Behavioral Interventions for Older Adults with HIV

(HiActivity Trial)

Recruiting at 1 trial location

Overseen By Bailey O'Keeffe, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Butler Hospital

Must be taking: Antiretroviral therapy

Disqualifiers: Cardiovascular disease, Hazardous substance use, others

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

Compensation: Varies

Number of Visits: Unknown

208 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on continuous antiretroviral therapy (ART) for more than 3 months to participate.

What data supports the effectiveness of the treatment Behavioral Interventions for Older Adults with HIV?

Research suggests that using a fitness tracker like Fitbit, combined with tailored interventions, may help improve physical activity in people living with HIV. Although step reminders alone were not effective, combining fitness tracking with personalized support could be more beneficial. ^{1 2 3 4 5}

Is the use of wearable activity monitors safe for older adults with HIV?

The studies reviewed do not report any safety concerns related to the use of wearable activity monitors, such as Fitbits, in interventions for people living with HIV. These devices are generally considered safe for human use. ^{1 3 4 6 7}

How is the treatment 'Behavioral Interventions for Older Adults with HIV' different from other treatments for HIV?

This treatment is unique because it combines behavioral strategies like cognitive behavioral therapy and social support with the use of a physical activity tracker to encourage exercise among older adults with HIV. Unlike traditional treatments that focus solely on medication, this approach aims to improve physical activity and overall well-being through motivation and support. ^{1 8 9 10 11}

What is the purpose of this trial?

The goal of this clinical trial is to examine 3 interventions designed to increase physical activity in older adults with HIV. We will examine 3 potential components of an intervention package: physical activity coaching, cognitive behavioral therapy targeted toward common barriers to physical activity such as low motivation or chronic pain, and a Fitbit-based social support intervention. Our primary outcome will be physical activity, defined as steps per day. Results will guide choice of intervention components to be used in an optimized behavioral intervention.

Research Team

Lisa Uebelacker, PhD

Principal Investigator

Butler Hospital

Jason Baker, MD

Principal Investigator

Hennepin Healthcare

Eligibility Criteria

This trial is for older adults over 50 living with HIV who are physically able to walk without help, speak English, and use a Fitbit app. They must be on antiretroviral therapy for at least 3 months and do less than 90 minutes of moderate exercise weekly. Participants need medical clearance if they have heart issues or experience chest pain.

Inclusion Criteria

Low PA: defined as self-report of < 90 minutes of moderate-vigorous PA (MVPA) per week in the previous 3 months AND less than 14 hours per week of sustained walking in the previous 4 weeks

HIV positive: defined by HIV antibody, detectable HIV RNA in plasma, or a note from the participant's HIV care provider

I have been on continuous HIV medication for more than 3 months.

Exclusion Criteria

I do not have any health issues that prevent me from being active or participating in a study.

Hazardous substance use, assessed via a score ≥15 on the Alcohol Use Disorders Identification Test (AUDIT) or ≥6 on the Drug Abuse Screening Test (DAST)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Optimization

Participants receive brief advice to exercise and a Fitbit activity tracker, followed by testing of three intervention components: PA Coaching, Cognitive-Behavioral intervention for PA, and Social Support for PA

16 weeks

Monthly check-ins (virtual or in-person)

Follow-up

Participants are monitored for changes in physical activity, mental health, and cardiovascular risk factors

4 weeks

Treatment Details

Interventions

• Brief Advice + a physical activity tracker
• Cognitive Behavioral Intervention for Physical Activity
• Physical Activity Coaching
• Social Support for Physical Activity

Trial Overview The study tests three methods to boost physical activity: coaching sessions, cognitive behavioral therapy to tackle barriers like low motivation or pain, and a social support system using Fitbit. The main goal is to increase the number of steps taken each day by participants.

Participant Groups

Group I: BASM + SS-PA Experimental Treatment 2 Interventions

Brief Advice and Self-Monitoring Social support for Physical Activity

Group II: BASM + PA Coaching + SS-PA Experimental Treatment 3 Interventions

Brief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity

Group III: BASM + PA Coaching + CB-PA + SS-PA Experimental Treatment 4 Interventions

Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity

Group IV: BASM + PA Coaching + CB-PA Experimental Treatment 3 Interventions

Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity

Group V: BASM + PA Coaching Experimental Treatment 2 Interventions

Brief Advice and Self-Monitoring Physical Activity Coaching

Group VI: BASM + CB-PA + SS-PA Experimental Treatment 3 Interventions

Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity

Group VII: BASM + CB-PA Experimental Treatment 2 Interventions

Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity

Group VIII: BASM Experimental Treatment 1 Intervention

Brief Advice and Self-Monitoring

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

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]

A new reliable coding method was developed to measure how behavior change techniques (BCTs) are delivered by counselors and received by clients during physical activity support interventions, showing nearly perfect interrater reliability (84% agreement for counselors and 86% for clients).

The most frequently delivered and received BCTs were related to Goals and Planning, Support Strategies, and Self Belief, indicating these areas are crucial for effective physical activity interventions for adults with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring behavior change technique delivery and receipt in physical activity behavioral interventions. Hoekstra, F., Collins, D., Dinwoodie, M., et al.[2022]

The mHealth intervention using the Fitbit Plus app for health coaching showed high feasibility and acceptability among 53 participants living with HIV, with 76.5% regularly using the app after 12 months.

While not statistically significant, there was a consistent trend indicating better ART adherence in the Fitbit Plus group compared to the standard care group, suggesting potential benefits of the intervention for improving medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Test of an mHealth Facilitated Health Coaching Intervention to Improve Medication Adherence among Persons Living with HIV. Ramsey, SE., Ames, EG., Uber, J., et al.[2022]

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]

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]

In a study of 616 low-income, majority Latina patients with obesity, one in three participants did not meet the step count criterion for valid Fitbit wear, highlighting challenges in using wearable activity monitors for accurate physical activity assessment.

Barriers such as older age, higher BMI, smartphone use issues, and negative emotional responses were identified as predictors of invalid data collection, suggesting that these factors need to be addressed to improve the effectiveness of wearable activity monitors in weight-loss interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining Valid Activity Monitor Data: A Multimethod Analysis of Weight-Loss Intervention Participants' Barriers to Wear and First 100 Days of Physical Activity. Orstad, SL., Gerchow, L., Patel, NR., et al.[2022]

In a study of 75 female breast cancer survivors, those who received a more intensive exercise intervention showed significantly higher adherence to wearing a Fitbit and higher levels of moderate-to-vigorous physical activity (MVPA) during a 12-week intervention compared to those with a lighter intervention.

After the intervention, while both groups experienced a decline in activity levels, the full intervention group maintained more stable adherence and activity patterns over the following 2 years, suggesting that a more active intervention strategy may lead to better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fitbit Use and Activity Levels From Intervention to 2 Years After: Secondary Analysis of a Randomized Controlled Trial. Hartman, SJ., Chen, R., Tam, RM., et al.[2022]

A national study of 2,864 individuals receiving HIV care revealed that many made positive health changes after their diagnosis, with 43% increasing physical activity and 59% improving their diet.

Significant numbers of smokers (49%) quit or reduced smoking, and 80% of substance users made similar changes, indicating that support for health-promoting behaviors could enhance the quality of life for people living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in health-promoting behavior following diagnosis with HIV: prevalence and correlates in a national probability sample. Collins, RL., Kanouse, DE., Gifford, AL., et al.[2022]

Older adults living with HIV face significant barriers to exercise, including low self-efficacy, lack of motivation, and physical limitations, which contribute to a sense of disability.

Social support and improved self-efficacy were found to be crucial in motivating participants to initiate and maintain an exercise routine, highlighting the importance of psychological and social factors in promoting physical activity among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Turning disability into ability: barriers and facilitators to initiating and maintaining exercise among older men living with HIV. Neff, HA., Kellar-Guenther, Y., Jankowski, CM., et al.[2021]

The review identified 16 eHealth systems designed to support ART adherence in adolescents, with a mix of basic (like SMS reminders) and advanced systems (like mobile apps and games), but only 10 showed positive effects on adherence outcomes.

While 9 of the systems were grounded in health behavior theories, there were significant gaps in considering adolescent developmental changes and the comprehensive application of behavior change techniques, indicating a need for more theoretically informed and developmentally appropriate designs in future eHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Theories and Motivational Features Underlying eHealth Interventions for Adolescent Antiretroviral Adherence: Systematic Review. Bezabih, AM., Gerling, K., Abebe, W., et al.[2022]

Intensive early adherence counseling significantly improved medication adherence and reduced the likelihood of viral treatment failure in HIV patients over an 18-month follow-up, with participants receiving counseling being 59% less likely to experience viral failure compared to those who did not receive counseling.

The use of an electronic alarm device did not show any significant effect on adherence or viral failure, suggesting that counseling is a more effective intervention for improving treatment outcomes in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes. Chung, MH., Richardson, BA., Tapia, K., et al.[2022]

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

Measuring behavior change technique delivery and receipt in physical activity behavioral interventions. [2022]

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

A Preliminary Test of an mHealth Facilitated Health Coaching Intervention to Improve Medication Adherence among Persons Living with HIV. [2022]

4. 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]

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Defining Valid Activity Monitor Data: A Multimethod Analysis of Weight-Loss Intervention Participants' Barriers to Wear and First 100 Days of Physical Activity. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Fitbit Use and Activity Levels From Intervention to 2 Years After: Secondary Analysis of a Randomized Controlled Trial. [2022]

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

Changes in health-promoting behavior following diagnosis with HIV: prevalence and correlates in a national probability sample. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Turning disability into ability: barriers and facilitators to initiating and maintaining exercise among older men living with HIV. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Behavioral Theories and Motivational Features Underlying eHealth Interventions for Adolescent Antiretroviral Adherence: Systematic Review. [2022]

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

A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes. [2022]