Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03438370
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2017-08-01
Brief Title:
Outcomes of Differentiated Models of Antiretroviral Treatment ART Provision
Sponsor:
Equip Lesotho
Organization:
Equip Lesotho
Study Overview
Official Title:
Outcomes of Differentiated Models of Antiretroviral Treatment ART Provision Multi-Month Dispensing MMD of ART in Community ART Distribution for Stable HIV Infected Patients
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MMD
Brief Summary:
The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients The objectives are to measure patient retention virological suppression provider and patient costs cost-effectiveness and patient acceptability amongst stable patients who receive ART at intervals of three and six months within community distribution models and to compare these to patients who receive ART directly from the clinic at three month intervals
Methods
A prospective parallel cluster-randomized non-inferiority trial with three study arms will be conducted 30 Clusters sites will be randomized in strata according to geographic location urban and rural to the 3 study arms as follows
Control arm sites at which patients will receive three monthly ART supply at the facility arm 3MF
Intervention arm 1 sites at which patients will receive three monthly ART supply in CAGs arm 3MC
Intervention arm 2 sites at which patients will receive six monthly ART supply in the community by a healthcare worker arm 6MCD
The study population will consist of stable HIV-infected adults who have received first-line ART for at least six months who have a viral load 1000 copiesml at baseline and who provide informed consent for inclusion in the study An average of 192 participants from each study site will be included with a total sample size of approximately 5760 participants
The primary outcome is retention in care defined as the proportion of patients remaining in care 12 months after study enrolment with the hypothesis that patient retention within the intervention arms will be non-inferior compared to the control arm Retention in care will also be compared between the three arms after 24 months
The secondary outcomes are
Viral suppression defined as the proportion of patients with virological suppression 1000 copiesml 12 and 24 months after study enrolment
Cost of providing ART defined as the cost per patient of providing ART in each of the three arms from a provider perspective
Cost of retaining a patient defined as the provider cost per patient retained and provider cost per patient retained with virological suppression in each of the three arms and the incremental cost-effectiveness ratio for the comparative arms
Methods
A prospective parallel cluster-randomized non-inferiority trial with three study arms will be conducted 30 Clusters sites will be randomized in strata according to geographic location urban and rural to the 3 study arms as follows
Control arm sites at which patients will receive three monthly ART supply at the facility arm 3MF
Intervention arm 1 sites at which patients will receive three monthly ART supply in CAGs arm 3MC
Intervention arm 2 sites at which patients will receive six monthly ART supply in the community by a healthcare worker arm 6MCD
The study population will consist of stable HIV-infected adults who have received first-line ART for at least six months who have a viral load 1000 copiesml at baseline and who provide informed consent for inclusion in the study An average of 192 participants from each study site will be included with a total sample size of approximately 5760 participants
The primary outcome is retention in care defined as the proportion of patients remaining in care 12 months after study enrolment with the hypothesis that patient retention within the intervention arms will be non-inferior compared to the control arm Retention in care will also be compared between the three arms after 24 months
The secondary outcomes are
Viral suppression defined as the proportion of patients with virological suppression 1000 copiesml 12 and 24 months after study enrolment
Cost of providing ART defined as the cost per patient of providing ART in each of the three arms from a provider perspective
Cost of retaining a patient defined as the provider cost per patient retained and provider cost per patient retained with virological suppression in each of the three arms and the incremental cost-effectiveness ratio for the comparative arms
Detailed Description:
Background In 2015 sub-Saharan Africa was still the region most affected by the HIV epidemic with 256 231-285 million people living with HIV in 2015 It is estimated that 42 of all people living with HIV PLHIV in Lesotho were receiving ART by 2015The United States Governments Presidents Emergency Plan for AIDS Relief PEPFAR has adopted the goals of 90-90-90 from UNAIDS and is supporting a swift implementation of the new World Health OrganizationsTest and Start guidelinesWith these goals PEPFAR also sets out to reduce new infections by 75 and to attain zero discrimination and stigma for all PLHIV
To assist countries to reach the goal of universal coverage EQUIP Innovation for health a new field support award from the USAID Office of HIV and AIDS that supports innovations in HIV clinical and community-based HIV treatment related services is evaluating communitybased care treatment and support models to create an enabling environment for massive scale-up of ART delivery and adherence support Based on this background EQUIP and and Elizabeth Glaser Pediatric AIDS Foundation EGPAF propose to conduct operational research that seeks to understand and measure the effectiveness of implementing a package of services that include multi-month dispensing MMD of ART drugs Community ART distribution models through Community ART Groups CAGs and Community Distribution points and routine viral load monitoring of stable patients in communities of PEPFARUSAID Lesotho scale-up districts
The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients The objectives are to measure patient retention virological suppression provider and patient costs cost-effectiveness and patient acceptability amongst stable patients who receive ART at intervals of three and six months within community distribution models and to compare these to patients who receive ART directly from the clinic at three month intervals
Methods
A prospective parallel cluster-randomized non-inferiority trial with three study arms will be conducted 30 Clusters sites will be randomized in strata according to geographic location urban and rural to the 3 study arms as follows
Control arm sites at which patients will receive three monthly ART supply at the facility arm 3MF
Intervention arm 1 sites at which patients will receive three monthly ART supply in CAGs arm 3MC
Intervention arm 2 sites at which patients will receive six monthly ART supply in the community by a healthcare worker arm 6MCD
Sites for inclusion in the study will be selected at which it is deemed to be feasible to implement multi-month dispensing of ART in the community
The study population will consist of stable HIV-infected adults who have received first-line ART for at least six months who have a viral load 1000 copiesml at baseline and who provide informed consent for inclusion in the study An average of 192 participants from each study site will be included with a total sample size of approximately 5760 participants For those sites randomized to the 3MC arm enrolled participants will be part of a CAG for the duration of the study For those sites randomized to the 6MCD arm enrolled participants will be dispensed a 6-month supply of ART in the community by a healthcare worker in between their annual clinical assessments All participants will have a clinical assessment and viral load testing at the clinic at least annually and participants will be followed-up for 24 months after enrolment
The primary outcome is retention in care defined as the proportion of patients remaining in care 12 months after study enrolment with the hypothesis that patient retention within the intervention arms will be non-inferior compared to the control arm Retention in care will also be compared between the three arms after 24 months
The secondary outcomes are
Viral suppression defined as the proportion of patients with virological suppression 1000 copiesml 12 and 24 months after study enrolment
Cost of providing ART defined as the cost per patient of providing ART in each of the three arms from a provider perspective
Cost of retaining a patient defined as the provider cost per patient retained and provider cost per patient retained with virological suppression in each of the three arms and the incremental cost-effectiveness ratio for the comparative arms
Qualitative research will include assessing the acceptability of multi-month dispensing of ART within CAGs and the community from both a patient and healthcare provider perspective Costs to patients will be compared between the three arms from data derived from patient surveys In addition indicators of potential facility level decongestion will be compared between arms which will include the median facility patient waiting time and average monthly number of patients newly initiated on ART with data derived from site surveys and routine facility-level data
This study will follow the ethical considerations specified by the Lesotho National Health Research and Ethics Committee
The results of the study are expected to inform health policy both nationally and regionally regarding the effectiveness of implementing a package of services consisting of MMD within CAGs and community distribution together with viral load monitoring for stable ART patients
To assist countries to reach the goal of universal coverage EQUIP Innovation for health a new field support award from the USAID Office of HIV and AIDS that supports innovations in HIV clinical and community-based HIV treatment related services is evaluating communitybased care treatment and support models to create an enabling environment for massive scale-up of ART delivery and adherence support Based on this background EQUIP and and Elizabeth Glaser Pediatric AIDS Foundation EGPAF propose to conduct operational research that seeks to understand and measure the effectiveness of implementing a package of services that include multi-month dispensing MMD of ART drugs Community ART distribution models through Community ART Groups CAGs and Community Distribution points and routine viral load monitoring of stable patients in communities of PEPFARUSAID Lesotho scale-up districts
The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients The objectives are to measure patient retention virological suppression provider and patient costs cost-effectiveness and patient acceptability amongst stable patients who receive ART at intervals of three and six months within community distribution models and to compare these to patients who receive ART directly from the clinic at three month intervals
Methods
A prospective parallel cluster-randomized non-inferiority trial with three study arms will be conducted 30 Clusters sites will be randomized in strata according to geographic location urban and rural to the 3 study arms as follows
Control arm sites at which patients will receive three monthly ART supply at the facility arm 3MF
Intervention arm 1 sites at which patients will receive three monthly ART supply in CAGs arm 3MC
Intervention arm 2 sites at which patients will receive six monthly ART supply in the community by a healthcare worker arm 6MCD
Sites for inclusion in the study will be selected at which it is deemed to be feasible to implement multi-month dispensing of ART in the community
The study population will consist of stable HIV-infected adults who have received first-line ART for at least six months who have a viral load 1000 copiesml at baseline and who provide informed consent for inclusion in the study An average of 192 participants from each study site will be included with a total sample size of approximately 5760 participants For those sites randomized to the 3MC arm enrolled participants will be part of a CAG for the duration of the study For those sites randomized to the 6MCD arm enrolled participants will be dispensed a 6-month supply of ART in the community by a healthcare worker in between their annual clinical assessments All participants will have a clinical assessment and viral load testing at the clinic at least annually and participants will be followed-up for 24 months after enrolment
The primary outcome is retention in care defined as the proportion of patients remaining in care 12 months after study enrolment with the hypothesis that patient retention within the intervention arms will be non-inferior compared to the control arm Retention in care will also be compared between the three arms after 24 months
The secondary outcomes are
Viral suppression defined as the proportion of patients with virological suppression 1000 copiesml 12 and 24 months after study enrolment
Cost of providing ART defined as the cost per patient of providing ART in each of the three arms from a provider perspective
Cost of retaining a patient defined as the provider cost per patient retained and provider cost per patient retained with virological suppression in each of the three arms and the incremental cost-effectiveness ratio for the comparative arms
Qualitative research will include assessing the acceptability of multi-month dispensing of ART within CAGs and the community from both a patient and healthcare provider perspective Costs to patients will be compared between the three arms from data derived from patient surveys In addition indicators of potential facility level decongestion will be compared between arms which will include the median facility patient waiting time and average monthly number of patients newly initiated on ART with data derived from site surveys and routine facility-level data
This study will follow the ethical considerations specified by the Lesotho National Health Research and Ethics Committee
The results of the study are expected to inform health policy both nationally and regionally regarding the effectiveness of implementing a package of services consisting of MMD within CAGs and community distribution together with viral load monitoring for stable ART patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None