Integrating PrEP delivery in public health family planning clinics: a protocol for a pragmatic stepped wedge cluster randomized trial in Kenya

Abstract Background 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. Methods 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. Discussion 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

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Integrating PrEP Delivery in Public Health Family Planning Clinics: A Protocol for a Pragmatic Stepped Wedge Cluster Randomized Trial in Kenya

10.21203/rs.3.rs-889587/v1 ◽

2021 ◽

Author(s):

Kenneth K Mugwanya ◽

Daniel Matemo ◽

Caitlin W Scoville ◽

Kristin M Beima-Sofie ◽

Allison Meisner ◽

...

Keyword(s):

Public Health ◽

Family Planning ◽

Hiv Prevention ◽

Randomized Trial ◽

Implementation Science ◽

Hiv Risk ◽

Cluster Randomized Trial ◽

Stepped Wedge ◽

Clinic Staff ◽

Cluster Randomized

Abstract Background: 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.Methods: 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.Discussion: 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.

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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

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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

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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

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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.

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