Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06129916
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-10-04
Brief Title:
Assessing the Acceptability Feasibility Effectiveness and Cost-effectiveness of LADB
Sponsor:
PATH
Organization:
PATH
Study Overview
Official Title:
Assessing the Acceptability Feasibility Effectiveness and Cost-effectiveness of Long-acting Depot Buprenorphine LADB for the Treatment of Opioid Dependence in Low- and Middle-income Countries LMIC a Multicentre International Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
None
Brief Summary:
The goal of the proposed study is to generate evidence on the acceptability feasibility effectiveness and cost-effectiveness of introducing long-acting depot buprenorphine LADB as an additional option for the treatment of opioid dependence in low- and middle-income countries LMIC among people who inject drugs PWID with opioid dependence The study results will be used to inform global and local policies and guidelines to introduce LADB as a treatment option and to advocate for access to a sustainable supply of LADB in LMIC
Detailed Description:
Despite the proven effectiveness of opioid agonist maintenance treatment OAMT its coverage and use remain low globally and particularly in low- and middle-income countries LMIC in part due to challenges related to limited choice of OAMT medication and dosing options The long-acting depot buprenorphine LADB formulation of OAMT with either weekly or monthly administration could provide a more discreet convenient and less stigmatizing form of treatment and the potential to improve client retention in care as well as economic stability It therefore may address unmet need among individuals who could benefit from OAMT and are not already taking it or who would prefer a long-acting option over current OAMT options Studies have demonstrated the effectiveness and acceptability of LADB among those with opioid dependence in high-income settings However there are no known such studies conducted in LMIC
The aim of the study is to determine the acceptability feasibility effectiveness public health impact and cost-effectiveness of introducing LADB in a range of LMIC
The study will collect data from participants with opioid use disorder service providers and health policymakersdecision-makers across seven diverse LMIC Egypt India Kyrgyzstan South Africa Tanzania Ukraine and Vietnam
This is a multicenter mixed-method study designed with community engagement and co-production The study consists of four interlinked modules Module 1 feasibility includes a process evaluation to monitor implementation and assess barriers drawing on program data and interviews with service providers and other key stakeholders Module 2 effectiveness involves a prospective cohort choice study among people with opioid dependence initiating LADB and following up over 48 weeks Module 3 values and preferences plus acceptability includes key informant interviews and focus group discussions with people with opioid dependence to understand overall acceptability values preferences experiences and concerns relating to LADB Module 4 public health impact and cost-effectiveness involves modeling based on collected data to estimate impact and cost-effectiveness of LADB in LMIC settings
The aim of the study is to determine the acceptability feasibility effectiveness public health impact and cost-effectiveness of introducing LADB in a range of LMIC
The study will collect data from participants with opioid use disorder service providers and health policymakersdecision-makers across seven diverse LMIC Egypt India Kyrgyzstan South Africa Tanzania Ukraine and Vietnam
This is a multicenter mixed-method study designed with community engagement and co-production The study consists of four interlinked modules Module 1 feasibility includes a process evaluation to monitor implementation and assess barriers drawing on program data and interviews with service providers and other key stakeholders Module 2 effectiveness involves a prospective cohort choice study among people with opioid dependence initiating LADB and following up over 48 weeks Module 3 values and preferences plus acceptability includes key informant interviews and focus group discussions with people with opioid dependence to understand overall acceptability values preferences experiences and concerns relating to LADB Module 4 public health impact and cost-effectiveness involves modeling based on collected data to estimate impact and cost-effectiveness of LADB in LMIC settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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