The four-factor personality model and its qualitative correlates among opioid agonist therapy clients.

Background: The Four Factor Personality Vulnerability model identifies four specific personality traits (e.g., sensation seeking [SS], impulsivity [IMP], anxiety sensitivity [AS], and hopelessness [HOP]) as implicated in substance use behaviors, motives for substance use, and co-occurring psychiatric conditions. Although the relationship between these traits and polysubstance use in opioid agonist therapy (OAT) clients has been investigated quantitatively, no study has examined the qualitative expression of each trait using clients' voice. Method: Nineteen Methadone Maintenance Therapy (MMT) clients (68.4% male, 84.2% white, mean age[SD] = 42.71 [10.18]) scoring high on one of the four personality traits measured by the Substance Use Risk Profile Scale [SURPS] completed a semi-structured qualitative interview designed to explore their lived experience of their respective trait. Thematic analysis was used to derive themes, which were further quantified using content analysis. Results: Themes emerging from interviews reflected (1) internalizing and externalizing symptoms, (2) adversity experiences, and (3) polysubstance use. Internalizing symptoms subthemes included symptoms of anxiety, fear, stress, depression, and avoidance coping. Externalizing subthemes included anger, disinhibited cognitions, and anti-social and risk-taking behaviors. Adverse experiences subthemes included poor health, poverty, homelessness, unemployment, trauma, and conflict. Finally, polysubstance use subthemes include substance types, methods of use, and motives. Differences emerged between personality profiles in the relative endorsement of various subthemes, including those pertaining to polysubstance use, that were largely as theoretically expected. Conclusion: Personality is associated with unique cognitive, affective, and behavioral lived experiences, suggesting that personality may be a novel intervention target in adjunctive psychosocial treatment for those undergoing OAT.

M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID.

BACKGROUND: Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. METHODS: The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial (M2HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. DISCUSSION: The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. TRIAL REGISTRATION: Clinicaltrials.gov NCT03981445 . Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201.