Intravaginal Ring UseWISHNCT02057419
Women's Input on Sexual Health
An observational study of Intravaginal Ring Use, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this study is to answer the following question: How do user sensory perceptions and experiences (USPEs) for IVRS differ between initial and continued use and how can this knowledge help product developers better understand how to design new IVR products and develop behavioral (or point-of-care)… 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
- Intravaginal Ring Use
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2014to 31 Mar 2018
- 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 (urine test) and not intending to get pregnant (self-report), report vaginal sex with a man in the past month, and present with a need/desire for contraception.
Who may be able to join
- are between the ages of 18 and 45 at prescreening,
- report vaginal sex with a man in the past month at prescreening,
- are not pregnant (self-report, confirmed at V1, V2, and V3 by urine HcG test) and report no intention to become pregnant during the course of the study,
- report negative or unknown HIV status,
- report a need for contraceptive products and
- are willing and able to provide informed consent.
Who cannot join
- self-report pregnancy, have a positive urine pregnancy test at Visits 1, 2, or 3, or intend to become pregnant during the course of the study,
- self-report breast feeding,
- self-report a vaginal delivery or other reproductive surgical procedure in the past 30 days,
- self-report being HIV-positive,
- self-report being diagnosed with or having an active sexually transmitted infection (STI) in the past 12 months,
- self-report an allergy or sensitivity to any of the study products,
Show all 9Show fewer
- do not have a cell phone or internet access,
- are unable or unwilling to give informed consent, or
- have any condition that, in the opinion of the study clinician(s) 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: Centers for Behavioral & Preventive Medicine
Providence, Rhode Island, 02906
About this study
Official title: K24: Advancing Reproductive Health: Women's Input on Sexual Health (Project WISH)
The purpose of this study is to answer the following question: How do user sensory perceptions and experiences (USPEs) for IVRS differ between initial and continued use and how can this knowledge help product developers better understand how to design new IVR products and develop behavioral (or point-of-care) interventions to optimize use?
Read the detailed description
Background: Sexual and reproductive health (SRH) is a global public health priority. Providing efficacious SRH technologies that have the greatest likelihood of use will have the greatest impact on women's health. Critical to use is "acceptability." However, current conceptualizations of adherence and acceptability fail to fully articulate and account for the user experience. Given the recent development of various IVR technologies and the potential for multipurpose technologies, the impact on global public health would be far-reaching, affecting reproductive health in women and men: decreasing STI incidence, minimizing unplanned pregnancies, and decreasing morbidity and mortality due to a range of other reproductive health conditions.
Condition: Participants will use an IVR for a period of three months and report sensory perceptions and use experiences.
Methodology and Data Collection: Volunteers (N~6-10) will first be screened for the study using a brief questionnaire. Those who are interested in contraception and are eligible based on their responses to the prescreen will then complete a clinical screening visit and pregnancy test. Once enrolled participants will complete a survey that asks questions about demographics and sexual and reproductive history.
During the course of the study, participants will evaluate their use of an IVR. IVRs will be used for three consecutive months. They will be given a three-month supply of the product at the beginning of the use period. About once a month, each participant will be required to complete a web survey about their experience with the study product.
All participants complete a final survey that will ask about their experiences with the study product.
- Conditions
- Intravaginal Ring Use
- Keywords
- contraception, contraceptive methods, user experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intravaginal Ring Users | Use IVR for 3-month period and report user sensory perceptions and experiences. |
What is being measured
The primary outcome is the main question the study is designed to answer.
USPE Scale Scores
User sensory perceptions and experiences (USPEs) with the IVR will be captured approximately monthly over a 90 day use period. USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely.
Product: IVR
USPE Scales: Initial Penetration and First Strokes: Smoothness/lubricity; Awareness: Feel (not) intravaginally during sex; Discharge Look: Appearance of discharge; Discharge: Sensations of discharge during and after sex inside and outside body; Pleasure: Participant and partner's stimulation
A higher score indicates greater agreement with subscale characteristics being reported on.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study start14 Apr 2014
- Primary completion24 Jun 2016
- Study completion31 Mar 2018
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 Intravaginal Ring UseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Kate Guthrie, PhD, Principal investigator, The Miriam Hospital: Centers for Behavioral & Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057419
- Sponsor's protocol ID
- TMH-506070
- Other IDs
- K24HD062645
- Acronym
- WISH
- Status last verified
- Oct 2025
- First submitted
- 31 Jan 2014
- Last updated
- 24 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- K24: Advancing Reproductive Health: Women's Input on Sexual Health (Project WISH)
- ClinicalTrials.gov ID
- NCT02057419
- Acronym / sponsor ID
- WISH / TMH-506070
- Conditions
- Intravaginal Ring Use
- Keywords
- contraception, contraceptive methods, user experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Apr 2014 (actual)
- Primary completion
- 24 Jun 2016 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to answer the following question: How do user sensory perceptions and experiences (USPEs) for IVRS differ between initial and continued use and how can this knowledge help product developers better understand how to design new IVR products and develop behavioral (or point-of-care) interventions to optimize use?
Detailed description
Background: Sexual and reproductive health (SRH) is a global public health priority. Providing efficacious SRH technologies that have the greatest likelihood of use will have the greatest impact on women's health. Critical to use is "acceptability." However, current conceptualizations of adherence and acceptability fail to fully articulate and account for the user experience. Given the recent development of various IVR technologies and the potential for multipurpose technologies, the impact on global public health would be far-reaching, affecting reproductive health in women and men: decreasing STI incidence, minimizing unplanned pregnancies, and decreasing morbidity and mortality due to a range of other reproductive health conditions.
Condition: Participants will use an IVR for a period of three months and report sensory perceptions and use experiences.
Methodology and Data Collection: Volunteers (N~6-10) will first be screened for the study using a brief questionnaire. Those who are interested in contraception and are eligible based on their responses to the prescreen will then complete a clinical screening visit and pregnancy test. Once enrolled participants will complete a survey that asks questions about demographics and sexual and reproductive history.
During the course of the study, participants will evaluate their use of an IVR. IVRs will be used for three consecutive months. They will be given a three-month supply of the product at the beginning of the use period. About once a month, each participant will be required to complete a web survey about their experience with the study product.
All participants complete a final survey that will ask about their experiences with the study product.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravaginal Ring Users | – | –Use IVR for 3-month period and report user sensory perceptions and experiences. |
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 (urine test) and not intending to get pregnant (self-report), report vaginal sex with a man in the past month, and present with a need/desire for contraception.
Key inclusion criteria (6 listed)
- are between the ages of 18 and 45 at prescreening,
- report vaginal sex with a man in the past month at prescreening,
- are not pregnant (self-report, confirmed at V1, V2, and V3 by urine HcG test) and report no intention to become pregnant during the course of the study,
- report negative or unknown HIV status,
- report a need for contraceptive products and
Key exclusion criteria (9 listed)
- self-report pregnancy, have a positive urine pregnancy test at Visits 1, 2, or 3, or intend to become pregnant during the course of the study,
- self-report breast feeding,
- self-report a vaginal delivery or other reproductive surgical procedure in the past 30 days,
- self-report being HIV-positive,
- self-report being diagnosed with or having an active sexually transmitted infection (STI) in the past 12 months,
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
USPE Scale Scores
Time frame: Up to 3 months
User sensory perceptions and experiences (USPEs) with the IVR will be captured approximately monthly over a 90 day use period. USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely. Product: IVR USPE Scales: Initial Penetration and First Strokes: Smoothness/lubricity; Awareness: Feel (not) intravaginally during sex; Discharge Look: Appearance of discharge; Discharge: Sensations of discharge during and after sex inside and outside body; Pleasure: Participant and partner's stimulation A higher score indicates greater agreement with subscale characteristics being reported on.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- 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.
Kate Guthrie, PhD principal investigator
The Miriam Hospital: Centers for Behavioral & Preventive Medicine
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 Intravaginal Ring Use, 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 9 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 24 Oct 2025. 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 24 Oct 2025). 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?
USPE Scale Scores (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2025.