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Despite advances in antiretroviral therapy, chronic immune activation continues to be observed among individuals with well-controlled HIV viral loads, and is associated with non-AIDS defining morbidities among people living with HIV. Alcohol use disorder impacts a significant proportion of individuals living with HIV, and alcohol exposure is known to damage the intestinal epithelium which may increase translocation of pathogens and their molecular products, driving systemic immune activation and dysregulation. The aim of this study was to determine if adults living with HIV with well-controlled viral loads, who also suffer from alcohol use disorder with and without hepatitis C virus co-infection (n=23), exhibit evidence of advanced systemic immune activation, intestinal damage, and microbial translocation, as compared to adults living with HIV who are not exposed to chronic alcohol or other substances of abuse (n=29). The impact of a 1-month intervention to treatment alcohol use disorder was also examined.
Alcohol use disorder was associated with evidence of advanced innate immune activation, alterations in monocyte phenotype including increased expression of Toll-like receptor 4, increased burden of stimulatory ligands for Toll-like receptor 4, and alterations in plasma cytokine signature, most notably elevations in soluble CD40 ligand and transforming growth factor beta. Alcohol-associated immune activation was more pronounced among individuals with hepatitis C virus co-infection.
Conclusions: Although the 1-month intervention to treat alcohol use disorder did not result in significant reductions in the interrogated indicators of immune activation, these findings suggest that chronic alcohol exposure is a major modifiable risk factor for chronic immune activation and dysregulation among people living with HIV.
Related protocols: CTN-0055
This study sought to understand participants’ perceptions of their assigned treatment in a randomized control trial examining the use of extended-release naltrexone versus treatment as usual for substance use disorders. Researchers administered semi-structured interviews among 22 prospective and actual participants in a larger clinical trial examining the feasibility of extended-release naltrexone for both opioid and alcohol use disorders among people living with HIV. Interviews were transcribed, coded, and analyzed thematically.
Participants described their study experience as mostly positive, but also concurrently held or developed study medication apprehensions and misperceptions. First, some participants described apprehension, lack of control, and uneasiness regarding their assigned treatment. Second, some participants perceived their treatment as “placebos” and/or were convinced that their treatment was ineffective, shaping perceptions of impact on their substance use. Third, some participants perceived study treatments as cure-alls for substance use disorders.
Conclusions: Participant perceptions of trial interventions may frame their experience and participation in clinical studies. These findings demonstrate the need for researchers and clinicians to consider how apprehension and a lack of medication receptivity may impact enrollment and participant autonomy. They also identify opportunities for greater community engagement in trial design and implementation in order to improve participant education about the nature of interventions and the potential of ongoing consent processes integrated throughout studies to promote participant understandings of study purposes and objectives.
Related protocols: CTN-0055
In randomized controlled trials (RCTs), “therapeutic optimism” describes a participant’s belief that they will benefit from the study treatment, despite the express goal of RCTs to test unknown aspects of interventions. Harboring such expectations may interfere with RCT participation experiences, particularly among marginalized populations, such as people with substance use disorders (PSUD) who may experience social and structural barriers to participation that also increase their vulnerability to therapeutic optimism. However, little research explores therapeutic optimism within substance use trials. Thus, researchers conducted a nested qualitative study within an RCT testing a treatment for alcohol and opioid use disorders in HIV clinics (CTN-0055 CHOICES study). Using interviews with 22 participants in Vancouver, Canada, analysis revealed themes relevant to therapeutic optimism that were specifically linked to intrinsic (e.g., health-related) or extrinsic motivations (e.g. stipend). First, compared to extrinsically motivated participants, intrinsically motivated participants held high expectations for the trial and attributed greater agency to the study medication. Second, intrinsically motivated participants expressing therapeutic optimism anticipated marked changes in their lives from the study/medication. Finally, some participants predicted the treatment would solve substance-related issues in their communities.
Conclusions: These findings highlight the interplay between therapeutic optimism and complex interpretations of RCT objectives among PSUD and lay the groundwork for innovations in the design and implementation of RCTs with vulnerable populations.
Related protocols: CTN-0055
The CHOICES study (CTN-0055) randomized participants with HIV and opioid use disorder (OUD) to HIV clinic-based extended-release naltrexone (XR-NTX), which which requires complete cessation of opioid use, versus treatment-as-usual (i.e., buprenorphine, methadone). Study participants randomized to XR-NTX were interviewed to assess their experiences with successful and unsuccessful XR-NTX induction.
Semi-structured qualitative interviews were completed with a convenience sample of study participants with HIV and OUD (n=37) randomized to XR-NTX in five HIV clinics between 2018 and 2019. All participants approached agreed to be interviewed. Interviews were digitally recorded, professionally transcribed, and analyzed using thematic analysis.
Participants included women (43%), African Americans (62%) and Hispanics (16%), between 27 to 69 years of age. Individuals who completed XR-NTX induction (n=20) reported experiencing (1) readiness for change, (2) a supportive environment during withdrawal including comfort medications, and (3) caring interactions with staff. Four contrasting themes emerged among participants (n=17) who did not complete induction: (1) concern and anxiety about withdrawal including past negative experiences, (2) ambivalence about or reluctance to stop opioids, (3) concerns about XR-NTX effects, and (4) preferences for other medications.
Conclusions: The results highlight opportunities to improve initiation of XR-NTX in high-need groups. Addressing expectations regarding induction may enhance XR-NTX initiation rates.
Related protocols: CTN-0055
Opioid use disorders (OUD) and hepatitis C or B co-infection (HEP) are common among people living with HIV (PLHIV). The impact of OUD on innate and adaptive immunity among PLHIV with and without HEP is unknown.
This study, part of CTN-0055 (CHOICES), investigated the impact of OUD on monocyte and T-cell phenotypes, cytokine responses to lipopolysaccharide (LPS) and phytohemagglutinin (PHA), and plasma inflammatory markers, among PLHIV with and without HEP. It was a cross-sectional study enrolling PLHIV receiving ART with and without OUD. Flow cytometry determined monocyte and T-cell phenotypes; LPS and PHA-induced cytokine production was assessed following LPS and PHA stimulation by multiplex cytokine array; plasma IL-6, soluble CD163, and soluble CD14 were measured by ELISA.
Twenty-two PLHIV with OUD and 37 PLHIV without OUD were included. PLHIV with OUD exhibited higher frequencies of intermediate and neoclassical monocytes when compared with PLHIV without OUD (P=0.0025; P=0.0001, respectively), regardless of HEP co-infection. Soluble CD163 and monocyte cell surface CD163 expression was increased among PLHIV with OUD and HEP, specifically. Regardless of HEP co-infection, PLHIV with OUD exhibited reduced production of IL-10, IL-8, IL-6, IL-1alpha, and TNF-alpha in response to LPS when compared with PLHIV without OUD; PHA-induced production of IL-10, IL-1alpha, IL-1beta, IL-6, and TNF-alpha were also reduced among individual with OUD.
Conclusions: OUD among PLHIV are associated with altered monocyte phenotypes and a dysregulated innate cytokine response. Defining underlying mechanisms of opioid-associated innate immune dysregulation among PLHIV should be prioritized to identify optimal OUD treatment strategies.
Related protocols: CTN-0055
This is the primary outcomes article for CTN-0055.
HIV-infected persons with substance use disorders are least likely to benefit from advances in HIV treatment. Integration of extended-release naltrexone (XR-NTX) into HIV clinics may increase engagement in the HIV care continuum by decreasing substance use. This non-blinded, randomized trial, CTN-0055 (CHOICES), compared 1) XR-NTX treatment initiation, 2) retention, and 3) safety of XR-NTX versus treatment as usual (TAU) for treating opioid use disorder (OUD) and/or alcohol use disorder (AUD) in HIV clinics. The study was set in HIV primary care clinics in Vancouver, British Columbia, and Chicago, Illinois. Fifty-one HIV-infected patients seeking treatment for opioid use disorder (OUD, n=16), alcohol use disorder (AUD, n=27), or both (n=8) were randomized. Primary outcomes were XR-NTX initiation (receipt of first injection within 4 weeks of randomization) and retention at 16 weeks. Secondary outcomes generated point estimates for change in substance use, HIV viral suppression (HIV RNA pcr < 200 copies/mL), and safety.
Results found that two-thirds (68%) of participants assigned to XR-NTX initiated treatment, and 88% of these were retained on XR-NTX at 16 weeks. By comparison, 96% of TAU participants initiated treatment, but only 50% were retained on medication at 16 weeks. Mean days of opioid use in past 30 days decreased from 19 to 10 for TAU (n=12) and from 18-13 for XR-NTX (n=10). Mean heavy drinking days decreased from 18 to 7 for TAU (n=11) and 13 to 6 for XR-NTX (n=12). Among those with OUD, HIV suppression improved from 67% to 80% for XR-NTX and 58% to 75% for TAU. XR-NTX was well-tolerated, with no precipitated withdrawals and 1 serious injection site reaction.
Conclusions: Extended-release naltrexone (XR-NTX) is feasible and safe for treatment of opioid use disorder and alcohol use disorder in HIV clinics. Treatment initiation appears to be lower and retention greater for XR-NTX compared with treatment as usual. The findings underscore the need for a multi-site trial to test the potential of XR-NTX for improving engagement in the HIV care continuum. Use of long-acting addiction pharmacotherapies such as XR-NTX may improve the capacity for HIV-infected patients with substance use disorders to better engage in HIV treatment and close gaps in the HIV care continuum.
Related protocols: CTN-0055