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

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decay of the intervention after it is withdrawn.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.

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