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

Completed · Not applicable

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT02185144

Run by

University of Pennsylvania

People needed

129

Starts

2014-02-01

Expected to finish

2019-08-01

Last updated by the study team

2019-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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