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Recruiting
NCT03135886
Project I Test: Implementing HIV Testing in Opioid Treatment Programs
Conditions: HIV/AIDS, Hepatitis C, Substance Use Disorders, Opioid-use Disorder
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 418
Sponsor: Columbia University
Location: Columbia University Medical Center New York New York
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).
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
Source: ClinicalTrials.gov (NCT03135886). StuddyBuddy aggregates publicly available trial information.