HIV/AIDSNCT03135886
Project I Test: Implementing HIV Testing in Opioid Treatment Programs
A study testing HIV and HCV Testing Practice Coaching Intervention and HIV Testing Practice Coaching Intervention in people with HIV/AIDS and Hepatitis C, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Hepatitis C, Substance Use Disorders
- What is being tested?
- HIV and HCV Testing Practice Coaching Intervention and HIV Testing Practice Coaching Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2017to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible sites must:
- See at least 150 unduplicated patients/year/site
- 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
- 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
- Have key staff willing to consent to participate in study surveys, qualitative interviews and intervention coaching throughout the study
Who cannot join
- Sites will be excluded if:
- Over 50% of patients served in the prior 6 months were HIV or HCV tested
- They are terminated via PI decision/discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Lauren Gooden, PhD, 786-703-9819, lkg2129@columbia.edu
Terri Liguori, M.Ed., Ed.S., 786-510-3666, tl2547@cumc.columbia.edu
About this study
Official title: 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:
Read more
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:
- 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).
- 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).
Read the 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.
- Conditions
- HIV/AIDS, Hepatitis C, Substance Use Disorders, Opioid-use Disorder
- Being tested
- Information Control, HIV and HCV Testing Practice Coaching Intervention, HIV Testing Practice Coaching Intervention
- Keywords
- HIV, HIV Testing, Hepatitis C Virus Testing, Opioid Use Disorder Treatment, Substance Use Disorders Treatment, Hepatitis C Virus, Practice Coaching
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis C, Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information ControlOther
The OTPs assigned to this group will be provided access to the NIDA/SAMHSA Blending Initiative product for HIV rapid testing. Resources generated from the HIV rapid testing Blending Initiative product include a fact sheet, resource guide, marketing materials, and an Excel-based budgeting tool. In addition to the HIV-specific materials, the website provides opportunities for training, self-study progress, workshop, and distance learning. OTPs also will receive a link to the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention training website which provides information and training courses. Sites also will receive a hard (or electronic) copy of the ARTAS implementation manual and information about the provision of HIV testing, linkage to care and PrEP.
HIV and HCV Testing Practice Coaching InterventionOther
The practice coaches (PCs) will work with the program team a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV and HCV testing and evidence--based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV and HCV testing. Also, due to the expense of HCV treatment, and potentially more complicated mechanisms for linking HCV-positive patients to further evaluation and care which may take more time than anticipated, PCs will provide OTPs with basic education and motivation about the importance of HCV testing for reasons other than immediate curative treatment. Information on PrEP also will be provided. The intervention will occur over approximately 29 weeks (or 6 months).
HIV Testing Practice Coaching InterventionOther
The practice coaches (PCs) will work with the programs a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV testing and evidence-based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV testing. Information on Pre-Exposure Prophylaxis (PrEP) also will be provided. The intervention will occur over approximately 29 weeks (or 6 months) consisting of four distinct evidence-based phases designed to establish competency in the implementation of organizational change towards establishing HIV testing outcomes among OTP clientele.
| Study group | Role | What they receive |
|---|---|---|
| HIV Testing Practice Coaching Intervention Group | Experimental | The HIV Testing Practice Coaching (PC) Intervention is designed to improve the provision and sustained implementation of on-site HIV testing and linkage to care among OTP patients. Receives: Other: HIV Testing Practice Coaching Intervention |
| HIV and HCV Testing Practice Coaching Intervention Group | Experimental | The HIV and HCV Testing Practice Coaching (PC) Intervention will leverage the HIV PC intervention and follow the same interventional steps described above, and, in addition, provide information and training to support joint HIV/HCV testing and linkage to care among OTP patients. Receives: Other: HIV and HCV Testing Practice Coaching Intervention |
| Information Control Group | Other | The administrators of OTPs assigned to the control condition will receive a website link to and hard copy of the NIDA/SAMHSA Blending Initiative product for HIV rapid testing. Receives: Other: Information Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of OTP patients HIV tested at 6 months post intervention or control, while controlling for HIV testing during the baseline period (T1)
The primary outcome measure will be a contrast of the proportion of OTP patients HIV tested during T3, controlling for HIV testing at baseline (T1). The primary test will be whether the proportion of patients tested across the two PC interventions--HIV Testing PC Intervention Group and HIV/HCV Testing PC Intervention Group--differs from the proportion of patients tested in the Information Control Group.
Measured: The period 7-12 months post site-randomization (T3).
Secondary outcomes (1)
Proportion of OTP patients HIV tested at 12 months post intervention or control
The secondary outcome measure will be the proportion of OTP patients HIV tested during T4, controlling for HIV testing at baseline (T1). One test will be whether the proportion of patients tested across the two PC interventions--HIV Testing PC Intervention Group and HIV/HCV Testing PC Intervention Group--differs from the proportion of patients tested in the Information Control Group. A second test will be whether the proportion of OTP patients HIV tested during T4 in the HIV Testing PC Intervention Group differs from the proportion of patients tested in the HIV/HCV Testing PC Intervention Group.
Measured: The period 13-18 months post site-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start12 Jun 2017
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, University of Miami, Boston Medical Center, Research Foundation for Mental Hygiene, Inc., San Francisco Department of Public Health, New York University Abu Dhabi
- Responsible party
- Principal investigator, Lisa Metsch, Columbia University
- Investigators
- Lisa Metsch, PhD, Principal investigator, Columbia UniversityDaniel Feaster, PhD, Principal investigator, University of MiamiJemima Frimpong, PhD, Principal investigator, New York University Abu DhabiLauren Gooden, PhD, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135886
- Sponsor's protocol ID
- AAAQ9986
- Other IDs
- R01DA043130
- Status last verified
- Aug 2026
- First submitted
- 26 Apr 2017
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data and associated documentation may become available to other researchers under a data-sharing agreement. All interested researchers must contact the PI and provide a proposal explaining the analysis that will be conducted and specify which IPD is needed to accomplish this.
Publications
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.
PubMed 37461594Frimpong JA, Parish CL, Feaster DJ, Gooden LK, Nelson MC, Matheson T, Siegel K, Haynes L, Linas BP, Assoumou SA, Tross S, Kyle T, Liguori TK, Toussaint O, 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. Trials. 2023 Sep 26;24(1):609. doi: 10.1186/s13063-023-07602-8.
PubMed 37749635
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs
- ClinicalTrials.gov ID
- NCT03135886
- Acronym / sponsor ID
- AAAQ9986
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, University of Miami, Boston Medical Center, Research Foundation for Mental Hygiene, Inc., San Francisco Department of Public Health, New York University Abu Dhabi
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| HIV Testing Practice Coaching Intervention Group | Experimental | Other: HIV Testing Practice Coaching InterventionThe HIV Testing Practice Coaching (PC) Intervention is designed to improve the provision and sustained implementation of on-site HIV testing and linkage to care among OTP patients. |
| HIV and HCV Testing Practice Coaching Intervention Group | Experimental | Other: HIV and HCV Testing Practice Coaching InterventionThe HIV and HCV Testing Practice Coaching (PC) Intervention will leverage the HIV PC intervention and follow the same interventional steps described above, and, in addition, provide information and training to support joint HIV/HCV testing and linkage to care among OTP patients. |
| Information Control Group | Other | Other: Information ControlThe administrators of OTPs assigned to the control condition will receive a website link to and hard copy of the NIDA/SAMHSA Blending Initiative product for HIV rapid testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible sites must:
Key exclusion criteria (3 listed)
- Sites will be excluded if:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information ControlThe OTPs assigned to this group will be provided access to the NIDA/SAMHSA Blending Initiative product for HIV rapid testing. Resources generated from the HIV rapid testing Blending Initiative product include a fact sheet, resource guide, marketing materials, and an Excel-based budgeting tool. In addition to the HIV-specific materials, the website provides opportunities for training, self-study progress, workshop, and distance learning. OTPs also will receive a link to the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention training website which provides information and training courses. Sites also will receive a hard (or electronic) copy of the ARTAS implementation manual and information about the provision of HIV testing, linkage to care and PrEP. | Other | Information Control Group |
| HIV and HCV Testing Practice Coaching InterventionThe practice coaches (PCs) will work with the program team a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV and HCV testing and evidence--based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV and HCV testing. Also, due to the expense of HCV treatment, and potentially more complicated mechanisms for linking HCV-positive patients to further evaluation and care which may take more time than anticipated, PCs will provide OTPs with basic education and motivation about the importance of HCV testing for reasons other than immediate curative treatment. Information on PrEP also will be provided. The intervention will occur over approximately 29 weeks (or 6 months). | Other | HIV and HCV Testing Practice Coaching Intervention Group |
| HIV Testing Practice Coaching InterventionThe practice coaches (PCs) will work with the programs a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV testing and evidence-based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV testing. Information on Pre-Exposure Prophylaxis (PrEP) also will be provided. The intervention will occur over approximately 29 weeks (or 6 months) consisting of four distinct evidence-based phases designed to establish competency in the implementation of organizational change towards establishing HIV testing outcomes among OTP clientele. | Other | HIV Testing Practice Coaching Intervention Group |
Primary outcome
Proportion of OTP patients HIV tested at 6 months post intervention or control, while controlling for HIV testing during the baseline period (T1)
Time frame: The period 7-12 months post site-randomization (T3).
The primary outcome measure will be a contrast of the proportion of OTP patients HIV tested during T3, controlling for HIV testing at baseline (T1). The primary test will be whether the proportion of patients tested across the two PC interventions--HIV Testing PC Intervention Group and HIV/HCV Testing PC Intervention Group--differs from the proportion of patients tested in the Information Control Group.
1 secondary outcome
Proportion of OTP patients HIV tested at 12 months post intervention or control
Time frame: The period 13-18 months post site-randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 37461594Frimpong 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.
- Derived from this study: PubMed 37749635Frimpong JA, Parish CL, Feaster DJ, Gooden LK, Nelson MC, Matheson T, Siegel K, Haynes L, Linas BP, Assoumou SA, Tross S, Kyle T, Liguori TK, Toussaint O, 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. Trials. 2023 Sep 26;24(1):609. doi: 10.1186/s13063-023-07602-8.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data and associated documentation may become available to other researchers under a data-sharing agreement. All interested researchers must contact the PI and provide a proposal explaining the analysis that will be conducted and specify which IPD is needed to accomplish this.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Metsch, PhD principal investigator
Columbia University
Daniel Feaster, PhD principal investigator
University of Miami
Jemima Frimpong, PhD principal investigator
New York University Abu Dhabi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV and HCV Testing Practice Coaching Intervention and HIV Testing Practice Coaching Intervention in people with HIV/AIDS and Hepatitis C, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Gooden, PhD (786-703-9819, lkg2129@columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of OTP patients HIV tested at 6 months post intervention or control, while controlling for HIV testing during the baseline period (T1) (time frame: The period 7-12 months post site-randomization (T3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.