Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Contingency Management in HIV Care for Both Stimulant Use ART Adherence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CoMBo Study Contingency Management for Both HIV And Stimulant Use in Primary Care
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoMBo
Brief Summary:
Methamphetamine use and associated sequelae have been rising and represent a major barrier to successful control of the HIV epidemic Methamphetamine use is associated with poor adherence to antiretroviral therapy for HIV and we propose a trial of contingency management providing incentives for behavioral change targeting both reduced methamphetamine use and improved adherence to HIV medications We will utilize a real-time point-of-care urine assay for both outcomes aiming to evaluate feasibility acceptability and preliminary effectiveness of HIV care-based contingency management We will also study hair levels as a quantitative outcome for reduction in methamphetamine use
Detailed Description:
Methamphetamine MA use is increasing in the United States along with a sharp rise in overdose deaths MA use is particularly prevalent among people with HIV PWH which can contribute to non-adherence to antiretroviral therapy ART and progression to AIDS Contingency management CM is an evidence-based intervention that has repeatedly demonstrated efficacy in stimulant use disorder treatment and has also proved efficacious in improving ART adherence for those in care Since uptake of CM outside of formal drug treatment programs has been limited incorporating CM into HIV primary care is an important opportunity to expand access to treatment for MA use disorder while also supporting ART adherence
This study addresses two barriers that have each limited outward expansion of CM into HIV primary care 1 feasibility challenges for CM in clinical practice settings as CM is traditionally delivered 2-3x weekly this study explores a de-intensified CM schedule eg once weekly visits in HIV primary care and 2 CM for ART adherence has been previously limited by the inaccuracy of indirect or non-timely measures of adherence
The study utilizes a novel point-of-care urine tenofovir assay to perform POC testing on the same urine specimen for both ART use and MA non-use enabling a truly paired CM intervention that addresses the following aims 1 a pilot RCT evaluating feasibility of de-intensified once weekly combined contingency management for reducing MA use and increasing ART adherence in HIV primary care compared to conventional twice weekly CM 2 in-depth interviews following RCT completion to qualitatively explore the acceptability of this intervention to participants and their primary care providers and 3 given incomplete ability to detect cumulative MA use with only once weekly urine testing we will study the correlation between monthly MA hair levels with monthly Timeline Followback interviews to validate use of hair MA levels to be able to quantitatively detect reduced use in addition to abstinence as a future study outcome
This study addresses two barriers that have each limited outward expansion of CM into HIV primary care 1 feasibility challenges for CM in clinical practice settings as CM is traditionally delivered 2-3x weekly this study explores a de-intensified CM schedule eg once weekly visits in HIV primary care and 2 CM for ART adherence has been previously limited by the inaccuracy of indirect or non-timely measures of adherence
The study utilizes a novel point-of-care urine tenofovir assay to perform POC testing on the same urine specimen for both ART use and MA non-use enabling a truly paired CM intervention that addresses the following aims 1 a pilot RCT evaluating feasibility of de-intensified once weekly combined contingency management for reducing MA use and increasing ART adherence in HIV primary care compared to conventional twice weekly CM 2 in-depth interviews following RCT completion to qualitatively explore the acceptability of this intervention to participants and their primary care providers and 3 given incomplete ability to detect cumulative MA use with only once weekly urine testing we will study the correlation between monthly MA hair levels with monthly Timeline Followback interviews to validate use of hair MA levels to be able to quantitatively detect reduced use in addition to abstinence as a future study outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None