Abstract

Good Participatory Practice (GPP) guidelines support and direct community engagement practices in biomedical HIV prevention trials, however no standardized metrics define the implementation and evaluation of these practices. Collaboratively, the Community Program staff of the HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) created a metric to describe, monitor, and evaluate one component of GPP, recruitment practices, in two HIV monoclonal Antibody Mediated Prevention (AMP) clinical trials, HVTN 703/HPTN 081 and HVTN 704/HPTN 085. Through consultation with community representatives from each clinical research site (hereafter "site(s)"), who made up the study Community Working Groups, recruitment strategy descriptors were developed for both trials to characterize responses to "How did you hear about the AMP study?" The Community Working Groups also helped to define and establish time points that were selected to allow comparisons across sites. Data were collected by 43 of 46 clinical research sites from January 1, 2017 to February 28, 2018. All 43 sites used multiple recruitment strategies successfully, but strategies varied by region. Globally, referrals was the most efficient and effective recruitment strategy as evidenced by the screening: enrollment ratio of 2.2:1 in Africa, and 2.1:1 in the Americas/Switzerland. Print materials were also valuable globally (3:1 Africa, 4.2:1 Americas/Switzerland). In Africa, in-person outreach was also quite effective (2.3:1) and led to the most enrollments (748 of 1186, 63%). In the Americas/Switzerland, outreach was also effective (2.6:1), but internet use resulted in the most screens (1893 of 4275, 44%) and enrollments (677 of 1531, 44%), compared to 12 of 2887 (0.4%) and 2 of 1204 (0.1%) in Africa, respectively. Standardized metrics and data collection aid meaningful comparisons of optimal community engagement methods for trial enrollment. Internet strategies had better success in the Americas/Switzerland than in sub-Saharan African countries. Data are essential in outreach staff efforts to improve screening-to-enrollment ratios. Because the effectiveness of recruitment strategies varies by region, it is critical that clinical research sites tailor community engagement and recruitment strategies to their local environment, and that they are supported with resources enabling use of a range of approaches.

Highlights

  • Community engagement is a key component of biomedical HIV prevention research [1]

  • Research networks funded by the National Institutes of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) include community engagement programs as a core component of network operations [6]

  • The HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN), funded through NIAID, are international collaborations of scientists, clinical trial sites, and community representatives who work with governments and industry in the global search for safe and effective ways to prevent HIV

Read more

Summary

Introduction

Community engagement is a key component of biomedical HIV prevention research [1]. It is a process of demonstrating mutual respect between community stakeholders, researchers, research sponsors, and other stakeholder groups to facilitate inclusion and collaboration with communities where clinical trials will be conducted [2]. Research networks funded by the National Institutes of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) include community engagement programs as a core component of network operations [6]. The HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN), funded through NIAID, are international collaborations of scientists, clinical trial sites, and community representatives who work with governments and industry in the global search for safe and effective ways to prevent HIV. The two parallel trials are known as the Antibody Mediated Prevention (AMP) studies

Objectives
Methods
Results
Discussion
Conclusion

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call

Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.