Dataset Information

The Cooperative Re-Engagement Controlled trial (CoRECT): A randomised trial to assess a collaborative data to care model to improve HIV care continuum outcomes.

ABSTRACT:

Background

Persons with HIV (PWH), aware of their HIV infection but not in care account for an estimated 42.6% of HIV transmissions in the United States. Health departments and clinics implemented a collaborative data-to-care strategy to identify persons newly out-of-care with the objective of increasing re-engagement, retention in medical care, and viral load suppression.

Methods

A multi-site, prospective randomised trial was conducted to identify newly out-of-care PWH using surveillance and clinic data in Connecticut (CT), Massachusetts (MA) and Philadelphia (PHL). All out-of-care participants were randomised to receive standard of care or an active public health intervention. Re-engagement in care was defined as having a documented CD4 count and/or HIV viral load within 90 days of randomization. Retention was defined as having at least two CD4 count and/or HIV viral load results ≥ 3 months apart within 12 months of randomization, and viral load suppression as having a viral load < 200 copies/ml within 12 months of randomization.

Findings

Between August 2016 and July 2018, 1893 out-of-care participants were randomised from CT (N = 654), MA (N = 630), and PHL (N = 609). Participants were male (69.5%), non-Hispanic Black (48.3%) and men who have sex with men (38.8%). Re-engagement within 90 days was significantly higher for the intervention group overall and in all three jurisdictions (All sites: 54.9% vs 42.1%, p < 0.0001; CT: 51.2% vs 41.9%, p = 0.02; MA: 52.7% vs 44.1%, p = 0.03; PHL 61.2% vs 40.3%, p < 0.0001). Retention in care over 12 months improved overall (p = 0.04). Median time to viral suppression was reduced overall (p = 0.0006); CT (p = 0.32), MA (p = 0.02) and PHL (p < 0.0001).

Interpretation

This trial showed that a collaborative, data-to-care strategy, and active public health intervention led by health departments significantly increases the proportion of PWH re-engaged in HIV care and may improve retention in care and decrease time to viral suppression.

SUBMITTER: Fanfair RN

PROVIDER: S-EPMC9903939 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Cooperative Re-Engagement Controlled trial (CoRECT): A randomised trial to assess a collaborative data to care model to improve HIV care continuum outcomes.

Fanfair Robyn Neblett RN Khalil George G Williams Tiffany T Brady Kathleen K DeMaria Alfred A Villanueva Merceditas M Randall Liisa M LM Jenkins Heidi H Altice Frederick L FL Camp Nasima N Lucas Crystal C Buchelli Marianne M Samandari Taraz T Weidle Paul J PJ

Lancet regional health. Americas 20210828

<h4>Background</h4>Persons with HIV (PWH), aware of their HIV infection but not in care account for an estimated 42.6% of HIV transmissions in the United States. Health departments and clinics implemented a collaborative data-to-care strategy to identify persons newly out-of-care with the objective of increasing re-engagement, retention in medical care, and viral load suppression.<h4>Methods</h4>A multi-site, prospective randomised trial was conducted to identify newly out-of-care PWH using surv ...[more]

PMID: 36777404

Similar Datasets

Project description:Background"Data to Care" (D2C) is a strategy which relies on a combination of public health surveillance data supplemented by clinic data to support continuity of HIV care. The Cooperative Re-Engagement Controlled Trial (CoRECT) was a CDC-sponsored randomized controlled trial of a D2C model, which provided an opportunity to examine the process of implementing an intervention for people with HIV (PWH) who are out-of-care across three public health department jurisdictions. Using the EPIS (Exploration, Preparation, Implementation, Sustainment) framework, we aimed to retrospectively describe the implementation process for each site to provide insights and guidance to inform future D2C activities implemented by public health agencies and their clinical and community partners.MethodsAfter completion of CoRECT, the three (Connecticut, Massachusetts, Philadelphia) trial sites reviewed study protocols and held iterative discussions to describe and compare their processes regarding case identification, interactions with partnering clinics and patients, and sustainability. The EPIS framework provided a structure for comparing key organizational and operational practices and was applied to the entire implementation process.ResultsThe trial sites varied in their implementation processes and the specific elements of the intervention. Factors including prior D2C experience, data management and analytic infrastructure, staff capacity, and relationships with clinic partners informed intervention development and implementation. Additionally, this review identified key lessons learned including to: (1) explore new supplemental sources for public health surveillance data; (2) work with stakeholders representing core functions/components in the early stages of the intervention design process; (3) build flexibility into all components of the follow-up activities; and (4) integrate data sharing, project management, and follow-up activities within existing DPH organizational structure.ConclusionThe CoRECT study provides a general blueprint and lessons learned for implementing a D2C intervention for re-engagement in HIV care. Interventions should be tailored to local operational and structural factors, and responsive to evolving clinical and public health practices.

Project description:IntroductionAdvances in HIV treatment have proven to be effective in increasing virological suppression, thereby decreasing morbidity, and increasing survival. Medication adherence is an important factor in reducing viral load among people living with HIV (PLWH) and in the elimination of transmission of HIV to uninfected partners. Achieving optimal medication adherence involves individuals taking their medications every day or as prescribed by their provider. However, not all PLWH in the USA are engaged in care, and only a minority have achieved suppressed viral load (viral load that is lower than the detectable limit of the assay). Sexual and gender minorities (SGM; those who do not identify as heterosexual or those who do not identify as the sex they were assigned at birth) represent a high-risk population for poor clinical outcomes and increased risk of HIV transmission, as they face barriers that can prevent optimal engagement in HIV care. Research in dyadic support, specifically within primary romantic partnerships, offers a promising avenue to improving engagement in care and treatment outcomes among SGM couples. Dyadic interventions, especially focused on primary romantic partnerships, have the potential to have a sustained impact after the structured intervention ends.Methods and analysisThis paper describes the protocol for a randomised control trial of a theory-grounded, piloted intervention (DuoPACT) that cultivates and leverages the inherent sources of support within primary romantic relationships to improve engagement in HIV care and thus clinical outcomes among persons who are living with HIV and who identify as SGM (or their partners). Eligible participants must report being in a primary romantic relationship for at least 3 months, speak English, at least one partner must identify as a sexual or gender minority and at least one partner must be HIV+ with suboptimal engagement in HIV care, defined as less than excellent medication adherence, having not seen a provider in at least the past 8 months, having a detectable or unknown viral load or not currently on antiretroviral therapy. Eligible consenting couples are allocated equally to the two study arms: a structured six-session couples counselling intervention (DuoPACT) or a three-session individually-delivered HIV adherence counselling intervention (LifeSteps). The primary aim is to evaluate the efficacy of DuoPACT on virological suppression among HIV+ members of SGM couples with suboptimal engagement in care. The DuoPACT study began its target enrolment of 150 couples (300 individuals) in August 2017, and will continue to enrol until June 2021.Ethics and disseminationAll procedures are approved by the Institutional Review Board at the University of California, San Francisco. Written informed consent is obtained from all participants at enrolment, and study progress is reviewed twice yearly by an external Safety Monitoring Committee. Dissemination activities will include formal publications and report back sessions with the community.Trial registration numberNCT02925949; Pre-results.

Project description:IntroductionAdolescents and youth living with HIV (AYLHIV) have lower retention in care, adherence to treatment, and viral suppression compared with adults. Stepped care is a process by which clients are assigned to increasingly intensive services or 'steps' according to level of need. Differentiated care, in which stable clients access less frequent services, can be combined with stepped care to align needs and preferences of youth to promote optimal engagement in care.Methods and analysisThis hybrid type I effectiveness implementation cluster randomised trial aims to evaluate a data-informed stepped care (DiSC) intervention for AYLHIV. AYLHIV ages 10-24 receiving care at 24 HIV treatment facilities in Kisumu, Homabay and Migori counties in Kenya will be enrolled. Twelve facilities will be randomised to the DiSC intervention, and 12 will provide standard care. A clinical assignment tool developed by the study team will be used at intervention sites to assign AYLHIV to one of four steps based on risk for loss to follow-up: differentiated care, standard care, counselling services or intensive support services. The primary clinical outcome is retention in care, specifically missed visits (failure to return within 30 days for any visit) and 12-month loss to follow-up. Implementation outcomes are based on the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Proportions of missed visits will be compared using mixed effect models clustered by facility and participant.Ethics and disseminationThis study has been approved by the University of Washington Institutional Review Board (STUDY00011096), Maseno University Ethical Review Committee (MUERC/00917/20) and the Kenya National Commission for Science, Technology and Innovation (444824). AYLHIV provide written informed consent when legally permitted, or assent with caregiver permission for minors. Study staff will work with a Community Advisory Board, including youth members, to disseminate results via discussions, presentations, journal publications and local or international conferences.Trial registration numberNCT05007717.

Project description:BackgroundCommunity mobilisation, engaging communities in a process to collectively enact change, could improve HIV testing and care engagement. In South Africa, current rates fall below those needed for epidemic control. We assessed whether community mobilisation increased HIV testing, linkage to care, and retention in care over time in intervention relative to control communities.MethodsWe conducted a cluster-randomised controlled trial in villages in the Agincourt sub-district of the rural Mpumalanga Province in South Africa. 15 villages were randomly assigned to either a community mobilisation intervention engaging residents to address social barriers to HIV testing and treatment (intervention arm) or to a control arm using balanced randomisation. Villages were eligible if they had been fully enumerated in 2014, had not been included in previous mobilisation activities, and included over 500 permanent adult residents aged 18-49 years. Primary outcomes included quarterly rates of HIV testing, linkage to care, and retention in care documented from health facility records among residents of the intervention and control communities over the 3-year study period. Intention-to-treat analyses employed generalised estimating equations stratified by sex. This trial is registered with ClinicalTrials.gov, NCT02197793.FindingsBetween Aug 1, 2015, and July 31, 2018, residents in eight intervention communities (n=20 544 residents) and seven control communities (n=17 848) contributed data; 92 residents contributed to both arms. Among men, HIV testing increased quarterly by 12·1% (relative change [RC] 1·121, 95% CI 1·099 to 1·143, p<0·0001) in the intervention communities and 9·5% (1·095, 1·075 to 1·114, p=0·011) in the control communities; although increases in testing were greater in the intervention villages, differences did not reach significance (exponentiated interaction coefficient 1·024, 95% CI 0·997 to 1·052, p=0·078). Among women, HIV testing increased quarterly by 10·6% (RC 1·106, 95% CI 1·097 to 1·114, p<0·0001) in the intervention communities and 9·3% (1·093, 1·084 to 1·102, p=0·053) in the control communities; increases were greater in intervention communities (exponentiated interaction coefficient 1·012, 95% CI 1·001 to 1·023, p=0·043). Quarterly linkage increased significantly among women in the intervention communities (RC 1·013, 95% CI 1·002 to 1·023, p=0·018) only. Quarterly linkage fell among men in both arms, but decreased significantly among men in the control communities (0·977, 0·954 to 1·002, p=0·043). Quarterly retention fell among women in both arms; however, reductions were tempered among women in the intervention communities (exponentiated interaction coefficient 1·003, 95% CI <1·000 to 1·006, p=0·062). Retention fell significantly among men in both arms with difference in rates of decline.InterpretationCommunity mobilisation was associated with modest improvements in select trial outcomes. The sum of these incremental, quarterly improvements achieved by addressing social barriers to HIV care engagement can impact epidemic control. However, achieving optimal impacts will probably require integrated efforts addressing both social barriers through community mobilisation and provision of improved service delivery.FundingUS National Institutes of Health, National Institute of Mental Health, and United States President's Emergency Plan for AIDS Relief through Right to Care and Project SOAR.

Project description:BackgroundSmall trials with short term follow up suggest pharmacists' interventions targeted at healthcare professionals can improve prescribing. In comparison with clinical guidance, contemporary statin prescribing is sub-optimal and achievement of cholesterol targets falls short of accepted standards, for patients with atherosclerotic vascular disease who are at highest absolute risk and who stand to obtain greatest benefit. We hypothesised that a pharmacist-led complex intervention delivered to doctors and nurses in primary care, would improve statin prescribing and achievement of cholesterol targets for incident and prevalent patients with vascular disease, beyond one year.MethodsWe allocated general practices to a 12-month Statin Outreach Support (SOS) intervention or usual care. SOS was delivered by one of 11 pharmacists who had received additional training. SOS comprised academic detailing and practical support to identify patients with vascular disease who were not prescribed a statin at optimal dose or did not have cholesterol at target, followed by individualised recommendations for changes to management. The primary outcome was the proportion of patients achieving cholesterol targets. Secondary outcomes were: the proportion of patients prescribed simvastatin 40 mg with target cholesterol achieved; cholesterol levels; prescribing of simvastatin 40 mg; prescribing of any statin and the proportion of patients with cholesterol tested. Outcomes were assessed after an average of 1.7 years (range 1.4-2.2 years), and practice level simvastatin 40 mg prescribing was assessed after 10 years.FindingsWe randomised 31 practices (72 General Practitioners (GPs), 40 nurses). Prior to randomisation a subset of eligible patients were identified to characterise practices; 40% had cholesterol levels below the target threshold. Improvements in data collection procedures allowed identification of all eligible patients (n = 7586) at follow up. Patients in practices allocated to SOS were significantly more likely to have cholesterol at target (69.5% vs 63.5%; OR 1.11, CI 1.00-1.23; p = 0.043) as a result of improved simvastatin prescribing. Subgroup analysis showed the primary outcome was achieved by prevalent but not incident patients. Statistically significant improvements occurred in all secondary outcomes for prevalent patients and all but one secondary outcome (the proportion of patients with cholesterol tested) for incident patients. SOS practices prescribed more simvastatin 40 mg than usual care practices, up to 10 years later.InterpretationThrough a combination of educational and organisational support, a general practice based pharmacist led collaborative intervention can improve statin prescribing and achievement of cholesterol targets in a high-risk primary care based population.Trial registrationInternational Standard Randomised Controlled Trials Register ISRCTN61233866.

Project description:Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection.The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis.If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in general practice, with major benefit to patients and society. If case finding is shown to be superior to standard detection, it will be recommended as the detection method in future treatment according to the Collabri model.ClinicalTrials.gov. NCT02678845 . Retrospectively registered on 7 February 2016.

Project description:ObjectiveTo evaluate the effectiveness of integrated care for chronic physical diseases and depression in reducing disability and improving quality of life.DesignA randomised controlled trial of multi-condition collaborative care for depression and poorly controlled diabetes and/or risk factors for coronary heart disease compared with usual care among middle aged and elderly peopleSettingFourteen primary care clinics in Seattle, Washington.ParticipantsPatients with diabetes or coronary heart disease, or both, and blood pressure above 140/90 mm Hg, low density lipoprotein concentration >3.37 mmol/L, or glycated haemoglobin 8.5% or higher, and PHQ-9 depression scores of ≥ 10.InterventionA 12 month intervention to improve depression, glycaemic control, blood pressure, and lipid control by integrating a "treat to target" programme for diabetes and risk factors for coronary heart disease with collaborative care for depression. The intervention combined self management support, monitoring of disease control, and pharmacotherapy to control depression, hyperglycaemia, hypertension, and hyperlipidaemia.Main outcome measuresSocial role disability (Sheehan disability scale), global quality of life rating, and World Health Organization disability assessment schedule (WHODAS-2) scales to measure disabilities in activities of daily living (mobility, self care, household maintenance).ResultsOf 214 patients enrolled (106 intervention and 108 usual care), disability and quality of life measures were obtained for 97 intervention patients at six months (92%) and 92 at 12 months (87%), and for 96 usual care patients at six months (89%) and 92 at 12 months (85%). Improvements from baseline on the Sheehan disability scale (-0.9, 95% confidence interval -1.5 to -0.2; P = 0.006) and global quality of life rating (0.7, 0.2 to 1.2; P = 0.005) were significantly greater at six and 12 months in patients in the intervention group. There was a trend toward greater improvement in disabilities in activities of daily living (-1.5, -3.3 to 0.4; P = 0.10).ConclusionsIntegrated care that covers chronic physical disease and comorbid depression can reduce social role disability and enhance global quality of life. Trial registration Clinical Trials NCT00468676.

Dataset Information

The Cooperative Re-Engagement Controlled trial (CoRECT): A randomised trial to assess a collaborative data to care model to improve HIV care continuum outcomes.

Background

Methods

Findings

Interpretation

Publications

The Cooperative Re-Engagement Controlled trial (CoRECT): A randomised trial to assess a collaborative data to care model to improve HIV care continuum outcomes.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets