Lifestyle Physical Activity for HIV/AIDS and Problem Drinking

Overseen By Michael D Stein, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Bipolar, Schizophrenia, Anorexia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how physical activity might benefit people living with HIV who also have unhealthy drinking habits. Participants will use a Fitbit to track their steps and will be divided into two groups. One group will receive support to incorporate physical activities into their daily routine, while the other group will receive assistance only with using the Fitbit (Fitbit Only Intervention). The study seeks individuals living with HIV, who have unhealthy drinking patterns, and engage in less than 150 minutes of physical activity each week. Participants should have a smartphone and reside in the U.S. As an unphased trial, this study provides a unique opportunity to enhance understanding of the benefits of physical activity for those with HIV and unhealthy drinking habits.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be able to confirm your HIV diagnosis through visual evidence of ART medication or medical record, suggesting that continuing ART is expected.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that lifestyle physical activity (LPA) programs are generally safe and manageable. Studies on LPA for people living with HIV (PLWH) have found that increased activity can help reduce alcohol use without major side effects. Participants in these studies did not report significant problems, indicating that LPA is a safe option.

Similarly, using a Fitbit to track activity has been studied in other groups. These studies often show positive outcomes, such as increased steps and improved fitness, without serious issues. Fitbits are popular and considered safe for tracking activity.

Overall, both LPA sessions and Fitbit use are well-tolerated in studies, with no serious safety concerns reported. Based on existing research, participants can expect a safe experience with these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how integrating lifestyle physical activity (LPA) with modern technology can help individuals with HIV/AIDS who also struggle with problem drinking. Unlike traditional treatments that might focus solely on medication or counseling, this approach includes personalized LPA sessions designed to incorporate more movement into daily routines, potentially enhancing both physical and mental health. The use of Fitbits adds a tech-savvy edge, allowing participants to track their progress and receive support for any device-related issues, which could improve adherence and motivation. This innovative approach aims to offer a holistic improvement in quality of life, beyond just managing symptoms.

What evidence suggests that this trial's treatments could be effective for addressing unhealthy alcohol use among persons living with HIV?

This trial compares two methods to promote physical activity among people with HIV who struggle with alcohol use. One group will use a Fitbit device to track their activity; studies have shown that this can motivate increased physical activity. The other group will receive additional support through Lifestyle Physical Activity (LPA) sessions, which might offer further benefits. Research suggests that regular activities like walking can boost both mental and physical health for people with HIV, and exercise can help reduce alcohol consumption. ^{3 6 7 8 9}

Who Is on the Research Team?

Lisa Quintiliani, PhD

Principal Investigator

Tufts Medical Center

Michael D Stein, MD

Principal Investigator

Boston University, School of Public Health - Health Law Policy & Management

Are You a Good Fit for This Trial?

This trial is for adults in the USA living with HIV and engaging in unhealthy drinking, which means more than 7 drinks per week for women or more than 14 for men. Participants should be less active than recommended (under 150 minutes of moderate exercise weekly), own a smartphone, can prove their HIV status, and have a U.S. mailing address. It's not for those with certain mental health conditions, eating disorders, severe medical issues preventing safe exercise, or those currently treated non-pharmacologically for alcohol use.

Inclusion Criteria

I can show proof of my HIV diagnosis through medication or medical records.

Has a U.S. mailing address

I drink more than the recommended weekly or single-occasion limits.

Exclusion Criteria

I am willing to share my sex assigned at birth.

I have been diagnosed with anorexia or bulimia according to DSM-5.

Limited or non-readers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either the LPA or Fitbit Only intervention for 12 weeks. The LPA arm receives 7 sessions with a trained interventionist, while the Fitbit Only arm receives brief check-in calls.

12 weeks

Follow-up

Participants are monitored for changes in physical activity and drinking outcomes at 3 and 6 months post-treatment.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fitbit
• Fitbit Only
• LPA Sessions

Trial Overview The study tests two methods to reduce unhealthy drinking among people with HIV through physical activity: one group will get lifestyle physical activity (LPA) sessions plus a Fitbit; the other gets only a Fitbit to track steps. The LPA group receives guidance from an interventionist over seven sessions to integrate LPA into daily life while the other group has check-ins by phone about Fitbit use.

How Is the Trial Designed?

Group I: Lifestyle Physical Activity (LPA) Experimental Treatment 1 Intervention

The LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine.

Group II: Fitbit Only Active Control 1 Intervention

The Fitbit only arm will receive only brief check in phone calls and only related to assisting with any Fitbit functioning issues.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

People living with HIV/AIDS can experience health benefits from regular physical activity similar to those seen in the general population, suggesting that exercise is beneficial regardless of disease status.

Significant improvements in psychological and physiological health can occur within the first 5 to 6 weeks of starting a physical activity program, but more research is needed to explore the long-term effects and practical methods for maintaining an active lifestyle in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and Positive Living in Human Immunodeficiency Virus/AIDS. Jaggers, JR.[2019]

Wearing a fitness tracker and receiving walk step reminders did not significantly increase physical activity levels among persons with HIV over a 6-month period, indicating that these methods alone are insufficient for promoting sustained activity.

The study emphasizes the importance of developing more tailored physical activity interventions that address the specific needs of individuals with HIV, rather than relying solely on generic reminders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Walk Step Reminders Improve Physical Activity in Persons Living With HIV in New York City?-Results From a Randomized Clinical Trial. Alvarez, G., Sanabria, G., Jia, H., et al.[2023]

In a study of 58 Hispanic adults living with HIV, self-reported physical activity (PA) was significantly higher than objectively measured PA, indicating that individuals may overestimate their activity levels.

The study found a substantial mismatch in PA classification among the International Physical Activity Questionnaire (IPAQ), ActiGraph accelerometer, and DigiWalker pedometer, suggesting that objective measures like accelerometers or pedometers are necessary for accurate PA assessment in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported physical activity in Hispanic adults living with HIV: comparison with accelerometer and pedometer. Ramírez-Marrero, FA., Rivera-Brown, AM., Nazario, CM., et al.[2021]

A systematic review of 24 studies found that the prevalence of sedentary lifestyles among HIV-infected individuals ranged from 19% to 73%, indicating a significant portion of this population may not engage in regular physical activity.

The review highlighted a lack of well-designed studies with adequate sample sizes, making it difficult to draw definitive conclusions about physical activity levels in HIV-infected individuals due to varying methods of assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity: do patients infected with HIV practice? How much? A systematic review. Schuelter-Trevisol, F., Wolff, FH., Alencastro, PR., et al.[2022]

In a study of 324 participants, HIV-positive individuals on highly active antiretroviral therapy (HAART) engaged in significantly less vigorous physical activity compared to those not on treatment, indicating a potential impact of HAART on physical activity levels.

The study found that injection drug use and viral load did not influence the levels of vigorous activity, suggesting that other factors related to HAART may contribute to reduced physical activity among these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in a cohort of HIV-positive and HIV-negative injection drug users. Smit, E., Crespo, CJ., Semba, RD., et al.[2018]

The SystemCHANGE intervention, involving 6 group sessions, successfully reduced daily carbohydrate intake and led to a weight loss of approximately 0.732 kg among sedentary adults living with HIV, compared to a weight gain in the control group.

Despite these positive changes in diet and weight, the intervention did not significantly improve physical activity levels or overall diet quality, indicating a need for more tailored approaches to enhance these aspects in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of the SystemCHANGE Intervention on Behaviors Related to Cardiovascular Risk in HIV+ Adults. Webel, AR., Moore, SM., Longenecker, CT., et al.[2022]

In an 18-week pilot study involving 24 sedentary individuals with HIV, the use of digital devices for exercise monitoring faced significant technical issues, which hindered data feedback and participant engagement.

Despite these challenges, participants showed some improvements in body composition, including reductions in BMI and hip circumference, although only 32% improved their cardiorespiratory fitness as measured by steady-state oxygen consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of Digital Device Performance in Monitoring Physical Exercise in a Pilot Study in Sedentary Persons with HIV. Bonato, M., Marmondi, F., Turrini, F., et al.[2023]

The Fitbit Zip® showed excellent agreement in measuring the number of steps taken among 34 adults living with HIV, with an intraclass correlation coefficient (ICC) of 0.99, indicating it is a reliable tool for step counting.

However, the device did not accurately measure distance walked, with a poor ICC of 0.20, and it failed to demonstrate construct validity for assessing overall physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Measurement Properties of the Fitbit Zip® Among Adults Living With HIV. Dagenais, M., Salbach, NM., Brooks, D., et al.[2020]

A high percentage (95%) of adults living with HIV consented to use wireless physical activity monitors (WPAMs) during a 25-week community-based exercise intervention, indicating strong initial interest in tracking physical activity.

However, WPAM usage declined significantly from 50% of days in the supervised phase to only 23% in the follow-up phase, suggesting the need for strategies to maintain engagement over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless physical activity monitor use among adults living with HIV in a community-based exercise intervention study: a quantitative, longitudinal, observational study. Turner, JR., Chow, J., Cheng, J., et al.[2023]

Citations

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2. withpower.com withpower.com/trial/phase-alcohol-use-disorders-aud-9-2022-53c4d

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8. mospace.umsystem.edu mospace.umsystem.edu/xmlui/bitstream/handle/10355/94065/HowlandChelseaResearch.pdf?sequence=1&isAllowed=y

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