Evidence map›Paper›PMID 39808648›Full record

ArticlePloS one2025

Acceptability of a dapivirine levonorgestrel vaginal ring in two Phase 1 trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019): Implications for multipurpose prevention technology development.

Barbara A Friedland, Holly Gundacker, Sharon L Achilles, Beatrice A Chen, Craig Hoesley, Barbra A Richardson, Clifton W Kelly, Jeanna Piper, Sherri Johnson, Brid Devlin and 13 more

2 registry-linked trialsAbstract readClinical Trial, Phase I
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT02855346 phase1completednot on this map

A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel Vaginal Rings

TypeinterventionalSponsorInternational Partnership for Microbicides, Inc.Ran2017 to 2017Enrolled24ConditionsHIV PreventionArms200 mg of DPV + 320 mg LNG, 200 mg of DPV
NCT03467347 phase1completednot on this map

A Randomized, Phase 1, Open-Label Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety and Bleeding Patterns Associated With 90-Day Use of Matrix Vaginal Rings Containing 200 mg Dapivirine and 320 mg Levonorgestrel

TypeinterventionalSponsorInternational Partnership for Microbicides, Inc.Ran2018 to 2019Enrolled25ConditionsHealthy, Contraception, Contraceptive Usage, WomenArmsVR: 200 mg DPV + 320 mg LNG
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
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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

23 authors.

Barbara A FriedlandCenter for Biomedical Research, Population Council, New York, NY, United States of America.
Holly GundackerStatistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Center, Seattle, Washington, United States of America.
Sharon L AchillesDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.ORCID https://orcid.org/0000-0002-7478-8262
Beatrice A ChenDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.ORCID https://orcid.org/0000-0002-4437-4632
Craig HoesleyUniversity of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, United States of America.
Barbra A RichardsonVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America.
Clifton W KellyStatistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Center, Seattle, Washington, United States of America.
Jeanna PiperNational Institutes of Allergy and Infectious Disease, NIH, Bethesda, Maryland, United States of America.
Sherri JohnsonFHI 360, Durham, North Carolina, United States of America.
Brid DevlinInternational Partnership for Microbicides, Silver Spring, Maryland, United States of America.
John SteytlerInternational Partnership for Microbicides, Silver Spring, Maryland, United States of America.
Kyle KleinbeckInternational Partnership for Microbicides, Silver Spring, Maryland, United States of America.
Bindi DangiInternational Partnership for Microbicides, Silver Spring, Maryland, United States of America.
Chantél FriendInternational Partnership for Microbicides, Silver Spring, Maryland, United States of America.
Mei SongDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
Barbara MenschPopulation Council, New York, NY, United States of America.
Ariane van der StratenRTI International, San Francisco, CA, United States of America.
Cindy JacobsonDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
Craig W HendrixDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
Jill BrownContraceptive Development Program, DIPHR, National Institute of Child Health and Human Development, NIH, Bethesda, Maryland, United States of America.
Diana BlitheContraceptive Development Program, DIPHR, National Institute of Child Health and Human Development, NIH, Bethesda, Maryland, United States of America.
Sharon L HillerDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network

Funding

SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
Laboratory Center (LC): Microbicide Trials NetworkUM1AI106707 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MELLORS, JOHN W, ROHAN, LISA CENCIA · 2014 to 2021
$27.1M
NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI106707NICHD NIH HHS HHSN275201200002CNICHD NIH HHS HHSN275201200002I
6 · The paper itself

Abstract

End-user feedback early in product development is important for optimizing multipurpose prevention technologies for HIV and pregnancy prevention. We evaluated the acceptability of the 90-day dapivirine levonorgestrel ring (DPV-LNG ring) used for 14 days compared to a dapivirine-only ring (DVR-200mg) in MTN-030/IPM 041 (n = 23), and when used for 90 days cyclically or continuously in MTN-044/IPM 053/CCN019 (n = 25). We enrolled healthy, non-pregnant, HIV-negative women aged 18-45 in Pittsburgh, PA and Birmingham, AL (MTN-030 only). Self-reports of vaginal bleeding and adherence (ring removals, expulsions) were collected via daily short message service. Acceptability data were recorded in face-to-face interviews at study exit. We assessed differences in acceptability by product characteristics and adherence; and associations between baseline characteristics/demographics, number of bleeding days, adherence, and overall acceptability. Most (21/23) women in the 14-day MTN-030 study and about half (13/25) in the 90-day MTN-044 study liked their assigned rings. In MTN-030 there were no significant associations between any variables and overall acceptability of either ring. In MTN-044, women who disliked the DPV-LNG ring had a significantly higher incidence of unanticipated vaginal bleeding, and reporting that vaginal bleeding changes were unacceptable than those who liked it. Although we found no overall association between adherence and acceptability, significantly more women who disliked (versus liked) the DPV-LNG ring reported expulsions during toileting. The DPV-LNG ring could meet the needs of women seeking simultaneous protection from HIV and unintended pregnancy. Addressing issues related to vaginal bleeding and expulsions early in product development will likely enhance acceptability of the DPV-LNG ring. Trial registration: Clinical Trial Registration: MTN-030/IPM 041: ClinicalTrials.gov NCT02855346; MTN-044/IPM 053/CCN019: ClinicalTrials.gov NCT03467347.

Indexed as

Contraceptive Devices, FemaleHIV InfectionsLevonorgestrelPatient Acceptance of Health CarePyrimidinesAdolescentAdultContraceptive Agents, FemaleFemaleHumansMiddle AgedPregnancyYoung AdultContraceptive Agents, FemaleDapivirineLevonorgestrelPyrimidines

Identifiers

PMID39808648
PMCPMC11731730

What OpenQuestion holds

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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.