Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02906215 |
Other study ID # |
R34DA041237 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2017 |
Est. completion date |
December 30, 2021 |
Study information
Verified date |
July 2022 |
Source |
University of Texas at Austin |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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.
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.