- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02906215
Mobile Application to Improve Care Coordination Among HIV Clinic and Substance Use Treatment Providers
July 22, 2022 updated by: Kasey Claborn, University of Texas at Austin
Many people living with HIV use illicit drugs and require treatment for both HIV and drug use, however, many barriers exist which prevent integration of dual care services.
This study will develop a novel intervention aimed at the provider-level which will combine an evidence-based training model with use of mobile technology to improve care coordination between providers at HIV clinics and substance use treatment facilities.
If proven effective, this intervention may be widely disseminated and easily implemented into existing clinic structures, thereby improving care coordination among providers and linkage to dual treatment for HIV-infected people who use drugs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Drug use is associated with poor linkages to HIV care, reduced retention in care, increased sexual risk behavior, and decreased adherence to medications, leading to inferior clinical outcomes, and increased HIV transmission.
HIV-infected people who use drugs (HPWUD) have higher rates of co-occurring psychiatric and medical diagnoses, resulting in increased utilization of services.
Many structural and systemic barriers impede the integration of treatment for HIV and substance use (SU).
The use of a mobile application combined with an evidence-based training model offers an innovative approach to improving care coordination and linking patients to care in need of dual treatment.
A mhealth application delivered via tablet device provides a unique channel to link HIV and SU treatment providers located at off-site clinics.
This study will be a Stage I pilot and feasibility study that will be the first to use a theory-based model of care coordination to develop a Care Coordination Intervention (CCI) for treatment providers serving HPWUD.
This study seeks to develop a secure mobile technology platform that will: (a) enable rapid communication among providers at multiple clinics, (b) improve linkage to dual care, and (c) improve coordination of patient services.
The CCI will also utilize an evidence-based training model to increase provider knowledge in relevant HIV, PrEP, and SU issues.
The proposed method of integrating dual care for patients is expected to be an efficient and easily disseminable platform for integrating HIV/SU care that will facilitate communication between providers at multiple clinics and allow for efficient management of patient treatment referrals and service utilization.
This project will examine acceptability, feasibility, and sustainability potential using mixed-methods.
A three-phase, top-down research approach to adapt, refine, and pilot test the intervention will be conducted.
Phase 1 will include individual interviews with key stakeholders and audits of referral and communication processes within each clinic.
Phase 2 will include development of the CCI.
The investigators will conduct a functionality test and conduct a series of interviews with key stakeholders to inform iterative revision of the CCI.
During Phase 3, the investigators will train providers in the CCI and evaluate the feasibility, acceptability, and sustainability potential among HIV and SU treatment providers located at two different clinics via a pre-, post-test design.
Data will be gathered at the organizational-, provider-, and patient-levels.
Compared to pre-implementation of the CCI in both clinics, the investigators expect that post-implementation data will result in: (H1) greater satisfaction of care coordination at the provider level; (H2) increased frequency and improved quality of interagency communications; (H3) enhanced interagency professional relationships; and (H4) increased dual care retention at the patient level.
The long-term goal is to expand the availability of sustainable interventions to improve coordination of HIV and SU treatment services.
Data from this research will form the basis of a future multisite R01 proposal for this early career, new investigator applicant.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- The University of Texas Dell Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Participants must:
- be at least 18 years of age,
- provide either HIV care or substance abuse treatment [e.g., physicians, residents, psychologists, mid-level providers],
- be employed at a participating recruitment site, and (d) able to provide informed consent.
Exclusion Criteria:
- Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent, active psychosis, and not fluent in English.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Care Coordination Intervention
The care coordination intervention will consist of a mobile application designed for treatment providers, an interagency communication protocol, and a series of cross-training in HIV and addiction issues.
|
cross-training in HIV/PrEP and substance use, plus a digital health tool to improve evidence-based screening, brief intervention, referral to treatment, and patient management across HIV, PrEP, and addiction treatment providers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Interagency Collaboration as measured by the "Levels of Collaboration" scale
Time Frame: 1-, 3-, and 6-months
|
1-, 3-, and 6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the Care Coordination Intervention
Time Frame: 6-months
|
Acceptability will assessed using satisfaction ratings.
|
6-months
|
|
Usability of the Mobile Application
Time Frame: 6-months
|
Usability will be assessed through quantifying online usage patterns.
|
6-months
|
|
Change in frequency and quantity of communication
Time Frame: 1-, 3-, and 6-months
|
Data will be extracted through the online dashboard to examine change in communication between providers at the two participating clinics.
|
1-, 3-, and 6-months
|
|
Provider Perception Inventory will assess change in provider-related stigma
Time Frame: 1-, 3-, and 6-months
|
This questionnaire measures health service providers' stigma in regards to HIV, substance use, and sexual risk behavior.
|
1-, 3-, and 6-months
|
|
Implementation Climate Scale
Time Frame: Baseline
|
This scale will measure the degree to which there is a strategic organizational climate supportive of the intervention implementation in each participating clinic.
|
Baseline
|
|
Change in Patient Treatment Retention in both HIV and Substance Use Services
Time Frame: 1-, 3-, and 6-months
|
Data will be extracted through the online dashboard to examine change in appointment attendance for patients enrolled in treatment at the participating HIV and substance use clinic.
|
1-, 3-, and 6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kasey Claborn, PhD, The University of Texas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
December 30, 2021
Study Registration Dates
First Submitted
August 23, 2016
First Submitted That Met QC Criteria
September 14, 2016
First Posted (Estimate)
September 20, 2016
Study Record Updates
Last Update Posted (Actual)
July 25, 2022
Last Update Submitted That Met QC Criteria
July 22, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34DA041237 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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