Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03135886
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2017-04-26
Brief Title:
Project I Test Implementing HIV Testing in Opioid Treatment Programs
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This study will test two active evidence-based practice coaching PC interventions to improve opioid treatment programs OTPs provision and sustained implementation of on-site 1 HIV testing and linkage to care and 2 HIVHepatitis C virus HCV testing and linkage to care among patients seekingreceiving substance use disorder treatment
Aims are
Aim 1 To evaluate the effectiveness of the PC interventions on improving patient uptake of HIV testing in OTPs including the incremental impact of the HIVHCV intervention on HIV testing
Aim 2 To examine using mixed-methods the impact of the PC interventions on the initiation and sustained provision of HIV testing and timely linkage to care
Aim 3 To evaluate the health outcomes health care utilization and cost-effectiveness of the PC interventions compared incrementally to one another and to the control condition
Primary Hypothesis
1 The two PC interventions will result in significantly higher proportions of patients tested for HIV than the information control condition during the initial impact period 7-12 months post-randomization or T3 controlling for the proportion of patients tested during the baseline period T1 Primary and during the sustained impact period 13-18 months post-randomization or T4 Secondary
2 The HIVHCV PC intervention will result in significantly higher proportions of patients tested for HIV than the HIV PC intervention during the initial impact period 7-12 months post-randomization or T3 controlling for the proportion of patients tested during the baseline period T1 Secondary and during the sustained impact period 13-18 months post-randomization or T4 Secondary
Aims are
Aim 1 To evaluate the effectiveness of the PC interventions on improving patient uptake of HIV testing in OTPs including the incremental impact of the HIVHCV intervention on HIV testing
Aim 2 To examine using mixed-methods the impact of the PC interventions on the initiation and sustained provision of HIV testing and timely linkage to care
Aim 3 To evaluate the health outcomes health care utilization and cost-effectiveness of the PC interventions compared incrementally to one another and to the control condition
Primary Hypothesis
1 The two PC interventions will result in significantly higher proportions of patients tested for HIV than the information control condition during the initial impact period 7-12 months post-randomization or T3 controlling for the proportion of patients tested during the baseline period T1 Primary and during the sustained impact period 13-18 months post-randomization or T4 Secondary
2 The HIVHCV PC intervention will result in significantly higher proportions of patients tested for HIV than the HIV PC intervention during the initial impact period 7-12 months post-randomization or T3 controlling for the proportion of patients tested during the baseline period T1 Secondary and during the sustained impact period 13-18 months post-randomization or T4 Secondary
Detailed Description:
Using the most recent National Survey of Substance Abuse Treatment Services N-SSATS data available from the Substance Abuse and Mental Health Services Administration SAMHSA as the sampling frame 51 sites will be randomly selected to participate in the study Site randomization to condition will occur on a rolling basis Selected sites will be invited to participate in the study and randomly assigned to one of the three intervention conditions 17 sites per condition -- information control HIV PC and HIVHCV PC The control condition will be an HIV testing informational product consisting of the official NIDASAMHSA Blending Initiative product HIV Rapid Testing in Substance Abuse Treatment Programs ARTAS intervention information and Pre-Exposure Prophylaxis PrEP information that will be provided to OTPs to educate and motivate them about the importance of offering on-site HIV testing and linkage to care In the active PC conditions champions and key OTP staff will be provided coaching and support for the implementation of an innovation ie offering HIV testing on-site and linking persons living with HIV to care and for sustaining resulting improvements in testing
De-identified aggregate client data on HIV and HCV testing and linkage to care will be provided by the sites for four 6-month-long time intervals T1 up to 6 months prior to randomization T2 during the interventioncontrol period up to 6 months post-randomziation T3 7-12 months post-randomization and T4 13-18 months post-randomization Qualitative and quantitative site-level data will also be collected immediately preceding randomization and again during interval T3
De-identified aggregate client data on HIV and HCV testing and linkage to care will be provided by the sites for four 6-month-long time intervals T1 up to 6 months prior to randomization T2 during the interventioncontrol period up to 6 months post-randomziation T3 7-12 months post-randomization and T4 13-18 months post-randomization Qualitative and quantitative site-level data will also be collected immediately preceding randomization and again during interval T3
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA043130 | NIH | None | httpsreporternihgovquickSearchR01DA043130 |