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Development and initial validation of a simple tool to screen for partner support or opposition to HIV prevention product use.

ABSTRACT: In HIV prevention trials, male partners have influenced women's ability to adhere to investigational products, including antiretroviral (ARV) containing vaginal rings. Validated scales can be useful tools to systematically measure complex constructs, such as those related to male partner engagement. Although multiple scales exist to assess physical, psychological and sexual violence within intimate relationships, fewer scales focus on supportive behaviors within these relationships. Our intervention involved development of a Healthy Relationship Assessment Tool (HEART) that assessed both positive and negative aspects of male partner involvement in women's HIV prevention. We identified and refined 127 potential items, representing intimate partner violence, agency and social support. A structured survey, including potential items and other sociodemographic and behavioral variables was administered to former microbicide trial and non-trial participants. We conducted an exploratory factor analysis (EFA) to identify a reduced set of constructs and items to screen women who might experience social harms or benefits from vaginal ring use. We examined associations between constructs and with other survey variables to assess content and construct validity. In a subset of 10 women who participated in the survey and qualitative interviews, we used qualitative data to predict survey scores. We retained five constructs with theoretical relevance and good-to-strong reliability for the tool, including: Traditional Values; Partner Support; Partner Abuse & Control; Partner Resistance to HIV Prevention; and HIV Prevention Readiness. Predicted associations between HEART constructs, and correspondence between participants' qualitative data and HEART scores were generally correct, while those between constructs and other sociodemographic variables were more mixed. Initial validation of the HEART tool was promising. The tool will be used during the CHARISMA pilot study at the Johannesburg MTN 025/HOPE site and validated as part of a randomized controlled trial of CHARISMA within a PrEP demonstration project. Beyond clinical trial settings, HEART could assist PrEP or antiretroviral treatment (ART) providers with an easy-to-administer tool to identify risk and tailor risk reduction, empowerment and adherence counseling for microbicides, PrEP or ART related services.

SUBMITTER: Tolley EE

PROVIDER: S-EPMC7755213 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Development and initial validation of a simple tool to screen for partner support or opposition to HIV prevention product use.

Tolley Elizabeth E EE Zissette Seth S Martinez Andres A Palanee-Phillips Thesla T Mathebula Florence F Tenza Siyanda S Hartmann Miriam M Montgomery Elizabeth T ET

PloS one 20201222 12

In HIV prevention trials, male partners have influenced women's ability to adhere to investigational products, including antiretroviral (ARV) containing vaginal rings. Validated scales can be useful tools to systematically measure complex constructs, such as those related to male partner engagement. Although multiple scales exist to assess physical, psychological and sexual violence within intimate relationships, fewer scales focus on supportive behaviors within these relationships. Our interven ...[more]

PMID: 33351805

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Project description:ObjectivesPatient-identified need is key to delivering holistic, supportive, person-centred care, but we lack tools enabling patients to express what they need to manage life with a long-term condition. The Support Needs Approach for Patients (SNAP) tool was developed to enable patients with advanced chronic obstructive pulmonary disease (COPD) identify and express their unmet support needs to healthcare professionals (HCPs), but its validity is unknown. This study aimed to establish face, content and criterion validity of the SNAP tool.DesignTwo-stage mixed-methods study involving patients with advanced COPD and their carers. Stage 1: Face and content validity assessed though focus groups involving patients and carers considering appropriateness, relevance and completeness of the SNAP tool. Data were analysed using conventional content analysis. Stage 2: Content and criterion validity assessed in a postal survey through patient self-completion of the SNAP tool and disease impact measures (Chronic Respiratory Questionnaire, COPD Assessment Test, and Hospital Anxiety and Depression Scale). Content validity assessed using summary statistics; criterion validity via correlations between tool items and impact measures.Settings and participantsTwo hundred and forty patients and carers participated. Stage 1 patient and informal carer participants were recruited from two primary care practices and Stage 2 patients from 28 practices. Participating practices located in the East of England were recruited via the NIHR Clinical Research Network: Eastern.ResultsPatients and carers found the tool patient-friendly and comprehensive, with potential clinical utility. No tool items were redundant. Clear correlations were found between tool items and the majority of items in the impact measures.ConclusionsThe SNAP tool has good face, content and criterion validity. It has potential to support the delivery of holistic, supportive, person-centred care by enabling patients to identify and express their unmet support needs to HCPs.

Project description:BACKGROUND:Recurrent bronchiectasis exacerbations are related to deterioration of lung function, progression of the disease, impairment of quality of life, and to an increased mortality. Improved detection of exacerbations has been accomplished in chronic obstructive pulmonary disease through the use of patient completed diaries. These tools may enhance exacerbation reporting and identification. The aim of this study was to develop a novel symptom diary for bronchiectasis symptom burden and detection of exacerbations, named the BEST diary. METHODS:Prospective observational study of patients with bronchiectasis conducted at Ninewells Hospital, Dundee. We included patients with confirmed bronchiectasis by computed tomography, who were symptomatic and had at least 1 documented exacerbation of bronchiectasis in the previous 12?months to participate. Symptoms were recorded daily in a diary incorporating cough, sputum volume, sputum colour, dyspnoea, fatigue and systemic disturbance scored from 0 to 26. RESULTS:Twenty-one patients were included in the study. We identified 29 reported (treated exacerbations) and 23 unreported (untreated) exacerbations over 6-month follow-up. The BEST diary score showed a good correlation with the established and validated questionnaires and measures of health status (COPD Assessment Test, r =?0.61, p =?0.0037, Leicester Cough Questionnaire, r =?-?0.52,p =?0.0015, St Georges Respiratory Questionnaire, r =?0.61,p <?0.0001 and 6?min walk test, r =?-?0.46,p =?0.037). The mean BEST score at baseline was 7.1 points (SD 2.2). The peak symptom score during exacerbation was a mean of 16.4 (3.1), and the change from baseline to exacerbation was a mean of 9.1 points (SD 2.5). Mean duration of exacerbations based on time for a return to baseline symptoms was 15.3?days (SD 5.7). A minimum clinically important difference of 4 points is proposed. CONCLUSIONS:The BEST symptom diary has shown concurrent validity with current health questionnaires and is responsive at onset and recovery from exacerbation. The BEST diary may be useful to detect and characterise exacerbations in bronchiectasis clinical trials.

Project description:IntroductionOral, vaginal and other pre-exposure prophylaxis (PrEP) products for HIV prevention are in various stages of development. Low adherence poses a serious challenge to successful evaluation in trials. In a previous study, we developed tools to screen for general adherence and specifically monitor intravaginal ring adherence within the context of HIV prevention clinical trials. This study aimed to further validate the screening tool and to adapt and provide initial psychometric validation for an oral pill monitoring tool.Materials and methodsWe administered a cross-sectional survey between June and October 2018 at a trial site located near Cape Town, South Africa, and another in Thika, Kenya, with 193 women who had experience using daily oral pills. We fit confirmatory factor analysis models on the screening tool items to assess our previously-hypothesized subscale structure. We conducted an exploratory factor analysis of oral PrEP monitoring items to determine the underlying subscale structure. We then assessed the construct validity of each tool by comparing subscales against each other within the current sample and against our original sample, from a study conducted in four sites in South Africa, including Cape Town.ResultsThe screening tool structure showed moderate evidence of construct validity. As a whole, the tool performed in a similar way to the original sample. The monitoring tool items, which were revised to assess perceptions about and experiences using daily oral PrEP, factored into five subscales that showed moderate to good reliability. Four of the five subscales had a similar structure overall to the vaginal ring monitoring tool from which they were adapted.ConclusionsAccurate measurement of HIV-prevention product adherence is of critical importance to the assessment of product efficacy and safety in clinical trials, and the support of safe and effective product use in non-trial settings. In this study, we provide further validation for these measures, demonstrating the screening tool's utility in additional populations and adapting the monitoring tool's utility for different HIV-prevention products.

Project description:BACKGROUND:Chemical exposures pose a significant threat to life. A rapid assessment by first responders and emergency nurses is required to reduce death and disability. Currently, no informatics tools exist to process victims of chemical exposures efficiently. The surge of patients into a hospital emergency department during a mass casualty incident creates additional stress on an already overburdened system, potentially placing patients at risk and challenging staff to process patients for appropriate care and treatment efficacy. Traditional emergency department triage models are oversimplified during highly stressed mass casualty incident scenarios in which there is little margin for error. Emerging mobile technology could alleviate the burden placed on nurses by allowing the freedom to move about the emergency department and stay connected to a decision support system. OBJECTIVE:This study aims to present and evaluate a new mobile tool for assisting emergency department personnel in patient management and triage during a chemical mass casualty incident. METHODS:Over 500 volunteer nurses, students, and first responders were recruited for a study involving a simulated chemical mass casualty incident. During the exercise, a mobile application was used to collect patient data through a kiosk system. Nurses also received tablets where they could review patient information and choose recommendations from a decision support system. Data collected was analyzed on the efficiency of the app to obtain patient data and on nurse agreement with the decision support system. RESULTS:Of the 296 participants, 96.3% (288/296) of the patients completed the kiosk system with an average time of 3 minutes, 22 seconds. Average time to complete the entire triage process was 5 minutes, 34 seconds. Analysis of the data also showed strong agreement among nurses regarding the app's decision support system. Overall, nurses agreed with the system 91.6% (262/286) of the time when it came to choose an exposure level and 84.3% (241/286) of the time when selecting an action. CONCLUSIONS:The app reliably demonstrated the ability to collect patient data through a self-service kiosk system thus reducing the burden on hospital resources. Also, the mobile technology allowed nurses the freedom to triage patients on the go while staying connected to a decision support system in which they felt would give reliable recommendations.

Project description:Background:To support patients with COPD in their self-management of symptom worsening, we developed Adaptive Computerized COPD Exacerbation Self-management Support (ACCESS), an innovative software application that provides automated treatment advice without the interference of a health care professional. Exacerbation detection is based on 12 symptom-related yes-or-no questions and the measurement of peripheral capillary oxygen saturation (SpO2), forced expiratory volume in one second (FEV1), and body temperature. Automated treatment advice is based on a decision model built by clinical expert panel opinion and Bayesian network modeling. The current paper describes the validity of ACCESS. Methods:We performed secondary analyses on data from a 3-month prospective observational study in which patients with COPD registered respiratory symptoms daily on diary cards and measured SpO2, FEV1, and body temperature. We examined the validity of the most important treatment advice of ACCESS, ie, to contact the health care professional, against symptom- and event-based exacerbations. Results:Fifty-four patients completed 2,928 diary cards. One or more of the different pieces of ACCESS advice were provided in 71.7% of all cases. We identified 115 symptom-based exacerbations. Cross-tabulation showed a sensitivity of 97.4% (95% CI 92.0-99.3), specificity of 65.6% (95% CI 63.5-67.6), and positive and negative predictive value of 13.4% (95% CI 11.2-15.9) and 99.8% (95% CI 99.3-99.9), respectively, for ACCESS' advice to contact a health care professional in case of an exacerbation. Conclusion:In many cases (71.7%), ACCESS gave at least one self-management advice to lower symptom burden, showing that ACCES provides self-management support for both day-to-day symptom variations and exacerbations. High sensitivity shows that if there is an exacerbation, ACCESS will advise patients to contact a health care professional. The high negative predictive value leads us to conclude that when ACCES does not provide the advice to contact a health care professional, the risk of an exacerbation is very low. Thus, ACCESS can safely be used in patients with COPD to support self-management in case of an exacerbation.

Dataset Information

Development and initial validation of a simple tool to screen for partner support or opposition to HIV prevention product use.

Publications

Development and initial validation of a simple tool to screen for partner support or opposition to HIV prevention product use.

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