Monoclonal Antibody-based Multipurpose Microbicides

NCT01859195 | Completed Results

• 2 other identifiers: DAIDS-ES-ID-11941U19AI096398
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Sexually Transmitted Infections (STI)

Keywords

HIV/STI; Prevention; Microbicides, Topical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• EVER Engaged in Behavior

  1 year

• Product Use CURRENT

  1 year

• Count (Number of Times) of Sexual Behavior

  1 year

Study Arms (1)

Female Participants

Participants who completed demographics and sexual behavior questionnaire.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Miriam Hospital: lead
• Boston University: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The Miriam Hospital - ReproHealth Team

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

These data are demographic and sexual behavior data associated with participants providing information to inform study product development.

Results Point of Contact

• Title: Principal Investigator
• Organization: The Miriam Hospital

scu-uvin@lifespan.org; kate.guthrie@lifespan.org

401-793-4775 or 401-793-8180

Study Officials

• Kathleen M Morrow, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: January 1, 2026
• Last Updated: February 23, 2026
• Results First Posted: November 6, 2017

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)