Women's Input on Sexual Health (WISH)

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?

Study Overview

• Status: Completed
• Conditions: Intravaginal Ring 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 Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital: Centers for Behavioral & Preventive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Intravaginal Ring Users; Use IVR for 3-month period and report user sensory perceptions and experiences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
USPE Scale Scores	User sensory perceptions and experiences (USPEs) with study products will be captured approximately monthly over a 90 day use period for each product evaluated. There are 3 use periods, therefore, the final USPE results will occur approximately 8-9 months following enrollment	up to an average of 8-9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience and Adherence Narratives	Participants will complete an in-depth qualitative interview (IDI) about their experiences with the study products following each 3 month use period. There are 3 use periods, therefore, the final IDI will occur approximately 9-10 months from enrollment	average of 9-10 months

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Kate Guthrie, PhD, The Miriam Hospital: Centers for Behavioral & Preventive Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2014
• Primary Completion (Actual): June 24, 2016
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 5, 2014
• First Posted (Estimated): February 7, 2014

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: contraception; user experience; contraceptive methods
• Other Study ID Numbers: TMH-506070; K24HD062645 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No