ART-CHESS: A Mobile Health Application to Support People Living With HIV and Addiction
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|ClinicalTrials.gov Identifier: NCT03873129|
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Substance Use Disorders||Behavioral: mobile health app (mHealth)||Phase 2|
Patients with substance use disorders are continuously at risk for relapse and other disruptive life events, which may lead to lapses in antiretroviral treatment and subsequent viral rebound, thereby increasing their level of infectivity. Behaviors that place others at risk for HIV transmission such as sharing drug paraphernalia and unprotected sex may also increase during these periods of social and behavioral instability.
Various biomedical, behavioral, and structural interventions have been used to prevent lapses in HIV care or minimize their impact when they occur. A potentially transformative strategy would be the one that makes novel use of ubiquitous technology and the existing clinical workforce to provide highly-effective, tailored support to the patients at greatest risk, at the time and place it is needed the most.
This study has 2 phases:
Phase I has been completed and it was an observational study, not a clinical trial. Patients who volunteered were recruited to use the mobile phone app to enter data, but it was not intended to improve their health or health care. The data collected during phase 1 will be used to inform the intervention in phase 2, where the study team hope to use the system to improve patient care.
Phase 2 will conduct a single-arm implementation study (with historical controls) of A-CHESS when implemented in 2 high-volume HIV clinics, providing evidence describing the effectiveness and durability of an mHealth strategy for maintaining viral suppression among patients with substance use disorders treated with ART.
The long-term goal of this project is to develop a comprehensive mHealth system that identifies the critical time-varying determinants of lapses in HIV care for substance using patients, and translates these diverse inputs into actionable, patient-specific alerts to clinical providers. This goal will be achieved by adapting and implementing an existing mHealth intervention, A-CHESS, which might improve HIV care for patients with substance use disorders through two mechanisms. First, existing A-CHESS services will improve treatment adherence by enhancing self-determination (i.e., intrinsic motivation, competence and social relatedness). Second, through new functionality incorporating predictive analytics with patient-level data, A-CHESS will identify moments when patients are at the highest risk for antiretroviral treatment failure, allowing clinic-based staff to provide targeted interventions that maximize the efficiency of care coordination resources.
If successful, this project would translate important individual and neighborhood-level data into timely and clinically-relevant knowledge that is accessible to the HIV care team, representing a major step forward in our ability to support patients with complex needs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase 2 is single group trial of A-CHESS when implemented in 2 high-volume HIV clinics, providing evidence describing the effectiveness and durability of an mHealth strategy for maintaining viral suppression among patients with substance use disorders treated with ART.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Optimizing HIV Care for Patients With Substance Use Disorders Using Predictive Analytics in a Mobile Health Application|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
participant will be using the A-CHESS mobile app for 12 months
Behavioral: mobile health app (mHealth)
A-CHESS is a mobile health app for participants to interact with their treatment team for 12 months.
Other Name: ART-CHESS
- Change in the Viral suppression among study semesters of A-CHESS use versus semesters of without A-CHESS use. [ Time Frame: Up to 12 months ]Viral suppression will be measured each 6 months period. HIV RNA< 200 copies/mL reflects viral suppression per protocol.
- Change in the Attendance at HIV Clinic Appointments among study semesters of A-CHESS use versus semesters of without A-CHESS use. [ Time Frame: up to 12 months ]Attendance at HIV clinic appointments
- Change in the Drug usage among study semesters of A-CHESS use versus semesters of without A-CHESS use. [ Time Frame: up to 12 months ]Change in the Drug usage among study semesters of A-CHESS use versus semesters of without A-CHESS use.
- Change in the Medication adherence among study semesters of A-CHESS use versus semesters of without A-CHESS use. [ Time Frame: up to 12 months ]Change in the Medication adherence among study semesters of A-CHESS use versus semesters of without A-CHESS use.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873129
|Contact: Sarah A Dietz, BSWemail@example.com|
|Contact: Ryan P Westergaard, MD, PhD, MPHfirstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin||Recruiting|
|Madison, Wisconsin, United States, 53597|
|Contact: Sarah A Dietz, BSW 608-890-1174 email@example.com|
|Contact: Ryan P Westergaard, MD, PhD, MPH 608.265.7927 firstname.lastname@example.org|
|Principal Investigator:||Ryan Westergaard, MD, PhD, MPH||University of Wisconsin, Madison|