Simple one-page resource explaining terms like “statistical significance,” “p-value,” “confidence interval” and other concepts used to describe and interpret the results of clinical trials.
Advocate’s Guide to Statistical Terms
What is Treatment as Prevention and What is it Not?
Simple, one-page factsheet developed in 2012 that defines treatment as prevention and what it can achieve.
Data Safety Monitoring Boards (DSMBs)
Clinical trials are monitored and regulated by a variety of entities, including independent bodies that review the trial protocol and data on an ongoing basis to ensure that the trial is ethical and should continue. This fact sheet is for advocates who would like to learn more about how these entities work, what they do, and what impact their recommendations can have on clinical trials.
Treatment as Prevention: Frequently asked questions
This FAQ was developed with input from the National Empowerment Network of People Living with HIV (NEPHAK) and Health GAP on the basis of national PLHIV dialogues on treatment as prevention conducted throughout Kenya. The questions and answers contain information relevant for a global audience—but have been written specifically for individuals living and working in low and middle income countries
Pharmacokinetics and Pharmacodynamics: A primer for HIV prevention advocates
Pharmacokinetics (PK) is the study of what happens to a drug when it is taken into the body; pharmacodynamics (PD) is the study of what happens to the body when a drug is taken. PK/PD research is a central aspect of the search for ARV-based prevention, and this factsheet is for advocates looking to understand some of the basic terms, aims and objectives of PK and PD studies.
FDA’s Advisory Committee Review of Daily Oral Truvada as PrEP to Reduce the Risk of HIV Infection: An advocate’s primer for public participation
This primer was developed to help advocates understand the mechanism of the US Food and Drug Administration’s external advisory committee. It was specifically developed in preparation for the US FDA review of Truvada for use as PrEP in 2012. It offers a guide to the workings of the external advisory committee (a set of outside experts who make recommendations) and ways for civil society to participate in the process.
GPP Blueprint for Stakeholder Engagement
The GPP Blueprint is a companion to the Good Participatory Practice guidelines for biomedical HIV prevention research. It is a step-by-step guide designed for the research team members in charge of stakeholder engagement. It presents questions, worksheets and explanations that can guide and generate a stakeholder engagement plan for a specific trial or research program.
MPT Product Development & Regulatory Issues 101
This webinar featured experts Dr. Joe Romano (NWJ Group/CAMI) and Dr. Jim Turpin (NIAID) who provided updates on the state of multipurpose prevention technologies (MPTs) research, the pipeline and potential manufacturing and regulatory pathways. MPTs are being developed to simultaneously prevent unintended pregnancy and protect against HIV and other sexually transmitted infections.Click to access the webinar slides and recording.
GPP Overview Presentation
An AVAC PowerPoint presentation from February 2012 outlining basic information about the Good Participatory Practice guidelines including history of development, structure, and participatory practices.
GPP Training Curriculum Overview
A short overview of AVAC’s Good Participatory Practice (GPP) Training Curriculum, explaining to potential trainers how to use training components, including sessions. It links users to sessions and sample agendas to help plan a GPP training.