clinical trials

  • An Interdisciplinary Framework for Measuring and Supporting Adherence in HIV Prevention Trials of ARV-Based Vaginal Rings

    Correct, consistent use of study products and measurement of adherence to study regimens have emerged as critical challenges in the evaluation of HIV prevention technologies. This article, published in a September 2014 supplement to the Journal of the International AIDS Society, presents an interdisciplinary framework for systematically investigating promising strategies to support product uptake and adherence and to measure adherence in randomized, blinded clinical trials of antiretroviral-based vaginal rings.

  • Microbicide Clinical Trial Adherence: Insights for Introduction

    Drawing primarily from data and experience from large-scale microbicide efficacy trials, this article published in the Journal of the International AIDS Society identifies lessons learned about adherence to study regimens in six areas: 1) adherence measurement in clinical trials, 2) comprehension of use instructions/instructions for use, 3) unknown efficacy and its effect on adherence/messages regarding effectiveness, 4) partner influence on use, 5) retention and continuation, and 6) the generalizability of trial participants' adherence behavior.

  • A Toolkit for Developing Bilingual Lexicons for International HIV Prevention Clinical Trials

    Researchers often use technical terminology that trial participants may not easily understand. Those working on international clinical trials face additional communication challenges when local languages do not have scientific or technical vocabularies in relevant subject areas. This toolkit guides researchers through a process for identifying or improving translations of clinical research terms that are difficult to translate or comprehend.

  • Advocates' Guide to Statistical Terms

    AVAC's fact sheet explains some of the main statistical terms used to describe the results of clinical trials, including statistical significance, confidence interval, and intent-to-treat analysis.

  • When Do You Stop an HIV Prevention Trial for Futility? A Primer for HIV Prevention Advocates

    This fact sheet examines why trials are stopped early for “futility,” explaining the meaning of this term in the context of a clinical trial, when such a recommendation is made, and how it might affect other trials.

  • Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials. Second edition.

    This 88-page document outlines good participatory practice (GPP) guidelines and systematic guidance on how trial funders, sponsors, and implementers can effectively engage with all stakeholders in the design and conduct of biomedical HIV prevention trials. The GPP guidelines are divided into three main sections: the importance of and need for GPP in biomedical HIV prevention trials, guiding principles of GPP, and optimal GPP practices for biomedical HIV prevention trials.

  • Gabi’s Gift (CAPRISA 004 Video)

    This five-minute video follows one woman from the beginning of her participation in the CAPRISA 004 study of tenofovir gel to her joy when hearing the results.

  • Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage Controversy, Convey Your Message, and Disseminate Results

    Using case studies and practical insights culled from communications experience in clinical trials from around the world, this handbook covers the spectrum of communications planning, strategies, and activities needed at each stage of a clinical trial. It offers practical guidance to clinical trial staff and research partners on how to anticipate and respond to the special communication challenges posed by the conduct of clinical research. First published in 2010, the handbook is now available online with additional resources, including videos, slide presentations and new case studies.

  • AVAC Fact Sheet: Data Safety Monitoring Boards

    This fact sheet helps advocates learn more about how 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. Some situations in which a data safety monitoring board has made a recommendation that affected the conduct of a trial are reviewed.