HivNCT05128136
A Crossover Study Evaluating 3 Non-medicated Silicone IVRs
A study testing Impact of ring size on adherence in people with Hiv and Pregnancy Related, run by Population Council at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hiv, Pregnancy Related
- What is being tested?
- Impact of ring size on adherence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jan 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 25Show fewer
- 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:
- Aged at least 18 years old at Screening based on self-report
- Sexually active, defined as having had penile-vaginal sex with a female 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 female partner for at least 6 months prior to Screening, based on self-report
- Female partner is eligible and consents to participation
- Healthy based on medical history and physical exam, including visual inspection of genitalia at Screening
- HIV-negative per test at Screening
- Negative for chlamydia, gonorrhea, trichomoniasis per tests at Screening (per local standard of care) at Screening
- Competent to provide written informed consent based on investigator's assessment
- Owns or has access to a Smart phone, per self-report
- Agrees to not participate in any other clinical research for the duration of this trial
Who cannot join
- 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)
Show all 23Show fewer
- 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.
- Using vaginal contraception (diaphragm, female condom, spermicide, IVR)
- Abnormal finding on examination or a social or medical condition which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data.
- Any other condition the clinician feels would jeopardize the health and wellbeing of the participant after assessing the participant's potential eligibility for the study
- Unable to comply with study requirements, including but not limited to, attending all study visits and using the IVRs as directed.
- Currently participating in any other clinical research trial involving investigational or marketed products
- Males:
- Known or suspected allergy to silicone, as reported by
- Positive test for HIV at Screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 30322
Albert Einstein College of Medicine,
New York, New York, 10461
About this study
Official title: 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
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.
Read the detailed description
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. Each couple will participate for approximately 4 months, including screening. After providing written informed consent at screening, females and their male partners will be evaluated against the inclusion and exclusion criteria by providing their medical, contraceptive, and sexual history as well as undergoing a clinical exam. The exam will include a visual inspection of the genitalia (men) and a speculum exam (women). Potential participants will be recruited by Emory University (Atlanta, GA) and Einstein College of Medicine (Bronx, NY) by contacting prior research participants who've consented to be contacted for new studies; advertising; and distribution of flyers in the study communities. All recruitment materials will be approved by the relevant IRBs prior to use. After screening, women will have an additional 4 visits and their male partners will have 1 additional in-person visit for enrollment and 3 remote visits. Before and after using each IVR, women will have a pelvic exam. If women report symptoms during interim visits, they will have a pelvic exam and will restart IVR use based on the clinical judgement of the site investigator. After enrollment, men who report symptoms possibly related to IVR use will be asked to attend the clinic for an examination. Follow-up visits (in-person for women and remote for men) will include counseling on protocol adherence, contraception, HIV risk reduction counseling. Women will be shown how to use the IVR at Visit 1/Enrollment and will be able to practice ring insertion and removal at that first visit. At monthly visits, women will be examined to check that the IVR is in place.
ADHERENCE: The primary adherence measure will be assessed via daily SMS text messages to women in which they will report if the IVR was out of the vagina in the previous 24h and if so, for how long. At monthly visits, women will respond to a computer assisted self-interview (CASI) questionnaire asking them to rate their adherence in terms of how well they feel they adhered to the IVR instructions for use. They will also be asked to report in more detail about expulsions and removals and the context in which those happen; feeling the ring during daily activities and during sex; and any symptoms experienced in the previous month.
PREFERENCE: We will ask women and their male partners to choose the IVR they think they will prefer at baseline -- before using any IVRs -- and then ask them to state their preference after using all 3 IVRs. Preferences at baseline and endline, and between males and females within each couple, will be compared.
ACCEPTABILITY: Acceptability will be assessed via the monthly CASI interviews according to an adapted version of the Merkatz et al IVR acceptability model.
SAFETY: Safety will be assessed by recording AEs.
- Conditions
- Hiv, Pregnancy Related
- Being tested
- Impact of ring size on adherence
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of ring size on adherenceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Silicone IVR 46mm external diameter | Experimental | Non-medicated 46 mm ring. Receives: Device: Impact of ring size on adherence |
| Silicone IVR 56mm external diameter | Experimental | Non-medicated 56mm ring. Receives: Device: Impact of ring size on adherence |
| Silicone IVR 66mm external diameter | Experimental | Non-medicated 66mm ring. Receives: Device: Impact of ring size on adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Up to 90 days
Secondary outcomes (3)
Acceptability
Participants will be asked to respond to a questionnaire measuring domains of acceptability at the end of using each of the 3 IVRs. Acceptability will be measured by the IVR acceptability measurement tool (IAMT). We will also explore the association between demographics, previous contraceptive use, parity, sexual/vaginal practices, and menses on acceptability. We will compare preferences between women and their male partners and we will compare actual preference at the end of the study with assumed preferences at baseline.
Measured: Up to 90 days
Collection of Adverse Events
To evaluate and compare the safety of 3 nonmedicated silicone IVRs each used and continuously for 30 days as measured by the number and percent of participants with AEs and serious AEs. AEs will be summarized overall by severity and by relation to product use. AEs that are potentially related could be abrasion or erythema due to the device.
Measured: Up to 90 days
Patterns of adherence
To explore patterns of adherence based on frequency of removals and expulsions per IVR and overall; duration of removals and expulsions per IVR and overall; reasons for removals for each IVR and overall; activities associated with expulsions per IVR and overall; and association between demographics and other background characteristics, sexual activity, and menstruation on adherence to each IVR and overall.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start20 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Emory University
- Responsible party
- Sponsor
- Investigators
- Barbara Friedland, MPH, Study director, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128136
- Sponsor's protocol ID
- 957
- Status last verified
- Feb 2023
- First submitted
- 20 Oct 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40211751Friedland BA, Sales JM, Atrio J, Plagianos MG, Burnett-Zieman JB, Shetty S, Roselli N, Rolston R, Gottert A, Avila K, Bruce IV, Sant'Anna Marinho C, Nguyen M, Merkatz R, Haddad LB. Preference, adherence, and acceptability of 3 nonmedicated intravaginal rings of differing external diameters: a randomized, crossover trial. Am J Obstet Gynecol. 2025 Sep;233(3):188.e1-188.e10. doi: 10.1016/j.ajog.2025.03.001. Epub 2025 Mar 8.
PubMed 40064412
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05128136
- Acronym / sponsor ID
- 957
- Conditions
- Hiv, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Emory University
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Each couple will participate for approximately 4 months, including screening. After providing written informed consent at screening, females and their male partners will be evaluated against the inclusion and exclusion criteria by providing their medical, contraceptive, and sexual history as well as undergoing a clinical exam. The exam will include a visual inspection of the genitalia (men) and a speculum exam (women). Potential participants will be recruited by Emory University (Atlanta, GA) and Einstein College of Medicine (Bronx, NY) by contacting prior research participants who've consented to be contacted for new studies; advertising; and distribution of flyers in the study communities. All recruitment materials will be approved by the relevant IRBs prior to use. After screening, women will have an additional 4 visits and their male partners will have 1 additional in-person visit for enrollment and 3 remote visits. Before and after using each IVR, women will have a pelvic exam. If women report symptoms during interim visits, they will have a pelvic exam and will restart IVR use based on the clinical judgement of the site investigator. After enrollment, men who report symptoms possibly related to IVR use will be asked to attend the clinic for an examination. Follow-up visits (in-person for women and remote for men) will include counseling on protocol adherence, contraception, HIV risk reduction counseling. Women will be shown how to use the IVR at Visit 1/Enrollment and will be able to practice ring insertion and removal at that first visit. At monthly visits, women will be examined to check that the IVR is in place.
ADHERENCE: The primary adherence measure will be assessed via daily SMS text messages to women in which they will report if the IVR was out of the vagina in the previous 24h and if so, for how long. At monthly visits, women will respond to a computer assisted self-interview (CASI) questionnaire asking them to rate their adherence in terms of how well they feel they adhered to the IVR instructions for use. They will also be asked to report in more detail about expulsions and removals and the context in which those happen; feeling the ring during daily activities and during sex; and any symptoms experienced in the previous month.
PREFERENCE: We will ask women and their male partners to choose the IVR they think they will prefer at baseline -- before using any IVRs -- and then ask them to state their preference after using all 3 IVRs. Preferences at baseline and endline, and between males and females within each couple, will be compared.
ACCEPTABILITY: Acceptability will be assessed via the monthly CASI interviews according to an adapted version of the Merkatz et al IVR acceptability model.
SAFETY: Safety will be assessed by recording AEs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Silicone IVR 46mm external diameter | Experimental | Device: Impact of ring size on adherenceNon-medicated 46 mm ring. |
| Silicone IVR 56mm external diameter | Experimental | Device: Impact of ring size on adherenceNon-medicated 56mm ring. |
| Silicone IVR 66mm external diameter | Experimental | Device: Impact of ring size on adherenceNon-medicated 66mm ring. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of ring size on adherenceThe 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. | Device | Silicone IVR 46mm external diameter, Silicone IVR 56mm external diameter, Silicone IVR 66mm external diameter |
Primary outcome
Adherence
Time frame: Up to 90 days
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
Preference
Time frame: Up to 90 days
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.
3 secondary outcomes
Acceptability
Time frame: Up to 90 days
Collection of Adverse Events
Time frame: Up to 90 days
Patterns of adherence
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Derived from this study: PubMed 40211751Gottert 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.
- Derived from this study: PubMed 40064412Friedland BA, Sales JM, Atrio J, Plagianos MG, Burnett-Zieman JB, Shetty S, Roselli N, Rolston R, Gottert A, Avila K, Bruce IV, Sant'Anna Marinho C, Nguyen M, Merkatz R, Haddad LB. Preference, adherence, and acceptability of 3 nonmedicated intravaginal rings of differing external diameters: a randomized, crossover trial. Am J Obstet Gynecol. 2025 Sep;233(3):188.e1-188.e10. doi: 10.1016/j.ajog.2025.03.001. Epub 2025 Mar 8.
- 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.
Barbara Friedland, MPH study director
Population Council
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact of ring size on adherence in people with Hiv and Pregnancy Related, run by Population Council at 2 sites 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 25 inclusion and 23 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 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence (time frame: Up to 90 days). The study lists 2 primary outcomes in all. 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 NCT05128136, which also lists 2 linked publications.
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 9 Feb 2023.