Project I Test: Implementing HIV Testing in Opioid Treatment Programs
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/26/2018 |
| Start Date: | June 12, 2017 |
| End Date: | August 2020 |
| Contact: | Lauren Gooden, PhD |
| Email: | lkg2129@columbia.edu |
| Phone: | 786-703-9819 |
A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs
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).
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).
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.
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.
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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Lisa Metsch, PhD
Phone: 786-703-9819
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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