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Trial record 56 of 1948 for:    Sexually Transmitted Diseases | NIH

Monoclonal Antibody-based Multipurpose Microbicides (Project WIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01859195
Recruitment Status : Active, not recruiting
First Posted : May 21, 2013
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Boston University
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
The Miriam Hospital

Tracking Information
First Submitted Date May 14, 2013
First Posted Date May 21, 2013
Results First Submitted Date May 17, 2017
Results First Posted Date November 6, 2017
Last Update Posted Date November 6, 2017
Study Start Date May 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2017)
Number of Participants: Comprehension of Study Product [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: May 17, 2013)
  • 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 ]
Change History Complete list of historical versions of study NCT01859195 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 2, 2017)
Number of Participants: Drug Delivery Systems Evaluations [ Time Frame: 1 year ]
Members of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Monoclonal Antibody-based Multipurpose Microbicides
Official Title Monoclonal Antibody-based Multipurpose Microbicides
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 Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • HIV
  • Sexually Transmitted Infections (STI)
Intervention Not Provided
Study Groups/Cohorts
  • Focus Group Stage
    ~20-24 participants, to comprise 3-6 focus groups
  • Cognitive Interview Stage
    ~12-16 participants in individual cognitive interviews
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 2, 2017)
36
Original Estimated Enrollment
 (submitted: May 17, 2013)
40
Estimated Study Completion Date August 2018
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01859195
Other Study ID Numbers DAIDS-ES-ID-11941
U19AI096398 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party The Miriam Hospital
Study Sponsor The Miriam Hospital
Collaborators
  • Boston University
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Kathleen M Morrow, PhD The Miriam Hospital
PRS Account The Miriam Hospital
Verification Date September 2017