Skip to main content
OpenTrials
Completed

NCT Number: NCT01859195

Monoclonal Antibody-based Multipurpose Microbicides

The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

The Miriam Hospital - ReproHealth Team

Providence, Rhode Island, 02903, United States

About this study

The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. The investigators will ask women to help design the best strategy for applying a vaginal product using a specific kind of applicator. The investigators want to identify designs that women think would be easy to prepare and insert. Women's thoughts and opinions will help researchers develop new products called microbicides that may protect against HIV and other sexually transmitted diseases, that are easy to use, and that will be acceptable to women who use them. If researchers can make products that are easy to use and that women like to use, the products will be used more often, and more infections will be prevented.

Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women who:

  • are between the ages of 18 and 45 at prescreening
  • report vaginal sex with a man in the past 12 months at prescreening
  • report negative pregnancy status and no intention to become pregnant during the course of the study
  • report negative or unknown HIV status, and
  • are willing and able to provide informed consent.

Exclusion criteria

Women who:

  • self-report being pregnant, or intention to become pregnant during the course of the study
  • self-report being HIV-positive
  • self-report an allergy or sensitivity to vaginal contraceptive film (VCF), nonoxynol-9 (N9), or product(s) containing N9
  • are unable or unwilling to give informed consent, or
  • have any condition that, in the opinion of the project leader or principle investigator, would compromise the participant's ability to participate in the study.

Treatment and study plan

Primary outcomes

  1. Frequency of Use

    Time frame: 1 year

    Frequency of product use during specified sex in the past 12 months. Response options: 0= None of the time; 1 = Some of the time, 2 = Half of the time, 3 = Most of the time; 4 = All of the time; 5 = Not applicable (did not have specified sex)

Other outcomes

  1. EVER Engaged in Behavior

    Time frame: 1 year

    Number of participants who ever engaged in specified behavior.

  2. Product Use CURRENT

    Time frame: 1 year

    Number of participants currently using specified product.

  3. Count (Number of Times) of Sexual Behavior

    Time frame: 1 year

    Number of times participant engaged in specified sex in the past 12 months.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • Boston University
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Acronym: Project WIND

Important dates

Study start
2013
Primary completion
2013
Study completion
2026
First posted
May 21, 2013
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.