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Understanding women's motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence.

ABSTRACT: 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.

SUBMITTER: Katz AWK

PROVIDER: S-EPMC6347781 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Understanding women's motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence.

Katz Ariana W K AWK Mensch Barbara S BS Woeber Kubashni K Musara Petina P Etima Juliane J van der Straten Ariane A

BMC women's health 20190125 1

<h4>Background</h4>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 stat ...[more]

PMID: 30683103

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Project description:IntroductionIn the Microbicide Trial Network MTN-003 (VOICE) study, a Phase IIB pre-exposure prophylaxis trial of daily oral or vaginal tenofovir (TFV), product adherence was poor based on pharmacokinetic (PK) drug detection in a random subsample. Here, we sought to compare behavioural and PK measures of adherence and examined correlates of adherence misreporting.MethodsWe included participants with PK and behavioural data from VOICE random subsample. Behavioural assessments included face-to-face interviews (FTFI), audio computer-assisted self-interviewing (ACASI) and pharmacy-returned product counts (PC). TFV concentrations < 0.31 ng/mL in plasma (oral group) and < 8.5 ng/swab in vaginal group were defined as "PK non-adherent." Logistic regression models were fit to calculate the combined predictive ability of the behavioural measures as summarized by area under the curve (AUC). Baseline characteristics associated with over-reporting daily product use relative to PK measures was assessed using a Generalized Linear Mixed Model.ResultsIn this random adherence cohort of VOICE participants assigned to active products, (N = 472), PK non-adherence was 69% in the oral group (N = 314) and 65% in the vaginal group (N = 158). Behaviourally, ≤ 10% of the cohort reported low/none use with any behavioural measure and accuracy was low (≤ 43%). None of the regression models had an AUC > 0.65 for any single or combined behavioural measures. Significant (p < 0.05) correlates of over-reporting included being very worried about getting HIV and being unmarried for the oral group; whereas for the vaginal group, being somewhat worried about HIV was associated with lower risk of over-reporting.ConclusionsPK measures indicated similarly low adherence for the oral and vaginal groups. No behavioural measure accurately predicted PK non-adherence. Accurate real-time measures to monitor product adherence are urgently needed.Trial registrationClinicalTrials.gov identifier: NCT00705679.

Project description:BackgroundDespite a more proactive approach to reducing new HIV infections in infants through lifelong treatment (Option B+ policy) for infected pregnant women, prevention of mother-to-child transmission of HIV (PMTCT) has not been fully effective in Papua, Indonesia. Mother-to-child transmission (MTCT) is the second greatest risk factor for HIV infection in the community, and an elimination target of <1% MTCT has not yet been achieved. The purpose of this study was to improve understanding of the implementation of Option B+ for PMTCT in Papua through investigation of facilitators and barriers to women's uptake and adherence to antiretroviral therapy (ART) in the program. This information is vital for improving program outcomes and success of program scale up in similar settings in Papua.MethodsIn-depth interviews were conducted with 20 women and 20 PMTCT health workers at two main referral hospitals for PMTCT in Papua. Development of interview guides was informed by the socio-ecological framework. Qualitative data were managed with NVivo11 software and themes were analysed using template analysis. Factors influencing women's uptake and adherence in Option B+ for PMTCT were identified through final analysis of key themes.ResultsFactors that motivated PMTCT uptake and adherence were good quality post-test HIV counselling, belief in the efficacy of antiretroviral (ARV) attained through personal or peer experiences, and a partner who did not prevent women from seeking PMTCT care. Key barriers for PMTCT participation included doubts about ARV efficacy, particularly for asymptomatic women, unsupportive partners who actively prevented women from seeking treatment, and women's concerns about community stigma and discrimination.ConclusionsResults suggest that PMTCT program success is determined by facilitators and barriers from across the spectrum of the socio-ecological model. While roll out of Option B+ as current national policy for pregnant women in Papua has improved detection and enrolment of HIV-positive women, health facilities need to address various existing and potential issues to ensure long-term adherence of women beyond the current PMTCT program, including during pregnancy, childbirth and breastfeeding.

Project description:BACKGROUND:Clinical treatment trials are increasingly being designed in primary mitochondrial disease (PMD), a phenotypically and genetically heterogeneous collection of inherited multi- system energy deficiency disorders that lack effective therapy. We sought to identify motivating factors and barriers to clinical trial participation in PMD. METHODS:A survey study was conducted in two independent mitochondrial disease subject cohorts. A discovery cohort invited subjects with well-defined biochemical or molecularly- confirmed PMD followed at a single medical center (CHOP, n = 30/67 (45%) respondents). A replication cohort included self-identified PMD subjects in the Rare Disease Clinical Research Network (RDCRN) national contact registry (n = 290/1119 (26%) respondents). Five-point Likert scale responses were analyzed using descriptive and quantitative statistics. Experienced and prioritized symptoms for trial participation, and patient attitudes toward detailed aspects of clinical trial drug features and study design. RESULTS:PMD subjects experienced an average of 16 symptoms. Muscle weakness, chronic fatigue, and exercise intolerance were the lead symptoms encouraging trial participation. Motivating trial design factors included a self-administered study drug; vitamin, antioxidant, natural or plant-derivative; pills; daily treatment; guaranteed treatment access during and after study; short travel distances; and late-stage (phase 3) participation. Relative trial participation barriers included a new study drug; discontinuation of current medications; disease progression; daily phlebotomy; and requiring participant payment. Treatment trial type or design preferences were not influenced by population age (pediatric versus adult), prior research trial experience, or disease severity. CONCLUSIONS:These data are the first to convey clear PMD subject preferences and priorities to enable improved clinical treatment trial design that cuts across the complex diversity of disease. Partnering with rare disease patient communities is essential to effectively design robust clinical trials that engage patients and enable meaningful evaluation of emerging treatment interventions.

Project description:The effectiveness of HIV pre-exposure prophylaxis (PrEP) requires consistent and correct product use, thus a deeper understanding of women's stated product formulation preferences, and the correlates of those preferences, can help guide future research. VOICE-D (MTN-003D), a qualitative ancillary study conducted after the VOICE trial, retrospectively explored participants' tablet and gel use, as well as their preferences for other potential PrEP product formulations.We conducted an analysis of quantitative and qualitative data from VOICE-D participants. During in-depth interviews, women were presented with pictures and descriptions of eight potential PrEP product formulations, including the oral tablet and vaginal gel tested in VOICE, and asked to discuss which product formulations they would prefer to use and why. Seven of the original product formulations displayed were combined into preferred product formulation categories based on exploratory factor and latent class analyses. We examined demographic and behavioural correlates of these preferred product formulation categories. In-depth interviews with participants were conducted, coded, and analysed for themes related to product preference.Of the 68 female participants who completed in-depth interviews (22 South Africa, 24 Zimbabwe, 22 Uganda), median age was 28 (range 21-41), 81% were HIV negative, and 49% were married or living with a partner. Four preferred product formulation categories were identified via exploratory factor analysis: 1) oral tablets; 2) vaginal gel; 3) injectable, implant, or vaginal ring; and 4) vaginal film or suppository. A majority of women (81%) expressed a preference for product formulations included in category 3. Characteristics significantly associated with each preferred product category differed. Attributes described by participants as being important in a preferred product formulation included duration of activity, ease of use, route of administration, clinic- versus self-administration, and degree of familiarity with product.While there was interest in a variety of potential PrEP product formulations, a majority of VOICE-D participants preferred long-acting methods. More research is needed to gain insight into end-users' product formulation preference to inform messaging and market segmentation for different PrEP products and resources to invest in products that target populations are most interested in using.NCT02358616.

Project description:UnlabelledInformation on motivations for research participation, may enable professionals to better tailor the process of recruitment and informed consent to the perspective of parents and children. Therefore, this systematic review assesses motivating and discouraging factors for children and their parents to decide to participate in clinical drug research. Studies were identified from searches in 6 databases. Two independent reviewers screened and selected relevant articles. Results were aggregated and presented by use of qualitative metasummary. 38 studies fulfilled the selection criteria and were of sufficient quality for inclusion in the qualitative metasummary. Most mentioned motivating factors for parents were: health benefit for child, altruism, trust in research, and relation to researcher. Most mentioned motivating factors for children were: personal health benefit, altruism and increasing comfort. Fear of risks, distrust in research, logistical aspects and disruption of daily life were mentioned most by parents as discouraging factors. Burden and disruption of daily life, feeling like a "guinea pig" and fear of risks were most mentioned as discouraging factors by children.ConclusionPaying attention to these motivating and discouraging factors of children and their parents during the recruitment and informed consent process in drug research increases the moral and instrumental value of informed consent.What is known• This systematic review pools the existing empirical literature on motivations of minors and their parents to consent or dissent to participation in clinical drug research. • The most mentioned motivating and discouraging factors for children and their parents to consent to participation in clinical drug research are identified aggregated and presented by use of qualitative metasummary. What is new: • This information can be used to adapt the research protocol, recruitment, and informed consent/assent process to the needs of children and their parents.

Dataset Information

Understanding women's motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence.

Publications

Understanding women's motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence.

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