Status:
UNKNOWN
Monoclonal Antibody-based Multipurpose Microbicides
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
Boston University
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Sexually Transmitted Infections (STI)
Eligibility:
FEMALE
18-45 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01859195
Start Date
May 1 2013
End Date
March 1 2022
Last Update
October 1 2021
Active Locations (1)
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1
The Miriam Hospital - ReproHelath Team
Providence, Rhode Island, United States, 02903