Monoclonal Antibody-based Multipurpose Microbicides (Project WIND)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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 Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Monoclonal Antibody-based Multipurpose Microbicides|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||August 2018|
Focus Group Stage
~20-24 participants, to comprise 3-6 focus groups
Cognitive Interview Stage
~12-16 participants in individual cognitive interviews
- 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.
- 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
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
|United States, Rhode Island|
|The Miriam Hospital - ReproHelath Team|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Kathleen M Morrow, PhD||The Miriam Hospital|