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Trial record 31 of 1169 for:    Sexually Transmitted Diseases | ( Map: United States ) | 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 : August 27, 2019
Sponsor:
Collaborators:
Boston University
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
The Miriam Hospital

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Cross-Sectional
Conditions HIV
Sexually Transmitted Infections (STI)
Enrollment 36
Recruitment Details Recruited May-Aug 2013 (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth. Volunteers complete prescreen survey. If eligible, each invited to participate in either (1) focus group or (2) individual cognitive interview (first ~20-24 for focus groups; remaining ~12-16 for interviews after FGs began).
Pre-assignment Details  
Arm/Group Title Focus Group Stage Cognitive Interview Stage
Hide Arm/Group Description ~20-24 participants, to comprise 3-6 focus groups ~12-16 participants in individual cognitive interviews
Period Title: Overall Study
Started 24 12
Completed 24 12
Not Completed 0 0
Arm/Group Title Focus Groups Cognitive Interviews Total
Hide Arm/Group Description Focus Groups Cognitive Interviews Total of all reporting groups
Overall Number of Baseline Participants 24 12 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
12
 100.0%
36
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
Female
24
 100.0%
12
 100.0%
36
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
Hispanic or Latino
1
   4.2%
4
  33.3%
5
  13.9%
Not Hispanic or Latino
23
  95.8%
8
  66.7%
31
  86.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 12 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  25.0%
3
  25.0%
9
  25.0%
White
15
  62.5%
8
  66.7%
23
  63.9%
More than one race
2
   8.3%
1
   8.3%
3
   8.3%
Unknown or Not Reported
1
   4.2%
0
   0.0%
1
   2.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants 12 participants 36 participants
24
 100.0%
12
 100.0%
36
 100.0%
1.Primary Outcome
Title Number of Participants: Comprehension of Study Product
Hide Description

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.

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Number of Participants: Focus Group Number of Participants: Cognitive Interviews
Hide Arm/Group Description:
Number of participants in focus group stage
Number of participants in cognitive interview stage
Overall Number of Participants Analyzed 24 12
Measure Type: Count of Participants
Unit of Measure: Participants
24
 100.0%
12
 100.0%
2.Other Pre-specified Outcome
Title Number of Participants: Drug Delivery Systems Evaluations
Hide Description Members of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Number of Participants: Focus Groups Number of Participants: Cognitive Interviews
Hide Arm/Group Description:
number of participants who completed focus group stage
number of participants who completed cognitive interview stage
Overall Number of Participants Analyzed 24 12
Measure Type: Count of Participants
Unit of Measure: Participants
24
 100.0%
12
 100.0%
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Focus Groups Cognitive Interviews
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Focus Groups Cognitive Interviews
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Focus Groups Cognitive Interviews
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Focus Groups Cognitive Interviews
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/12 (0.00%) 
This is a formative qualitative data study, designed to gather narrative participant-relevant information related to study product development and evaluation.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator
Organization: The Miriam Hospital
Phone: 401-793-4775 or 401-793-8180
EMail: scu-uvin@lifespan.org; kate.guthrie@lifespan.org
Layout table for additonal information
Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01859195     History of Changes
Other Study ID Numbers: DAIDS-ES-ID-11941
U19AI096398 ( U.S. NIH Grant/Contract )
First Submitted: May 14, 2013
First Posted: May 21, 2013
Results First Submitted: May 17, 2017
Results First Posted: November 6, 2017
Last Update Posted: August 27, 2019