Funding Source and Project Period: NIAID, U01-AI6833, 2007-2013

Key Personnel:

Principal Investigator: Alex Carballo-Dieguez, Ph.D.

Project Overview

Topical microbicides are products currently under development that could be applied inside the vagina or the rectum prior to intercourse to prevent or significantly decrease the chances of HIV transmission. The Microbicide Trials Network (MTN) microbicide development plan has been designed to move candidate microbicides such as VivaGel™ from the preclinical evaluation phase through to licensure.


The Adolescent Trials Network (ATN) has been the only national network focused on studying the emerging HIV epidemic in teens infected through sex or drug-injecting behaviors. The MTN collaborated with the ATN to carry out MTN 004, “Phase I Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women” and ATN 062. ATN 062 aims to examine the circumstances that contribute to or detract from microbicide-use adherence, acceptability, and overall attitudes towards microbicides among MTN 004 participants.


The specific aims of this study are to: 1) increase the accuracy of reporting on gel use adherence; 2) provide a behavioral marker of protocol adherence; and 3) test advances in information technology tools that may be used in microbicide trials to improve collection of behavioral data. ATN 062 was conducted at three ATN Study Sites: University of Puerto Rico, San Juan, PR; University of South Florida, Tampa, FL; and University of Pittsburgh, Pittsburgh, PA. Healthy, sexually active HIV-uninfected women 18-24 years of age were enrolled in the MTN 004 study and offered the option of enrolling in ATN 062. Sixty-one participants enrolled in MTN 004, of whom 59 enrolled in ATN 062. Participants were randomized to use either VivaGel™, VivaGel Placebo, or HEC Placebo Gel applied vaginally twice daily for 14 days.



To assess microbicide use adherence, acceptability, and attitudes among women enrolled in MTN 004, ATN 062 used a computerized phone diary, which participants called twice daily while using the gel; computer-mediated teleconferences with a web-cam to perform in-depth interviews at study visits focusing on participant experiences using the study gel; and email messages from participants regarding gel use and any problems with the study product or the phone diary system. We have completed data collection and are currently in the process of analyzing data and preparing manuscripts to disseminate findings.