SEATTLE — May 24, 2018
Neither frequency of alcohol use, binge drinking, marijuana, nor other drug use negatively impacts retention and adherence rates in phase I clinical trials of preventive HIV vaccines. These were the findings revealed in a meta-analysis performed by an HIV Vaccine Trials Network (HVTN) Research and Mentorship Program (RAMP) scholar to assess the patterns of substance use among enrolled participants, and the impact substance use has on retention in phase 1 preventive HIV vaccine clinical trials. Findings were published in the journal Vaccines on 21 February 2018.
The analysis was conducted by reviewing data from 10 HVTN phase 1 preventive HIV vaccine clinical trials conducted between February 2009 and September 2014 in the Americas and Switzerland. Investigators assessed the following three measures of adherence/retention: missing at least one protocol-specified clinic visit, not completing the vaccination schedule, and early termination from clinic follow-up for any reason including HIV infection. Among the 964 participants enrolled, 170 (18%) missed a clinic visit and 78 (8%) terminated early from clinic follow-up; 75/774 (10%) who were in studies with multiple vaccination time points did not complete their vaccination series.
“Our RAMP scholar program provides a unique opportunity to introduce medical students to HIV prevention research and spark their interest in a career as a future leader in the field. In three months of on-site work, Dr. Arame Thiam-Diouf analyzed our substance use data for phase 1 participants,” said Michele Andrasik, Ph.D., Director of Social Behavioral Sciences and Community Engagement, HVTN and Senior Staff Scientist at Fred Hutchinson Cancer Research Center, where Thiam-Diouf conducted the meta-analysis.
RAMP is a competitive award program that provides mentoring, training, project, and salary funding as well as professional development opportunities for African-American and Latinx medical students interested in conducting independent research in the field of HIV prevention, and HIV vaccine research in particular. This is a collaborative program between the HVTN, the National Institute of Mental Health and the National Institute of Allergy and Infectious Diseases, initiated in 2011. It has benefited 58 students to date.
“My experience with the RAMP program had a profound impact on my aspirations to pursue clinical research while in medical school, and continuing to do so now as a physician. In addition, going through the entire research process from Institutional Review Board approval to publication as a medical student has given me a unique advantage and prepared me well for the hurdles of medical research, particularly in relation to HIV,” said Dr. Arame Thiam-Diouf.
Current evidence suggests that conducting randomized controlled clinical trials in alcohol and drug-using populations poses additional challenges, including lower retention rates and difficulty maintaining contact with trial participants. Evidence also links substance use to higher risk sexual behaviors such as condomless sex, transactional sex, and having sex while high or when intoxicated. Findings from the meta-analysis affirmed that among phase 1 preventive HIV vaccine trial participants, engaging in binge drinking behavior is associated with higher rates of unprotected sex, which may be an indicator of increased risk for acquiring HIV and should be included in risk reduction counseling when appropriate. Investigators conducted the meta-analysis to address the absence of data on the relationship between substance use and retention in preventive HIV vaccine trials for participants with lower HIV risk profiles.
“This program highlights the importance of involving medical trainees in HIV prevention research with the goal of grooming the investigators and clinicians to effectively prevent and treat HIV infection in our country. Our RAMP scholar program provides an important entry point for involving future medical practitioners and researchers into the important issues associated with the HIV epidemic in the United States,” said Larry Corey, M.D., Principal Investigator of the HVTN and virologist and president and director emeritus at Fred Hutchinson Cancer Research Center.
Note to the editor: The published manuscript can be accessed by clicking the following link: www.elsevier.com/locate/vaccine
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About the HIV Vaccine Trials Network (HVTN)
The HVTN is the world’s largest publicly funded collaboration bringing together global study participants, communities and acclaimed scientific leadership on a journey to find an effective HIV vaccine. The network is founded on a relationship of trust with global communities who work with specialized teams using science to serve global populations in the pursuit to find answers that will impact and change lives. The HVTN’s headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington.
About HVTN RAMP Scholars
The HIV Vaccine Trials Network, in collaboration with the National Institute of Mental Health and the National Institute of Allergy and Infectious Diseases, is investing in the next generation of HIV prevention researchers by providing African American and Latinx medical students with opportunities to conduct independent research while receiving mentoring, project and salary funding, training, and professional development opportunities. Please direct any enquiries on RAMP Scholars to: firstname.lastname@example.org