NCT03135886

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 418 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

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

Interventions

Type	Name	Description
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.
OTHER	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).
OTHER	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.

Timeline

• Start date: 2017-06-12
• Primary completion: 2026-01-31
• Completion: 2026-07-31
• First posted: 2017-05-02
• Last updated: 2025-07-29

Locations

1 site across 1 country: United States