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Monoclonal Antibody-based Multipurpose Microbicides (Project WIND)

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ClinicalTrials.gov Identifier: NCT01859195
Recruitment Status : Active, not recruiting
First Posted : May 21, 2013
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Boston University
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
The Miriam Hospital

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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 or disease
HIV Sexually Transmitted Infections (STI)

Study Design
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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Monoclonal Antibody-based Multipurpose Microbicides
Study Start Date : May 2013
Actual Primary Completion Date : September 2013
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Focus Group Stage
~20-24 participants, to comprise 3-6 focus groups
Cognitive Interview Stage
~12-16 participants in individual cognitive interviews


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants: Comprehension of Study Product [ Time Frame: 1 year ]

    Focus groups captured participant understandings (in narrative form) of plant-produced monoclonal antibodies, how they come about, how they are manufactured, how they differ from other anti-HIV actives, etc. Participant-derived language informed development of study materials, including study product instruction sheets and informed consent materials and documents.

    Cognitive Interview assessed Participant comprehension of language used in insertion instruction materials, and monoclonal antibody education and informed consent materials.



Other Outcome Measures:
  1. Number of Participants: Drug Delivery Systems Evaluations [ Time Frame: 1 year ]
    Members of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Kathleen M Morrow, PhD The Miriam Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01859195     History of Changes
Other Study ID Numbers: DAIDS-ES-ID-11941
U19AI096398 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2013    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: September 2017

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

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