Monoclonal Antibody-based Multipurpose Microbicides (Project WIND)
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.
Sexually Transmitted Infections (STI)
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Monoclonal Antibody-based Multipurpose Microbicides|
- 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 ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||July 2016|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Focus Group Stage
~20-24 participants, to comprise 3-6 focus groups
Cognitive Interview Stage
~12-16 participants in individual cognitive interviews
Please refer to this study by its ClinicalTrials.gov identifier: 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|