Project WIND: Monoclonal Antibody-based Multipurpose Microbicides

• Sponsor: The Miriam Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01859195
• Collaborator: Boston University (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 36
• Location: 1
• Duration (Months): 106
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV; Sexually Transmitted Infections (STI)

Study Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Monoclonal Antibody-based Multipurpose Microbicides
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Aug 1, 2013
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Focus Group Stage ~20-24 participants, to comprise 3-6 focus groups
Cognitive Interview Stage ~12-16 participants in individual cognitive interviews

Outcome Measures

Primary Outcome Measures

1. Number of Participants: Comprehension of Study Product [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.

Other Outcome Measures

1. Number of Participants: Drug Delivery Systems Evaluations [1 year]

   Members of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Miriam Hospital - ReproHelath Team	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

• The Miriam Hospital
• Boston University
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Kathleen M Morrow, PhD, The Miriam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Miriam Hospital
• ClinicalTrials.gov Identifier: NCT01859195
• Other Study ID Numbers: DAIDS-ES-ID-11941; U19AI096398
• First Posted: May 21, 2013
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by The Miriam Hospital: HIV/STI; Prevention; Microbicides, Topical
• Additional relevant MeSH terms: Sexually Transmitted Diseases

Study Results

Participant Flow

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).

Arm/Group Title	Focus Group Stage	Cognitive Interview Stage
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

Baseline Characteristics

Arm/Group Title	Focus Groups	Cognitive Interviews	Total
Arm/Group Description	Focus Groups	Cognitive Interviews	Total of all reporting groups
Overall Participants	24	12	36
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	24 100%	12 100%	36 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	24 100%	12 100%	36 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (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%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 25%	3 25%	9 25%
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%	1 2.8%
Region of Enrollment (Count of Participants)
United States	24 100%	12 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants: Comprehension of Study Product
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Number of Participants: Focus Group	Number of Participants: Cognitive Interviews
Arm/Group Description	Number of participants in focus group stage	Number of participants in cognitive interview stage
Measure Participants	24	12
Count of Participants [Participants]	24 100%	12 100%

2. Other Pre-specified Outcome

Title	Number of Participants: Drug Delivery Systems Evaluations
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Number of Participants: Focus Groups	Number of Participants: Cognitive Interviews
Arm/Group Description	number of participants who completed focus group stage	number of participants who completed cognitive interview stage
Measure Participants	24	12
Count of Participants [Participants]	24 100%	12 100%

Adverse Events

Time Frame	4 months
Arm/Group Title	Focus Groups		Cognitive Interviews
Arm/Group Description
All Cause Mortality
	Focus Groups		Cognitive Interviews
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/12 (0%)
Serious Adverse Events
	Focus Groups		Cognitive Interviews
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Focus Groups		Cognitive Interviews
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/12 (0%)

Limitations/Caveats

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.