N/A
N=29
Monoclonal Antibody-based Multipurpose Microbicides
HIV · Sexually Transmitted Infections (STI)
Bottom Line
View on ClinicalTrials.gov: NCT01859195 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Frequency of Use — 1.14; 1.31; 0.00; 0.00 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Miriam Hospital
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Use |
1.14; 1.31; 0.00; 0.00; 3.62; 1.00 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01859195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.