NCT02906215

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

3.8 years

First QC Date

August 23, 2016

Last Update Submit

July 22, 2022

Conditions

Keywords

mHealthimplementationPrEPdigital health

Outcome Measures

Primary Outcomes (1)

  • Change in Interagency Collaboration as measured by the "Levels of Collaboration" scale

    1-, 3-, and 6-months

Secondary Outcomes (6)

  • Acceptability of the Care Coordination Intervention

    6-months

  • Usability of the Mobile Application

    6-months

  • Change in frequency and quantity of communication

    1-, 3-, and 6-months

  • Provider Perception Inventory will assess change in provider-related stigma

    1-, 3-, and 6-months

  • Implementation Climate Scale

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

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.

Behavioral: Care Coordination Intervention

Interventions

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

Care Coordination Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent, active psychosis, and not fluent in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Dell Medical School

Austin, Texas, 78712, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kasey Claborn, PhD

    The University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2016

First Posted

September 20, 2016

Study Start

September 1, 2017

Primary Completion

June 30, 2021

Study Completion

December 30, 2021

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations