Adherence and Its Measurement in Microbicide Clinical Trials

17-18 December 2007│Washington, DC

Commissioned by: Microbicide Donors' Committee
Organizers & Sponsors: Alliance for Microbicide Development (AMD) and Family Health International (FHI)

Meeting Report

Executive Summary: Adherence and Its Measurement in Microbicide Clinical Trials
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Overview

Understanding adherence--that is, whether trial participants use the test product as specified?is critical to the successful implementation of microbicide effectiveness trials. Such trials are designed to compare HIV sero-incidence rates between an experimental and comparator/placebo product, assuming roughly similar levels of adherence in each arm. Poor participant compliance with trial protocols reduces the likelihood of detecting differences in HIV rates between study arms, making it difficult to demonstrate the effectiveness of that product even if it is truly efficacious. Assuring product adherence will also be a critical challenge for post-trial study and "roll-out" of both vaginal and oral microbicides when those emerge successfully from effectiveness trials. Unlike interventions such as vaccines or male circumcision that involve a provider who can ensure product administration, new prevention technologies like pills and topical microbicides are "user-controlled", that is, reliant on trial participants and, ultimately, consumers to use them consistently and correctly.

A growing number of researchers worldwide have been working on different approaches to encourage and measure adherence of new HIV prevention technologies, and consensus was accumulating that it was time to take a hard, close look at those approaches to assess their productivity and their value relative to one another. Thus, the Alliance for Microbicide Development (AMD) and Family Health International (FHI) sponsored a two-day expert meeting in December 2007 on "Adherence and Its Measurement in Microbicide Clinical Trials" as a project of the "Quick Working Group" under the aegis of the Microbicide Donors' Committee. The meeting convened researchers working on clinical trials of microbicides and other HIV prevention products, and researchers knowledgeable about adherence in other relevant fields. Its purpose was to critically evaluate different approaches to measuring adherence in completed and ongoing trials, provide guidance on the best ways to design protocols to ensure adherence to protocol and product use, and how best to measure sexual and adherence behavior to facilitate assessment of product effectiveness.

Outline of Proceedings

Introduction

• Orientation to Adherence Measurement Issues (Nancy Padian)
• Baseline Participant Statistics (Stephanie Tillman)

Measuring and Optimizing Adherence Before and During a Trial

• MIRA (Adriane van der Straten)
• MDP 301 (Robert Pool, Sheena McCormack)
• HPTN 035 (Ann Colletti)
• CAPRISA 004 (Leila Mansoor)
• ATN-062/MTN-004 (Alex Carballo-Dieguez)
• Assessing and Analyzing Adherence after Trial Completion
• Savvy Ghana (Betsy Tolley)
• CONRAD cellulose sulfate (Mark Weaver)
• Carraguard® (Barbara Friedland, Barbara Mensch, Johanna Rankin)
• HPTN 035 Sub-study (Betsy Tollwy)
• HPTN 035b (Pamina Gorbach)
• Subgroup Analyses (Doug Taylor, Barbra Richardson)

Outside Input

• Lessons from Practice ? Adherence to ART (Leine Stuart)
• HSV-2 Treatment and HIV Prevention Studies (Connie Celum)
• Adherence to Antiretroviral Therapy in the Adherence and Evaluation of Protease Therapy (ADEPT) Study (Carol Golin)
• FDA Perspectives (Jeff Murray)

For additional information, please contact Alliance Writer/Research Associate, Stephanie Tillman.