IAVI is in the process of publishing a series of tools to support AIDS vaccine and other HIV prevention clinical research.
Integrating Gender Issues into AIDS Vaccine Clinical Research: a training manual for sub-Saharan Africa
The Gender Training Manual provides a flexible set of participatory training exercises that can be used to assist AIDS vaccine clinical research staff, community advisory boards and others to understand gender and sexuality issues, the importance of enrolling equitable numbers of men and women in clinical trials and how gender can affect participation in AIDS vaccine clinical research. It will support training participants in examining gender-related barriers to recruitment and retention, and in integrating a gender perspective into various elements of the research process such as informed consent, counseling and the research center environment.
Audience: Experienced trainers working with clinical research staff, community advisory boards and others working in the AIDS vaccine field in sub-Saharan Africa.
Availability: Hardcopy, CD-ROM and available as a PDF.
Clinical Guidance: Essential Approaches for the Conduct of IAVI Clinical Research
This document outlines essential processes and practices required to conduct IAVI-sponsored research. The guidance applies to both clinical trials and observational and behavioral studies, and provides a flexible framework considering variation in the specific research and socio-cultural contexts. It takes into account the needs of the research team, study volunteers, and community, and aims to ensure that the research itself, associated capacity building efforts and service delivery activities meet high ethical and quality standards.
Audience: IAVI-sponsored staff working on clinical trials, observational and behavioral research studies globally.
Availability: Available as a PDF.
Quality Improvement: A Toolkit for HIV Prevention Research Centers
The Quality Improvement (QI) Toolkit is a set of participatory strategies and tools designed to facilitate improvements in the quality of the overall environment of HIV prevention research centers and the various processes a volunteer experiences from outreach and recruitment through the conclusion of a study. Quality Improvement, or the process of continuously assessing and improving the quality of services to ensure volunteers’ satisfaction and a high standard of quality, is designed to complement existing quality assurance and quality control mechanisms. The QI Toolkit is comprised of three components: a manual which explains the QI process, participatory tools and a facilitator’s guide.
Audience: Research center staff conducting HIV prevention clinical trials and/or observational studies
and community agents who support HIV prevention research centers.
Availability: August 2010 as Hardcopy, CD-ROM and PDF download.
Community Advisory Board (CAB) Toolkit
The CAB Toolkit provides guidelines and innovative approaches that can be used to advance good policy and practice around community engagement. Its content is driven from the community engagement experiences at IAVI partner research centers in developing countries, taking into consideration the need for local adaptation and context appropriate solutions. It is designed to be used as a reference as needs arise throughout all stages of CAB development and operations. Guidelines are provided in a number of areas including ensuring appropriate representation from the community, roles and responsibilities of researchers and CAB members, and CAB member training.
Audience: Developed for IAVI sponsored research centers, but can be used as a reference in other settings.
Availability: August 2010 as PDF download.
Difficult Trial Concepts (DTC) Visual Aids
These visual aids are a set of laminated cards which illustrate complex research concepts in story-board format. They are meant to be used by counseling staff, as needed, to provide more information to volunteers who are having difficulty understanding research concepts. Currently, the DTC series includes story-boards on “randomization,” “placebo,” and “blinding”. These cards are meant to augment existing tools to help ensure a high-level of volunteer understanding.
Audience: HIV vaccine prevention research staff. These visual aids are most appropriate for communicating research concepts to low-literacy volunteer populations.
Availability: August 2010 as PDF download.
Note: Tools can be adapted for use in a number of different contexts and settings. All tools were developed in collaboration with IAVI-sponsored research partners.