ArticleAIDS (London, England)2015
Disclosure of pharmacokinetic drug results to understand nonadherence.
Article in AIDS (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02358616 (An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial), which is not on this map. Cited by 67 papers, 1 of them a synthesis that pooled it.
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.
An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial
Who cites it
67 citing papers in PubMed, 1 synthesis or guideline pooled it, 76 citations in OpenAlex.
- Motivations and barriers to uptake and use of female-initiated, biomedical HIV prevention products in sub-Saharan Africa: an adapted meta-ethnography.BMC public health · 2017Pooled it
- Trial
- Tenofovir, emtricitabine, lamivudine and dolutegravir concentrations in plasma and urine following drug intake cessation in a randomized controlled directly observed pharmacokinetic trial to aid point-of-care testing.The Journal of antimicrobial chemotherapy · 2024Trial
- Acceptability and Use of the Dapivirine Vaginal Ring and Daily Oral Pre-exposure Prophylaxis (PrEP) During Breastfeeding in South Africa, Malawi, Zimbabwe, and Uganda.AIDS and behavior · 2023Trial
- Acceptability and Feasibility of Providing Adherence Feedback Based on Tenofovir Diphosphate in Dried Blood Spots: Results from a Pilot Study Among Patients and Providers in Cape Town, South Africa.AIDS and behavior · 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
- Does the Ring Work? Perceptions and Understanding of the Efficacy of a Dapivirine Vaginal Ring for HIV Prevention Amongst Women in a Placebo-Controlled Trial.AIDS and behavior · 2022Trial
- Experiences with simultaneous use of contraception and the vaginal ring for HIV prevention in sub-Saharan Africa.BMC women's health · 2021Trial
- The Power of the Shared Experience: MTN-020/ASPIRE Trial Participants' Descriptions of Peer Influence on Acceptability of and Adherence to the Dapivirine Vaginal Ring for HIV Prevention.AIDS and behavior · 2020Trial
- Impact of Male Partner Involvement on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial.AIDS and behavior · 2020Trial
- Social harms in female-initiated HIV prevention method research: state of the evidence.AIDS (London, England) · 2019Trial
- End-user preference for and choice of four vaginally delivered HIV prevention methods among young women in South Africa and Zimbabwe: the Quatro Clinical Crossover Study.Journal of the International AIDS Society · 2019Trial
- Perspectives of US women participating in a candidate PrEP study: adherence, acceptability and future use intentions.Journal of the International AIDS Society · 2019Trial
- Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE.AIDS and behavior · 2019Trial
- Maximizing participant retention in a phase 2B HIV prevention trial in Kampala, Uganda: The MTN-003 (VOICE) Study.HIV clinical trials · 2018Trial
- Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results.AIDS (London, England) · 2018Trial
- Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial.Journal of acquired immune deficiency syndromes (1999) · 2017Trial
- Acceptability and use of a dapivirine vaginal ring in a phase III trial.AIDS (London, England) · 2017Trial
- Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?AIDS and behavior · 2016Trial
- Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study.Journal of the International AIDS Society · 2016Trial
7 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 10 institutions in 4 countries.
Funding
Abstract
objectivesIn VOICE, a phase IIB trial of daily oral and vaginal tenofovir for HIV prevention, at least 50% of women receiving active products had undetectable tenofovir in all plasma samples tested. MTN-003D, an ancillary study using in-depth interviews (IDIs) and focus group discussions (FGDs), together with retrospective disclosure of plasma tenofovir pharmacokinetic results, explored adherence challenges during VOICE.
methodsWe systematically recruited participants with pharmacokinetic data (median six plasma samples), categorized as low (0%, N = 79), inconsistent (1-74%, N = 28) or high (≥75%; N = 20) on the basis of frequency of tenofovir detection. Following disclosure of pharmacokinetic results, reactions were captured and adherence challenges systematically elicited; IDIs and FGDs were audio-recorded, transcribed, coded and thematically analysed.
resultsWe interviewed 127 participants from South Africa, Uganda and Zimbabwe. The most common reactions to pharmacokinetic results included surprise (41%; low pharmacokinetic), acceptance (39%; inconsistent pharmacokinetic) and happiness (65%; high pharmacokinetic). On the basis of participants' explanations, we developed a typology of adherence patterns: noninitiation, discontinuation, misimplementation (resulting from visit-driven use, variable taking, modified dosing or regimen) and adherence. Fear of product side effects/harm was a frequent concern, fuelled by stories shared among participants. Although women with high pharmacokinetic levels reported similar concerns, several described strategies to overcome challenges. Women at all pharmacokinetic levels suggested real-time drug monitoring and feedback to improve adherence and reporting.
conclusionRetrospective provision of pharmacokinetic results seemingly promoted candid discussions around nonadherence and study participation. The effect of real-time drug monitoring and feedback on adherence and accuracy of reporting should be evaluated in trials.
Indexed as
Identifiers
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.