|First Submitted Date ICMJE||June 4, 2012|
|First Posted Date ICMJE||June 5, 2012|
|Last Update Posted Date||March 14, 2016|
|Start Date ICMJE||July 2012|
|Primary Completion Date||June 2015 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||HIV Viral Suppression [ Time Frame: 12 months ]
The primary outcome variable is binary: HIV viral suppression (<= 200 copies/ml), as determined by blood draw at/near the 12 month follow-up versus presence of viral load > 200 or death (all-cause mortality). We are aware that, for patients on therapy, the goal of antiretroviral therapy is achieving a viral load "below the limit of detection of the assay" which currently is usually < 40 copies/ml. However, we have chosen to define "suppression" as <= 200 copies/ml to be consistent with the January 2011 Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.
|Original Primary Outcome Measures ICMJE
||HIV Viral Supression [ Time Frame: 12 months ]
The primary outcome variable is binary: HIV viral suppression (< 200copies/ml), as determined by blood draw at the 12 month follow-up versus presence of viral load > 200 or death (all-cause mortality). We are aware that, for patients on therapy, the goal of antiretroviral therapy is achieving a viral load "below the limit of detection of the assay" which currently is usually < 40 copies/ml. However, we have chosen to define "suppression" as < 200 copies/ml to be consistent with the January 2011 Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.
|Change History||Complete list of historical versions of study NCT01612169 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users|
|Official Title ICMJE||NIDA CTN Protocol 0049. Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users|
Primary Objective: This study will evaluate the most effective strategy in achieving HIV virologic suppression among HIV-infected substance users recruited from the hospital setting who are randomly assigned to one of three treatment conditions: 1) Patient Navigator (PN); 2) Patient Navigator + Contingency Management (PN+CM); and 3) Treatment as Usual (TAU).
Primary Hypothesis: The rate of viral suppression (plasma HIV viral load of <= 200 copies/mL) relative to non-suppression or all-cause mortality in the 3 study groups will differ from each other at the 12 month follow-up.
Sub-hypothesis 1. The rate of virologic suppression (plasma HIV viral load of <= 200 copies/mL) in the PN+CM group will be greater than that in the TAU group.
Sub-hypothesis 2. The rate of virologic suppression in the PN+CM group will be greater than that in the PN group.
Sub-hypothesis 3. The rate of virologic suppression in the PN group will be greater than that in the TAU group.
This study is a 3-arm randomized, prospective trial in which HIV-infected inpatients who report substance use at screening will be randomized in 1:1:1 ratio to Patient Navigator (PN) vs. Patient Navigator + Contingency Management (PN+CM) vs. Treatment as Usual (TAU). Randomization will occur after screening, informed consent, baseline assessment and collection of biological (blood) specimens. Participants assigned to the PN and PN+CM groups will meet (ideally at bedside if the participant is still hospitalized at the time of randomization) with the Patient Navigator interventionist and will complete up to 11 intervention sessions over the 6-month-long intervention period. Participants assigned to the TAU group will receive care as it is typically offered in the inpatient setting. Follow-up visits will be conducted at approximately 6 and 12 months post-randomization.
To minimize patient and staff burden, sites may implement a pre-screening procedure with permission from their respective IRBs to determine which inpatients would meet the study's AIDS-defining illness/CD4 count/viral load inclusion criteria. Pre-screening, screening, enrollment, assessment, randomization and the initial intervention visit will (ideally) occur during the participant's stay at an inpatient facility. Recognizing that participants may be recruited at various stages of illness during their inpatient visit, however, this may not be possible. To allow maximum flexibility, all activities that occur after the screening informed consent may be completed after the patient has been discharged from the hospital. The intervention duration will be 6 months with sessions ideally occurring weekly during the first month, bi-weekly during months 2 and 3 and monthly during months 4- 6. Follow-up visits will occur at approximately 6 and 12 months post-randomization. Therefore, the total duration of individual participation in the study is approximately 12 months.
Prior to approaching patients to recruit them into the study, members of the medical teams within each hospital (i.e., attending physicians, fellows, residents and nurse practitioners) who are involved in patient care and who know the patients' HIV-infected status will assess the medical stability of the patients. If a patient has expressed interest in potentially participating in research and is deemed medically stable, then a study staff member will meet with the patient at bedside to discuss the study. Strict ethical guidelines regarding professional conduct and confidentiality will be enforced for all study staff.
Prior to screening individuals to determine their eligibility to participate, the research staff will briefly explain the study purpose, procedures, potential risks and benefits and voluntary nature of participation. Individuals willing to be screened to determine eligibility will provide written informed consent, including providing HIPAA authorization for medical record abstraction. After signing the consent and HIPAA forms, participants will be offered copies of the forms to keep for their records.
After the enrollment process (providing written informed consent and completing a locator form) is complete and a brief rapport-building discussion between the interviewer and participant has taken place, the research interviewer will administer the baseline assessment through a handheld Computer Assisted Personal Interview (CAPI) device. The CAPI system displays each assessment question on a computer monitor, allowing the interviewer to read the questions and then enter the participants' responses directly into the computer. The baseline assessment will include, but not be limited to questions on participant demographics, HIV care, medication adherence, substance use and co morbid conditions such as hepatitis, depression, etc.
Collection of Biologic Specimens:
We will collect blood specimens at the baseline, 6-month and 12-month follow-up visits to evaluate the primary outcome, HIV virologic suppression, as well as to measure CD4 count, and complete blood count (CBC). Blood specimen processing will be done by sites' local laboratories. In the event that a blood specimen cannot be collected for any reason (e.g., vein is "dry", participant is lost to follow-up, etc.) or the result of a collected specimen is not available (e.g., not enough specimen drawn, lab processing error, etc.), the study team may abstract and use non-study lab results for the purpose of evaluating the HIV virologic suppression outcome and measuring CD4 count and CBC. Participants randomized to the intervention groups may also provide urine for drug screening.
Participants will be randomized in a 1:1:1 fashion to one of the 3 treatment groups. Randomization will be stratified by site. The randomization procedure will be conducted in a centralized process through the Data and Statistical Center (DSC2). After the baseline assessment is successfully completed, a designated study staff member will perform the randomization. Randomization for each participant is done over the Internet using the Enrollment Module in AdvantageEDC (the study electronic data capture system).
The 3 treatment conditions/study groups are: 1) Patient Navigator intervention (PN), 2) Patient Navigator plus Contingency Management (PN+CM) intervention and 3) Treatment as Usual (TAU).
The patient navigator (PN) approach includes five functions: 1) establishing an effective working relationship; 2) encouraging identification and use of strengths, abilities and assets; 3) supporting client control over goal setting and the search for needed resources; 4) viewing the community as a resource and identifying informal sources of support; and 5) conducting case management as an active community based activity. Specifically, patient navigators will provide the following to all study participants randomized to the PN group: 1) four initial meetings, ideally having the first one during hospitalization and three within the first 3 weeks of hospital discharge, and 2) after the initial four meetings, patient navigators will meet with the PN group participants ideally twice monthly during months 2 and 3 and once during months 4 - 6.
Study participants randomized to the patient navigator plus contingency management (PN+CM) group will receive the patient navigation (PN) intervention as outlined above and in Section 11.2 of the sponsor protocol combine with contingency management (CM). For participants randomly assigned to the PN+CM study group, patient navigators will: 1) effectively communicate the incentive plan to the participant, 2) track each of the seven target behaviors that may earn participant incentives, 3) verify occurrence of the target behaviors, 4) deliver incentives according to the protocol, and 5) maintain a record of incentives delivered.
Participants assigned to the treatment as usual (TAU) group will receive the standard treatment provided at participating sites for linking patients to HIV and substance use care.
Follow-up visits will be conducted at approximately 6- and 12-months post-randomization and will involve follow-up CAPIs and blood collection.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Publications *||Metsch LR, Feaster DJ, Gooden L, Matheson T, Stitzer M, Das M, Jain MK, Rodriguez AE, Armstrong WS, Lucas GM, Nijhawan AE, Drainoni ML, Herrera P, Vergara-Rodriguez P, Jacobson JM, Mugavero MJ, Sullivan M, Daar ES, McMahon DK, Ferris DC, Lindblad R, VanVeldhuisen P, Oden N, Castellón PC, Tross S, Haynes LF, Douaihy A, Sorensen JL, Metzger DS, Mandler RN, Colfax GN, del Rio C. Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial. JAMA. 2016 Jul 12;316(2):156-70. doi: 10.1001/jama.2016.8914.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2015|
|Primary Completion Date||June 2015 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Participating individuals must:
Individuals will be excluded from the study if they:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01612169|
|Other Study ID Numbers ICMJE||AAAK1709
U10DA013720-11 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||
|Responsible Party||Lisa Metsch, Columbia University|
|Study Sponsor ICMJE||Columbia University|
|PRS Account||Columbia University|
|Verification Date||March 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP