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Research Site FAQ

  OVERVIEW and CONTACTS

  1. Can you provide an executive summary and schema of the REPRIEVE trial and the Mechanistic Substudy of REPRIEVE?
  2. How many sites will be involved?
  3. How many participants will be recruited to the REPRIEVE trial and the Mechanistic Substudy?
  4. What will be expected of sites participating in the REPRIEVE trial and in the Mechanistic Substudy of REPRIEVE
  5. How can sites formally express interest in participating in the REPRIEVE trial?
  6. Who can answer my questions pertaining to REPRIEVE trial start-up and conduct?

SITE APPROVAL and PROTOCOL ACTIVATION

  1. Can you provide an overview of the Site Approval and Protocol Activation processes for sites participating in the main study and identify the parties responsible for overseeing these processes?
  2. Can site approval and protocol activation take place at the same time as contracting?
  3. Are there additional requirements for Site Approval and Protocol Activation for sites participating in both the main REPRIEVE (A5332) trial and Mechanistic Substudy (A5333s)?
  4. Are there additional requirements for International Sites?
  5. What is the timeline for Site Approval and Protocol Activation and for recruitment of the first trial participant?
  6. Can you elaborate on the request that each site identify a cardiologist to collaborate with the Site Investigators on the trial?

OVERVIEW and CONTACTS

1. Can you provide an executive summary and schema of the REPRIEVE trial and the Mechanistic Substudy of REPRIEVE?

2. How many sites will be involved?

We are targeting approximately 100 sites, predominantly sites in the United States, to participate in this study.  We are interested in collaborating with sites outside of the United States that are able to meet all the regulatory requirements and obtain access to the study drug. To date, more than 110 sites in the United States, and internationally, have expressed interest in participating in REPRIEVE.

3. How many participants will be recruited to the REPRIEVE trial and the Mechanistic Substudy?

A total of 6,500 participants will be recruited to the REPRIEVE trial, with 800 participants also enrolling in the substudy.

4. What will be expected of sites participating in the REPRIEVE trial and in the Mechanistic Substudy of REPRIEVE?

Sites participating in the REPRIEVE trial will be expected to enroll approximately 50-100 participants and follow them for up to 6 years. The enrollment period is 30 months, with an anticipated average of 3-4 participants enrolled per month at each site. Sites will monitor for side effects from the study drug and capture relevant study endpoints. Each site will have a partnership between an HIV provider and Cardiologist.

Sites participating in the substudy will additionally be expected to obtain coronary artery assessments by CT angiography (baseline and 2 years) and obtain and process blood samples for advanced immunologic studies.  It is anticipated that each site participating in the substudy will enroll 25-30 participants over the enrollment period.

Conduct of research following good clinical practices will be expected of all participating research sites.

5. How can sites formally express interest in participating in the REPRIEVE trial?

Sites interested in participating in the REPRIEVE trial can fill out the Site Survey and email this to the REPRIEVE Site Selection Committee at reprieve.sites@fstrf.org. headed by Dr. Carl Fichtenbaum.

Who can answer my questions pertaining to REPRIEVE trial start-up and conduct?

Please send all questions to reprieve.sites@fstrf.org, an email list-serve which is staffed by REPRIEVE team members with expertise to address various issues relating to site approval, protocol activation, contracting, and the conduct of A5332 and A5333s.

Once your site is activated and ready to enroll participants, please email actg.corea5332@fstrf.org, an email-list serve staffed by REPRIEVE team members with expertise to address questions specific to conducting the REPRIEVE trial.

SITE APPROVAL and PROTOCOL ACTIVATION

1. Can you provide an overview of the Site Approval and Protocol Activation processes for sites participating in the main study and identify the parties responsible for overseeing these processes?

Site Approval is a process facilitated the NIAID Division of AIDS (DAIDS) Office of Clinical Site Oversight (OCSO) Program Officer and requires completion of various staff trainings and site SOP verifications. This process will ensure that the site’s personnel are adequately trained in the electronic systems that will be used to manage the REPRIEVE trial as well as basic Human Subjects Protection (HSP) and Good Clinical Practice (GCP) standards.  The approved SOPs, Clinical Quality Management Plan (CQMP) and Pharmacy Establishment Plan (PEP) will serve as resources for staff to ensure that the conduct of REPRIEVE will be to the DAIDS standards to ensure the highest quality data from this trial. An OSCO Program Officer will communicate with Principal Investigators at individual sites to help with the completion of this process.

Protocol Activation is a process facilitated through the ACTG Network Coordinating Center (NCC) and is focused on site-readiness to conduct the specific activities within the REPRIEVE protocol as well as execution of a contract with the ACTG Leadership and Operations Center (LOC).  While there are some Protocol Activation steps that cannot be completed until Site Approval is provided (such as Protocol Registration), sites are encouraged to work on both approval processes concurrently to avoid delays.

Once your site receives approval of DAIDS Protocol Registration, your CRS Leader and Coordinator will receive an email inviting them to complete the Site Protocol Activation Checklist on the ACTGNetwork.org member website. Only after all requirements have been met, please submit the completed checklist to proceed with site activation.

2. Can site approval and protocol activation take place at the same time as contracting?

Yes. We recognize that at some institutions IRB approval may be delayed by the institution until a contract is signed.  Where feasible, we encourage sites to work on all processes together as this will speed the process of being able to enroll participants into the study.

3. Are there additional requirements for Site Approval and Protocol Activation for sites participating in both the main REPRIEVE (A5332) trial and Mechanistic Substudy (A5333s)?

Yes. These additional requirements pertain to training and validation of techniques in the performance of coronary computed tomography angiography and in the collection and processing of peripheral blood mononuclear cells. Not all sites participating in the main REPRIEVE trial will participate in the Mechanistic Substudy. The Mechanistic Substudy leadership team (MGH CT Core Lab) will communicate directly with sites under consideration for dual participation in both the main REPRIEVE and the Mechanistic Substudy.

4. Are there additional requirements for International Sites?”

Yes. International sites invited to participate in REPRIEVE will be contacted directly regarding additional agreements and regulatory procedures required of them.

5. What is the timeline for Site Approval and Protocol Activation and for recruitment of the first trial participant?

Site Approval and Protocol Activation may take between 2-6 months, depending upon site characteristics and the rate at which sites are able to complete documentation regarding readiness to participate. This includes the time it will take to complete the trial contract process with the ACTG Leadership Operations Committee. Note that with international sites, Site Approval and Protocol Activation may take much longer. Beginning in the fall 2014, sites were contacted with logistic information about the Site Approval and Protocol Activation processes. We anticipate that the first subjects will be enrolled by the spring of 2015 and we aim to have all participating sites ready to enroll subjects by November 2015.

6. Can you elaborate on the request that each site identify a cardiologist to collaborate with the Site Investigators on the trial?

It is recommended that each site identify a Cardiologist who will collaborate with the local site Investigators on the REPRIEVE trial. The collaborating cardiologist may be a site-affiliated Junior Cardiologist (including a Cardiology Fellow) or Senior Cardiologist who is interested in volunteering to participate intellectually and practically in the conduct of REPRIEVE. A connection with this cardiologist is anticipated to facilitate discussion of questions which may arise in relation to cardiovascular events and/or coronary CT angiography findings (the latter for sites participating in the REPRIEVE Mechanistic Substudy). Such a connection may also facilitate referrals for clinical cardiovascular consultation, as needed. Finally, it is expected that collaboration with a site Cardiologist on this project will promote future interdisciplinary intellectual pursuits in the field of coronary heart disease risk in HIV. Stimulating this kind of interdisciplinary research is one of the goals of the REPRIEVE trial. If a site requires assistance identifying an appropriate Cardiology collaborator, members of the REPRIEVE Operational Leadership Committee can make recommendations.

We’re currently seeking study participants to take part in REPRIEVE. Please contact us to learn more.

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