Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501781
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-02
Brief Title:
Peer Behavioral Activation Utilization to Address Structural Racism and Discrimination and Improve HIV Outcomes in High-Risk Substance-Using Populations
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Peer Behavioral Activation Utilization to Address Structural Racism and Discrimination and Improve HIV Outcomes in High-Risk Substance-Using Populations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
PUSH
Brief Summary:
This randomized Type 1 hybrid effectiveness-implementation trial N186 will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEPART Peer Activate-LAI compared to enhanced treatment as usual ETAU for a largely Black substance-using population living with or at high risk for HIV Specific aims are to
Aim 1 Evaluate the effectiveness of Peer Activate-LAI over 12-months on a LAI-PrEPART adherence primary receipt of all 6 maintenance injections within 7-day window and b substance use secondary WHOASSIST urine toxicology and c Explore the moderating role of SRD-related factors exploratory
Aim 2 To evaluate the implementation of Peer Activate-LAI including feasibility acceptability fidelity and adoption guided by RE-AIM and Proctors model1213 assessed using mixed methods including a rapid ethnographic assessment of how SRD-related factors may affect implementation
Aim 3 To evaluate the economic viability of Peer Activate-LAI including a cost of implementation and sustainment and b cost-effectiveness from multiple stakeholder perspectives
This study will inform a potentially scalable cost-effective model for facilitating effective adherence to LAI formulations of PrEPART within Black substance-using populations with multiple minority identities who to date have had limited support for improving LAI adherence for HIV treatment and prevention
Aim 1 Evaluate the effectiveness of Peer Activate-LAI over 12-months on a LAI-PrEPART adherence primary receipt of all 6 maintenance injections within 7-day window and b substance use secondary WHOASSIST urine toxicology and c Explore the moderating role of SRD-related factors exploratory
Aim 2 To evaluate the implementation of Peer Activate-LAI including feasibility acceptability fidelity and adoption guided by RE-AIM and Proctors model1213 assessed using mixed methods including a rapid ethnographic assessment of how SRD-related factors may affect implementation
Aim 3 To evaluate the economic viability of Peer Activate-LAI including a cost of implementation and sustainment and b cost-effectiveness from multiple stakeholder perspectives
This study will inform a potentially scalable cost-effective model for facilitating effective adherence to LAI formulations of PrEPART within Black substance-using populations with multiple minority identities who to date have had limited support for improving LAI adherence for HIV treatment and prevention
Detailed Description:
Background Substance use continues to be a major driver of HIV acquisition and has been associated with suboptimal ART adherence treatment interruption and inability to achieve or maintain viral suppression Use of PrEP a key tool for HIV prevention is disproportionately lower in racialethnic minorities as well as people who inject drugs Factors related to structural racism and discrimination SRD may contribute to low rates of adherence in these populations New long-acting injectable LAI formulations of PrEPART provide a potential biomedical intervention to overcome adherence challenges however due to the prolonged subtherapeutic period after LAI discontinuation ensuring adherence is crucial
A peer-delivered reinforcement-based intervention may be a promising solution for improving LAI adherence Our team has developed through several rounds of stakeholder feedback a peer-delivered behavioral activation and problem-solving intervention Peer Activate Peer Activate focuses on problem-solving skills to improve adherence to ART andor PrEP both at the individual level and socialstructural barriers to care ie transportation housing and includes behavioral activation to promote engagement in rewarding substance-free activities in ones environment and structured daily activities to promote treatment adherence Delivery by a peer with formal training and shared lived experiences enhances the impact of the intervention on SRD-related factors However Peer Activate has not been evaluated in the context of LAI PrEPART
Preliminary Studies This proposal builds upon our teams prior studies demonstrating 1 our ability to engage patients with and at risk for HIV facing multiple barriers due to SRD and provide LAI PrEPART in community-based settings 2 the feasibility and acceptability of Peer Activate and promise in improving HIV treatment adherence for people who use substances and 3 promise for cost-effectiveness
Approach We propose a randomized Type 1 hybrid effectiveness-implementation trial N186 to test the effectiveness and implementation of Peer Activate for LAI PrEPART Peer Activate-LAI vs enhanced treatment as usual for a predominantly Black substance using population living with or at high risk for HIV evaluating the following over 12 months
1 effectiveness a LAI PrEPART adherence primary receipt of all 6 maintenance injections within 7-day window b substance use secondary urine toxicology self-report c SRD as moderators of effectiveness exploratory
2 Implementation of Peer Activate-LAI including feasibility acceptability fidelity and adoption guided by RE-AIM and Proctors model910 assessed using mixed methods including a rapid ethnographic assessment of how SRD-related factors may affect implementation and
3 Economic viability of Peer Activate-LAI including cost of implementation and sustainment and cost-effectiveness from multiple stakeholder perspectives Implications
This study will inform a potentially scalable cost-effective model for facilitating effective adherence to LAI formulations of ARTPrEP within Black substance using populations who to date have had limited support for improving LAI adherence for HIV ARTPrEP
A peer-delivered reinforcement-based intervention may be a promising solution for improving LAI adherence Our team has developed through several rounds of stakeholder feedback a peer-delivered behavioral activation and problem-solving intervention Peer Activate Peer Activate focuses on problem-solving skills to improve adherence to ART andor PrEP both at the individual level and socialstructural barriers to care ie transportation housing and includes behavioral activation to promote engagement in rewarding substance-free activities in ones environment and structured daily activities to promote treatment adherence Delivery by a peer with formal training and shared lived experiences enhances the impact of the intervention on SRD-related factors However Peer Activate has not been evaluated in the context of LAI PrEPART
Preliminary Studies This proposal builds upon our teams prior studies demonstrating 1 our ability to engage patients with and at risk for HIV facing multiple barriers due to SRD and provide LAI PrEPART in community-based settings 2 the feasibility and acceptability of Peer Activate and promise in improving HIV treatment adherence for people who use substances and 3 promise for cost-effectiveness
Approach We propose a randomized Type 1 hybrid effectiveness-implementation trial N186 to test the effectiveness and implementation of Peer Activate for LAI PrEPART Peer Activate-LAI vs enhanced treatment as usual for a predominantly Black substance using population living with or at high risk for HIV evaluating the following over 12 months
1 effectiveness a LAI PrEPART adherence primary receipt of all 6 maintenance injections within 7-day window b substance use secondary urine toxicology self-report c SRD as moderators of effectiveness exploratory
2 Implementation of Peer Activate-LAI including feasibility acceptability fidelity and adoption guided by RE-AIM and Proctors model910 assessed using mixed methods including a rapid ethnographic assessment of how SRD-related factors may affect implementation and
3 Economic viability of Peer Activate-LAI including cost of implementation and sustainment and cost-effectiveness from multiple stakeholder perspectives Implications
This study will inform a potentially scalable cost-effective model for facilitating effective adherence to LAI formulations of ARTPrEP within Black substance using populations who to date have had limited support for improving LAI adherence for HIV ARTPrEP
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