Lifestyle Physical Activity for HIV/AIDS and Problem Drinking

Overseen by Lisa Quintiliani, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston University

Disqualifiers: Bipolar, Schizophrenia, Anorexia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if increasing physical activity using a Fitbit can help people with HIV who drink too much. One group gets extra help to be more active, while the other just uses the Fitbit. The goal is to see if being more active can reduce drinking and improve health. Fitbit devices have been widely used in various studies to promote physical activity and have shown effectiveness in increasing activity levels and improving health outcomes.

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.

What data supports the effectiveness of the treatment Fitbit-Based Physical Activity Intervention for people with HIV/AIDS and problem drinking?

Research suggests that regular physical activity can provide health benefits for people living with HIV/AIDS, similar to those seen in the general population. However, a study found that using a Fitbit with walk step reminders did not significantly improve physical activity levels in people with HIV, indicating that additional tailored interventions may be necessary. ^{1 2 3 4 5}

Is using a Fitbit or similar device safe for people with HIV/AIDS?

The studies reviewed did not report any safety concerns related to using Fitbit devices or similar fitness trackers among people living with HIV. However, technical issues with the devices were noted, which affected the study outcomes and participants' engagement. ^{1 5 6 7 8}

How is the Lifestyle Physical Activity treatment for HIV/AIDS and problem drinking different from other treatments?

This treatment is unique because it uses a Fitbit to encourage physical activity, which is not a standard approach for managing HIV/AIDS and problem drinking. It focuses on increasing physical activity through wearable technology and lifestyle sessions, rather than traditional medication or therapy. ^{1 3 4 5 9}

Research Team

Michael D Stein, MD

Principal Investigator

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

Lisa Quintiliani, PhD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Fitbit (Other)
• Fitbit Only (Other)
• LPA Sessions (Behavioral Intervention)

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.

Participant Groups

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+

Sophie Kornowski

Boston University

Chief Executive Officer since 2022

MBA from the University of Chicago, Doctorate in Pharmacy from Paris Descartes University

Dr. Patrizia Cavazzoni

Boston University

Chief Medical Officer

MD from McGill University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Dr. George F. Koob

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Executive Officer since 2014

PhD in Neurobiology from the Scripps Research Institute

Dr. Patricia Powell

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Medical Officer since 2015

MD from an accredited institution

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Physical activity in a cohort of HIV-positive and HIV-negative injection drug users. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity: do patients infected with HIV practice? How much? A systematic review. [2022]

5. England 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of the SystemCHANGE Intervention on Behaviors Related to Cardiovascular Risk in HIV+ Adults. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Failure of Digital Device Performance in Monitoring Physical Exercise in a Pilot Study in Sedentary Persons with HIV. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Assessing the Measurement Properties of the Fitbit Zip® Among Adults Living With HIV. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Self-reported physical activity in Hispanic adults living with HIV: comparison with accelerometer and pedometer. [2021]