NCT03135886 Project I Test: Implementing HIV Testing in Opioid Treatment Programs
| NCT ID | NCT03135886 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | HIV/AIDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 418 participants |
| Start Date | 2017-06-12 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 418 participants in total. It began in 2017-06-12 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Lisa Metsch, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT03135886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV/AIDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03135886 currently recruiting?
Yes, NCT03135886 is actively recruiting participants. Contact the research team at lkg2129@columbia.edu for enrollment information.
Where is the NCT03135886 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT03135886 clinical trial?
NCT03135886 is sponsored by Columbia University. The principal investigator is Lisa Metsch, PhD at Columbia University. The trial plans to enroll 418 participants.
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