NCT03135886

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Recruiting now NA Last updated 29 July 2025

What this trial tests

NA trial testing Information Control in HIV/AIDS in 418 participants. Currently enrolling.

Timeline

12 June 2017

Primary endpoint
31 January 2026

31 July 2026

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	418
Start date	12 June 2017
Primary completion	31 January 2026
Estimated completion	31 July 2026
Sites	1 location across United States

Drugs / interventions tested

• Information Control
• HIV and HCV Testing Practice Coaching Intervention
• HIV Testing Practice Coaching Intervention

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Hepatitis C — all drugs for Hepatitis C →
• Substance Use Disorders — all drugs for Substance Use Disorders →
• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

Columbia University

Who can join

18 and older, any sex, with HIV/AIDS or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Frimpong JA, Parish CL, Feaster DJ, Gooden LK, et al · · 2023 · PMID 37749635 · DOI 10.1186/s13063-023-07602-8
2. 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
   Frimpong JA, Parish C, Feaster DJ, Gooden LK, et al · · 2023 · DOI 10.21203/rs.3.rs-3059783/v1