Monoclonal Antibody-based Multipurpose Microbicides

The Miriam Hospital36 enrolled

Overview

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.

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

Conditions

HIV Sexually Transmitted Infections (STI)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Miriam Hospital - ReproHealth Team

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

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)

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.