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Monoclonal Antibody-based Multipurpose Microbicides (Project WIND)

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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

Study Type: Observational
Study Design: Observational Model: Other;   Time Perspective: Cross-Sectional
Conditions: HIV
Sexually Transmitted Infections (STI)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Focus Group Stage ~20-24 participants, to comprise 3-6 focus groups
Cognitive Interview Stage ~12-16 participants in individual cognitive interviews

Participant Flow:   Overall Study
    Focus Group Stage   Cognitive Interview Stage
STARTED   24   12 
COMPLETED   24   12 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Focus Groups No text entered.
Cognitive Interviews No text entered.
Total Total of all reporting groups

Baseline Measures
   Focus Groups   Cognitive Interviews   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   12   36 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      24 100.0%      12 100.0%      36 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
United States   24   12   36 


  Outcome Measures

1.  Primary:   Number of Participants: Comprehension of Study Product   [ Time Frame: 1 year ]

2.  Other Pre-specified:   Number of Participants: Drug Delivery Systems Evaluations   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is a formative qualitative data study, designed to gather narrative participant-relevant information related to study product development and evaluation.


  More Information

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:  
Name/Title: Principal Investigator
Organization: The Miriam Hospital
phone: 401-793-4775 or 401-793-8180
e-mail: scu-uvin@lifespan.org; kate.guthrie@lifespan.org



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: November 6, 2017