Lessons Learned from ULACNet-101: Starting a Clinical Trial Amidst a Pandemic

In November 2021, the UCSF Global Cancer Program launched the first study of the CAlifornia-Mexico-Puerto RicO (“CAMPO”) Collaboration for Prevention of HPV-related cancer in populations living with HIV in Puerto Rico. This is the first clinical trial to be led by the HDFCCC Global Cancer Program and will examine innovative approaches to cervical and anal cancer prevention among populations living with HIV in Latin America. Given the high prevalence of both HPV-related cancers and HIV in Latin America, there is a key need to optimize approaches to screening, vaccination, and treatment in the region. This study is in partnership with the University of Puerto Rico Comprehensive Cancer Center in San Juan, and the National Cancer Institute and the National Institute for Public Health in Mexico. The CAMPO award is part of the National Cancer Institute Division of Cancer Prevention’s US-Latin American-Caribbean Clinical Trials Network (ULACNet) for Prevention of HPV-related Cancers in People Living with HIV.

The below update on the CAMPO program features lessons learned in starting this clinical trial in the midst of the COVID-19 pandemic. The below article was originally published as part of the National Cancer Institute ULACNet January 2022 newsletter. Read the NCI news highlight on the CAMPO project below:

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Clinical trials are essential to keep improving and advancing prevention and treatment of medical conditions, as well as improvement of the overall health of the global population. During the past 3 years, the world has faced multiple challenges together and, for researchers initiating trials, these challenges have not been scarce. Here are some lessons learned during the initiation of ULACNet-101 in Puerto Rico.

Administrative Lessons. Due to COVID-19, quarantine and lock down of multiple offices and facilities delayed most of the administrative processes. To ensure their continuation, we established an emergency action plan. While working remotely, communication was constant with continuous phone calls, emails and virtual meetings. The submission of IRB protocols with multiple study sites was a challenge. Nonetheless, teamwork and constant communication ensured that the protocols and amendments were submitted and approved promptly.

Frances Vazquez preparing the ATILA machine to run the first sample.
Frances Vazquez preparing the ATILA machine to run the first sample.

Clinical Lessons. In Puerto Rico only 3 physicians are certified in High Resolution Anoscopy (HRA) (already committed to various trials). To ensure availability of physicians for ULACNet-101, we started HRA training of 2 new physicians (one of them is supported full time by a Diversity Supplement from the NCI) and established collaborations with other studies and the Anal Neoplasia Clinic (ANC) the UPRCCC. As a challenge, we encountered that clinical materials were scarce, as personal protective equipment, medications and some laboratory materials were prioritized for COVID-19 treatment or testing. To help with this, we requested support from the hospital administration and the ANC. Additionally, multiple Standard Operating Procedures (SOPs) were created to ensure all the processes were standardized. COVID-19 prevention measures were established for participant’s visits and were included in the SOPs.

Laboratory Lessons. To prepare for the trial, a laboratory space in Comprehensive Cancer Center Hospital from Puerto Rico was assigned and fully equipped. Equipment included centrifuges, ATILA BioSystems Real-Time PCR machine, a computer, a printer, and a PCR Workstation (to prevent contamination of the samples and reagents). Before study initiation, all laboratory procedures were validated, and SOPs were created from scratch to be used in sample management, processing, storage, and shipment. Originally the HPV genotyping results from the ATILA machine were available as a table with the results from all the samples analyzed. A new template was created in the ATILA program by the Puerto Rico team to be able to upload individual patient’s results in the Advantage eClinical platform.

Recruitment Lessons. The input of the local Community Advisory Board has been essential for recruitment aspects of the study. Additionally, while working with government clinics, private clinics, and community organizations, we have learned collaborations are not “one size fits all”. Each type of organization may require a formal or informal agreement based on funding (state, federal, private funds) and structure (community organizations vs government organizations). When establishing collaborations, it is important to do research on the organization you wish to work with and their needs. Collaborations should provide some level of mutual benefit for them to be successful. For example, some clinics have standard quality measures they must meet, including compliance with screening rates and/or they may have resource, space or staffing limitations that may affect screening. To address these needs, our study will screen participants and share results with their clinic upon patient approval.

From left to right: Dr. Miriam Matos (gynecologist), Tania de Jesus Espinosa (clinical coordinator/nurse), Vanessa Gomez-Vargas (field coordinator), Sandra Garcia-Camacho (lead coordinator), Dr. Ana Patricia Ortiz (local-PI), Frances Vazquez-Sanchez (laboratory coordinator).
From left to right: Dr. Miriam Matos (gynecologist), Tania de Jesus Espinosa (clinical coordinator/nurse), Vanessa Gomez-Vargas (field coordinator), Sandra Garcia-Camacho (lead coordinator), Dr. Ana Patricia Ortiz (local-PI), Frances Vazquez-Sanchez (laboratory coordinator).

To continue with the recruitment efforts during the pandemic, the team designed an in-depth webinar about ULACNet-101 and presented it to clinics via videocalls or videoconferences. Additionally, many of our organization’s (UPRCCC) studies target similar study populations. We took advantage of this and had a meeting with the all the coordinators of research studies recruiting persons living with HIV. Coordinators united efforts and materials to maximize recruitment from the same population pool and set up referrals between the multiple studies.

During this historical time, we have learned how unpredictable our day to day has become. However, we have learned many lessons. It is important to maintain the safety of our participants, while we continue to conduct research to improve their health and quality of life. To ensure this, our biggest lesson learned was that we had to rely on two factors to successfully start a clinical trial during the pandemic, communication, and teamwork.

The CAMPO U54 award is part of the National Cancer Institute Division of Cancer Prevention’s US-Latin American-Caribbean Clinical Trials Network (ULACNet) for Prevention of HPV-related Cancers in People Living with HIV.

This article was originally posted on the NCI webspage. Please find the link to the original posting here.