Monoclonal Antibody-based Multipurpose Microbicides (Project WIND)

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.

Study Overview

• Status: Completed
• Conditions: HIV; Sexually Transmitted Infections (STI)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • The Miriam Hospital - ReproHealth Team

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Females who are 18-45 years old, HIV negative or unknown (self report), non-pregnant and not intending to get pregnant (self report), and report vaginal sex with a man in the past 12 months.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Female Participants; Participants who completed demographics and sexual behavior questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Use	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)	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EVER Engaged in Behavior	Number of participants who ever engaged in specified behavior.	1 year
Product Use CURRENT	Number of participants currently using specified product.	1 year
Count (Number of Times) of Sexual Behavior	Number of times participant engaged in specified sex in the past 12 months.	1 year

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: Boston University; National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Kathleen M Morrow, PhD, The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 17, 2013
• First Posted (Estimated): May 21, 2013

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Prevention; HIV/STI; Microbicides, Topical
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases
• Other Study ID Numbers: DAIDS-ES-ID-11941; U19AI096398 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No