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Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Primary Purpose

HIV/AIDS, Hepatitis C, Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Information Control
HIV and HCV Testing Practice Coaching Intervention
HIV Testing Practice Coaching Intervention
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring HIV, HIV Testing, Hepatitis C Virus Testing, Opioid Use Disorder Treatment, Substance Use Disorders Treatment, Hepatitis C Virus, Practice Coaching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Eligible sites must:

    1. See at least 150 unduplicated patients/year/site
    2. Be capable and willing to prospectively collect data on the number of patients who a) are offered any HIV and/or HCV tests; b) completed these tests; c) are referred to care/evaluation (and type of referral) if positive; and d) are linked to care/evaluation within 30 days of diagnosis
    3. Be capable and willing to provide patient demographics, testing data within demographic categories of gender and race/ethnicity (in aggregate) and data on HIV/HCV test reimbursement processes and outcomes
    4. Have key staff willing to consent to participate in study surveys, qualitative interviews and intervention coaching throughout the study

Exclusion Criteria:

  • Sites will be excluded if:

    1. Over 50% of patients served in the prior 6 months were HIV or HCV tested
    2. They are terminated via PI decision/discretion

Sites / Locations

  • Columbia University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

HIV Testing Practice Coaching Intervention Group

HIV and HCV Testing Practice Coaching Intervention Group

Information Control Group

Arm Description

The HIV Testing Practice Coaching (PC) Intervention is designed to improve the provision and sustained implementation of on-site HIV testing and linkage to care among OTP patients.

The HIV and HCV Testing Practice Coaching (PC) Intervention will leverage the HIV PC intervention and follow the same interventional steps described above, and, in addition, provide information and training to support joint HIV/HCV testing and linkage to care among OTP patients.

The administrators of OTPs assigned to the control condition will receive a website link to and hard copy of the NIDA/SAMHSA Blending Initiative product for HIV rapid testing.

Outcomes

Primary Outcome Measures

Proportion of OTP patients HIV tested at 6 months post intervention or control, while controlling for HIV testing during the baseline period (T1)
The primary outcome measure will be a contrast of the proportion of OTP patients HIV tested during T3, controlling for HIV testing at baseline (T1). The primary test will be whether the proportion of patients tested across the two PC interventions--HIV Testing PC Intervention Group and HIV/HCV Testing PC Intervention Group--differs from the proportion of patients tested in the Information Control Group.

Secondary Outcome Measures

Proportion of OTP patients HIV tested at 12 months post intervention or control
The secondary outcome measure will be the proportion of OTP patients HIV tested during T4, controlling for HIV testing at baseline (T1). One test will be whether the proportion of patients tested across the two PC interventions--HIV Testing PC Intervention Group and HIV/HCV Testing PC Intervention Group--differs from the proportion of patients tested in the Information Control Group. A second test will be whether the proportion of OTP patients HIV tested during T4 in the HIV Testing PC Intervention Group differs from the proportion of patients tested in the HIV/HCV Testing PC Intervention Group.

Full Information

First Posted
April 26, 2017
Last Updated
June 16, 2023
Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, University of Miami, Johns Hopkins University, Boston Medical Center, Research Foundation for Mental Hygiene, Inc., San Francisco Department of Public Health, Aspire Health Partners
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1. Study Identification

Unique Protocol Identification Number
NCT03135886
Brief Title
Project I Test: Implementing HIV Testing in Opioid Treatment Programs
Official Title
A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, University of Miami, Johns Hopkins University, Boston Medical Center, Research Foundation for Mental Hygiene, Inc., San Francisco Department of Public Health, Aspire Health Partners

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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) HIV/Hepatitis C virus (HCV) testing and linkage to care among patients seeking/receiving 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 HIV/HCV 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: 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). The HIV/HCV 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 HIV/HCV PC. The control condition will be an HIV testing informational product consisting of the official NIDA/SAMHSA 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 (i.e., 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 intervention/control 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Hepatitis C, Substance Use Disorders, Opioid-use Disorder
Keywords
HIV, HIV Testing, Hepatitis C Virus Testing, Opioid Use Disorder Treatment, Substance Use Disorders Treatment, Hepatitis C Virus, Practice Coaching

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a cluster randomized controlled trial (RCT) where approximately 51 sites will be randomly inducted into the study. Site randomization to condition will occur on a rolling basis in intervals of approximately 14-18 days. Selected sites will be invited to participate in the study and randomly assigned to one of the three conditions (described below).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIV Testing Practice Coaching Intervention Group
Arm Type
Experimental
Arm Description
The HIV Testing Practice Coaching (PC) Intervention is designed to improve the provision and sustained implementation of on-site HIV testing and linkage to care among OTP patients.
Arm Title
HIV and HCV Testing Practice Coaching Intervention Group
Arm Type
Experimental
Arm Description
The HIV and HCV Testing Practice Coaching (PC) Intervention will leverage the HIV PC intervention and follow the same interventional steps described above, and, in addition, provide information and training to support joint HIV/HCV testing and linkage to care among OTP patients.
Arm Title
Information Control Group
Arm Type
Other
Arm Description
The administrators of OTPs assigned to the control condition will receive a website link to and hard copy of the NIDA/SAMHSA Blending Initiative product for HIV rapid testing.
Intervention Type
Other
Intervention Name(s)
Information Control
Intervention Description
The OTPs assigned to this group will be provided access to the NIDA/SAMHSA Blending Initiative product for HIV rapid testing. Resources generated from the HIV rapid testing Blending Initiative product include a fact sheet, resource guide, marketing materials, and an Excel-based budgeting tool. In addition to the HIV-specific materials, the website provides opportunities for training, self-study progress, workshop, and distance learning. OTPs also will receive a link to the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention training website which provides information and training courses. Sites also will receive a hard (or electronic) copy of the ARTAS implementation manual and information about the provision of HIV testing, linkage to care and PrEP.
Intervention Type
Other
Intervention Name(s)
HIV and HCV Testing Practice Coaching Intervention
Intervention Description
The practice coaches (PCs) will work with the program team a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV and HCV testing and evidence--based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV and HCV testing. Also, due to the expense of HCV treatment, and potentially more complicated mechanisms for linking HCV-positive patients to further evaluation and care which may take more time than anticipated, PCs will provide OTPs with basic education and motivation about the importance of HCV testing for reasons other than immediate curative treatment. Information on PrEP also will be provided. The intervention will occur over approximately 29 weeks (or 6 months).
Intervention Type
Other
Intervention Name(s)
HIV Testing Practice Coaching Intervention
Intervention Description
The practice coaches (PCs) will work with the programs a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV testing and evidence-based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV testing. Information on Pre-Exposure Prophylaxis (PrEP) also will be provided. The intervention will occur over approximately 29 weeks (or 6 months) consisting of four distinct evidence-based phases designed to establish competency in the implementation of organizational change towards establishing HIV testing outcomes among OTP clientele.
Primary Outcome Measure Information:
Title
Proportion of OTP patients HIV tested at 6 months post intervention or control, while controlling for HIV testing during the baseline period (T1)
Description
The primary outcome measure will be a contrast of the proportion of OTP patients HIV tested during T3, controlling for HIV testing at baseline (T1). The primary test will be whether the proportion of patients tested across the two PC interventions--HIV Testing PC Intervention Group and HIV/HCV Testing PC Intervention Group--differs from the proportion of patients tested in the Information Control Group.
Time Frame
The period 7-12 months post site-randomization (T3).
Secondary Outcome Measure Information:
Title
Proportion of OTP patients HIV tested at 12 months post intervention or control
Description
The secondary outcome measure will be the proportion of OTP patients HIV tested during T4, controlling for HIV testing at baseline (T1). One test will be whether the proportion of patients tested across the two PC interventions--HIV Testing PC Intervention Group and HIV/HCV Testing PC Intervention Group--differs from the proportion of patients tested in the Information Control Group. A second test will be whether the proportion of OTP patients HIV tested during T4 in the HIV Testing PC Intervention Group differs from the proportion of patients tested in the HIV/HCV Testing PC Intervention Group.
Time Frame
The period 13-18 months post site-randomization.
Other Pre-specified Outcome Measures:
Title
OTPs' incremental cost-effectiveness ratio (ICER)
Description
The ICER is a statistic used to summarize the cost-effectiveness of a health care intervention and is defined by the difference in cost between two possible interventions, divided by the difference in their effect. One ICER will be calculated for the difference between the Information Control Group and HIV Testing PC Intervention Group. A second ICER will be calculated for the difference between the HIV Testing PC Intervention Group and the HIV/HCV Testing PC Intervention Group.
Time Frame
6 months post randomization (T2).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Eligible sites must: See at least 150 unduplicated patients/year/site Be capable and willing to prospectively collect data on the number of patients who a) are offered any HIV and/or HCV tests; b) completed these tests; c) are referred to care/evaluation (and type of referral) if positive; and d) are linked to care/evaluation within 30 days of diagnosis Be capable and willing to provide patient demographics, testing data within demographic categories of gender and race/ethnicity (in aggregate) and data on HIV/HCV test reimbursement processes and outcomes Have key staff willing to consent to participate in study surveys, qualitative interviews and intervention coaching throughout the study Exclusion Criteria: Sites will be excluded if: Over 50% of patients served in the prior 6 months were HIV or HCV tested They are terminated via PI decision/discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Gooden, PhD
Phone
786-703-9819
Email
lkg2129@columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Debra Annane, MS, MPH
Phone
786-703-9829
Email
da2734@columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Metsch, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Feaster, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jemima Frimpong, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauren Gooden, PhD
Organizational Affiliation
Columbia University
Official's Role
Study Director
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Gooden, PhD
Phone
786-703-9819
Email
lkg2129@columbia.edu
First Name & Middle Initial & Last Name & Degree
Debra Annane, MPH
Phone
786-703-9829
Email
da2734@columbia.edu
First Name & Middle Initial & Last Name & Degree
Lisa Metsch, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data and associated documentation may become available to other researchers under a data-sharing agreement. All interested researchers must contact the PI and provide a proposal explaining the analysis that will be conducted and specify which IPD is needed to accomplish this.

Learn more about this trial

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

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