A Randomized, Comparative Safety Study of a Prefilled Plastic and User-Filled Paper Applicator With Candidate Microbicide Tenofovir 1% Gel

Cohen, Jessica A. MHS, CIP*; Brache, Vivian BS; Foster, Jennifer PhD*; Cochon, Leila BS; Callahan, Marianne MEd; Schwartz, Jill MD

Sexually Transmitted Diseases: June 2013 - Volume 40 - Issue 6 - p 476–481
doi: 10.1097/OLQ.0b013e3182927ab1
Original Study

Background: A bridging study was performed to compare the safety, dose delivery, and acceptability of a prefilled plastic and user-filled paper applicator to assess whether a low-cost, user-filled, paper applicator could serve as a delivery option for tenofovir (TFV) 1% vaginal microbicide gel.

Methods: The study used a randomized crossover design with 25 healthy women randomized to begin with the prefilled or user-filled applicator. Within each study arm, participants delivered two 4.0-mL doses of TFV 1% gel vaginally for 7 days, with one dose delivered at the clinic each morning and a second dose delivered at home each evening. To assess the primary objective, applicator safety, colposcopy examinations were performed at 2 time points in each study arm.

Results: There were no colposcopic findings or adverse events attributable to either applicator. One case of vulvovaginal candidiasis was considered possibly related to gel use. On average, the user-filled applicator delivered 96% of the target dose, with 85% of doses falling within ±10% of the average dose volume. Participants found both applicators comparable for ease of use, insertion, and dispensing gel, with 60% of participants preferring the user-filled applicator.

Conclusions: This study suggests that both applicators are safe, and most women delivered TFV with the user-filled applicator as directed. Participants found both applicators acceptable, with a slight majority preferring the user-filled applicator. Incorporating a low-cost, user-filled, paper applicator to deliver TFV could help reduce costs and improve access to TFV 1% gel, especially in resource-limited settings heavily impacted by HIV.

A study comparing plastic prefilled and paper user-filled applicators for tenofovir gel found both applicators safe and acceptable. Most women delivered accurate volumes of tenofovir with the user-filled applicator.

From the *PATH, Seattle, WA; †Profamilia, Santo Domingo, Dominican Republic;and ‡CONRAD, Arlington, VA

The authors thank Breanne Grady, Project Coordinator at PATH, and Chalyce Grace, Clinical Trial Monitor at CONRAD, for their contributions to the study. The authors also thank the staff at Profamilia for helping implement the study as well as the study participants whose participation made this study possible.

Sources of support: This project was made possible by the generous support of the American people through the US Agency for International Development (USAID) under the terms of the Technologies for Health Cooperative Agreement No. GPH-A-00-01-00005. CONRAD provided the tenofovir gel for this study with support from USAID.

Conflict of interest: There are no conflicts of interest among any of the authors.

The contents are the responsibility of PATH and do not necessarily reflect the views of USAID or the US government.

Registration: Clinical Trials. Government Registry No.: NCT01283555.

Correspondence: Jessica Cohen, MHS, CIP, PATH, PO Box 900922, Seattle, WA 98109. E-mail: jcohen@path.org.

Received for publication July 25, 2012, and accepted February 11, 2013.

© Copyright 2013 American Sexually Transmitted Diseases Association