Trial record 16 of 26 for:    " April 17, 2013":" May 17, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Monoclonal Antibody-based Multipurpose Microbicides (Project WIND)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Boston University
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01859195
First received: May 14, 2013
Last updated: March 26, 2014
Last verified: May 2013
  Purpose

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 either participate in a focus group with approximately 3-7 other women or a one-on-one cognitive interview. All participants will complete a brief questionnaire. Some women may enroll in both stages.

Each focus group will take approximately 1.5-2.5 hours. Group leaders will talk to women about their experiences using vaginal products and will provide participants with study products to look at and touch. All participants will be asked to come up with ideas of how to make the products easy to use and acceptable to women who use them. Group leaders will encourage discussion about the different designs. After this, group leaders will talk about a specific type of microbicide and ask women about their opinions. In particular, researchers and participants will talk about the language that would be best understood by women who would use these products or be in studies to evaluate them.

Each cognitive interview will take approximately 1.5-2.5 hours. Each participant will be asked about different product designs and application instructions, and will be asked her thoughts, opinions, and potential concerns about each. She will also evaluate sample language that will be used to help women understand the products and how to use them.


Condition
HIV
Sexually Transmitted Infections (STI)

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Monoclonal Antibody-based Multipurpose Microbicides

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Evaluate participant language suggestions, as measured by qualitative data collected in focus groups and cognitive interviews [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evaluate designs of drug delivery system, based on qualitative data collected during focus groups and cognitive interviews [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2013
Estimated Study Completion Date: July 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Focus Group Stage
~20-24 participants, to comprise 3-6 focus groups
Cognitive Interview Stage
~12-16 participants in individual cognitive interviews

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859195

Locations
United States, Rhode Island
The Miriam Hospital - ReproHelath Team
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Boston University
Investigators
Principal Investigator: Kathleen M Morrow, PhD The Miriam Hospital
  More Information

No publications provided

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01859195     History of Changes
Other Study ID Numbers: DAIDS-ES-ID-11941, U19AI096398
Study First Received: May 14, 2013
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by The Miriam Hospital:
HIV/STI
Prevention
Microbicides, Topical

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Infection
Virus Diseases
Anti-Infective Agents
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014