Evidence map›Paper›PMID 40211751›Full record

Trial reportPerspectives on sexual and reproductive health2025

Development and Validation of a Multidimensional Intravaginal Ring Acceptability Scale Among US Women and Their Male Partners.

Ann Gottert, Barbara A Friedland, Marlena Plagianos, Brady Zieman, Jessica M Sales, Jessica Atrio, Shakti Shetty, Caio Sant'Anna Marinho, Nicole Roselli, Ruth Merkatz and 2 more

Registry-linked trialAbstract readRandomized Controlled TrialValidation Study
In one paragraph

Trial report in Perspectives on sexual and reproductive health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05128136 (A 3-month Pilot Crossover Study in 24 US Couples to Compare Adherence, Preference and Acceptability of 3 Non-medicated Silicone Intravaginal Rings), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05128136 nacompletednot on this map

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

TypeinterventionalSponsorPopulation CouncilRan2022 to 2023Enrolled48ConditionsHiv, Pregnancy RelatedArmsImpact of ring size on adherence
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Ann GottertPopulation Council, Social and Behavioral Sciences Research, Washington, District of Columbia, USA.
Barbara A FriedlandPopulation Council, Center for Biomedical Research, New York, New York, USA.
Marlena PlagianosPopulation Council, Center for Biomedical Research, New York, New York, USA.
Brady ZiemanPopulation Council, Center for Biomedical Research, New York, New York, USA.
Jessica M SalesEmory University, Atlanta, Georgia, USA.
Jessica AtrioAlbert Einstein College of Medicine, Bronx, New York, USA.
Shakti ShettyEmory University, Atlanta, Georgia, USA.
Caio Sant'Anna MarinhoAlbert Einstein College of Medicine, Bronx, New York, USA.
Nicole RoselliNYU Grossman School of Medicine/Bellevue Hospital Center, New York, New York, USA.
Ruth MerkatzPopulation Council, Center for Biomedical Research, New York, New York, USA.
Irene BrucePopulation Council, Center for Biomedical Research, New York, New York, USA.
Lisa B HaddadPopulation Council, Center for Biomedical Research, New York, New York, USA.

Funding

An Etonogestrel/Ethinyl Estradiol/QGriffithsin (ETG/EE/QGRFT) IVR to Prevent Pregnancy and HIVR01AI150360 · NIAID · POPULATION COUNCIL · PI DERBY, NINA R., FRIEDLAND, BARBARA A · 2020 to 2024
$4.7M
NIAID NIH HHS R01 AI150360
6 · The paper itself

Abstract

objectiveIntravaginal rings (IVRs) are marketed or in development for contraception and other indications. We sought to develop and validate the IVR Acceptability Scale (IVR-AS) as a multidimensional, standardized tool for assessing IVR acceptability among end-users in the United States.

methodsScale items reflect specific aspects of IVR acceptability for women and male partners. Response options range from 1 (not-at-all acceptable) to 5 (highly acceptable). We evaluated the IVR-AS within a randomized, crossover clinical trial of three nonmedicated silicone IVRs of differing external diameters (46, 56, 66 mm) in heterosexual couples who used each for ~30 days, then completed a self-administered survey. We conducted exploratory factor analysis and multivariable regression to assess convergent validity. Follow-up in-depth interviews with all participants explored scale salience.

resultsTwenty-four couples participated (mean age 27). The final 19-item women's scale (Cronbach's alpha = 0.93) included six subdimensions: ease of use; experience and sensation; effect on sexual desire/engagement, and effect on vaginal sex (all alphas > 0.78). The final eight-item men's scale comprised two subdimensions: effect on sexual desire/engagement and effect on vaginal sex (all alphas > 0.89). For both sexes, higher overall/subdimension scores were consistently associated with favorable assessments of the ring, for example, ease of insertion/removal; adherence (most p < 0.001). The 46/56 mm IVRs had higher overall and subdimension scores than the 66 mm IVR (most p < 0.001). Qualitative reports reinforced the salience of scale subdimensions and item content.

conclusionThe IVR-AS captures multiple dimensions of IVR acceptability among women and their partners. The scales demonstrated excellent reliability and convergent validity. Further validation is warranted in future studies.

trial registrationClinical Trials.gov: NCT05128136. https://clinicaltrials.gov/study/NCT05128136?intr=non-medicated%20silicone%20ring&rank=2.

Indexed as

ContraceptionContraceptive Devices, FemalePatient Acceptance of Health CareSexual PartnersAdultCross-Over StudiesFemaleHumansMaleReproducibility of ResultsSurveys and QuestionnairesUnited StatesYoung Adultcontraceptioncouplesend‐user researchHIV preventionmeasurementreproductive healthscalevaginal ring

Identifiers

PMID40211751
PMCPMC12204125

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.