PATH FOR TRIPLES BUSHAUNA FREEMAN MICHAEL BLANK, P.I. SUMR PROGRAM 2016 PHILADELPHIA, PA AUGUST 18, 2016

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1 PATH FOR TRIPLES BUSHAUNA FREEMAN MICHAEL BLANK, P.I. SUMR PROGRAM 2016 PHILADELPHIA, PA AUGUST 18, 2016

2 OVERVIEW HIV/AIDS on a global, national, and state level Background and Study Design The Intervention (Nurse Health Navigator) Enrollment Statistics Participants characteristics (Baseline) Example Case Study Discussion Acknowledgments

3 CURRENT STATUS OF THE HIV/AIDS EPIDEMIC Worldwide Statistics There were approximately 36.7 million people living with HIV 2.1 million people became newly infected with HIV New HIV infections have decreased by 6% since 2010 US Statistics More than 1.2 million people in the US are living with HIV, and 1 in 8 of them don t know it Gay and bisexual men, particularly young African American/Hispanic gay and bisexual men, are most affected Philadelphia There are an estimated 30,000 people living with HIV in the Greater Philadelphia Region (Philadelphia Department of Health) Sources :Joint United Nations Progamme on HIV/AIDS, W.H.O., & the Philadelphia Department of Health (2015)

4 PURPOSE To determine if assigning a Nurse Health Navigator Intervention to patients who are triply diagnosed with HIV, substance use disorder (SUD), and serious mental illness (SMI) can improve the health and quality of life for these individuals by assisting them with their adherence to medical, psychiatric, and substance abuse treatment.

5 HPTN 058 STUDY DESIGN PATH FOR TRIPLES: STUDY DESIGN Nurse Health Navigator Recruited patients from multiple inpatient and outpatient locations within the greater Philadelphia area Provides assistance with medication and counseling adherence, meets at least weekly with patients Treatment as Usual Control Group-patients receive standard treatment of care Office Follow- ups conducted: 0-(Baseline) 3- months 6- months 9months Received tokens for each office visit (Septa) to assist with travel needs

6 ARMS NHN (Experimental Arm) Treatment as Usual (Control Arm) Meets with patients weekly Provides memory aids and education regarding side effects and other treatment aspects, engages with participants' social networks and treatment providers, and supports active community outreach. Accompany the patient to appointments, or make collateral contacts with other care providers to provide housing, food, employment, etc. Participants continue with their current care strategy

7 INTERVENTION CASCADE Estimated % Experimental Successful All experimental receive basic intervention (70% ) 80% Adherent YE S NO Social Support (10% ) 80% Adherent YE S NO Control Treatment- as-usual Sample of 300 Randomization The goal is 80% adherence Cell Phones (5% ) 80% Adherent YE S NO Directly Observed Therapy (5% ) 80% Adherent YE S NO (5% ) 80% Adherent (5% ) Not Successful 1) At weekly observational period, if target is less than 80%, the next level of intensity will be implemented until 80% adherence is maintained for three observation periods, then it reverts back to the higher level. 2) If 80% is not obtained, then the intervention cascade increases to the next level of intensity.

8 INCLUSION CRITERIA 18 or older; HIV+; with a detectable viral load Newly diagnosed w/hiv or not currently in care for HIV Have a history of mental illness; Ability to speak English; Ability to provide informed consent; Have co-occurring substance use or abuse Willingness to provide locator information Willingness to be randomized to PFT or TAU

9 ENROLLMENT BY STUDY SITES Sites Penn Presbyterian Medical Center Mazzoni Center Pennsylvania Hospital Episcopal Hospital Hospital of the University of Pennsylvania Kirkbride Center Comhar Inc. Community Mental Health Gaudenzia Prevention Point Philadelphia Referrals from other Studies ActionAids Jonathan Lax Treatment Center

10 SUBJECT ENROLLMENT STATS Target enrollment 240 Number of participants determined to be ineligible 229 Number of participants enrolled in the NHN group (experimental) 34 Number of participants in the TAU group (standard/control) 34 Total number of participants enrolled in both arms 68

11 Demographic of Recruited Participants Race Asian 1% Black or African American 81% Other 3% White 15% Total 100%

12 Baseline Characteristics Gender (%female) 34% Gender (%male) 57% Other (Transgender [MtF]) Total 9% 100%

13 Exposure to the interventions: NHN Case study of Bob 49 year old Caucasian male Homosexual Triply diagnosed: HIV, depression, and history of substance use disorder (alcohol, crack cocaine, hallucinogens, amphetamines, and heroin) Homeless Occupation: Voluntary Work weekly

14 INTERVIEW QUESTIONS: Question: Since enrollment in this study, has anyone become a stable resource or beneficial support system for you? Response: Yes, she has become a substantial person in my life. We have a steady relationship and communicate weekly. She is very sensitive to my needs and flexible with irregular schedule. Question: Exactly how long (years) have you used drugs and/or substances for recreational purposes? Response: About 35+ years. Question: How has your drug use impacted your life? Response: Quite negatively, it has particularly affected my housing situation for the last two years. Question: What are your short /long term goals post completion of this study? Response: Well, my long term goal will always be adhering to my medication as I have in the past grown resistant to previously used drugs. Acquiring stable housing would have to be my short term goal moving forward at least within the next three months. Question: Do you think this study has affected your life and in what ways? Response: It has impacted me to be more cognizant and approach life in a more positive manner. PFT as well as my nurse consistently reminds me to adhere to my medications.

15 SUMMARY OF CASE STUDY Even though there have been recruitment and retention issues, most individuals similar to Bob, have progressed tremendously from being a participant in the experimental group The relationship between him and the Nurse Health Navigator has blossomed into one of great influence as he not only continues to adhere to his medication as a part of the adherence component, but also completes weekly nurse visits and follow-up research interviews

16 RESULTS Results are ongoing as this is Year Two of a five year study.

17 RECRUITMENT AND RETENTION BARRIERS Many individuals who do qualify for this study are triply diagnosed, but many of their viral loads are undetectable, approximately 69% of participants. With the study roughly at its midpoint (Year 2 out of 5), efforts are being made to increase recruitment and overall reach the target enrollment goal of 240 individuals. As noted, a lot of participants that are initially recruited simply do not qualify based on the detectable viral load requirement, with the rate of undetectable viral loads in Philadelphia at 51%. Overall, this vulnerable population has the tendency to lose contact after the first office follow up at 3 months. Likewise, factors of life coinciding with frequent drug use such as incarceration, lack of employment, and lack of communication decrease the ability and interest to continue participation.

18 LESSONS LEARNED The ability to interview and to screen individuals for participation within PFT Developed strategies to work with vulnerable populations, particularly those who are triply diagnosed Improved understanding and appreciation for the field of epidemiology

19 Protocol Team Principal Investigator: Michael B Blank, PhD Donna M Coviello, PhD Rebeka Lovato, BA David Kelly Ashley Jackson Kaitlin Apostol