Acceptability Study of Vaginal Films for HIV Prevention (FACE)

University of Pittsburgh

Status: Completed

Conditions: Anti-Infective Agents; HIV Infections

Treatments: Other: No intervention (not applicable)

Study type: Observational

Funder types: Other

Identifiers

NCT01231763

PRO10080621 (UPittsburgh IRB#)

Details and patient eligibility

About

This study is being done to find out what women would want in a film vaginal product for human immunodeficiency virus (HIV) prevention, especially what it should look like and how to apply it.

The investigators hypothesize that women will prefer a smooth, clear, and rectangular quick-dissolve vaginal film for HIV prevention over a textured, opaque, square quick-dissolve vaginal film.

Full description

The lives of 25 million people have ended due to HIV-related causes since the start of the AIDS epidemic in 1981 (1). Each year, AIDS continues to claim the lives of millions of people, with an estimated two million deaths worldwide in 2008 (2). Heterosexual transmission of HIV accounts for the majority of new infections and disproportionately affects women both in the United States and globally (2, 3). There is an urgent need for agents to prevent the sexual transmission of HIV, particularly agents that may be controlled by women.

Quick dissolve films such as Listerene® Breath Strips have been developed for inexpensive delivery of drugs and vitamins. As products for HIV prevention, quick dissolve films offer a host of potential advantages including low cost, control by the receptive partner, discreet and applicator-free use, low mess, portability, easy storage, stability, targeting to site of exposure, reduction of systemic toxicity by bypassing first-pass metabolism, and the incorporation of multiple active microbicidal compounds (4, 5).

In the course of developing agents for HIV prevention, determination of valued characteristics is important for product refinement and for enhancement of future use likelihood. Knowledge regarding acceptability can also inform product promotion and educational campaigns (6).

Enrollment: 84 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female 18-30 years old at time of enrollment
• Able to provide written informed consent

Exclusion criteria

• Not sexually active, defined as no vaginal sex at any time in the past year
• Pregnant by self-report

Trial design

84 participants in 1 patient group

Healthy volunteers

Treatment:

Other: No intervention (not applicable)