s) in an electronic format, by secure E-mail, within 7 calendar days after they become available. A final package containing the analysis plan, results and supporting statistical SAS program documentation shall be delivered electronically to the CDC COR and Project Officer(s) within 30 calendar days of the final acceptance of a manuscript by a peer-reviewed scientific journal for each manuscript containing data analyzed under this Contract.

Subtask 5B: During each option period, the Contractor shall coordinate, schedule and conduct every ix weeks, a statistical analyst conference calls among the data managers, analysts and CDC COR and Project Officers to review current and newly proposed analyses. The objective of the calls is to review the analysis log and discuss any statistical, epidemiologic and other data- related issues and develop solutions for timely, sound and valid HOPS data analyses.

Subtask 5C: The Contractor shall maintain and submit to the CDC COR and Project Officer(s) within 7 calendar days of the completion of the statistical analyst call (Subtask 5B), a log of analyses, to include the status of ongoing, completed or new requests in each option period.

Task 6 Reports

Subtask 6A: Annual Data Report (HOPS Project Profiles): During each option period, the Contractor shall produce an annual summary report of the data collected up until that point in time under this contract and incorporating the data collected prior to this contract, which the data collected under this contract extend. This report shall be presented at the annual project review referenced in Subtask 4C. This data summary shall include at minimum summary data on patient demographics, patient enrollment, measures of health status such as CD4 cell counts and HIV viral loads, medication prescription practices, and results of sexually transmitted disease testing. The activities at each of the HOPS study sites (Attachment J.1) related to Ending the HIV Epidemic, such as patient programs and interventions to support timely provision of HIV treatment, adherence to HIV care, linkage to services and continuity of care (with the number of HOPS patients served through each activity) shall be summarized and presented. The summary shall be produced for all HOPS sites in aggregate and separately for each participating HOPS clinic.

The aggregate and the site level reports shall be submitted to the CDC COR and Project Officers via email 30 calendar days before the annual project review. Each study site listed in Attachment J.1 shall receive their own site level report as well as the aggregate report. The Contractor shall establish through discussions with the CDC COR and Project Officer(s) the content and format of this data summary prior to execution of activities awarded under this contract.

Subtask 6B: Annual Study Status Reports: The Contractor shall submit to the CDC COR and Project Officer(s) annual progress reports that summarize the status of work performed and include a description of study subject recruitment practices, goals, and accomplishment of the tasks outlined under the contract. The purpose of the report is to keep the CDC COR and Project Officer(s) informed of the status of duties and accomplishments. Areas of critical interest to the CDC COR and Project Officer(s) include the status of IRB approval. The annual report shall be given to the CDC COR and project Officer(s) in final form within 45 calendar days of the end of the relevant option period.

Items that must be included in each progress report are as follows:

a. Status of IRB approval at each site

b. Steps taken by each study site to meet enrollment goals

c. Summarized across the whole HOPS and separately by site:

i. Number of new participants enrolled during the preceding 12 months

ii. Number of participants on whom any data were abstracted in the preceding 12 months

iii. Number of participants lost-to-follow up, moved, died, or withdrew from the study.

iv. Number of current participants without a clinic visit in the past 12 months,

v. Number of participants who have completed T-ACASI/ W-CASI and survey offer and participation rates

d. Summary of quality assurance activities carried out under Task 4 including dates of travel and locations visited.

e. Changes and additions made to the activities carried out under Tasks 2, 3 and 4 as a result of quality assurance activities carried out under Task 4.

Subtask 6C: Final Report: 21 calendar days prior to the completion of this contract, a final report shall be submitted to the CDC CO, COR and Project Officer(s) that will include:

a. Final number and characteristics of participants enrolled

b. Narrative outlining accomplishments and shortcomings in meeting Contract requirements.

c. A list of all scientific findings that are a result of analysis of any data collected under this contract. This list shall include a) scientific findings presented publicly but that may not have been published in a scientific or medical journal (e.g., at professional scientific meetings) and b) scientific findings designated for publication in a scientific or medical journal with each item categorized as “published”, “in press” and “in development”. For each listed item, the Contractor shall provide the authors, the title, and the meeting or journal in which the finding appeared, or if not yet presented then the meeting or journal in which they are designated or planned to appear.

Under the FAR Clause 52.227-17 Rights in Data – Special Works (Section I.1), the data obtained under this contract becomes the property of the United States Government. Except as otherwise specifically provided for in this contract, the Contractor shall not use, release, reproduce, distribute, or publish any data first produced in the performance of this contract, nor authorize others to do so, without written permission of the Contracting Officer.

SECTION 5 TRAINING

Necessary training associated with this contract includes (1) Annual human research protection training for all study personnel engaged in patient contact, (2) HOPS research protocol implementation (e.g. screening, consent, enrollment, data collection and tracking procedures), (3) software associated with the implementation of the HOPS protocol. Trainings shall encompass initial and refresher training as needed.

SECTION 6 TRAVEL

Travel associated with this contract shall include: (1) a one-day kick-off meeting during the base year of the contract to take place within 2 weeks of contact award at the CDC in Atlanta, GA; (2) a one day annual year-end review meeting to take place within 30 days of the end of the current performance period at the CDC on Atlanta, GA (3) ne annual site visit ( one day duration) to each participating HOPS clinic to ensure adherence to all applicable study policies as described in Manual of Standard Operating Procedures (SOPs) and OHRP human subject research requirements; and (4) an annual two-day program review among active HOPS sites to include one representative from each participating HOPS clinic. The two-day program review(subtask 4C) shall occur at a host HOPS site in one of the metropolitan areas where there are existing HOPS study sites or in Atlanta, GA. All travel rates shall be in accordance with the Federal Travel Regulations.

SECTION 7 – GOVERNMENT FURNISHED MATERIALS

None.

SECTION 8 – PERIOD OF PERFORMANCE

The contract shall be performed in one 12-month base period and four 12-month option periods, if exercised by the Government:

Base Period – September 30, 2020 to September 29, 2021

Option Period 1– September 30, 2021 to September 29, 2022 Option Period 2 – September 30, 2022 to September 29, 2023 Option Period 3 – September 30, 2023 to September 29, 2024 Option Period 4 - September 30, 2024 to September 29, 2025

SECTION 9 – DELIVERABLES/REPORTING SCHEDULE

Item

Description Quantity or No.

of Copies

Delivery Date

Deliver To

COR, PO