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A Mixed-Methods Study Examining Adherence to and Acceptability of Intravaginal Rings for HIV Prevention: Behavioral Results of MTN-027

  • José A. BauermeisterEmail author
  • Jesse M. Golinkoff
  • Alex Carballo-Diéguez
  • Rebecca Giguere
  • Daniela López
  • Craig J. Hoesley
  • Beatrice A. Chen
  • Peter Anderson
  • Charlene S. Dezzutti
  • Julie Strizki
  • Carol Sprinkle
  • Faye Heard
  • Wayne Hall
  • Cindy Jacobson
  • Jennifer Berthiaume
  • Ashley Mayo
  • Barbra A. Richardson
  • Jeanna Piper
  • the Microbicide Trials Network 027 Study Team
Original Paper

Abstract

Intravaginal rings (IVR) containing antiretroviral drugs are a promising method for HIV prevention. We triangulated quantitative and qualitative assessments to evaluate the acceptability of four IVRs used continuously for 28 days as part of a Phase I trial (N = 48 HIV-negative women; ages 18–45). Adherence was high throughout the trial, yet 30% of participants reported involuntary IVR expulsions followed by re-insertion. Most participants (93.6%) felt comfortable with the IVR being inside their body. Participants reported liking the IVR more (36.2%) or the same amount (55.3%) since starting the study. When given the option of choosing between the IVR and/or a male condom for HIV-prevention, most reported preferring the IVR (n = 29, 63.0%), and over a quarter of the sample reported liking them equally (n = 12, 26.1%). We observed no differences in IVR acceptability across the study arms. High adherence and acceptability underscores the promise of an IVR as a female-controlled, sustained mechanism for HIV prevention.

Keywords

Microbicide HIV prevention Women Vaginal ring 

Resumen

Un anillo intra-vaginal (AIV) que contiene medicamentos antirretrovirales (ARV) constituye un método prometedor para prevenir el VIH. Triangulamos los datos cuantitativos y cualitativos para evaluar la aceptabilidad de cuatro AIV usados continuamente por 28 días durante un estudio clínico Fase 1 (N = 48 mujeres seronegativas entre las edades de 18-45 años). La adherencia fue alta durante el estudio, aunque un 30% de las participantes reportaron expulsiones involuntarias del AIV seguidas por la re-inserción. La mayoría de las participantes (93.6%) se sintieron cómodas con tener el AIV dentro de su cuerpo. La mayoría de las mujeres reportaron que les gustó el AIV más (36.2%) o igual (55.3%) desde iniciar el estudio. Dada la opción de elegir entre el AIV y/o un condón masculino para la prevención del VIH, la mayoría reportó preferir el AIV (n = 29, 63.0%), y más de un cuarto de la muestra reportó que ambos métodos les gustaron de igual manera (n = 12, 26.1%). No observamos diferencias en la aceptabilidad entre los cuatro anillos. La alta adherencia y aceptabilidad demuestran la promesa que conlleva un AIV como método de prevención del VIH que es controlado por las mujeres y de uso continuo.

Notes

Funding

The study was designed and implemented by the Microbicide Trials Network (MTN). The MTN is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Merck & Co. Inc., Kenilworth, NJ, USA was a pharmaceutical collaborator on this study.

Compliance with Ethical Standards

Conflict of interest

The authors declare that there are no conflicts of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • José A. Bauermeister
    • 1
    Email author
  • Jesse M. Golinkoff
    • 1
  • Alex Carballo-Diéguez
    • 2
    • 3
  • Rebecca Giguere
    • 2
  • Daniela López
    • 4
  • Craig J. Hoesley
    • 5
  • Beatrice A. Chen
    • 6
    • 7
  • Peter Anderson
    • 8
  • Charlene S. Dezzutti
    • 6
    • 7
  • Julie Strizki
    • 9
  • Carol Sprinkle
    • 10
  • Faye Heard
    • 5
  • Wayne Hall
    • 7
  • Cindy Jacobson
    • 7
  • Jennifer Berthiaume
    • 11
  • Ashley Mayo
    • 12
  • Barbra A. Richardson
    • 11
  • Jeanna Piper
    • 13
  • the Microbicide Trials Network 027 Study Team
  1. 1.School of NursingUniversity of PennsylvaniaPhiladelphiaUSA
  2. 2.Department of PsychiatryColumbia UniversityNew YorkUSA
  3. 3.HIV Center for Clinical and Behavioral StudiesNew York State Psychiatric InstituteNew YorkUSA
  4. 4.Department of PsychiatryUniversity of MichiganAnn ArborUSA
  5. 5.School of MedicineUniversity of Alabama at BirminghamBirminghamUSA
  6. 6.School of MedicineUniversity of PittsburghPittsburghUSA
  7. 7.Department of Obstetrics, Gynecology & Reproductive SciencesMagee-Women’s Research InstitutePittsburghUSA
  8. 8.Skaggs School of Pharmacy and Pharmaceutical SciencesUniversity of ColoradoAuroraUSA
  9. 9.Merck & Co. Inc.KenilworthUSA
  10. 10.University of Pittsburgh Medical CenterPittsburghUSA
  11. 11.Fred Hutchinson Cancer Research CenterUniversity of WashingtonSeattleUSA
  12. 12.FHI360DurhamUSA
  13. 13.Division of AIDSNational Institutes of HealthBethesdaUSA

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