Clinical trial NCT03135886: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Weill Medical College of Cornell University
name: University of Miami
name: Boston Medical Center
name: Research Foundation for Mental Hygiene, Inc.
name: San Francisco Department of Public Health
name: New York University Abu Dhabi
First posted: 2017-05-02
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of OTP patients HIV tested at 6 months post intervention or control, while controlling for HIV testing during the baseline period (T1)
timeFrame: The period 7-12 months post site-randomization (T3).
Secondary outcomes:
measure: Proportion of OTP patients HIV tested at 12 months post intervention or control
timeFrame: The period 13-18 months post site-randomization.
Other outcomes:
measure: OTPs' incremental cost-effectiveness ratio (ICER)
timeFrame: 6 months post randomization (T2).
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Lisa Metsch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Daniel Feaster, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University Abu Dhabi
name: Jemima Frimpong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Lauren Gooden, PhD
role: STUDY_DIRECTOR
References:
citation: Frimpong JA, Parish C, Feaster DJ, Gooden LK, Matheson T, Haynes L, Linas BP, Assoumou SA, Tross S, Kyle T, Nelson CM, Liguori TK, Toussaint O, Siegel K, Annane D, Metsch LR. A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs. Res Sq [Preprint]. 2023 Jun 28:rs.3.rs-3059783. doi: 10.21203/rs.3.rs-3059783/v1.