Trial Outcomes & Findings for Monoclonal Antibody-based Multipurpose Microbicides (NCT NCT01859195)
NCT ID: NCT01859195
Last Updated: 2021-10-01
Results Overview
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.
UNKNOWN
36 participants
1 year
2021-10-01
Participant Flow
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).
Participant milestones
| Measure |
Focus Group Stage
\~20-24 participants, to comprise 3-6 focus groups
|
Cognitive Interview Stage
\~12-16 participants in individual cognitive interviews
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
12
|
|
Overall Study
COMPLETED
|
24
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Monoclonal Antibody-based Multipurpose Microbicides
Baseline characteristics by cohort
| Measure |
Focus Groups
n=24 Participants
Focus Groups
|
Cognitive Interviews
n=12 Participants
Cognitive Interviews
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearFocus 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.
Outcome measures
| Measure |
Number of Participants: Focus Group
n=24 Participants
Number of participants in focus group stage
|
Number of Participants: Cognitive Interviews
n=12 Participants
Number of participants in cognitive interview stage
|
|---|---|---|
|
Number of Participants: Comprehension of Study Product
|
24 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearMembers of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development
Outcome measures
| Measure |
Number of Participants: Focus Group
n=24 Participants
Number of participants in focus group stage
|
Number of Participants: Cognitive Interviews
n=12 Participants
Number of participants in cognitive interview stage
|
|---|---|---|
|
Number of Participants: Drug Delivery Systems Evaluations
|
24 Participants
|
12 Participants
|
Adverse Events
Focus Groups
Cognitive Interviews
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigator
The Miriam Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place