Project I Test: Implementing HIV Testing in Opioid Treatment Programs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Over 50% of patients served in the prior 6 months were HIV or HCV tested
They are terminated via PI decision/discretion
Trial design
Design model
Parallel
Treatments tested in this trial
Information Control
Other interventionThe 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
Other interventionThe 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
Other interventionThe 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.
Treatment groups
418 Participants
are divided into 3 treatment groupsGroup A: HIV Testing Practice Coaching Intervention GroupExperimental treatment 1 intervention
Group B: HIV and HCV Testing Practice Coaching Intervention GroupExperimental treatment 1 intervention
Group C: Information Control GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
The period 7-12 months post site-randomization (T3).Secondary outcomes
1
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.
Time frame
The period 13-18 months post site-randomization.Other outcomes
1
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.
Time frame
6 months post randomization (T2).Sponsors and contacts
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Columbia University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Weill Medical College of Cornell University
Collaborator
University of Miami
Collaborator
Boston Medical Center
Collaborator
Research Foundation for Mental Hygiene, Inc.
Collaborator
San Francisco Department of Public Health
Collaborator
New York University Abu Dhabi
Collaborator
Source ClinicalTrials.gov