Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV

Abstract Background : Stigma and discrimination related to HIV and key populations at high risk of HIV have the potential to impede the implementation of effective HIV prevention and treatment programmes at scale. Studies measuring the impact of stigma on these programmes are rare. We are conducting an implementation science study of HIV-related stigma in communities and health settings within a large, pragmatic cluster-randomized trial of a universal testing and treatment intervention for HIV prevention in Zambia and South Africa and will assess how stigma affects, and is affected by, implementation of this intervention. Methods/Design : A mixed-method evaluation will be nested within HIV prevention trials network (HPTN) 071/PopART (Clinical Trials registration number NCT01900977), a three-arm trial comparing universal door-to-door delivery of HIV testing and referral to prevention and treatment services, accompanied by either an immediate offer of anti-retroviral treatment to people living with HIV regardless of clinical status, or an offer of treatment in-line with national guidelines, with a standard-of-care control arm. The primary outcome of HPTN 071/PopART is HIV incidence measured among a cohort of 52 500 individuals in 21 study clusters. Our evaluation will include integrated quantitative and qualitative data collection and analysis in all trial sites. We will collect quantitative data on indicators of HIV-related stigma over 3 years from large probability samples of community members, health workers and people living with HIV. We will collect qualitative data, including in-depth interviews and observations from members of these same groups sampled purposively. In analysis, we will: (1) compare HIV-related stigma measures between study arms, (2) link data on stigma to measures of the success of implementation of the PopART intervention and (3) explore changes in the dominant drivers and manifestations of stigma in study communities and the health system. Discussion : HIV-related stigma may impede the successful implementation of HIV prevention and treatment programmes. Using a novel study-design nested within a large, community randomized trial we will evaluate the extent to which HIV-related stigma affects and is affected by the implementation of a comprehensive combination HIV prevention intervention including a universal test and treatment approach.

Download Full-text

A real-world stepped wedge cluster randomized trial of practice facilitation to improve cardiovascular care

Implementation Science ◽

10.1186/s13012-015-0341-y ◽

2015 ◽

Vol 10 (1) ◽

Cited By ~ 26

Author(s):

Clare Liddy ◽

William Hogg ◽

Jatinderpreet Singh ◽

Monica Taljaard ◽

Grant Russell ◽

...

Keyword(s):

Randomized Trial ◽

Real World ◽

Cluster Randomized Trial ◽

Practice Facilitation ◽

Stepped Wedge ◽

Cluster Randomized ◽

Cardiovascular Care

Download Full-text

Digital Adherence Technology for Tuberculosis Treatment Supervision: A Stepped-Wedge Cluster Randomized Trial

SSRN Electronic Journal ◽

10.2139/ssrn.3749223 ◽

2020 ◽

Author(s):

Adithya Cattamanchi ◽

Rebecca R. Crowder ◽

Alex Kityamuwesi ◽

Noah Kiwanuka ◽

Maureen Lamunu ◽

...

Keyword(s):

Randomized Trial ◽

Cluster Randomized Trial ◽

Tuberculosis Treatment ◽

Stepped Wedge ◽

Cluster Randomized

Download Full-text

RACE-IT – Rapid Acute Coronary Syndrome Exclusion using the Beckman Coulter Access high-sensitivity cardiac troponin I: A stepped-wedge cluster randomized trial

Contemporary Clinical Trials Communications ◽

10.1016/j.conctc.2021.100773 ◽

2021 ◽

pp. 100773

Author(s):

Joseph Miller ◽

Bernard Cook ◽

Gulmohar Singh-Kucukarslan ◽

Amy Tang ◽

Shooshan Danagoulian ◽

...

Keyword(s):

Acute Coronary Syndrome ◽

Randomized Trial ◽

Cardiac Troponin ◽

Troponin I ◽

High Sensitivity ◽

Cluster Randomized Trial ◽

Cardiac Troponin I ◽

Stepped Wedge ◽

Coronary Syndrome ◽

Cluster Randomized

Download Full-text

On the centrosymmetry of treatment effect estimators for stepped wedge and related cluster randomized trial designs

Statistics & Probability Letters ◽

10.1016/j.spl.2020.109022 ◽

2021 ◽

Vol 172 ◽

pp. 109022

Author(s):

Rhys Bowden ◽

Andrew B. Forbes ◽

Jessica Kasza

Keyword(s):

Randomized Trial ◽

Treatment Effect ◽

Cluster Randomized Trial ◽

Stepped Wedge ◽

Cluster Randomized

Download Full-text

Spread and scale of an electronic deprescribing software to improve health outcomes of older adults living in nursing homes: study protocol for a stepped wedge cluster randomized trial

Trials ◽

10.1186/s13063-021-05729-0 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Marc-Eric Nadeau ◽

Justine L. Henry ◽

Todd C. Lee ◽

Émilie Bortolussi-Courval ◽

Carole Goodine ◽

...

Keyword(s):

Older Adults ◽

Randomized Trial ◽

Study Design ◽

Long Term Care ◽

Cluster Randomized Trial ◽

Stepped Wedge ◽

Term Care ◽

Medication Reviews ◽

Cluster Randomized

Abstract Background Medication overload or problematic polypharmacy is a major problem causing widespread harm, particularly to older adults. Taking multiple medications increases the risk of potentially inappropriate medications (PIMs), and residents in long-term care (LTC) are frequently prescribed 10 or more medications at once. One strategy to address this problem is for the physician and/or pharmacist to perform regular medication reviews; however, this process can be complicated and time-consuming. With a prescription review, medications may be decreased, changed, or stopped altogether. MedReviewRx is a software that runs an analysis using deprescribing rules to produce a report to guide medication reviews addressing medication overload for residents in LTC. Methods This study will employ a mixed methods effectiveness-implementation hybrid type 2 study design. To measure effectiveness, a stepped wedge cluster randomized trial design is planned, which allows us to approximate a randomized clinical trial. Approximately 1000 residents living in LTC will be recruited from five facilities in New Brunswick. The study will begin with 3 months of baseline data on rates of deprescribing. Thereafter, every 3 months a new cluster will enter the intervention mode. The intervention consists of medication reviews augmented with the MedReviewRx software, which will be used by staff and clinicians in the facilities. The estimated study duration is 18 months and the main outcome will be the proportion of patients with one or more PIMs deprescribed (reduced/stopped or changed to a safer alternative) in the 90 days following a prescription review. The goal is to study the impact of MedReviewRx on medication overload among older adults living in LTC. In typical fashion of a stepped wedge cluster randomized trial, each cluster acts as an internal control (before and after) as well as a control for the other clusters (external control). Qualitative data collected will include resident/caregiver attitudes towards deprescribing and semi-structured interviews with staff working in the long-term care homes. Discussion This study design addresses issues with seasonality and allows all clusters to participate in the intervention, which is an advantage when the intervention is related to quality improvement. This study will provide valuable information on PIM use, cost savings, and facilitators and challenges associated with medication reviews and deprescribing. This study represents an important step towards understanding and promoting tools to guide safe and rational reduction of PIM use among older adults. Trial registration NCT04762303, Registered February 21, 2021.

Download Full-text