Solic. Attach 1 - HOPS SOW.pdf

Statement of Work

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) estimates that over one million Americans are living with human immunodeficiency virus (HIV) and over 30,000 were newly diagnosed with HIV in 2020. 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 and acquired immunodeficiency syndrome (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.

The guidelines include recommendations regarding the initiation, use, and appropriate modifications of treatment with combination antiretroviral therapy (cART), the treatment and prevention of opportunistic illnesses as well as complications and comorbidities related to long term chronic HIV infection. 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 such 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, which 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, the study has encompassed complete standardized and confidential medical chart abstraction from adults receiving routine HIV-related outpatient care. Study results have been widely disseminated

(over 95 publications to date) and presented at international and national conferences. The anticipated effort will continue the medical data abstraction and behavioral survey data collection being performed under the current 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, in order 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 is aligned with the key strategy for “Ending the HIV

Epidemic; A Plan for America”, which is to 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 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 patients with HIV 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; https://naaccord.org/) The datasets shall include the entirety of patient medical record while at https://naaccord.org/ 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

In addition to medical chart abstraction, the Contractor shall support the ongoing behavioral survey data collection for HOPS participants. Two additional surveys/enhanced data collection tasks per year are anticipated. These tasks will be 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 adult patients with HIV receiving care at eight HIV-specialty outpatient clinics

(incorporated herein as Attachment 3) 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 3. The data are 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 3. In addition to quarterly transfer of datasets to the

CDC, de-identified HOPS data are also submitted annually to the NA-ACCORD data management center.

The Contractor shall provide management of data collection and maintain quality control and data integrity. This shall involve conducting basic and advanced statistical data analyses, including complex longitudinal regression analyses of data collected; and the participation in the interpretation and public dissemination of findings. The Contractor shall assist in planning and collecting data for two additional surveys/enhanced data collection tasks per year. 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 prior 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 3). It is essential to the success of the 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 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 in the event current participants are removed or elect to discontinue participation). The contractor shall be responsible for hiring, training, and supervising all data abstraction and analysis staff and shall ensure 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 3) 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 2,300 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. The Contractor shall –

Task 1: Preparation:

Subtask 1.1: Collect data from medical records and behavioral surveys at the eight HIV specialty clinic sites in attachment 3.

Subtask 1.2: Ensure that the contractor and all HOPS clinic sites where data collection shall take place

(listed in Attachment 3) have obtained a current Federal Wide Assurance (FWA) number before any work is performed. See https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/fwa-instructions/index.html.

Subtask 1.3: Ensure that each HOPS clinic site maintains local 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 Contracting Officer’s Representative (COR) 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 COR receives 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 COR within 14 business days of the date such communication takes place.

Subtask 1.4: Provide requisite site-level materials to COR to ensure CDC IRB and OMB approval. The

Contractor shall ensure that the COR 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 28 business days of the information request.

Subtask 1.5: 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 COR within four business days after request has been made. The Contractor shall train all study personnel in administering informed consent to patients before enrolling patients in the HOPS, and train in ensuring that consent forms are stored in a private and secure manner, i.e., not accessible to persons unauthorized to view them.

https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/fwa-instructions/index.html https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/fwa-instructions/index.html

Subtask 1.6: Provide and execute a detailed 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 (Attachment 3). 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. The continuity plan shall be delivered to the COR within 30 calendar days of contract award.

Subtask 1.7: Hire and train all persons employed to abstract, enter, and update medical records abstraction data (these persons are also referred to as “Research Consultants or “data abstractors”). 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. Due to the complexity of the medical records documentation for adults with HIV, it is expected that technical details, codes, and medical abbreviations related to patient care will be abstracted with high degree of accuracy, with Research

Consultants seeking clarifications from treating physicians, as needed. The Contractor shall, in coordination with the COR, establish parameters for data abstractor training prior to execution of contract performance. The parameters for training of data abstractors shall be discussed and reviewed by the Contractor and COR on an annual basis.

Subtask 1.8: Identify and train designated project personnel at each site in Attachment 3 in administering the T-ACASI/W-CASI behavioral survey (Attachment 5), including the systematic offering of the survey to all eligible patients to maximize 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 behavioral survey at least once per year.

Subtask 1.9: 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 COR within the first 90 calendar days of contract performance period and updated annually.

Subtask 1.10: Attend a one-day kick-off meeting during the base year of the contract to take place within 2 weeks of contract award virtually, or at the CDC in Atlanta, GA. The contractor shall create an agenda before the kick-off meeting and deliver notes after the meeting.

Task 2: Data Collection

Subtask 2.1 Provide training and technical support to all software users (including persons performing data abstraction, administering the behavioral survey, and conducting data management and analyses) in order to perform the contract requirements.

Subtask 2.2 Have in place all necessary services, qualified personnel, material, equipment, and facilities within 14 calendar days of the start of the base period of the award 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. The Contractor shall perform abstraction of data items at study sites incorporated herein as Attachment 3. Data specified in the HIV

Outpatient Study data dictionary (Attachment 4) shall be abstracted from no fewer than 2,300 active patients across all participating sites (“active patients” are those who have made at least one visit to the clinic within 18-months of the start of each period of the contract), and no fewer than 50 active patients from each individual site. Data to be collected as specified in the data dictionary include the following – patient demographics, patient social and behavioral characteristics that may increase their chances of

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 the date of withdrawal from the study and the 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 insurance information, antiretroviral treatment, and cause of death information. The data elements collected for each individual patient shall be linked to each other using HOPS patient identification number using an exact (deterministic) link, to enable summarizing data for each participant at each medical visit or clinic encounter and over calendar time since 1993; or since the beginning of HOPS data collection for that HOPS participant, whichever came later.

Subtask 2.3: Enter all medical chart abstraction data from participating HOPS sites listed in

Attachment 3 into an industry standard web-based medical record abstraction application, either manually or by automatic transfer from the 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 required hardware and software for data entry. The Contractor shall incorporate software updates to account for clinical developments in HIV care and treatment (e.g., adding new diagnoses, treatments, laboratory values, etc.) and execute all necessary related software modifications as requested by the COR. The contractor shall maintain stable variable definitions and coding system for HOPS Study data collected since 1993, and additional data to be collected during the new contract period. This is critical for ensuring the validity of such data for longitudinal analyses and for the overall value this project.

Subtask 2.4: Compile the data collected from HOPS participants at participating HOPS sites listed in

Attachment 3. 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 COR 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 Section 9, Deliverables/Reporting

Schedule (below). The datasets shall combine, using a unique HOPS patient identification number, the newly collected data with that obtained from HOPS participants under the previous HOPS contracts that followed HOPS participants since 1993.

Subtask 2.5: Conduct the behavioral survey (Attachment 5) data collection within 30 calendar days of the start of the base period of the award the contractor shall via T-ACASI or a W-CASI survey among patients participating in this study at the Attachment 3 sites. The information collected shall include age, sex at birth, 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 HIV pre-exposure prophylaxis) use among partners. All patients enrolled in this research protocol are to be offered participation in the T-ACASI/W-CASI behavioral survey annually. Patients are to complete the survey by logging into a secure and encrypted website, or by dialing a toll-free 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, 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 behavioral surveys from the clinics. The contractor shall submit a weekly report to the COR of survey 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 behavioral survey data collected under the contract with the pre-existing T-ACASI/W-CASI behavioral survey data. The Contractor shall provide a database of all T-

ACASI/ W-CASI behavioral survey results collected to date to the COR within 45-calendar days of the end of each quarter via a secure method of data transfer consistent with CDC Information Technology

Security protocols as described in subtask 2.4 (see Section 9, Deliverables/Reporting Schedule).

Subtask 2.6: 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 content of up two additional surveys/enhanced data collections tasks will be determined by any emergent needs for a greater level of detail on site procedures or on the medical or psychosocial aspects of care for persons with HIV. Based on consultation with the CDC Project Officer(s) and the

COR, the Contractor shall establish the content and format of these additional surveys/enhanced data collection tasks prior to execution of contract activities to be submitted to the COR for approval.

Task 3: Data Management and Quality Assurance

Subtask 3.1: Assure the quality and integrity of data abstracted from participating HOPS sites in

Attachment 3. 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 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 project requirements 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.

Subtask 3.2: 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. Prioritize, in coordination with the COR, the gaps and errors that require re-review of medical records and ensure resolution of all prioritized errors or gaps within 60 - 90 calendar days of identification. Such errors or gaps include missing start dates of HIV treatment, lack of medical encounter in the past 18 months, missing or inconsistent demographic or visit detail information, 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 3.3: Securely maintain, manage, and transmit data outlined in subtask 2.4 and 2.5 using a secure method of data transfer consistent with CDC Information Technology Security protocols, as specified in

Section 9, Deliverables/Reporting Schedule.

Subtask 3.4: Submit de-identified data outlined in subtask 2.4 to the North American AIDS Cohort

Collaboration on Research & Design as part of its collaboration with the HIV Outpatient Study. The global data transfer is requested by NA-ACCORD once per year and typically requested between May and September. It shall be delivered within 60 calendar days of a request and formatted according to the specifications of the NA-ACCORD data center, which are updated each year. An example of data submissions document is found in Attachment 6.

Subtask 3.5: Ensure and verify that among active HOPS patients (defined as having made at least one visit to the medical practice within 18 months of the start of each option period of the contract ), at least

90% of patients have ever been offered the T-ACASI/W-CASI behavioral survey and at least 80% of active patients (patients who have had a visit within 18 months of the start of each option period of the contract), who do not have a documented refusal, have been offered the T-ACASI/W-CASI behavioral survey each year. This performance shall be documented in reports as per subtask 4.5.

Subtask 3.6: Provide quarterly, and annual summary reports of the data collected 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 behavioral survey as outlined in Task 2. The annual summary shall contribute toward a combined site visit Report Summary Data deliverable and shall be delivered within 45-calendar days of the end of the fiscal year. The content of the Quarterly Summary shall be abbreviated as compared with the annual summary, and it will be established through discussions with the COR and delivered in a Microsoft Power Point presentation together with datasets specified in subtask 3.3 within 45 calendar days of the end of the quarter.

Task 4: Performance Management

Subtask 4.1: Review site performance and data quality by making at least one, one day annual site visit to each participating HOPS clinic to ensure adherence to all applicable study policies as described in the

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 3. If any informed consent forms are found to be incomplete or missing, the Contractor shall notify the COR and the site investigator within one business day of the date of such a finding.

Subtask 4.2: Have a formal meeting with the HOPS Principal Investigator (i.e., clinic physician) during the annual HOPS clinic site visits to review site progress and status, including any concerns related to staffing, completeness, and timeliness of HOPS data entry and administration; and status of T-

ACASI/W-ACASI behavioral survey 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 COR within 14 calendar days of the completion of the site visit and forward a copy to the Principal

Investigator. The site report shall include – (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 and types of outstanding HOPS data entry queries; (4) number of patients offered the T-

ACASI/W-CASI behavioral survey in the past 12 months; (5) number of active patients who have never completed the T-ACASI/W-ACASI behavioral survey 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 offering of the T-ACASI/W-CASI behavioral survey 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 4.3: 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 clinic. The program review shall occur at a host HOPS site in one of the metropolitan areas where there are existing HOPS study sites (Attachment 3); or at the CDC 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 COR. The annual program review will be attended by

(1) the 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; presentation of findings from the preceding year; and planning for future data collection, research, and analytic activities. The review of site and study progress shall include measures relevant to tracking the goals for the Ending the HIV Epidemic initiative to include – cluster of differentiation 4

(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 3) 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 during each period of the contract 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 COR and Project

Officer(s) and 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 –

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

b. Identify and procure all audio/visual needs.

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

d. Pay for production of, and distribute, any necessary documents.

Subtask 4.4: Deliver to the COR a summary of data collection quality assurance activities executed under subtask 3.2. This summary shall be delivered quarterly together with the datasets under subtask 2.5.

Subtask 4.5: On a quarterly basis, 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 behavioral surveys completed in the prior quarter. The summary shall present data for all HOPS enrolled and active participants, with active defined as having made at least one visit to a participating HOPS medical clinic within 18-months of the current project period in effect. 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 COR 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 COR within 45 calendar days after the end of each quarter.

Subtask 4.6: Assess each abstractor’s performance and provide refresher training for the data during the annual site visit, and by periodic phone-calls and online meetings 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 seven business days of the conference call.

Subtask 4.7: Coordinate and schedule bimonthly telephone conference calls among the HOPS site investigators to review scientific progress with project administration and data collection. The contractor shall provide a summary of the call discussion within seven business days of the conference call to the

COR for review and, upon acceptance, distribute to the HOPS site investigators and the CDC.

Subtask 4.8: Coordinate and schedule biweekly conference calls with the 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 with next action steps shall be provided to the COR within five business days after the conference call.

Subtask 4.9: Attend leadership-level data management and analytics calls with the NA-ACCORD data group and COR 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 5.1: Analyze data collected under the contract, together with pre-existing data for HOPS patients, to produce scientific research that informs the prevention and treatment of HIV infection. During each option period, the Contractor shall provide statistical support for eight new and separate scientific analyses of the data specified above and contribute to the preparation of four scientific manuscripts for

CDC clearance and journal submission. The Contractor shall develop, modify, and finalize analysis plans in consultation with HOPS Site Investigators and per guidance of the COR. The Contractor shall have a demonstrated proficiency with a published record of longitudinal epidemiologic and health services data analyses, proven statistical 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 as outlined in the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE), see http://www.strobe-statement.org/. For each separate analysis, a draft analytic plan and results shall be delivered to the COR in an electronic format via secure email, within seven calendar days after they become available. For each scientific manuscript containing data analyzed under this contract, a final package containing the final analysis plan, results, and supporting statistical SAS program documentation shall be delivered electronically to the COR within 30 calendar days of the final acceptance of a manuscript by a peer-reviewed scientific journal.

Subtask 5.2: Coordinate, schedule and conduct every six weeks, a statistical analyst conference call among the data managers, analysts, and COR to review current and newly proposed analyses during each option period. The objective of the call 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 5.3: Maintain and submit to the COR within seven calendar days of the completion of the statistical analyst call (subtask 5.2), a log of analyses to include the status of ongoing, completed, or new requests in each project period in effect.

Task 6 Reports

Subtask 6.1: Annual Data Report (HOPS Project Profiles) – During each project period in effect, the

Contractor shall produce an annual summary report of the data collected up until that point in time which incorporates the data collected prior to the current effort. The report shall be presented at the annual project review referenced in subtask 4.3. 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 3) related to Ending the HIV Epidemic such as patient programs and interventions to support timely provision of HIV treatment, adherence to HIV care, and linkage to services 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 COR via email 30 calendar days before the annual project review. Each study site listed in Attachment 3 shall receive their own site level report as well as the aggregate report. The Contractor shall establish through discussions with the COR the content and format of this data summary prior to execution of activities awarded under this contract.

Subtask 6.2: Annual Study Status Reports – the Contractor shall submit to the COR 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 as outlined herein. The purpose of the report is to keep the COR informed of the status of duties and accomplishments. Areas of critical interest to the COR include the status of IRB approval. The annual report shall be provided to the COR in final form no earlier than 45 calendar days before the end of each performance period.

Items that shall 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 on whom any data were abstracted in the preceding 18 months

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

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

vi. Number of participants who have completed T-ACASI/ W-CASI behavioral survey 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 6.3: Final Report – 21 calendar days prior to contract completion, a final report shall be submitted to the COR. It shall 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 1) scientific findings presented publicly but that may not have been published in a scientific or medical journal (e.g., at professional scientific meetings); and

2) scientific findings designated for publication in a scientific or medical journal with each item categorized as “published”, “in press”, or “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.

Subtask 6.4: Transition Plan - The Contractor shall provide a Transition Plan for the transition or phase-in of this workload as well as phase-out. The Transition Plan shall include a technical and management transition approach that is clear and complete including the timeline and resources required for the transition. The Transition Plan shall detail the planned transition methodology in logical sequence to ensure a smooth transition of all subtasks in this Statement of Work without interruption or degradation of service levels. The Transition Plan shall include an approach that ensures the successful achievement while limiting impact to existing programs/projects. The

Transition Plan shall also include a complete description of risks (cost, technical and performance to both the Contractor and the Government), issues and risk mitigation strategies. FAR 52.237-3 --

Continuity of Services (Jan 1991) in hereby incorporated by reference and is applicable and applies to the Contractor’s Transition Plan.

Contractor shall provide (specific set of deliverables) during phase-out.

a. A Final Report which details i) Final number and characteristics of participants enrolled.

ii) Narrative outlining accomplishments and shortcomings in meeting Contract requirements.

iii) A list of all scientific findings that are a result of analysis of any data collected under this contract.

b. A compiled SAS dataset which includes data collected during all HOPS contracts or cooperative agreement since 1993 and data dictionaries, that specify variable names, formats, with applicable codes and labels.

c. SAS programs that detail data quality assurance steps for datasets produced under this contract

Per FAR 52.227-17, Rights in Data-Special Works (Dec 2007), the data obtained under this contract becomes the property of the United States Government. 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 trainings to be conducted by the Contractor under this contract include: (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); and (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 two weeks of contract award and could be conducted virtually or 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 virtually or at the CDC in Atlanta, GA; (3) one annual site visit

(one day in 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 4.3) 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. All travel must be pre-approved by the COR.

SECTION 7 – GOVERNMENT FURNISHED PROPERTY - N/A

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Item

Description

Quantity or

No.

of Copies

Delivery Time

Deliver

To

Subtask

1.3

Local IRB renewal documentation and other relevant communications with the local IRB

1 EACH Within 14 business days of communication

COR

Subtask

1.3

Written documentation detailing a study protocol deviation and its resolution

1 PER

OCCURRENCE

Within 24 hours of its occurrence

COR

Subtask

1.4

Data collection tool screen shots and all relevant documentation

1 EACH Within 28 business days of the information request

COR

Subtask

1.5

Written documentation of local IRB approvals and completed human subjects protection training by study staff

1 EACH Within 4 business days after request has been made

COR

Subtask

1.6

Detailed continuity plan 1 EACH Within 30 calendar days of notice of award

COR

Subtask

1.9

Manual of Standard Operating

Procedures (SOPs)

1 EACH Within 90 calendar days of September 30.

COR

Subtask

2.4

Quarterly medical records abstraction

SAS datasets

1 EACH Within 45 calendar days of the end of each quarter: January 1, April 1, July 1, and

October 1

COR

Subtask

2.5

ACASI behavioral survey datasets 1 EACH Within 45 calendar days of the end of each

COR

quarter: January 1, April 1, July 1, and

October 1

Subtask

2.5

Weekly ACASI behavioral survey report

1 EACH Within 3 calendar days of the end of the week.

COR

Subtask

2.7

Develop, document, and periodically update System Security Plans (SSPs).

Develop and implement Plan of Action and Milestones designed to correct deficiencies and reduce or eliminate vulnerabilities.

1 EACH Within 14 business days of contract issuance and every 365 days thereafter

COR,

ISSO

Subtask

3.4

Copy of NA-ACCORD data submission 1 EACH Within 60 calendar days of each submission

COR

Subtask

3.6

Quarterly and annual summary reports 1 EACH Within 45 calendar days of the end of the fiscal year

COR

Subtask

4.2

Site visit report of 600 to 1000 words including action plans

1 EACH Within 14 calendar days of site visit completion

COR

Subtask

4.4

Data collection quality assurance activities summary

1 EACH Within 45 calendar days of the end of each quarter: January 1, April 1, July 1, and

October 1

COR

Subtask

4.5

Site data entry progress summary 1 EACH Within 45 calendar days of the end of the quarter

COR

Subtask

4.6

Abstractor call summary 1 EACH Within 7 business days of the conference call

COR

Subtask

4.7

Investigator conference call summary 1 EACH Within 7 business days of the conference call

COR

Subtask

4.8

Bi-weekly CDC review call summary 1 EACH Within 5 business days after the conference call

COR

Subtask

5.1

An analytic plan and results for each analysis

1 EACH Within 7 calendar days after analysis is completed

COR

Subtask

5.1

Analysis plan, results and supporting statistical SAS program documentation

1 EACH Within 30 calendar days of the final acceptance of a manuscript

COR

Subtask

5.3

Log of analyses 1 EACH Within 7 calendar days after completion of analyst call

COR

Subtask

6.1

HOPS Project Profiles 1 EACH Within 30 calendar days before the annual project review

COR

Subtask

6.2

Annual Study Status Reports 1 EACH No earlier than 45 calendar days before the end of the relevant performance period

COR

Subtask

6.3

Final Report 1 EACH Within 21 calendar days prior to the completion of the contract

COR

Subtask

6.4

Transition-related deliverables I EACH COR

SECTION 9 – SPECIAL CONSIDERATION

Electronic and Information Technology Accessibility

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce

Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by

Federal employees who are not individuals with disabilities, unless an undue burden…