Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Hepatitis C Clinical Trial

Official title:

A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03135886
• Other study ID #: AAAQ9986
• Secondary ID: R01DA043130
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2017
• Est. completion date: January 31, 2025

Study information

• Verified date: June 2023
• Source: Columbia University
• Contact: Lauren Gooden, PhD
• Phone: 786-703-9819
• Email: lkg2129[@]columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• HIV/AIDS
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Information Control
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.
• HIV and HCV Testing Practice Coaching Intervention
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).
• HIV Testing Practice Coaching Intervention
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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (9)

Lead Sponsor	Collaborator
Columbia University	Aspire Health Partners, Boston Medical Center, Johns Hopkins University, National Institute on Drug Abuse (NIDA), Research Foundation for Mental Hygiene, Inc., San Francisco Department of Public Health, University of Miami, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OTPs' incremental cost-effectiveness ratio (ICER)	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.	6 months post randomization (T2).
Primary	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.	The period 7-12 months post site-randomization (T3).
Secondary	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.	The period 13-18 months post site-randomization.