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  • 1
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    Online Resource
    Abstract A002: Logistical issues in implementing a clinical trial on oral cancer prevention through HPV vaccination: Implementation of Ulacnet201 in Mexico
    American Association for Cancer Research (AACR) ; 2022
    In:  Cancer Prevention Research Vol. 15, No. 12_Supplement_2 ( 2022-12-01), p. A002-A002
    Details
    In: Cancer Prevention Research, American Association for Cancer Research (AACR), Vol. 15, No. 12_Supplement_2 ( 2022-12-01), p. A002-A002
    Abstract: This poster describes logistical issues related to implementing a randomized, double- blinded, placebo-controlled Phase III interventional trial on the nine-valent HPV vaccine (9vHPV) among cisgender men and transgender women living with HIV, at the Mexico site. The trial seeks to demonstrate that 9vHPV reduces the incidence of persistent oral HPV infection (a surrogate for HPV-associated oropharyngeal cancer) with the 9 vaccine types. Five-hundred participants will be randomized in a 1:1 allocation to receive 9vHPV or placebo, stratified based on clinical site (Brazil, Mexico, Puerto Rico) and age. The team invites potential participants through local community organizations and public HIV clinics. People may be invited when waiting in line in the morning to get laboratory testing done, when they have an appointment for HIV care or through their treating physician or a community organizer. Initially, we worked at a single HIV clinic, although we did distribute study flyers to treating physicians at other clinics. As of mid-2022 we began enrolling at two additional clinics. Participants are prescreened when initially invited or by phone to prevent unnecessary trips for those ineligible. Once prescreened, participants are given an appointment for their first study visit; reminders about their first or other study visits are sent by text message 2-3 times before the appointment. Participants are provided with financial compensation in cash at each visit. We have implemented both study-wide mechanisms and additional locally-designed strategies and forms to guarantee quality control. For example, registering participant issues, study agent trail and persons invited, pre-screened and enrolled (including reasons for exclusion). Data is registered on paper forms and in a bespoke data base program (DatStat, designed at Moffitt Cancer Center). DatStat carries out the randomization (only the Mexico site pharmacist is unblinded) and requires a wireless internet connection, which can sometimes fail even though a router is installed by the study at each clinic. Vaccine and syringe importation can be time consuming and cause enrollment delays, given the need to acquire permissions for importation or problems getting the shipment out of Customs. Making sure shipments go through an airport with better functioning Customs offices is also important. Citation Format: Betania Allen-Leigh, Alejandra Portillo-Romero, Manuel Quiterio, Maribel Acosta, Abraham Rivera- Ramirez, Guillermina Sanchez, Aurelio Cruz, Tonatiuh Barrientos, Carlos Magis, Kimberly Isaacs-Soriano, Martha E. Abrahamsen, Margaret House, Emma Brofsky, Vikrant Sahasrabuddhe, Timothy Wilkin, Anna Giuliano, Luisa Villa, Eduardo Lazcano-Ponce. Logistical issues in implementing a clinical trial on oral cancer prevention through HPV vaccination: Implementation of Ulacnet201 in Mexico [abstract]. In: Proceedings of the Second Biennial NCI Meeting: Translational Advances in Cancer Prevention Agent Development (TACPAD); 2022 Sep 7-9. Philadelphia (PA): AACR; Can Prev Res 2022;15(12 Suppl_2): Abstract nr A002.
    Type of Medium: Online Resource
    ISSN: 1940-6215
    URL: Article
    DOI: 10.1158/1940-6215.TACPAD22-A002
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2022
    detail.hit.zdb_id: 2422346-3
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  • 2
    Online Resource
    Online Resource
    Advancing Malaria Prevention and Control in Africa Through the Peace Corps-US President’s Malaria Initiative Partnership
    SAGE Publications ; 2020
    In:  Global Advances in Health and Medicine Vol. 9 ( 2020-01), p. 216495612097610-
    Details
    In: Global Advances in Health and Medicine, SAGE Publications, Vol. 9 ( 2020-01), p. 216495612097610-
    Abstract: Peace Corps is a US government volunteer service agency which provides trained Volunteers to assist host countries in addressing critical development challenges at the community level. The US President’s Malaria Initiative provides technical expertise and financial resources to reduce malaria morbidity and mortality in focus countries in sub-Saharan Africa. Objective We aim to describe the nature of the collaboration between Peace Corps and President’s Malaria Initiative (PMI) and highlight examples of the partnership in select countries. Methods We conducted an analysis of retrospective data obtained from Peace Corps and PMI for the years 2014–2019. Results Volunteers were able to learn about and work on malaria prevention and control with PMI in three key ways: a malaria-specific training program for staff and Volunteers; malaria-focused small grants; and extension of Volunteer assignments for a third year to support malaria projects. Successful Peace Corps projects supported by PMI, at the community level, were highlighted, with a focus on Rwanda, Benin, Zambia, Madagascar, and Senegal. In Fiscal Year 2019, 1408 Volunteers contributed to malaria prevention activities in 18 Peace Corps programs across Africa, of which 15 were PMI focus countries. While the majority of documented work by Volunteers has involved social and behavior change, there were many other ways to partner with PMI staff. Conclusion Each of the proven interventions that PMI supports for malaria prevention and control may have a role for Volunteer involvement. Combined with the technical expertise and the relationships that PMI staff have with national-level counterparts in PMI focus countries, the continued collaboration between Peace Corps and PMI can accelerate the fight against malaria.
    Type of Medium: Online Resource
    ISSN: 2164-9561 , 2164-9561
    URL: Article
    DOI: 10.1177/2164956120976107
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2709002-4
    detail.hit.zdb_id: 3162457-1
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  • 3
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    Online Resource
    Abstract 20: Development of International Cancer Research Partnerships Through the NCI US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)
    American Association for Cancer Research (AACR) ; 2021
    In:  Cancer Epidemiology, Biomarkers & Prevention Vol. 30, No. 7_Supplement ( 2021-07-01), p. 20-20
    Details
    In: Cancer Epidemiology, Biomarkers & Prevention, American Association for Cancer Research (AACR), Vol. 30, No. 7_Supplement ( 2021-07-01), p. 20-20
    Abstract: Purpose: Persons living with HIV have elevated risks of HPV-related cervical, anogenital, and oropharyngeal cancers. Yet, research on optimization and implementation of prevention interventions (prophylactic HPV vaccination, cervical and anogenital cancer screening and triage, and precancer therapeutics) for HPV-related cancers among persons living with HIV has been limited. With a goal to expand this evidence, and building on strong academic research partnerships developed for HIV research between institutions in the US and the Latin American and the Caribbean (LAC) region, the US National Cancer Institute (NCI) initiated ULACNet, a new Cooperative Agreement clinical trials network in 2019. Methods: ULACNet comprises of three Partnership Centers each led by US-based institutions (University of California San Francisco, Weill Medical College of Cornell University, and Fred Hutchinson Cancer Research Center), working collaboratively with US and LAC institutions and with the NCI to develop and conduct multicenter prevention clinical trials focused on filling key scientific gaps and evaluating novel interventions. Results: ULACNet encompasses six countries (US, Mexico, Puerto Rico, Brazil, Peru, and Dominican Republic), twenty partner institutions, and over 100 collaborating scientific investigators, clinical and public health practitioners, research staff, and patient advocates. ULACNet will collaboratively conduct nine prevention clinical trials (two prophylactic HPV vaccine trials in adults and perinatally-HIV infected adolescents, three trials for clinical validation of molecular biomarkers and imaging technologies for screening and triage, two candidate HPV therapeutic vaccine trials, and two trials of topical therapeutic agents). Facilitation across network partners is achieved via a Coordinating Committee and three Working Groups (focused on HPV testing and screening, precancer treatment, and recruitment and retention activities). Conclusion: ULACNet seeks to leverage established academic global health partnerships to conduct high quality collaborative clinical trials to inform clinical practice and ultimately reduce the burden of highly preventable HPV-related cancers in persons living with HIV worldwide. Citation Format: Emma Brofsky, Margaret House, Brandy Heckman-Stoddard, Mostafa Nokta, Satish Gopal, Vikrant Sahasrabuddhe. Development of International Cancer Research Partnerships Through the NCI US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet) [abstract]. In: Proceedings of the 9th Annual Symposium on Global Cancer Research; Global Cancer Research and Control: Looking Back and Charting a Path Forward; 2021 Mar 10-11. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2021;30(7 Suppl):Abstract nr 20.
    Type of Medium: Online Resource
    ISSN: 1055-9965 , 1538-7755
    URL: Article
    DOI: 10.1158/1538-7755.ASGCR21-20
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2021
    detail.hit.zdb_id: 2036781-8
    detail.hit.zdb_id: 1153420-5
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