Microbicide clinical trial adherence: insights for introduction

Area of Science:

• * Public Health
• * Infectious Diseases
• * Clinical Trials

Background:

• * Two decades of microbicide research have not definitively established efficacy for vaginal HIV prevention products.
• * Correct and consistent product use is essential for microbicides to prevent HIV infection.
• * Adherence data from trials are vital for future research, implementation, and post-marketing surveillance.

Purpose of the Study:

• * To identify and discuss lessons learned regarding adherence from large-scale microbicide efficacy trials.
• * To provide recommendations for improving adherence in future microbicide trials and implementation programs.

Main Methods:

• * Analysis of data and experiences from completed large-scale microbicide efficacy trials.
• * Identification of six key areas of adherence challenges and lessons learned.

Main Results:

• * Six critical areas impacting adherence were identified: measurement, instruction comprehension, perceived efficacy, partner influence, retention, and generalizability.
• * Examples from microbicide trials illustrate these adherence challenges.
• * Recommendations are provided for each adherence topic.

Conclusions:

• * Understanding and addressing adherence is paramount for the successful implementation of vaginal microbicides for HIV prevention.
• * Lessons learned from past trials can guide the design and execution of future safety, efficacy, and implementation studies.
• * Effective strategies are needed to ensure correct and consistent use for maximum public health impact.