HIVProject WINDNCT01859195

Monoclonal Antibody-based Multipurpose Microbicides

An observational study of HIV and Sexually Transmitted Infections (STI), run by The Miriam Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV, Sexually Transmitted Infections (STI)
How many people: 36 participants
Where: 1 siteUnited States
Study dates: May 2013to Jan 2026
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Miriam Hospital - ReproHealth Team
Providence, Rhode Island, 02903

Other trials in United States

About this study

Read the detailed description

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 complete a brief demographics and sexual behavior questionnaire.

Conditions: HIV, Sexually Transmitted Infections (STI)
Keywords: HIV/STI, Prevention, Microbicides, Topical
Medical subject headings: Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01859195
Study group	Role	What they receive
Female Participants		Participants who completed demographics and sexual behavior questionnaire.

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Use
Frequency of product use during specified sex in the past 12 months. Response options: 0= None of the time; 1 = Some of the time, 2 = Half of the time, 3 = Most of the time; 4 = All of the time; 5 = Not applicable (did not have specified sex)
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Jan 2026

First posted21 May 2013 (estimated)
Study startMay 2013
Primary completionAug 2013
Study completionJan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01859195
Sponsor's protocol ID: DAIDS-ES-ID-11941
Other IDs: U19AI096398
Acronym: Project WIND
Status last verified: Feb 2026
First submitted: 14 May 2013
Last updated: 23 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Monoclonal Antibody-based Multipurpose Microbicides
ClinicalTrials.gov ID: NCT01859195
Acronym / sponsor ID: Project WIND / DAIDS-ES-ID-11941
Conditions: HIV, Sexually Transmitted Infections (STI)
Keywords: HIV/STI, Prevention, Microbicides, Topical
Study type: Observational
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: The Miriam HospitalUniversity, hospital or other
Collaborators: Boston University, National Institute of Allergy and Infectious Diseases (NIAID)
Study start: May 2013 (actual)
Primary completion: Aug 2013 (actual)
Study completion: Jan 2026 (actual)
First posted: 21 May 2013 (estimated)
Results: Posted 6 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire.

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Female Participants	–	–Participants who completed demographics and sexual behavior questionnaire.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
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.

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Frequency of Use
Time frame: 1 year
Frequency of product use during specified sex in the past 12 months. Response options: 0= None of the time; 1 = Some of the time, 2 = Half of the time, 3 = Most of the time; 4 = All of the time; 5 = Not applicable (did not have specified sex)

Results and safety

Results posted to the registry on 6 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Female Participants	29	29

Primary outcome: Frequency of Use

Time frame: 1 year. Mean (Standard Deviation). Unit: units on a scale

Measure	Female Participants n = 29
How often used lubricant during VAGINAL sex in PAST 12 MONTHS?	1.14 (1.25)
How often used condom during VAGINAL sex in PAST 12 MONTHS?	1.31 (1.73)
How often used vaginal film during VAGINAL sex in PAST 12 MONTHS?	0.00 (0.00)
How often used diaphragm during VAGINAL sex in PAST 12 MONTHS?	0.00 (0.00)
How often used condom during ANAL sex in PAST 12 MONTHS?	3.62 (2.27)
How often used condom Giving ORAL sex in PAST 12 MONTHS?	1.00 (2.00)

Population analysed: Numbers analyzed for each scale may differ from overall sample as some items may not have been answered by a given participant.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Female Participants	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Limitations and caveats (from the sponsor): These data are demographic and sexual behavior data associated with participants providing information to inform study product development.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathleen M Morrow, PhD principal investigator

The Miriam Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV and Sexually Transmitted Infections (STI), run by The Miriam Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Use (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01859195.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.