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PATH For Triples Study: Medication and Lifestyle Adherence for HIV+ Patients

NCT02185144 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2019-10-04

No results posted yet for this study

Summary

The PATH for Triples (PFT) Study is an effectiveness trial comparing a nurse health navigator (NHN) model for HIV+ persons with severe mental illness and substance abuse (i.e., triply diagnosed) with Treatment as Usual (TAU). The team completed a Phase II trial of the nurse health navigator model for HIV+ persons with severe mental illness that showed the intervention was effective. The investigators are now testing the intervention in a real world setting with patients recruited from psychiatric and substance abuse inpatient units in Philadelphia using a longitudinal design. The intervention is set up as a cascade where non-adherent patients receive additional visits from the study nurses. It is hypothesized that patients assigned to the NHN will have better medication compliance, reduced viral loads and improved CD4 counts compared to patients assigned to TAU. It is also hypothesized that the PFT intervention group will be more cost effective compared to TAU. This group of triply diagnosed patients are at very high risk of negative health outcomes and secondary transmission of HIV and, therefore, the study is of high public health significance.

Conditions

Interventions

BEHAVIORAL

PATH For Triples

In addition to providing weekly home-health nursing focused psycho-education aimed at insuring adherence to drug treatment regimen, the nurse health navigator model provided in PFT combines continuous and integrated care across mental health, substance abuse, and infectious disease provides. The nurses will accompany the patient to appointments, or make collateral contacts with other care providers. Often the nurses serve as intermediaries and ensure accurate and timely information exchange. Their specialized training also allows them to monitor side effects of medications and advocate for the patients with their various specialty providers. A treatment cascade approach is utilized when the patient is non-adherent to treatment allowing for increased patient monitoring.

BEHAVIORAL

Treatment as Usual

Control subjects receive enhanced TAU care which will consist of the opportunity to complete the full complement of baseline instruments that will then be shared with their outpatient mental health case manager to facilitate linkage with needed MH, SA, and ID care

Sponsors & Collaborators

Principal Investigators

  • Michael B Blank, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02185144 on ClinicalTrials.gov