Monoclonal Antibody-based Multipurpose Microbicides

HIV Clinical Trial

— Project WIND  

Official title:

Monoclonal Antibody-based Multipurpose Microbicides

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01859195
• Other study ID #: DAIDS-ES-ID-11941
• Secondary ID: U19AI096398
• Status: Active, not recruiting
• Start date: May 2013
• Est. completion date: March 2022

Study information

• Verified date: September 2021
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: March 2022
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases
• Sexually Transmitted Infections (STI)

Locations

Country	Name	City	State
United States	The Miriam Hospital - ReproHelath Team	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
The Miriam Hospital	Boston University, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants: Drug Delivery Systems Evaluations	Members of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development	1 year
Primary	Number of Participants: Comprehension of Study Product	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.	1 year