Monoclonal Antibody-based Multipurpose Microbicides
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 10/14/2017 |
| Start Date: | May 2013 |
| End Date: | December 2017 |
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.
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.
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.
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