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

October 1, 2019 updated by: University of Pennsylvania

The PFT Intervention: Linking Triply Diagnosed Inpatients to Community Care

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In response to PA-12-281, HIV/AIDS, Drug Use, and Vulnerable Populations in the US (R01), we are conducting an effectiveness trial among persons triply diagnosed (mental illness, substance abuse, HIV) recruited from inpatient psychiatric units in Philadelphia. Despite general recognition that persons with serious mental illness (SMI) are at heightened risk to contract and transmit human immunodeficiency virus (HIV), systematic HIV testing in mental health settings is rare. Using discarded blood samples over a six-month period, our research team found in excess of 10% HIV seroprevalence in two inpatient psychiatric units in Philadelphia. We argued then that HIV testing should be routinely conducted in those settings. In a five-year longitudinal effectiveness trial, we will identify HIV positive SMI inpatients through rapid testing. Those who are newly diagnosed or who were previously diagnosed but not currently engaged in HIV treatment and who also are substance using will be offered an opportunity to participate in a randomized community trial. Previously, we have conducted a Phase II trial of PATH for Positives (PFP) in which we observed broad and far-reaching effects of an intervention utilizing a nurse health navigator (NHN) model for HIV+ SMI clients. The current study builds on what we learned previously to provide a nurse health navigator (NHN) model as integrated treatment of the targeted individuals in "real world" conditions and to monitor the implementation of PATH for Triples (PFT). The target population is arguably among the highest risk patient populations for poor treatment outcomes. Based on past experience, we expect to enroll about 75% of those eligible on a rolling basis, or ~240 participants who will then be randomized. This will yield ~120 PFT and ~120 Treatment as Usual (TAU) participants over a 36-month recruitment window before attrition. A similar population in PFP resulted in a 17% attrition rate, so we estimate complete data for at least 75% of participants resulting in a complete dataset of ~180 participants (90 PFT, and 90 TAU). PFT participants will receive NHN services for 6 months. Data will be collected at baseline, 3, 6, and 9 months for each participant. Participants will be followed longitudinally for an additional 3 months post intervention to measure any decay of the intervention after it is withdrawn. Experimental participants will begin PFT while still receiving inpatient services and the project nurses will participate in discharge planning and facilitate linkage to Mental Health (MH), Substance Abuse (SA), and Infectious Disease (ID) care in the Philadelphia community. The NHN will also meet 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. We expect better retention in treatment for PFT participants and improvement in other outcomes including viral load, CD4, indicators of psychological and social functioning, and cost effectiveness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: PATH for Triples (PFT)
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
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.
PLACEBO_COMPARATOR: Treatment as Usual (TAU)
Participants in the the Treatment as Usual (TAU) group receive usual treatment after inpatient care.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HIV status based on viral load from baseline through 9 months
Time Frame: Baseline, 3, 6, 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
Time Frame: Baseline, 3, 6, 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medical, psychiatric and substance abuse services used by study participants over the 9-month duration of the study using Medicaid Claims Data
Time Frame: 9 months
To assess the cost effectiveness of PFT compared to Treatment as Usual using Medicaid Claims Data.
9 months
Change in HIV knowledge and intentions from baseline through 9 months using the HIV Intention and Knowledge Measure
Time Frame: Baseline, 3, 6, 9 months
Baseline, 3, 6, 9 months
Change in HIV risk behaviors based on the Risk Assessment Battery from baseline through 9 months
Time Frame: Baseline, 3, 6, 9 months
Baseline, 3, 6, 9 months
Change in mental health functioning using the BASIS24 from baseline through 9 months
Time Frame: Baseline, 3, 6, 9 months
Baseline, 3, 6, 9 months
Change in alcohol use using the ASSIST Measure from baseline through 9 months
Time Frame: Baseline, 3, 6, 9 months
Baseline, 3, 6, 9 months
Change in alcohol use based on the Seek, Test, Treat and Retain for Vulnerable Populations: Data Harmonization Measure from baseline through 9 months
Time Frame: Baseline, 3, 6, 9 months
Baseline, 3, 6, 9 months
Change in drug use based on the ASSIST from baseline through 9 months
Time Frame: Baseline, 3, 6, 9 months
Baseline, 3, 6, 9 months
Change in drug use based on the Seek, Test, Treat and Retain for Vulnerable Populations: Data Harmonization Measure from baseline through 9 months
Time Frame: Baseline, 3, 6 and 9 months
Baseline, 3, 6 and 9 months
Change in quality of life based on the SF12 from baseline through 9 months
Time Frame: Baseline, 3, 6 and 9 months
Baseline, 3, 6 and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael B Blank, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01DA036503-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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