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

Bauermeister, José A.; Golinkoff, Jesse; Carballo‐Diéguez, Alex; Giguere, Rebecca; López, Daniela; Hoesley, Craig; Chen, Beatrice A.; Anderson, Peter L.; Dezzutti, Charlene S.; Strizki, Julie; Sprinkle, Carol; Heard, Faye; Hall, Wayne; Jacobson, Cindy; Berthiaume, Jennifer; Mayo, Ashley J.; Richardson, Barbra A.; Piper, Jeanna

doi:10.1007/s10461-019-02457-0

Cited by 10 publications

(4 citation statements)

References 31 publications

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“…Following screening, 151 publications describing 123 studies with 34,740 ring users and 5,694 hypothetical users were included. Twenty-five studies were excluded from meta-analysis due to reporting product continuation without also reporting general acceptability [10,[28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47], reporting continuous rather than labelled categorical or dichotomous outcomes [48] and reporting preference data only [49,50] (Figure 1). Some secondary manuscripts of the included studies assessed acceptability across ring groups with different characteristics (e.g.…”

Section: Resultsmentioning

confidence: 99%

Vaginal ring acceptability: A systematic review and meta-analysis of vaginal ring experiences from around the world

et al. 2022

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Section: Resultsmentioning

confidence: 99%

Vaginal ring acceptability: A systematic review and meta-analysis of vaginal ring experiences from around the world

et al. 2022

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“…In two cases, however, the placement of the ring was uncomfortable. Several Phase I trials of other rings also reported some instances when women could feel the ring or might experience some cramping ( 16 , 27 ). In a Phase III trial of the dapivirine HIV prevention vaginal ring, participants reported experiencing heaviness and pelvic pain especially during initial months of the trial and equated this to improper placement of the ring.…”

Section: Discussionmentioning

confidence: 99%

Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial

Tolley

Hanif

Thurman

et al. 2023

Front. Reprod. Health

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IntroductionMost women face multiple and co-occurring risks from unwanted pregnancy, human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) at some point during their lifetime. While a range of contraceptive methods exist and options for HIV prevention are increasing, to date, only male and female condoms provide multipurpose protection from both pregnancy and disease.MethodsFrom September 2017 to December 2018, 60 women from the United States and the Dominican Republic, randomized 1:1 to continuous or interrupted use and 4:1 to active vs. placebo ring, participated in a Phase I trial to assess the safety and tolerability of a three-month multipurpose intravaginal ring (IVR) containing the antiviral tenofovir and the contraceptive levonorgestrel. This study examines survey responses from all participants and qualitative data from a subset of 17 women to assess acceptability of and preferences for IVR characteristics.ResultsOverall, women liked the concept of a multipurpose IVR and found it easy to insert and remove. Initial concerns about the size or thickness of the ring generally disappeared with use experience. Women weighed trade-offs between the ease of continuous use for a longer duration against concerns about hygiene and discoloration of the ring when left in place during menses. Whether randomized to continuous or interrupted use, most women found ring attributes (size, thickness, flexibility) very acceptable. They provided recommendations via survey and qualitative interviews for ring modifications that would further increase acceptability. Insights into women's use experiences also suggest the need for clear counseling messages and introduction strategies that can facilitate women's choice and use of prevention methods.DiscussionStudy findings suggest that a multipurpose IVR would make a valuable contribution to women's sexual and reproductive health options, and that both continuous and interrupted use strategies may be preferred.

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“…In further testing of this VRV+MK-2048 prototype ring (a 48-subject Phase I trial to evaluate the safety, pharmacokinetics and pharmacodynamics of vaginal rings; dimensions 54 × 4 mm; similar to NuvaRing ® and Ornibel ® , Table 1), twelve women (25%) reported a single partial or complete involuntary expulsion of the ring, while two women (4.2%) reported two or more expulsions [191,192]. Expulsions generally occurred during menses, while urinating or during a bowel movement, and most participants were able to reinsert the ring immediately.…”

Section: Vicriviroc (Mk-4176) and Mk-2048mentioning

confidence: 99%

The ins and outs of drug-releasing vaginal rings: a literature review of expulsions and removals

Boyd

Merkatz

Variano

et al. 2020

Expert Opinion on Drug Delivery

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1. Introduction 2. Factors potentially affecting ring expulsion 2.1. Dimensions of the human vagina 2.2. Ring dimensions 2.3. Types and grades of polymeric materials used to manufacture vaginal rings Silicone elastomers Ethylene vinyl acetate copolymers Thermoplastic polyurethanes2.4. Mechanical performance of rings 2.5. Ring insertion and location of ring placement in the vagina 2.6. Changes in cervical/vaginal laxity due to parity and age 2.7. Quantity of fluid in the vaginaendogenous / menstrual / ejaculate 2.8. Concurrent use of vaginal drug products and personal lubricants 2.9. User practices 3. Review of literature on involuntary ring expulsions 3.1. Advice in the event of ring expulsions 3.2. Drug-free rings 3.3. Progesterone and progestogen-only rings Megestrol acetate Levonorgestrel

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

Cited by 10 publications

References 31 publications

Vaginal ring acceptability: A systematic review and meta-analysis of vaginal ring experiences from around the world

Vaginal ring acceptability: A systematic review and meta-analysis of vaginal ring experiences from around the world

Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial

The ins and outs of drug-releasing vaginal rings: a literature review of expulsions and removals

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