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Improving the HIV PrEP continuum of care using an intervention for healthcare providers: a stepped-wedge study protocol.

ABSTRACT: INTRODUCTION:Pre-exposure prophylaxis (PrEP) has demonstrated to be a highly effective method for preventing HIV; however, many individuals with PrEP indications are not receiving PrEP. Primary care settings provide an opportunity to offer PrEP to a wide range of patients. In this paper, we describe the PrEP Optimisation Intervention (PrEP-OI), which includes a PrEP Coordinator and a web-based panel management tool (called PrEP-Rx), and is targeted at healthcare providers (HCPs) to increase PrEP uptake and persistence among those at risk for acquiring HIV. METHODS AND ANALYSIS:The PrEP-OI study evaluates the efficacy of the PrEP intervention (PrEP Coordinator + PrEP-Rx) to increase PrEP prescriptions through a stepped-wedge design among 10 primary care clinical sites in the San Francisco Department of Public Health. The number of PrEP initiation prescriptions constitute the primary outcome, and we hypothesise that the mean number of PrEP prescriptions written will significantly increase after the clinics initiate PrEP-OI versus before this intervention. Secondary objectives include: 1-differences in PrEP initiation, duration of use and reasons for discontinuation based on patient's age, race/ethnicity and sex/gender, and by clinic and HCP characteristics, 2-sustainability of the intervention during a 12-month follow-up after the stepped-wedge phase, and 3-facilitators and barriers of PrEP delivery and experiences with the proposed PrEP intervention through qualitative interviews with HCPs. The results of this study can provide valuable insight into methods to reduce the burden of PrEP care on HCPs and improve PrEP continuum of care. ETHICS AND DISSEMINATION:This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board. Study staff will disseminate findings locally (eg, the UCSF Centre for AIDS Prevention Studies' Community Engagement Core), statewide (eg, the California Department of Public Health's Office of AIDS) and nationally and internationally at conferences related to HIV. TRIAL REGISTRATION NUMBER:NCT03532191.

SUBMITTER: Ming K

PROVIDER: S-EPMC7454188 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Improving the HIV PrEP continuum of care using an intervention for healthcare providers: a stepped-wedge study protocol.

Ming Kristin K Shrestha Isha I Vazquez Alexander A Wendelborn James J Jimenez Veronica V Lisha Nadra N Neilands Torsten B TB Scott Hyman H Liu Albert A Steward Wayne W Johnson Mallory O MO Saberi Parya P

BMJ open 20200714 7

<h4>Introduction</h4>Pre-exposure prophylaxis (PrEP) has demonstrated to be a highly effective method for preventing HIV; however, many individuals with PrEP indications are not receiving PrEP. Primary care settings provide an opportunity to offer PrEP to a wide range of patients. In this paper, we describe the PrEP Optimisation Intervention (PrEP-OI), which includes a PrEP Coordinator and a web-based panel management tool (called PrEP-Rx), and is targeted at healthcare providers (HCPs) to incre ...[more]

PMID: 32665393

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Project description:IntroductionElder abuse is prevalent and associated with different forms of ill health. Despite this, healthcare providers are often unaware of abusive experiences among older patients and many lack training about elder abuse. The overall aim of this study is to determine the effectiveness of an educational intervention on healthcare providers' propensity to ask older patients questions about abusive experiences.Methods and analysisHealthcare providers at hospital clinics and primary healthcare centres in Sweden will undergo full-day education about elder abuse between the fall of 2021 and spring of 2023. The education consists of (1) theory and group discussions; (2) forum theatre, a form of interactive theatre in which participants are given the opportunity to practise how to manage difficult patient encounters; and (3) post-training reflection on changing practices.The design is a non-randomised cluster, stepped wedge trial in which all participants (n=750) gradually transit from control group to intervention group with 6-month interval, starting fall 2021. Data are collected using the Responding to Elder Abuse in GERiAtric care-Provider questionnaire which was distributed to all clusters at baseline. All participants will also be asked to answer the questionnaire in conjunction with participating in the education as well as at 6-month and 12-month follow-up. Main outcome is changes in self-reported propensity to ask older patients questions about abuse post-intervention compared with pre-intervention. Linear mixed models including cluster as a random effect will be used to statistically evaluate the outcome.Ethics and disseminationThe study has been approved by the Swedish Ethical Review Authority. The results will be published in peer-reviewed journals and conference proceedings. If the intervention is successful, a manual of the course content will be published so that the education can be disseminated to other clinics.Trial registration numberNCT05065281.

Project description:IntroductionAchieving a sustained improvement in hand-hygiene compliance is the WHO's first global patient safety challenge. There is no RCT evidence showing how to do this. Systematic reviews suggest feedback is most effective and call for long term well designed RCTs, applying behavioural theory to intervention design to optimise effectiveness.MethodsThree year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals (16 Intensive Therapy Units [ITU]; 44 Acute Care of the Elderly [ACE] wards) routinely implementing a national cleanyourhands campaign). Intervention-based on Goal & Control theories. Repeating 4 week cycle (20 mins/week) of observation, feedback and personalised action planning, recorded on forms. Computer-generated stepwise entry of all hospitals to intervention. Hospitals aware only of own allocation.Primary outcomedirect blinded hand hygiene compliance (%).ResultsAll 16 trusts (60 wards) randomised, 33 wards implemented intervention (11 ITU, 22 ACE). Mixed effects regression analysis (all wards) accounting for confounders, temporal trends, ward type and fidelity to intervention (forms/month used). INTENTION TO TREAT ANALYSIS: Estimated odds ratio (OR) for hand hygiene compliance rose post randomisation (1.44; 95% CI 1.18, 1.76;p<0.001) in ITUs but not ACE wards, equivalent to 7-9% absolute increase in compliance. PER-PROTOCOL ANALYSIS FOR IMPLEMENTING WARDS: OR for compliance rose for both ACE (1.67 [1.28-2.22]; p<0.001) & ITUs (2.09 [1.55-2.81]; p<0.001) equating to absolute increases of 10-13% and 13-18% respectively. Fidelity to intervention closely related to compliance on ITUs (OR 1.12 [1.04, 1.20]; p = 0.003 per completed form) but not ACE wards.ConclusionDespite difficulties in implementation, intention-to-treat, per-protocol and fidelity to intervention, analyses showed an intervention coupling feedback to personalised action planning produced moderate but significant sustained improvements in hand-hygiene compliance, in wards implementing a national hand-hygiene campaign. Further implementation studies are needed to maximise the intervention's effect in different settings.Trial registrationControlled-Trials.com ISRCTN65246961.

Project description:BACKGROUND:Antiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings. METHODS:The Partners Scale Up Project is a prospective, pragmatic implementation evaluation, designed as a stepped-wedge, cluster-randomized trial, operating at 24 clinics in Kenya. In collaboration with the Kenya Ministry of Health, we are catalyzing scaled implementation of PrEP delivery integrated in HIV care clinics. The intervention package includes staff training, clinic streamlined access to PrEP commodity from the Kenya Medical Supply Authority, and ongoing intensive technical assistance to rigorously assess how PrEP delivery is implemented. PrEP service delivery including retention efforts are conducted by the clinic staff with no additional resources from the project. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and Consolidated Framework for Implementation Science Research, project progress and learning are documented through ongoing monitoring and process evaluations, including chart abstraction and individual and key informant interviews, to evaluate pragmatic rollout and understand barriers and facilitators for successful PrEP delivery in this setting. In this staged rollout design, each step provides data for both pre-implementation (baseline) and implementation periods, and we will compare time points across steps in the baseline versus implementation periods. DISCUSSION:Cost-effective delivery models are urgently needed to maximize the public health impact of PrEP and ART. The Partners Scale Up Project will set the stage for full-scale PrEP implementation fully run and owned by the Kenya Ministry of Health. The work combines nationally sponsored PrEP delivery with technical support and implementation science from academic partners, defining a new but sustainable paradigm for public health collaboration. TRIAL REGISTRATION:Registered with ClinicalTrials.gov on February 14, 2017: NCT03052010 .

Project description:BackgroundGlobal scale-up of HIV pre-exposure prophylaxis (PrEP) includes services to HIV-negative people in partnerships with people living with HIV (serodifferent couples). Data are needed on HIV outcomes, including uptake and adherence to PrEP and antiretroviral treatment (ART), to describe the impact of integrating PrEP into an existing HIV program.MethodsUsing a stepped-wedge cluster randomized trial design, we launched PrEP delivery for HIV-negative members of serodifferent couples in Uganda by integrating PrEP into existing ART programs for people living with HIV. The program provided PrEP training for ART providers, ongoing technical assistance, and a provisional supply chain mechanism for PrEP medication. Primary data on PrEP initiation, PrEP refills, ART initiation, and HIV viremia at 6 months (measured at 42-270 days) were collected through data abstraction of medical records from HIV-serodifferent couples sequentially enrolling at the ART clinics. Modified Poisson regression models, controlling for time and cluster, compared viral suppression (<1000 copies/ml) before and after launch of the PrEP program. This trial was registered at ClinicalTrials.gov, NCT03586128.FindingsFrom June 1, 2018-December 15, 2020, 1,381 HIV-serodifferent couples were enrolled across 12 ART clinics in Kampala and Wakiso, Uganda, including 730 enrolled before and 651 after the launch of PrEP delivery. During the baseline period, 99.4% of partners living with HIV initiated ART and 85.0% were virally suppressed at 6 months. Among HIV-negative partners enrolled after PrEP launched, 81.0% (527/651) initiated PrEP within 90 days of enrolling; among these 527, 11.2% sought a refill 6 months later. In our powered intent-to-treat analysis, 82.1% and 76.7% of partners living with HIV were virally suppressed, respectively, which was not a statistically significant difference (RR=0.94, 95% CI: 0.82-1.07) and was stable across sensitivity analyses.InterpretationIntegration of PrEP into ART clinics reached a high proportion of people in HIV-serodifferent relationships and did not improve the already high frequency of HIV viral suppression among partners living with HIV.FundingNational Institute of Mental Health (R01MH110296).

Project description:BackgroundDespite decades of global efforts to tackle HIV-related stigma, previous interventions designed to reduce stigma have had limited effects that were typically in the small- to-moderate range. The knowledge gaps and challenges for combating HIV-related stigma are rooted both in the complexity of the stigma and in the limitations of current conceptualizations of stigma reduction efforts. Recent research has shown the promise of resilience-based approaches that focus on the development of strengths, competencies, resources, and capacities of people living with HIV (PLWH) and their key supporting systems (e.g., family members and healthcare providers) to prevent, reduce, and mitigate the negative effects of stigma. However, the resilience-based approach, while hypothesized, has rarely been empirically tested in large intervention trials, especially in resource-limited settings.MethodsIn this study, we propose to develop, implement, and evaluate a theory-guided, multilevel, multimodal resilience-based intervention via a stepped wedge cluster randomized trial among 800 PLWH and their biological or surrogate family members, as well as 320 healthcare providers in Guangxi, China with a longitudinal follow-up period of 36 months at 6-month intervals. The primary outcome will be viral suppression and the intermediate outcomes will include perceived stress and medication adherence of PLWH as well as resilience measures at the level of the individual, the family, and the healthcare system.DiscussionThe proposed study will be one of the first large scale efforts to examine whether resilience among PLWH can be fostered and sustained through a multilevel and multi-component HIV-related stigma intervention and whether a resilience-based intervention can improve clinical outcomes and quality of HIV care among PLWH in a low-resource setting. If efficacious, the intervention components could be tailored to other groups of PLWH and adapted for other low- and middle-income countries.Trial registrationThis trial is registered at ClinicalTrials.gov, registration number NCT05174936, registered 13 December 2021. https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=3&cx=-jg9qo2.

Project description:BackgroundAdherent pre-exposure prophylaxis (PrEP) uptake can prevent HIV infections. Despite the high HIV incidence, Chinese key populations have low PrEP uptake and adherence. New interventions are needed to increase PrEP adherence among key populations in China. Co-creation methods are helpful to solicit ideas from the community to solve public health problems. The study protocol aims to describe the design of a stepped-wedge trial and to evaluate the efficacy of co-created interventions to facilitate PrEP adherence among key populations in China.MethodsThe study will develop intervention packages to facilitate PrEP adherence among Chinese key populations using co-creation methods. The study will then evaluate the efficacy of the co-created intervention packages using a stepped-wedge randomized controlled trial. This four-phased closed cohort stepped-wedge design will have four clusters. Each cluster will start intervention at three-month intervals. Seven hundred participants who initiated PrEP will be recruited. Participants will be randomized to the clusters using block randomization. The intervention condition includes receiving co-created interventions in addition to standard of care. The control condition is the standard of care that includes routine clinical assessment every 3 months. All participants will also receive an online follow-up survey every 3 months to record medication adherence and will be encouraged to use a WeChat mini-app for sexual and mental health education throughout the study. The primary outcomes are PrEP adherence and retention in PrEP care throughout the study period. We will examine a hypothesis that a co-created intervention can facilitate PrEP adherence. Generalized linear mixed models will be used for the primary outcome analysis.DiscussionDeveloping PrEP adherence interventions in China faces barriers including suboptimal PrEP uptake among key populations, the lack of effective PrEP service delivery models, and insufficient community engagement in PrEP initiatives. Our study design addresses these obstacles by using co-creation to generate social media-based intervention materials and embedding the study design in the local healthcare system. The study outcomes may have implications for policy and intervention practices among CBOs and the medical system to facilitate PrEP adherence among key populations.Trial registrationThe study is registered in Clinical Trial databases in China (ChiCTR2100048981, July 19, 2021) and the US (NCT04754139, February 11, 2021).

Project description:Adolescent girls and young women account for a disproportionate fraction of new HIV infections in Africa and are a priority population for HIV prevention, including provision of pre-exposure prophylaxis (PrEP). Anchoring PrEP delivery to care settings like family planning (FP) services that women already access routinely may offer an efficient platform to reach HIV at-risk women. However, context-specific implementation science evaluation is needed. The Family Planning Plus Project is a prospective, pragmatic implementation evaluation, designed as a stepped wedge, cluster randomized trial, at 12 clinics in Kenya. In collaboration with the Kenya Ministry of Health and Kisumu County Department of Health, we will introduce integration of HIV risk screening and PrEP delivery in public health FP clinics. The core multifaceted implementation strategies to integrate PrEP in FP clinics will include: (1) PrEP delivery by existing FP clinic staff, (2) health provider training, (3) PrEP technical assistance to coach and mentor providers, (4) joint supervision with Kisumu County health officials, and (5) stakeholder engagement. All core components of PrEP delivery-including screening for HIV risk, HIV testing, dispensing, adherence and risk reduction counseling, assessment of side effects, and provision of refills, or safety assessment-will be conducted by existing FP clinic staff as part of a standard care service package. The goal is to catalyze sustainable scale-up within existing infrastructures beyond the project. We will rigorously evaluate implementation outcomes and impact, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, and we will use Organizational Readiness for Implementing Change (ORIC) and the Consolidated Framework for Implementation Science Research (CFIR) to assess readiness to implement and contextual enablers and barriers of implementation, including how clinics innovate efficient delivery systems. Anchoring PrEP delivery to existing FP systems and staffing has tremendous potential to address barriers that women face in accessing HIV prevention and PrEP care, including lack of time, cost, and stigma of visiting a facility solely for HIV prevention. The FP Plus Project will initiate preparation for full-scale and sustainable model of integration of comprehensive HIV prevention services, including PrEP implementation, in public health FP clinics in low-income settings. Trial registration Registered with ClinicalTrials.gov on December 14, 2020: NCT04666792.

Project description:BackgroundSchizophrenia is a persistent and debilitating mental illness, and its prognosis depends largely on supportive care and systematic treatment. In developing countries like China, families constitute the major caregiving force for schizophrenia and are faced with many challenges, such as lack of knowledge, skills, and resources. The approach to support family caregiving in an accessible, affordable, feasible, and cost-effective way remains unclear. The wide-spread use of WeChat provides a promising and cost-effective medium for support.ObjectiveWe aim to present a protocol for assessing a WeChat-based integrative family intervention (WIFI) to support family caregiving for schizophrenia.MethodsWe will develop a WIFI program that includes the following three core components: (1) psychoeducation (WeChat official account), (2) peer support (WeChat chat group), and (3) professional support (WeChat video chat). A rigorous stepped-wedge cluster randomized trial will be used to evaluate the implementation, effectiveness, and cost of the WIFI program. The WIFI program will be implemented in 12 communities affiliated with Changsha Psychiatric Hospital through the free medicine delivery process in the 686 Program. The 12 communities will be randomized to one of four fixed sequences every 2 months during an 8-month intervention period in four clusters of three communities each. Outcomes will be assessed for both family caregivers and people with schizophrenia. Family caregivers will be assessed for their knowledge and skills about caregiving, social support, coping, perceived stigma, caregiver burden, family functioning, positive feelings, and psychological distress. People with schizophrenia will be assessed for their symptoms, functioning, quality of life, recovery, and rehospitalization. Cost data, such as intervention costs, health care utilization costs, and costs associated with lost productivity, will be collected. Moreover, we will collect process data, including fidelity and quality of program implementation, as well as user attitude data. Treatment effects will be estimated using generalized linear maximum likelihood mixed modeling with clusters as a random effect and time as a fixed effect. Cost-effectiveness analysis will be performed from the societal perspective using incremental cost-effectiveness ratios. Qualitative analysis will use the grounded theory approach and immersion-crystallization process.ResultsThe study was funded in August 2018 and approved by the institutional review board on January 15, 2019. Preliminary baseline data collection was conducted in May 2019 and completed in September 2019. The WIFI program is expected to start in September 2020.ConclusionsThis is the first study to assess a WeChat-based mHealth intervention to support family caregiving for schizophrenia in China. The innovative study will contribute to the development of a more cost-effective and evidence-based family management model in the community for people with schizophrenia, and the approach could potentially be integrated into national policy and adapted for use in other populations.Trial registrationClinicalTrials.gov NCT04393896; https://clinicaltrials.gov/ct2/show/NCT04393896.International registered report identifier (irrid)PRR1-10.2196/18538.

Dataset Information

Improving the HIV PrEP continuum of care using an intervention for healthcare providers: a stepped-wedge study protocol.

Publications

Improving the HIV PrEP continuum of care using an intervention for healthcare providers: a stepped-wedge study protocol.

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