NCT02185144

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Feb 2014

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

Study Start

First participant enrolled

February 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

5.5 years

First QC Date

June 30, 2014

Last Update Submit

October 1, 2019

Conditions

HIV

Keywords

HIV, mental health, substance abuse

Outcome Measures

Primary Outcomes (2)

  • Change in HIV status based on viral load from baseline through 9 months

    Change in viral load based on collection of blood specimens at baseline, 3, 6 and 9 months

    Baseline, 3, 6, 9 months

  • Change in HIV status based on CD4 count from baseline through 9 months

    Change in CD4 count based on collection of blood specimens at baseline, 3, 6 and 9 months

    Baseline, 3, 6, 9 months

Secondary Outcomes (9)

  • Medical, psychiatric and substance abuse services used by study participants over the 9-month duration of the study using Medicaid Claims Data

    9 months

  • Change in HIV knowledge and intentions from baseline through 9 months using the HIV Intention and Knowledge Measure

    Baseline, 3, 6, 9 months

  • Change in HIV risk behaviors based on the Risk Assessment Battery from baseline through 9 months

    Baseline, 3, 6, 9 months

  • Change in mental health functioning using the BASIS24 from baseline through 9 months

    Baseline, 3, 6, 9 months

  • Change in alcohol use using the ASSIST Measure from baseline through 9 months

    Baseline, 3, 6, 9 months

  • +4 more secondary outcomes

Study Arms (2)

PATH for Triples (PFT)

EXPERIMENTAL

The Nurse Health Navigator (NHN) meets at least weekly with the experimental participants to implement the adherence component of PFT using approaches tailored to the communication and comprehension of the person that includes memory aids, education regarding side effects and other treatment aspects, engagement with participants' social networks and treatment providers, and active community outreach. PFT will be implemented for 6 months and participants will be followed for an additional 3 months to allow examination of potential decay of the intervention after it is withdrawn.

Behavioral: PATH For Triples

Treatment as Usual (TAU)

PLACEBO COMPARATOR

Participants in the the Treatment as Usual (TAU) group receive usual treatment after inpatient care.

Behavioral: Treatment as Usual

Interventions

PATH For TriplesBEHAVIORAL

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.

PATH for Triples (PFT)
Treatment as UsualBEHAVIORAL

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

Treatment as Usual (TAU)

Eligibility Criteria

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

You may qualify if:

  • or older;
  • HIV+;
  • Newly diagnosed w/HIV or not currently in care for HIV;
  • Receiving psychiatric inpatient care;
  • Have a serious mental illness;
  • Have co-occurring substance use or abuse;
  • Ability to speak English;
  • Ability to provide informed consent;
  • Willingness to provide locator information;
  • Willingness to be randomized to PFT or TAU.
  • Resident of the City of Philadelphia

You may not qualify if:

  • HIV-;
  • Persons who are unable to provide informed consent;
  • Inability to speak English;
  • Not willing to provide locator information;
  • Not competent to provide informed consent;
  • If HIV status is unknown, they refused to be tested;
  • Not a resident of the City of Philadelphia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Blank MB, Himelhoch SS, Balaji AB, Metzger DS, Dixon LB, Rose CE, Oraka E, Davis-Vogel A, Thompson WW, Heffelfinger JD. A multisite study of the prevalence of HIV with rapid testing in mental health settings. Am J Public Health. 2014 Dec;104(12):2377-84. doi: 10.2105/AJPH.2013.301633. Epub 2014 Feb 13.

    PMID: 24524493BACKGROUND

MeSH Terms

Conditions

Psychological Well-BeingSubstance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Michael B Blank, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 9, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

October 4, 2019

Record last verified: 2019-10

Locations

US(1)