This trial is active, not recruiting.

Conditions hiv, sexually transmitted infections (sti)
Sponsor The Miriam Hospital
Collaborator Boston University
Start date May 2013
End date September 2013
Trial size 40 participants
Trial identifier NCT01859195, DAIDS-ES-ID-11941, U19AI096398


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective cross-sectional
~20-24 participants, to comprise 3-6 focus groups
~12-16 participants in individual cognitive interviews

Primary Outcomes

Evaluate participant language suggestions, as measured by qualitative data collected in focus groups and cognitive interviews
time frame: 1 year
Evaluate designs of drug delivery system, based on qualitative data collected during focus groups and cognitive interviews
time frame: 1 year

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.

Additional Information

Official title Monoclonal Antibody-based Multipurpose Microbicides
Principal investigator Kathleen M Morrow, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by The Miriam Hospital.