Dataset Information

Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

ABSTRACT: VOICE-a phase 2B, placebo-controlled, randomized trial testing daily use of an antiretroviral tablet (tenofovir or Truvada) or daily use of tenofovir gel in 5029 women from South Africa, Uganda, and Zimbabwe-found none of the drug regimens effective in reducing HIV-1 acquisition in the intent-to-treat analysis. More than half of women assigned to active products in a case cohort sample had no drug detected in any plasma specimens tested during the trial. Yet, in response to questions asked of participants during the trial, ?90 % of doses were reportedly taken. To explore factors associated with low adherence, a behavioral termination visit questionnaire was developed after early closure of the oral tenofovir and vaginal gel arms. We hypothesized that participants would be more forthcoming about nonuse after they exited the trial than during monthly/quarterly follow-up visits. Comparison of adherence reporting at routine follow-up visits with reporting at trial termination, however, indicates that disclosure of product nonadherence did not increase at the termination visit as anticipated. In resource-limited settings where women value the ancillary benefits provided by trial participation and are concerned that disclosure of nonuse may jeopardize trial participation, objective measures of adherence may yield more meaningful data regarding the inability or reluctance to use than measures of product use derived from self-report.

SUBMITTER: Mensch BS

PROVIDER: S-EPMC5354168 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

Mensch Barbara S BS Brown Elizabeth R ER Liu Karen K Marrazzo Jeanne J Chirenje Zvavahera Mike ZM Gomez Kailazarid K Piper Jeanna J Patterson Karen K van der Straten Ariane A

AIDS and behavior 20161101 11

VOICE-a phase 2B, placebo-controlled, randomized trial testing daily use of an antiretroviral tablet (tenofovir or Truvada) or daily use of tenofovir gel in 5029 women from South Africa, Uganda, and Zimbabwe-found none of the drug regimens effective in reducing HIV-1 acquisition in the intent-to-treat analysis. More than half of women assigned to active products in a case cohort sample had no drug detected in any plasma specimens tested during the trial. Yet, in response to questions asked of pa ...[more]

PMID: 26906023

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Project description:BackgroundPatient characteristics are associated with adherence, which has implications for planning clinical research or designing payment systems that reward superior outcomes. It is unclear to what extent clinician efforts to improve adherence can attenuate these associations.MethodsTo identify factors predicting visit and medication adherence in settings designed to optimize adherence, we did a retrospective analysis of participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT recruited participants at 632 sites in North America, Puerto Rico, and the U.S. Virgin Islands for random assignment to antihypertensive treatment with amlodipine, chlorthalidone, or lisinopril. Site investigators reported clinic characteristics at the time they applied to participate in the study and research coordinators used standardized methods to measure patient characteristics. We defined adequate visit adherence as attending at least 80 % of scheduled visits; adequate medication adherence was defined as taking 80 % or more of the randomly assigned medication at all study visits.ResultsThe 31,250 ALLHAT participants eligible for the visit adherence analysis attended 78.5 % of scheduled study visits; 68.9 % attended more than 80 % of scheduled visits. Clinic setting was predictive of both forms of adherence; adherence was worst at private clinics; clinics that enrolled more study participants had superior adherence. Adjusting for clinic characteristics and clinical factors, women, younger participants, Blacks and smokers were less likely to have adequate visit adherence. Among the 28,967 participants eligible for the medication adherence analysis, 21,261 (73.4 %) reported adequate medication adherence. In adjusted analyses, younger and less educated participants, Blacks, and smokers were less likely to report adequate adherence.ConclusionsParticipant demographics were associated with adherence despite strenuous efforts to optimize adherence. Our results could inform decisions by researchers planning trials and policymakers designing payment systems.Trial registrationNCT00000542 . Registered 27 October 1999.

Project description:BackgroundAdvances in voice technology have raised new possibilities for apps related to daily health maintenance. However, the usability of such technologies for older users remains unclear and requires further investigation.ObjectiveWe designed and evaluated two innovative mobile voice-added apps for food intake reporting, namely voice-only reporting (VOR) and voice-button reporting (VBR). Each app features a unique interactive procedure for reporting food intake. With VOR, users verbally report the main contents of each dish, while VBR provides both voice and existing touch screen inputs for food intake reporting. The relative usability of the two apps was assessed through the metrics of accuracy, efficiency, and user perception.MethodsThe two mobile apps were compared in a head-to-head parallel randomized trial evaluation. A group of 57 adults aged 60-90 years (12 male and 45 female participants) was recruited from a retirement community and randomized into two experimental groups, that is, VOR (n=30) and VBR (n=27) groups. Both groups were tested using the same set of 17 food items including dishes and beverages selected and allocated to present distinct breakfast, lunch, and dinner meals. All participants used a 7-inch tablet computer for the test. The resulting data were analyzed to evaluate reporting accuracy and time efficiency, and the system usability scale (SUS) was used to measure user perception.ResultsFor eight error types identified in the experiment, the VBR group participants were significantly (P<.001) more error prone owing to the required use of button-tapping actions. The highest error rates in the VOR group were related to incomprehensible reporting speech (28/420, 6.7%), while the highest error rates in the VBR group were related to failure to make required button taps (39/378, 10.3%). The VOR group required significantly (P<.001) less time to complete food reporting. The overall subjective reactions of the two groups based on the SUS surpassed the benchmark and were not significantly different (P=.20).ConclusionsExperimental results showed that VOR outperformed VBR, suggesting that voice-only food input reporting is preferable for elderly users. Voice-added apps offer a potential mechanism for the self-management of dietary intake by elderly users. Our study contributes an evidence-based evaluation of prototype design and selection under a user-centered design model. The results provide a useful reference for selecting optimal user interaction design.Trial registrationInternational Standard Randomized Controlled Trial Registry ISRCTN17335889; http://www.isrctn.com/ISRCTN17335889.

Project description:BackgroundRetention in clinical care is important for people living with HIV (PLWH). Evidence suggests that missed clinic visits are associated with interruptions in antiretroviral therapy (ART), lower CD4 counts, virologic failure, and overlooked coinfections. We identified factors associated with missed routine clinic visits in the African Cohort Study (AFRICOS).MethodsIn 2013, AFRICOS began enrolling people with and without HIV in Uganda, Kenya, Tanzania, and Nigeria. At enrollment and every 6 months thereafter, sociodemographic questionnaires are administered and clinical outcomes assessed. Missed clinic visits were measured as the self-reported number of clinic visits missed in the past 6 months and dichotomized into none or one or more visits missed. Logistic regression with generalized estimating equations was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for associations between risk factors and missed visits.ResultsBetween January 2013 and March 2020, 2937 PLWH were enrolled, of whom 2807 (95.6%) had initiated ART and 2771 had complete data available for analyses. Compared to PLWH 50+, missed clinic visits were more common among those 18-29 years (aOR 2.33, 95% CI 1.65-3.29), 30-39 years (aOR 1.59, 95% CI 1.19-2.13), and 40-49 years (aOR 1.42, 95% CI 1.07-1.89). As compared to PLWH on ART for < 2 years, those on ART for 4+ years were less likely to have missed clinic visits (aOR 0.72, 95% CI 0.55-0.95). Missed clinic visits were associated with alcohol use (aOR 1.34, 95% CI 1.05-1.70), a history of incarceration (aOR 1.42, 95% CI 1.07-1.88), depression (aOR 1.47, 95% CI 1.13-1.91), and viral non-suppression (aOR 2.50, 95% CI 2.00-3.12). As compared to PLWH who did not miss any ART in the past month, missed clinic visits were more common among those who missed 1-2 days (aOR 2.09, 95% CI 1.65-2.64) and 3+ days of ART (aOR 7.06, 95% CI 5.43-9.19).ConclusionsInconsistent clinic attendance is associated with worsened HIV-related outcomes. Strategies to improve visit adherence are especially needed for young PLWH and those with depression.

Project description:BACKGROUND:In biomedical prevention trials, correct and consistent use of the investigational product is crucial to determine efficacy. Product adherence in VOICE, a phase 2B randomized trial of a vaginal gel and oral tablets for HIV prevention, was low (~ 34%), yet self-reported adherence and retention was high (> 90%). This analysis from VOICE-D, a post-trial qualitative ancillary study, explores motivations to participate in VOICE, and possible sources of misalignment between the stated priorities of the trial and the participants. METHODS:VOICE-D enrolled 171 former VOICE participants to investigate, among other things, reasons for joining and remaining in the trial. Local language in-depth interviews and focus groups were transcribed and translated into English and coded and analyzed using NVivo. Data on motivation to join obtained from a VOICE termination visit survey of 106 participants were also analyzed to corroborate the VOICE-D findings. RESULTS:Participants primarily participated for personal health benefits (e.g. free healthcare and HIV testing) and reported remaining enrolled from a sense of commitment to the trial. Altruistic motivations were the most commonly stated motivation on the termination visit survey; qualitatively, many of those stating altruistic reasons also desired personal health benefits. Joining for financial reimbursement was not commonly mentioned. Social networks influenced recruitment and spread therapeutic misconception. CONCLUSIONS:Women's participation for personal health benefits highlighted their desire to monitor their HIV risk and overall health. Helping participants view use of investigational products as improving social capital and reminding participants of their study responsibilities may improve trial outcomes. Understanding the reasons for participating in studies will help to ensure alignment between priorities of researchers and participants. TRIAL REGISTRATION:NCT02358616 ; Posted February 9, 2015, retrospectively registered.

Dataset Information

Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

Publications

Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

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