A Crossover Study Evaluating 3 Non-medicated Silicone IVRs
A 3-month Pilot Crossover Study in 24 US Couples to Compare Adherence, Preference and Acceptability of 3 Non-medicated Silicone Intravaginal Rings (IVRs) of Different External Diameters, Each Used for 30 Days
1 other identifier
interventional
48
1 country
2
Brief Summary
The overall aim of this study is to assess different external diameters of intravaginal rings (IVRs) for adherence, preference, and acceptability. To assess these domains, women in male-partnered relationships will use three different size IVRs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Jan 2022
Shorter than P25 for not_applicable hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedFebruary 9, 2023
February 1, 2023
12 months
October 20, 2021
February 8, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Adherence
To determine which of 3 non-medicated IVRs each used continuously for 30 days yields the highest adherence as measured by the proportion of women who are adherent to instructions for IVR use for each for \~30 days continuously, based on daily text messages
Up to 90 days
Preference
To assess which of 3 non-medicated IVRs each used continuously for 30 days is preferred by women and their male partners based on self reported preference by completing a questionnaire during and by the end of the study. Women and male partners will be asked to state their preference for one of the 3 IVRs at the end of the study.
Up to 90 days
Secondary Outcomes (3)
Acceptability
Up to 90 days
Collection of Adverse Events
Up to 90 days
Patterns of adherence
90 days
Study Arms (3)
Silicone IVR 46mm external diameter
EXPERIMENTALNon-medicated 46 mm ring.
Silicone IVR 56mm external diameter
EXPERIMENTALNon-medicated 56mm ring.
Silicone IVR 66mm external diameter
EXPERIMENTALNon-medicated 66mm ring.
Interventions
The study design is a randomized, open-label, parallel group 3-way crossover study comparing adherence, preference and overall acceptability of 3 different-sized placebo IVRs (IVRs A, B and C) in 24 US couples. At enrollment, each couple will be randomly assigned to 1 of 6 sequences of IVR use: A-B-C, A-C-B, B-A-C, B-C-A, C-A-B or C-B-A. Each couple will use each of the 3 IVRs (IVRs A, B and C) for 30 days per IVR, 90 days total.
Eligibility Criteria
You may qualify if:
- Females:
- Aged 18-40 years old, inclusive, at Screening based on self-report
- Sexually active, defined as having had penile-vaginal sex with a male partner at least four times per month (e.g. once a week), on average, in the three months before Screening
- In a mutually monogamous relationship with the same male partner for at least 6 months prior to Screening, based on self-report
- Male partner is eligible and consents to participation
- Healthy based on medical history and physical exam at Screening
- Currently using effective non-vaginal contraception for at least 3 months prior to screening, including injectable, oral contraception, contraceptive patch or sterilization (male or female) based on self-report
- HIV-negative per test at Screening
- Not pregnant per urine pregnancy test at Screening and Enrollment
- Negative for chlamydia, gonorrhea, trichomoniasis or urinary tract infection (UTI) at screening
- Symptomatic vulvovaginal candidiasis or bacterial vaginosis (BV) at Screening. (Participants who test positive at initial screening may be treated and rescreened after completing treatment).
- Competent to provide written informed consent based on Investigator's assessment
- Owns or has access to Smart phone per self-report
- Agrees to not participate in any other clinical research for the duration of this trial
- Males:
- +10 more criteria
You may not qualify if:
- Females:
- Known or suspected allergy to silicone, as reported by participant
- Positive pregnancy test at Screening or Enrollment based on urine hCG test
- Positive for HIV per test at Screening
- Presence of any clinically significant genital epithelial findings (e.g. abrasions, ulcerations, lacerations, or vesicles) suspicious of STIs at Screening or Enrollment
- Positive chlamydia, gonorrhea, or trichomoniasis test at Screening (or Enrollment)
- Current urinary complaints or diagnosed UTI at Screening (or Enrollment)
- Presence of genital abnormalities via visual exam with speculum that would contraindicate IVR use at Screening or Enrollment
- Significant uterine or vaginal prolapse, or urethral obstruction
- Recurrent vaginitis (three or more episodes within the prior year)
- Unexplained vaginal bleeding per self-report within the 3 months before Screening
- Currently breastfeeding per self-report
- Partial or complete hysterectomy per self-report
- Gynecological surgery in the 6 months prior to Screening per self-report
- Within 6 weeks post abortion or 6 months postpartum, per Self-report.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Population Councillead
- Albert Einstein College of Medicinecollaborator
- Emory Universitycollaborator
Study Sites (2)
Emory University
Atlanta, Georgia, 30322, United States
Albert Einstein College of Medicine,
New York, New York, 10461, United States
Related Publications (1)
Gottert A, Friedland BA, Plagianos M, Zieman B, Sales JM, Atrio J, Shetty S, Sant'Anna Marinho C, Roselli N, Merkatz R, Bruce I, Haddad LB. Development and Validation of a Multidimensional Intravaginal Ring Acceptability Scale Among US Women and Their Male Partners. Perspect Sex Reprod Health. 2025 Jun;57(2):144-153. doi: 10.1111/psrh.70009. Epub 2025 Apr 11.
PMID: 40211751DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Barbara Friedland, MPH
Population Council
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- We propose a randomized, open-label, parallel group, 3-way crossover study comparing adherence, preference and overall acceptability of 3 different-sized placebo IVRs (IVRs A, B and C) in 24 couples. At enrollment, each woman will be randomly assigned to 1 of 6 sequences of IVR use (A-B-C, A-C-B, etc.) and will use each of the 3 IVRs (A, B and C) for 30d per IVR (90d total).
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2021
First Posted
November 19, 2021
Study Start
January 20, 2022
Primary Completion
December 31, 2022
Study Completion
January 31, 2023
Last Updated
February 9, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share