Monoclonal Antibody-based Multipurpose Microbicides

Conditions: Sexually Transmitted Infections (STI)
HIV

Registration Number: NCT01859195

Lead Sponsor: The Miriam Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: UNKNOWN

Sex: Female

Target Recruitment: 36

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants: Comprehension of Study Product	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.

Secondary Outcome Measures