Monoclonal Antibody-based Multipurpose Microbicides (Project WIND)
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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 |
- 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 2015 |
| 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 |
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.
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 LocationsPlease 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 |
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: | February 3, 2015 |
| 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 Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015