Clinical Research Directory

Physical Activity for PLWH and Unhealthy Drinking

Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Antiretroviral therapy (ART) has shown increasing life expectancy and decreased HIV-related deaths, leading to a growing older adult HIV population. Yet, HIV accelerates the aging process and increases the risk for numerous chronic health conditions that compromise physical and mental health functioning and quality of life. Thus, PLWH continue to have shorter life expectancies relative to the general population and these multimorbidities explain this increased risk. In this context, unhealthy alcohol use among PLWH can further increase the risk for negative outcomes. Physical activity (PA) interventions can be used as an effective way to address unhealthy alcohol use among PLWH. Previous PA interventions have shown low generalizability and high loss to follow-up. Therefore, an intervention that is home-based, including lifestyle physical activity (LPA) with mobile health-delivered components is designed following the physical activity (PA) paradigm. Participants in this randomized controlled trial will be assigned to one of two study arms -- either the LPA or Fitbit Only intervention - both lasting 12-weeks. Both study arms will utilize a Fitbit to track daily step counts. In addition to utilizing a Fitbit, the LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine. The Fitbit only arm will receive only brief check-in phone calls and only related to assisting with any Fitbit functioning issues. Follow-up assessments will take place at 3 and 6 months.

Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial

This study aims to evaluate the impact of public health interventions on changes in healthy lifestyle habits over time and their subsequent effects on health outcomes. The investigators hypothesize that exposing at-risk populations to structured physical activity programs, education on healthy nutrition, promotion of the Mediterranean diet, and workshops focused on strengthening psychological resilience will lead to improvements in anthropometric, oxidative, metabolic, and psychological parameters. Anthropometric and laboratory measures will be collected at multiple time points throughout the study. The longitudinal follow-up will span 12 months. It is anticipated that sustained adherence to healthy lifestyle behaviors will result in positive lifestyle changes and enhanced health-related quality of life.

IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention

This study is a hybrid type 3, cluster randomized implementation trial to examine effective strategies to scale up the Brief Alcohol Intervention (BAI) in ART clinics in Vietnam. One arm will receive only facilitation for BAI implementation. Facilitation is a flexible strategy that helps clinics to address common barriers, such as counselor skills, competing priorities, and resource deficits. In the other arm, in addition to facilitation, clinic staff, irrespective of their own alcohol use, will be offered the BAI themselves as experiential learning (EBAI) to address their own alcohol-related attitudes and behaviors. Clinic staff responsible for delivering the BAI to patients will also be offered 3 consolidation activities to integrate their own experiences with their delivery of the BAI.

IGHID 12219 - A Brief Alcohol Intervention for PrEP Users

The purpose of this study is to evaluate the effectiveness of a brief alcohol intervention (BAI) vs. standard of care (SOC) to improve pre-exposure prophylaxis (PrEP) use among PrEP initiators and re-initiators.

Screening and Brief-Intervention of Post-war Alcohol Consumption in Public Hospital Outpatients

Background: High prevalence of alcohol-consumption among conflict-affected population has been reported in some low-and-middle income countries. However, studies that assess the effectiveness of screening and brief-intervention (SBI) in the reduction of unhealthy alcohol consumptions among conflict-affected hospital outpatients in Tigray are insufficient. Objective: This study aims to test the effectiveness of Screening and Brief-Intervention (SBI) in the reduction of unhealthy alcohol consumptions among conflict-affected hospital outpatients in Tigray. Method: About 1260 outpatients will be screened for alcohol consumption using Alcohol Use Disorder Identification Test (AUDIT). Those who will have "8-19" scores in the AUDIT will be allocated to "Intervention" and "Control" groups using block randomization and they will be followed at 6 and 12 months of follow - up. The Intervention group will receive simple advice, brief-counseling and 6-and 12-months follow-up screening of alcohol consumptions. However, outpatients in control group will only receive 6- and 12-months follow-up screening of alcohol consumptions. Data will be entered to and will be analyzed using SPSS V 26. Means, standard deviations and percentages will be used for descriptive statistics. Bivariate and multivariate logistic regression, at 95% of confidence interval and p-value of \<0.05, will be used to identify correlates of alcohol consumption. Independent sample t-test and Mann-Whitney U test will be used to compare AUDIT mean scores of normally and none-normally distributed continuous variables between intervention and control groups respectively.

Telehealth for Pain and Unhealthy Drinking Among PLWH

This randomized controlled trial is a between-groups design to compare the Motivational and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief Advice and Information Control condition. Two-hundred and fifty participants who have HIV with moderate or greater chronic pain will be randomized for the trial. Recruitment will take place through digital media. A unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. Consent and baseline assessment will be completed remotely. Following baseline assessment, participants will complete two weeks of ecological momentary assessment (EMA) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. Following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. Participants will complete outcome assessment measures at 3- and 6-months post-baseline. Following the 3-month outcome assessment, participants will complete another two weeks of EMA.

Systematic Implementation of Patient-centered Care for Alcohol Use Trial: Beyond Referral to Treatment

The Systematic Implementation of Patient-centered Care for Alcohol Use Trial is a pragmatic, cluster-randomized, effectiveness-implementation trial testing two interventions in Kaiser Permanente Washington to systematically implement shared decision-making with primary care patients with symptoms due to alcohol use: a primary care intervention and a centralized intervention. An anticipated 25 primary care clinics will be randomized to one of three conditions: usual care or the primary care or centralized interventions.