ArticleJournal of pharmaceutical and biomedical analysis2016
Post-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence.
Article in Journal of pharmaceutical and biomedical analysis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 31 citations in OpenAlex.
- Efficacy of the Dapivirine Vaginal Ring Accounting for Imperfect Adherence.AIDS and behavior · 2024Trial
- How a menu of adherence support strategies facilitated high adherence to HIV prevention products among adolescent girls and young women in sub-Saharan Africa: a mixed methods analysis.Journal of the International AIDS Society · 2023Trial
- Women's experience receiving drug feedback and adherence counseling in MTN-025/HOPE - an HIV Prevention open-label trial of the Dapivirine Vaginal Ring.AIDS and behavior · 2022Trial
- Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial.Journal of acquired immune deficiency syndromes (1999) · 2022Trial
- Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study.BMC public health · 2021Trial
- Correlates of Adherence to the Dapivirine Vaginal Ring for HIV-1 Prevention.AIDS and behavior · 2021Trial
- Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial.AIDS and behavior · 2021Trial
- Refining the in vitro release test method for a dapivirine-releasing vaginal ring to match in vivo performance.Drug delivery and translational research · 2023Article
- The Vaginal Microbiota, Bacterial Biofilms and Polymeric Drug-Releasing Vaginal Rings.Pharmaceutics · 2021Review
- Sharing Objective Measures of Adherence to a Vaginal Microbicide Promotes Candor About Actual Use and Bolsters Motivation to Prevent HIV.AIDS and behavior · 2021Article
- Client-Centered Adherence Counseling with Adherence Measurement Feedback to Support Use of the Dapivirine Ring in MTN-025 (The HOPE Study).AIDS and behavior · 2021Article
- Greater dapivirine release from the dapivirine vaginal ring is correlated with lower risk of HIV-1 acquisition: a secondary analysis from a randomized, placebo-controlled trial.Journal of the International AIDS Society · 2020Article
- Pharmacokinetics of the Protein Microbicide 5P12-RANTES in Sheep following Single-Dose Vaginal Gel Administration.Antimicrobial agents and chemotherapy · 2017Article
- Residual hormone levels in used contraceptive rings as a measurement of adherence to vaginal ring use.Contraception · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Adherence measurement for microbicide use within the clinical trial setting remains a challenge for the HIV prevention field. This paper describes an assay method used for determining residual dapivirine levels in post-use vaginal rings from clinical trials conducted with the Dapivirine Vaginal Matrix Ring-004 developed by the International Partnership for Microbicides to prevent male to female HIV transmission. Post-use assay results from three Ring-004 clinical trials showed that of the 25mg drug load, approximately 4mg of dapivirine is released from the matrix ring over a 28-day use period. Data obtained by both in vitro and in vivo studies indicate that dapivirine is released according to a diffusion mechanism, as determined by conformance of both data sets to the Higuchi equation. This, coupled with the low variability associated with batch production over two manufacturing sites and 20 batches of material, provides evidence that post-use ring analysis can contribute to the assessment of adherence to ring use. Limitations of this method include the potential of intra-participant and inter-participant variability and uncertainty associated with measuring the low amount of dapivirine actually released relative to the drug load. Therefore, residual drug levels should not serve as the only direct measurement for microbicide adherence in vaginal ring clinical trials but should preferably be used as part of a multi-pronged approach towards understanding and assessing adherence to vaginal ring use.
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What OpenQuestion holds
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.