HIVNCT02906215
Mobile Application to Improve Care Coordination Among HIV Clinic and Substance Use Treatment Providers
A study testing Care Coordination Intervention in people with HIV and Substance Use, run by University of Texas at Austin at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Substance Use, Care Coordination
- What is being tested?
- Care Coordination Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent, active psychosis, and not fluent in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Dell Medical School
Austin, Texas, 78712
About this study
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.
Read the 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.
- Conditions
- HIV, Substance Use, Care Coordination
- Being tested
- Care Coordination Intervention
- Keywords
- mHealth, implementation, PrEP, digital health
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Coordination InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Care Coordination Intervention | Experimental | 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. Receives: Behavioral: Care Coordination Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interagency Collaboration as measured by the "Levels of Collaboration" scale
Measured: 1-, 3-, and 6-months
Secondary outcomes (6)
Acceptability of the Care Coordination Intervention
Acceptability will assessed using satisfaction ratings.
Measured: 6-months
Usability of the Mobile Application
Usability will be assessed through quantifying online usage patterns.
Measured: 6-months
Change in frequency and quantity of communication
Data will be extracted through the online dashboard to examine change in communication between providers at the two participating clinics.
Measured: 1-, 3-, and 6-months
Provider Perception Inventory will assess change in provider-related stigma
This questionnaire measures health service providers' stigma in regards to HIV, substance use, and sexual risk behavior.
Measured: 1-, 3-, and 6-months
Implementation Climate Scale
This scale will measure the degree to which there is a strategic organizational climate supportive of the intervention implementation in each participating clinic.
Measured: Baseline
Change in Patient Treatment Retention in both HIV and Substance Use Services
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.
Measured: 1-, 3-, and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Sep 2017
- Primary completion30 Jun 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kasey Claborn, University of Texas at Austin
- Investigators
- Kasey Claborn, PhD, Principal investigator, The University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906215
- Sponsor's protocol ID
- R34DA041237
- Status last verified
- Jul 2022
- First submitted
- 23 Aug 2016
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Claborn K, Becker S, Ramsey S, Rich J, Friedmann PD. Mobile technology intervention to improve care coordination between HIV and substance use treatment providers: development, training, and evaluation protocol. Addict Sci Clin Pract. 2017 Mar 14;12(1):8. doi: 10.1186/s13722-017-0073-1.
PubMed 28288678
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application to Improve Care Coordination Among HIV Clinic and Substance Use Treatment Providers
- ClinicalTrials.gov ID
- NCT02906215
- Acronym / sponsor ID
- R34DA041237
- Conditions
- HIV, Substance Use, Care Coordination
- Keywords
- mHealth, implementation, PrEP, digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 20 Sep 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Care Coordination Intervention | Experimental | Behavioral: Care Coordination InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must:
Key exclusion criteria (1 listed)
- Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent, active psychosis, and not fluent in English.
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 |
|---|---|---|
| Care Coordination Interventioncross-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 | Behavioural | Care Coordination Intervention |
Primary outcome
Change in Interagency Collaboration as measured by the "Levels of Collaboration" scale
Time frame: 1-, 3-, and 6-months
6 secondary outcomes
Acceptability of the Care Coordination Intervention
Time frame: 6-months
Usability of the Mobile Application
Time frame: 6-months
Change in frequency and quantity of communication
Time frame: 1-, 3-, and 6-months
Provider Perception Inventory will assess change in provider-related stigma
Time frame: 1-, 3-, and 6-months
Implementation Climate Scale
Time frame: Baseline
Change in Patient Treatment Retention in both HIV and Substance Use Services
Time frame: 1-, 3-, and 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 28288678Claborn K, Becker S, Ramsey S, Rich J, Friedmann PD. Mobile technology intervention to improve care coordination between HIV and substance use treatment providers: development, training, and evaluation protocol. Addict Sci Clin Pract. 2017 Mar 14;12(1):8. doi: 10.1186/s13722-017-0073-1.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kasey Claborn, PhD principal investigator
The University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Coordination Intervention in people with HIV and Substance Use, run by University of Texas at Austin 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 25 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interagency Collaboration as measured by the "Levels of Collaboration" scale (time frame: 1-, 3-, and 6-months). 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 NCT02906215, which also lists 1 linked publication.
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 25 Jul 2022.