Experimentally Induced Reductions in Alcohol Consumption and Brain, Cognitive, and Clinical Outcomes in Older Persons With and Those Without HIV Infection (30-Day Challenge Study): Protocol for a Nonrandomized Clinical Trial.

BACKGROUND: Both alcohol consumption and HIV infection are associated with worse brain, cognitive, and clinical outcomes in older adults. However, the extent to which brain and cognitive dysfunction is reversible with reduction or cessation of drinking is unknown. OBJECTIVE: The 30-Day Challenge study was designed to determine whether reduction or cessation of drinking would be associated with improvements in cognition, reduction of systemic and brain inflammation, and improvement in HIV-related outcomes in adults with heavy drinking. METHODS: The study design was a mechanistic experimental trial, in which all participants received an alcohol reduction intervention followed by repeated assessments of behavioral and clinical outcomes. Persons were eligible if they were 45 years of age or older, had weekly alcohol consumption of 21 or more drinks (men) or 14 or more drinks (women), and were not at high risk of alcohol withdrawal. After a baseline assessment, participants received an intervention consisting of contingency management (money for nondrinking days) for at least 30 days followed by a brief motivational interview. After this, participants could either resume drinking or not. Study questionnaires, neurocognitive assessments, neuroimaging, and blood, urine, and stool samples were collected at baseline, 30 days, 90 days, and 1 year after enrollment. RESULTS: We enrolled 57 persons with heavy drinking who initiated the contingency management protocol (mean age 56 years, SD 4.6 years; 63%, n=36 male, 77%, n=44 Black, and 58%, n=33 people with HIV) of whom 50 completed 30-day follow-up and 43 the 90-day follow-up. The planned study procedures were interrupted and modified due to the COVID-19 pandemic of 2020-2021. CONCLUSIONS: This was the first study seeking to assess changes in brain (neuroimaging) and cognition after alcohol intervention in nontreatment-seeking people with HIV together with people without HIV as controls. Study design strengths, limitations, and lessons for future study design considerations are discussed. Planned analyses are in progress, after which deidentified study data will be available for sharing. TRIAL REGISTRATION: ClinicalTrials.gov NCT03353701; https://clinicaltrials.gov/study/NCT03353701. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53684.

Antiretroviral treatment adherence as a mediating factor between psychosocial variables and HIV viral load.

Psychosocial factors may directly impact HIV health measures such as viral load (VL) whether or not patients are taking antiretroviral treatment (ART) consistently. Structural equation modeling plus Baron and Kenny's (1986) four-step approach were used to test a mediated model predicting VL among 246 HIV-infected adults who were on ART. Exogenous variables were social support, barriers to adherence, and stress. Moderators were alcohol use, marijuana use, and neurocognitive impairment. A small positive association between marijuana use and ART adherence approached significance. Only barriers to adherence predicted a decrease in adherence rates and an increase in VL. No other factors were significantly associated with either VL or adherence, and no interaction effects between exogenous variables and moderators were identified. The association between barriers to adherence and VL was partially mediated by ART adherence. Findings provide modest support for a direct link between psychosocial variables and a virologic response to ART.

Exploring Substance Use and HIV Treatment Factors Associated with Neurocognitive Impairment among People Living with HIV/AIDS.

Neurocognitive (NC) impairment remains prevalent among people living with HIV (PLWH) and may be exacerbated by alcohol and drug use. This cross-sectional study assesses the degree to which alcohol and other drug use, time from HIV diagnosis to treatment, and years living with HIV affect three areas of NC functioning among HIV-seropositive adults. NC functioning in 370 PLWH living in Miami, FL was assessed using the Auditory Verbal Learning Test, the Short Category Test, Booklet Format, and the Color Trails Test 2 (CTT2). Participants reported the number of days using alcohol, marijuana, and cocaine over the previous 3 months, the number of known years living with HIV and length of time from HIV diagnosis to seeking care. Bivariate linear regression and multivariate linear regression were used to test associations between independent and dependent variables. Mean scores on NC measures were significantly lower than published norms; 39% of participants scored ≥1 standard deviation below normative sample means on >2 NC tests. No significant associations were found between alcohol or cocaine use and any NC measure. Years living with HIV was associated with CTT2 in the bivariate analysis (ß = 1.031; p = 0.007). In multivariate analysis, each day of marijuana use and years living with HIV were associated with a 0.32 (p = 0.05) point and 1.18 (p = 0.03) points poorer performance score on the CTT2, respectively. Results suggest that both marijuana use and duration of HIV infection may affect cognitive functioning among PLWH in ways that may impair their ability to follow important treatment guidance.