scholarly journals Optimizing the efficiency and implementation of cash transfers to improve adherence to antiretroviral therapy: study protocol for a cluster randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Laura Packel ◽  
Prosper Njau ◽  
Carolyn Fahey ◽  
Angela Ramadhani ◽  
William H. Dow ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Cash Transfers ◽  
Cash Transfer ◽  
Hiv Care ◽  
Effective Strategy ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone region, Tanzania. Methods We will conduct a type I hybrid implementation–effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with a mobile health technology (mHealth) system. Specifically, our team will expand the intervention to 32 clinics and enroll 1984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic). Discussion This trial will provide evidence not only about the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond. Trial registration ClinicalTrials.gov NCT04201353. Registered on December 17, 2019

scholarly journals Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy: Study Protocol for A Cluster Randomized Controlled Trial

2020 ◽  
Author(s):  
Laura Packel ◽  
Prosper Njau ◽  
Carolyn Fahey ◽  
Angela Ramadhani ◽  
William H Dow ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Cash Transfers ◽  
Cash Transfer ◽  
Hiv Care ◽  
Effective Strategy ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background: Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone Region, Tanzania.Methods: We will conduct a type I hybrid implementation – effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with an mobile health technology (mHealth) system. Specifically, our team will expand the intervention to 32 clinics and enroll 1,984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome; and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic).Discussion: This trial will provide evidence about not only the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.

scholarly journals Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy: Study Protocol for A Cluster Randomized Controlled Trial

2020 ◽  
Author(s):  
Laura Packel ◽  
Prosper Njau ◽  
Carolyn Fahey ◽  
Angela Ramadhani ◽  
William H Dow ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Cash Transfers ◽  
Cash Transfer ◽  
Hiv Care ◽  
Effective Strategy ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background: Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone Region, Tanzania.Methods: We will conduct a type I hybrid implementation – effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with an mobile health technology (mHealth) system through measurement of implementation science constructs. Specifically, our team will expand the intervention to 32 clinics and enroll 1,984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome; and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic).Discussion: This trial will provide evidence about not only the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.Trial Registration: Clinicaltrails.govRegistration Number: NCT04201353 Date of Registration: December 17th, 2019URL for Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04201353

scholarly journals Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy: A Cluster Randomized Controlled Trial (Study Protocol)

2020 ◽  
Author(s):  
Laura Packel ◽  
Prosper Njau ◽  
Carolyn Fahey ◽  
Angela Ramadhani ◽  
William H Dow ◽  
...  
Keyword(s):  
Viral Suppression ◽  
Controlled Trial ◽  
Scale Up ◽  
Cash Transfers ◽  
Cash Transfer ◽  
Hiv Care ◽  
Effective Strategy ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background : Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve outcomes along the HIV care continuum, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. Specifically, gaps exist in understanding: 1) whether short-term cash transfers can increase viral suppression in larger, effectiveness studies; and 2) an implementation model or set of best practices that facilitate scale up and enhance sustainability. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based implementation strategy to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone Region, Tanzania. Methods: We will conduct a type I hybrid implementation – effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with an mHealth system through measurement of implementation science constructs. Specifically, our team will expand the intervention to 32 clinics and enroll 1,984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome – a key indicator for monitoring progress towards HIV epidemic control; and (b) evaluate the implementation challenges and successes by measuring implementation outcomes at multiple levels (patient, provider, clinic). Discussion: This trial will provide evidence about not only the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.

scholarly journals Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy: Study Protocol for A Cluster Randomized Controlled Trial

2020 ◽  
Author(s):  
Laura Packel ◽  
Prosper Njau ◽  
Carolyn Fahey ◽  
Angela Ramadhani ◽  
William H Dow ◽  
...  
Keyword(s):  
Viral Suppression ◽  
Controlled Trial ◽  
Scale Up ◽  
Cash Transfers ◽  
Cash Transfer ◽  
Hiv Care ◽  
Effective Strategy ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background : Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve outcomes along the HIV care continuum, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. Specifically, gaps exist in understanding: 1) whether short-term cash transfers can increase viral suppression in larger, effectiveness studies; and 2) an implementation model or set of best practices that facilitate scale up and enhance sustainability. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based implementation strategy to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone Region, Tanzania.Methods: We will conduct a type I hybrid implementation – effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with an mHealth system through measurement of implementation science constructs. Specifically, our team will expand the intervention to 32 clinics and enroll 1,984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome – a key indicator for monitoring progress towards HIV epidemic control; and (b) evaluate the implementation challenges and successes by measuring implementation outcomes at multiple levels (patient, provider, clinic). Discussion: This trial will provide evidence about not only the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.

scholarly journals Integration of a task strengthening strategy for hypertension management into HIV care in Nigeria: a cluster randomized controlled trial study protocol

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Angela A. Aifah ◽  
Oluwatosin Odubela ◽  
Ashlin Rakhra ◽  
Deborah Onakomaiya ◽  
Jiyuan Hu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Implementation Strategy ◽  
Controlled Trial ◽  
Hiv Care ◽  
Hypertension Management ◽  
Hypertension Control ◽  
Implementation Phase ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract Background In regions with weak healthcare systems, critical shortages of the healthcare workforce, and increasing prevalence of dual disease burdens, there is an urgent need for the implementation of proven effective interventions and strategies to address these challenges. Our mixed-methods hybrid type II effectiveness-implementation study is designed to fill this evidence-to-practice gap. This study protocol describes a cluster randomized controlled trial which evaluates the effectiveness of an implementation strategy, practice facilitation (PF), on the integration, adoption, and sustainability of a task-strengthening strategy for hypertension control (TASSH) intervention within primary healthcare centers (PHCs) in Lagos State, Nigeria. Design Guided by the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM), this study tests the impact of a proven effective implementation strategy to integrate hypertension management into the HIV care cascade, across 30 PHCs. The study will be conducted in three phases: (1) a pre-implementation phase that will use CFIR to develop a tailored PF intervention for integrating TASSH into HIV clinics; (2) an implementation phase that will use RE-AIM to compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and (3) a post-implementation phase that will use RE-AIM to evaluate the effect of PF vs. self-directed condition on adoption and sustainability of TASSH. The PF intervention components comprise (a) an advisory board to provide leadership support for implementing TASSH in PHCs; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses. Discussion This study is one of few, if any trials, to evaluate the impact of an implementation strategy for integrating hypertension management into HIV care, on clinical and implementation outcomes. Findings from this study will advance implementation science research on the effectiveness of tailoring an implementation strategy for the integration of an evidence-based, system-level hypertension control intervention into HIV care and treatment. Trial registration ClinicalTrials.gov (NCT04704336). Registered on 11 January 2021.

scholarly journals Integration of a Task Strengthening Strategy for Hypertension Management into HIV Care in Nigeria: a Cluster Randomized Controlled Trial Study Protocol

2021 ◽  
Author(s):  
Angela Aifah ◽  
Oluwatosin Odubela ◽  
Ashlin Rakhra ◽  
Deborah Onakomaiya ◽  
Jiyuan Hu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Implementation Strategy ◽  
Controlled Trial ◽  
Hiv Care ◽  
Hypertension Management ◽  
Implementation Phase ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract BackgroundIn regions with weak healthcare systems, critical shortages of the healthcare workforce, and increasing prevalence of dual disease burdens, there is an urgent need for the implementation of proven effective interventions and strategies to address these challenges. Our mixed-methods hybrid type II effectiveness-implementation study is designed to fill this evidence-to-practice gap. This study protocol describes a cluster randomized controlled trial which evaluates the effectiveness of an implementation strategy, practice facilitation (PF), on the integration, adoption, and sustainability of a task-strengthening strategy for hypertension control (TASSH) intervention within primary healthcare centers (PHCs) in Lagos State, NigeriaDesignGuided by the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM), this study tests the impact of a proven effective implementation strategy to integrate hypertension management into the HIV care cascade, across 30 PHCs. The study will be conducted in three phases: 1) a pre-implementation phase that will use CFIR to develop a tailored PF intervention for integrating TASSH into HIV clinics; 2) an implementation phase that will use RE-AIM to compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and 3) a post-implementation phase that will use RE-AIM to evaluate the effect of PF vs. self-directed condition on adoption and sustainability of TASSH. The PF intervention components comprise: (a) an advisory board to provide leadership support for implementing TASSH in PHCs; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses.DiscussionThis study is the first trial to evaluate the impact of an implementation strategy for integrating hypertension management into HIV care, on clinical and implementation outcomes. Findings from this study will advance implementation science research on the effectiveness of tailoring an implementation strategy for the integration of an evidence-based, systems level hypertention control intervention into HIV care and treatment.Trial registrationClinicalTrials.gov (NCT04704336). Registered on 11 January 2021.

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