Dataset Information

Effectiveness of an mHealth intervention to increase adherence to triage of HPV DNA positive women who have performed self-collection (the ATICA study): A hybrid type I cluster randomised effectiveness-implementation trial.

ABSTRACT:

Background

Human Papillomavirus (HPV) self-collection offered by community health workers (CHWs) during home visits has been hampered by low levels of triage Pap among HPV-positive women. We investigated effectiveness of a mHealth intervention to increase adherence to triage Pap.

Methods

We conducted a hybrid type I cluster randomised effectiveness-implementation trial in Jujuy, Argentina. CHWs (clusters) were eligible if actively offering HPV self-collection and served at least 26 women aged 30 years and over. Women were eligible if they conducted self-collection and provided a mobile phone number. 260 CHWs were randomly allocated (3:2 ratio) to a multi-component intervention (Up to four SMS messages sent to HPV-positive women, and one SMS message to CHWs to prompt a visit of women with no triage Pap 60 days after a positive-test), or control group (Usual care: Women instructed to attend their health centre 30 days after HPV self-collection to pick-up results). The primary effectiveness outcome was percentage of HPV-positive women with triage 120 days after the HPV-test result. We evaluated implementation of the intervention using the RE-AIM framework.

Findings

221 CHWs (132 intervention, 89 control group) contacted 5389 women; and 5351 agreed to participate (3241 intervention, 2110 control group). In total 314/445 (70·5%) HPV-positive women of the intervention group had triage at 120 days after the HPV result, compared to 163/292 (55·1%) in the control group: 15·5% point improvement; 95%CI: 6·8-24·1; relative risk: 1·28; 95%CI: 1·11-1·48. 97·2% of women accepted the intervention and 86·9% of CHWs agreed to its adoption.

Interpretation

The multicomponent mHealth intervention was effective in increasing the percentage of HPV-positive women who had triage Pap, allowing for many more women at risk of cervical cancer to receive timely follow-up.

Funding

National Cancer Institute of the National Institutes of Health (USA) under Award Number R01CA218306.

SUBMITTER: Arrossi S

PROVIDER: S-EPMC9159703 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of an mHealth intervention to increase adherence to triage of HPV DNA positive women who have performed self-collection (the ATICA study): A hybrid type I cluster randomised effectiveness-implementation trial.

Arrossi Silvina S Paolino Melisa M Antelo Victoria Sánchez VS Thouyaret Laura L Kohler Racquel E RE Cuberli Milca M Flores Liliana L Serra Verónica V Viswanath Kasisomayajula K Orellana Liliana L

Lancet regional health. Americas 20220213

<h4>Background</h4>Human Papillomavirus (HPV) self-collection offered by community health workers (CHWs) during home visits has been hampered by low levels of triage Pap among HPV-positive women. We investigated effectiveness of a mHealth intervention to increase adherence to triage Pap.<h4>Methods</h4>We conducted a hybrid type I cluster randomised effectiveness-implementation trial in Jujuy, Argentina. CHWs (clusters) were eligible if actively offering HPV self-collection and served at least 2 ...[more]

PMID: 35655914

Similar Datasets

Project description:BackgroundCervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for self-collection with the potential to increase coverage, but still requires triage to identify which HPV+ women need diagnostic and treatment procedures. However, achieving high levels of triage adherence can be challenging, especially among socially vulnerable women. This paper describes the ATICA protocol (Application of Communication and Information Technologies to Self-Collection, for its initials in Spanish), aimed at evaluating the implementation strategy and the effectiveness of a multi-component mobile health (mHealth) intervention to increase adherence to triage among women with HPV+ self-collected tests.MethodsWe will use an effectiveness-implementation hybrid type I trial with a mixed-methods evaluation approach. A cluster randomized trial design including 200 community health workers (CHWs) will evaluate whether the mHealth intervention increases adherence to triage among HPV+ women who self-collected at home during a CHW visit within 120 days after a positive result. The intervention includes an initial mobile phone text message (SMS) alert and subsequent reminders sent to HPV+ women. For those who do not adhere to triage within 60 days of a positive HPV test, an email and SMS will be sent to the CHWs to promote contact with these women during home visits. We will use the Consolidated Framework for Implementation Research (CFIR) as an organizing and analytic framework to evaluate the implementation of the intervention while also drawing on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). We will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women. Combining both qualitative and quantitative data will provide rich insights into local implementation challenges and successes.DiscussionFindings from the implementation evaluation will be applicable to programs that use or are planning to incorporate HPV self-collection and/or mHealth interventions in different settings and countries. This innovative study will also serve as a model for using implementation science in the region.Trial registrationClinicalTrials.gov, NCT03478397 . Registered on 20 March 2018.

Project description:BackgroundThe ATICA study was a Hybrid I type randomized effectiveness-implementation trial that demonstrated effectiveness of a multicomponent mHealth intervention (Up to four SMS messages sent to HPV-positive women, and one SMS message to CHWs to prompt a visit of women with no triage Pap 60 days after a positive-test), to increase adherence to triage of HPV positive women (ATICA Study). We report data on perceptions of health decision-makers and health-care providers regarding the intervention implementation and scaling-up.MethodsA qualitative study was carried out based on individual, semi-structured interviews with health decision-makers (n = 10) and health-care providers (n = 10). The themes explored were selected and analyzed using domains and constructs of the Consolidated Framework for Implementation Research (CFIR) and the maintenance dimension of the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.ResultsBoth health-care providers and decision-makers had a positive assessment of the intervention through most included constructs: knowledge of the intervention, intervention source, design quality, adaptability, compatibility, access to knowledge and information, relative advantage, women's needs, and relative priority. However, some potential barriers were also identified including: complexity, leadership engagement, external policies, economic cost, women needs and maintenance. Stakeholders conditioned the strategy's sustainability to the political commitment of national and provincial health authorities to prioritize cervical cancer prevention, and to the establishment of the ATICA strategy as a programmatic line of work by health authorities. They also highlighted the need to ensure, above all, that there was staff to take Pap tests and carry out the HPV-lab work, and to guarantee a constant provision of HPV-tests.ConclusionHealth decision-makers and health-care providers had a positive perception regarding implementation of the multicomponent mHealth intervention designed to increase adherence to triage among women with HPV self-collected tests. This increases the potential for a successful scaling-up of the intervention, with great implications not only for Argentina but also for middle and low-income countries considering using mHealth interventions to enhance the cervical screening/follow-up/treatment process.

Project description:BACKGROUND:SMS interventions are effective in promoting a variety of health behaviors; however, there is limited information regarding the use of SMS for cervical cancer screening and follow-up care. The Application of Communication and Information Technologies to Self-Collection study aims to evaluate a multicomponent mobile health intervention to increase triage adherence among women with human papillomavirus (HPV)-positive self-collected tests in Jujuy, Argentina. Here, we describe the formative results used to design the content of the SMS to be tested in the trial. OBJECTIVE:This study aimed to understand the cultural and contextual elements, women's beliefs, and perceptions regarding the use of SMS by the health care system and women's preferences about the message content. METHODS:We conducted five focus groups (FGs), stratified by rural or urban residence and age. All participants were aged 30 years or older and had performed HPV self-collection. Participatory techniques, including brainstorming, card-based classification, and discussions were used to debate the advantages and disadvantages of messages. We openly coded the discussions for agreements and preferences regarding the SMS content. Messages for both HPV-negative and HPV-positive women were validated through interviews with health authorities and 14 HPV-tested women. The final versions of the messages were pilot-tested. RESULTS:A total of 48 women participated in the FGs. Participants rejected receiving both negative and positive HPV results by SMS because, for them, the delivery of results should be done in a face-to-face interaction with health professionals. They stressed the importance of the SMS content informing them that results were available for pick up and reflecting the kind of relationship that they have with the community health workers and the nearest health center. Women considered that a personalized SMS was important, as was the use of a formal yet warm tone. Owing to confidentiality issues, not using the word "HPV" was also a key component of the desired SMS content; therefore, the final message included the term "self-collection" without the mention of HPV infection. Results from the validation stage and pilot test showed high acceptability of the final version of the message. CONCLUSIONS:The results suggest that SMS is accepted when notifying women about the availability of the HPV test result, but it should not replace the delivery of results in face-to-face, doctor-patient encounters. In addition, messages must be tailored and must have a persuasive tone to motivate women to adhere to the triage.

Project description:Background: Mechanical thrombectomy (MT) can improve the outcomes of patients with large vessel occlusion (LVO), but a minority of patients with LVO are treated and there are disparities in timely access to MT. In part, this is because in most regions, including Alabama, the emergency medical service (EMS) transports all patients with suspected stroke, regardless of severity, to the nearest stroke center. Consequently, patients with LVO may experience delayed arrival at stroke centers with MT capability and worse outcomes. Alabama's trauma communications center (TCC) coordinates EMS transport of trauma patients by trauma severity and regional hospital capability. Our aims are to develop a severity-based stroke triage (SBST) care model based on Alabama's trauma system, compare the effectiveness of this care pathway to current stroke triage in Alabama for improving broad, equitable, and timely access to MT, and explore stakeholder perceptions of the intervention's feasibility, appropriateness, and acceptability. Methods: This is a hybrid type 1 effectiveness-implementation study with a multi-phase mixed methods sequential design and an embedded observational stepped wedge cluster trial. We will extend TCC guided stroke severity assessment to all EMS regions in Alabama; conduct stakeholder interviews and focus groups to aid in development of region and hospital specific prehospital and inter-facility stroke triage plans for patients with suspected LVO; implement a phased rollout of TCC Coordinated SBST across Alabama's six EMS regions; and conduct stakeholder surveys and interviews to assess context-specific perceptions of the intervention. The primary outcome is the change in proportion of prehospital stroke system patients with suspected LVO who are treated with MT before and after implementation of TCC Coordinated SBST. Secondary outcomes include change in broad public health impact before and after implementation and stakeholder perceptions of the intervention's feasibility, appropriateness, and acceptability using a mixed methods approach. With 1200 to 1300 total observations over 36 months, we have 80% power to detect a 15% improvement in the primary endpoint. Discussion: This project, if successful, can demonstrate how the trauma system infrastructure can serve as the basis for a more integrated and effective system of emergency stroke care.

Project description:BackgroundMood-stabilizing medications are a cornerstone of treatment for people with bipolar disorder, though approximately half of these individuals are poorly adherent with their medication, leading to negative and even severe health consequences. While a variety of approaches can lead to some improvement in medication adherence, there is no single approach that has superior adherence enhancement and limited data on how these approaches can be implemented in clinical settings. Existing data have shown an increasing need for virtual delivery of care and interactive telemedicine interventions may be effective in improving adherence to long-term medication.MethodsCustomized adherence enhancement (CAE) is a brief, practical bipolar-specific approach that identifies and targets individual patient adherence barriers for intervention using a flexibly administered modular format that can be delivered via telehealth communications. CAE is comprised of up to four standard treatment modules including Psychoeducation, Communication with Providers, Medication Routines, and Modified Motivational Interviewing. Participants will attend assigned module sessions with an interventionist based on their reasons for non-adherence and will be assessed for adherence, functioning, bipolar symptoms, and health resource use across a 12-month period. Qualitative and quantitative data will also be collected to assess barriers and facilitators to CAE implementation and reach and adoption of CAE among clinicians in the community.DiscussionThe proposed study addresses the need for practical adherence interventions that are effective, flexible, and designed to adapt to different settings and patients. By focusing on a high-risk, vulnerable group of people with bipolar disorder, and refining an evidence-based approach that will integrate into workflow of public-sector care and community mental health clinics, there is substantial potential for improving bipolar medication adherence and overall health outcomes on a broad level.Trial registrationThe study was registered on ClinicalTrials.gov NCT04622150 on November 9, 2020.

Project description:BackgroundWhile influenza vaccines are the most effective measure for preventing influenza, uptake rates in China remain relatively low. Rapid Verbal Persuasion (RVP), with highly rapid fashion, has a strong evidence base in promoting behavior change. Despite this, it is underused or rarely evaluated in the context of vaccination. Additionally, the success of RVP implementation in vaccination clinics hinges on the motivation of vaccination staff, which remains critical even with stable contextual factors. Multifaceted incentive-based implementation strategies, which aim to enhance motivation to promote the implementation of evidence-based practices, could be advantageous. This study protocol outlines an implementation-effectiveness hybrid type 2 design to evaluate the effectiveness of both the incentive-based implementation strategies on implementation outcomes and RVP on increasing influenza vaccination rates.MethodThis study will be conducted as a two-tiered cluster of randomized controlled trials over three months. Initially, 32 vaccination clinics will be randomly allocated to one of two study arms: (a) implementation of RVP or (b) no implementation. At the end of the study period, differences in influenza vaccination status between the intervention and control groups will be compared (primary outcome). Subsequently, a cluster randomized factorial trial will be conducted, involving 16 clinics implementing RVP. This trial will aim to compare the impact of various implementation strategies (different combinations of incentives) on fidelity in RVP implementation (primary outcome). Data collection for the primary outcomes will include unannounced exit interviews. Modified Poisson regression models and generalized linear mixed-effects models will be utilized to analyze the association between primary outcomes and interventions.ConclusionThe study aims to enhance the influenza vaccination rate in China by developing financial and non-financial incentives that allow vaccination staff to deliver RVP with greater motivation. Furthermore, the evidence generated from this multi-center trial will assist policymakers in improving current incentive systems within immunization services.Trial registrationChinese Clinical Trial Registry. Trial identifier: ChiCTR2400091302 (Registration Date: October 25, 2024); ChiCTR2400091324 (Registration Date: October 25, 2024).

Project description:BackgroundThe extent of human interaction needed to achieve effective and cost-effective use of mobile health (mHealth) apps for individuals with mild to moderate alcohol use disorder (AUD) remains largely unexamined. This study seeks to understand how varying levels of human interaction affect the ways in which an mHealth intervention for the prevention and treatment of AUDs works or does not work, for whom, and under what circumstances.ObjectiveThe primary aim is to detect the effectiveness of an mHealth intervention by assessing differences in self-reported risky drinking patterns and quality of life between participants in three study groups (self-monitored, peer-supported, and clinically integrated). The cost-effectiveness of each approach will also be assessed.MethodsThis hybrid type 1 study is an unblinded patient-level randomized clinical trial testing the effects of using an evidence-based mHealth system on participants' drinking patterns and quality of life. There are two groups of participants for this study: individuals receiving the intervention and health care professionals practicing in the broader health care environment. The intervention is a smartphone app that encourages users to reduce their alcohol consumption within the context of integrative medicine using techniques to build healthy habits. The primary outcomes for quantitative analysis will be participant data on their risky drinking days and quality of life as well as app use from weekly and quarterly surveys. Cost measures include intervention and implementation costs. The cost per participant will be determined for each study arm, with intervention and implementation costs separated within each group. There will also be a qualitative assessment of health care professionals' engagement with the app as well as their thoughts on participant experience with the app.ResultsThis protocol was approved by the Health Sciences Minimal Risk Institutional Review Board on November 18, 2019, with subsequent annual reviews. Recruitment began on March 6, 2020, but was suspended on March 13, 2020, due to the COVID-19 pandemic restrictions. Limited recruitment resumed on July 6, 2020. Trial status as of November 17, 2021, is as follows: 357 participants were enrolled in the study for a planned enrollment of 546 participants.ConclusionsThe new knowledge gained from this study could have wide and lasting benefits related to the integration of mHealth systems for individuals with mild to moderate AUDs. The results of this study will guide policy makers and providers toward cost-effective ways to incorporate technology in health care and community settings.Trial registrationClinicalTrials.gov NCT04011644; https://clinicaltrials.gov/ct2/show/NCT04011644.International registered report identifier (irrid)DERR1-10.2196/31109.

Dataset Information

Effectiveness of an mHealth intervention to increase adherence to triage of HPV DNA positive women who have performed self-collection (the ATICA study): A hybrid type I cluster randomised effectiveness-implementation trial.

Background

Methods

Findings

Interpretation

Funding

Publications

Effectiveness of an mHealth intervention to increase adherence to triage of HPV DNA positive women who have performed self-collection (the ATICA study): A hybrid type I cluster randomised effectiveness-implementation trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets