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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Care Coordination Intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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