Clinical trial NCT01859195: Monoclonal Antibody-based Multipurpose Microbicides
Official title: Monoclonal Antibody-based Multipurpose Microbicides
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Sexually Transmitted Infections (STI)
Keywords: HIV/STI
Prevention
Microbicides, Topical
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2013-05-21
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants: Comprehension of Study Product
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Number of Participants: Drug Delivery Systems Evaluations
timeFrame: 1 year
Locations:
city: Providence
country: United States
facility: The Miriam Hospital - ReproHelath Team
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Kathleen M Morrow, PhD
role: PRINCIPAL_INVESTIGATOR
References: