Behavioral Activation for People with HIV

Overseen By Laura Nnadi, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Severe cognitive impairment

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program can help individuals aged 50 and older with HIV become more active, less lonely, and improve their eating habits. Participants will receive coaching in three areas: behavioral activation (a type of therapy) to encourage social engagement, physical activity to enhance health and prevent falls, and nutrition to promote better eating habits. The trial seeks participants who are HIV-positive, experience some loneliness or depression, and can visit an HIV center in Baltimore. As an unphased trial, this study offers a unique opportunity to contribute to research that may improve the quality of life for those living with HIV.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this behavioral intervention program is safe for people with HIV?

Research has shown that Behavioral Activation, combined with guidance on nutrition and exercise, is generally safe for people with HIV. Although specific safety data for these activities is limited, they aim to enhance mental and physical health without medications or surgeries.

Previous studies on Behavioral Activation have not identified any major side effects. This method includes activities that boost mood and reduce loneliness, without involving invasive procedures. Since this trial does not test new drugs, safety concerns are minimal. The focus remains on lifestyle changes, which participants typically manage well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for people with HIV because they focus on a holistic approach to improving quality of life through behavioral changes, nutrition, and physical activity, rather than relying solely on medication. The Behavioral Activation coaching is unique because it helps participants engage in rewarding social activities tailored to their values, which can boost mental health and social connections. The Physical Activity Coaching emphasizes personalized exercise plans that improve strength and balance, which are crucial for aging individuals with HIV. Lastly, the Nutritional Assessment offers tailored dietary advice with the input of a registered dietician, ensuring participants have access to healthy food options and recipes. This multifaceted approach aims to enhance overall well-being, addressing aspects of life that are often overlooked in standard HIV care.

What evidence suggests that this trial's treatments could be effective for people with HIV?

This trial will evaluate three interventions for people with HIV: Behavioral Activation, Physical Activity Coaching, and Nutritional Assessment. Research has shown that Behavioral Activation, which participants in this trial may receive, boosts mental health and daily life skills for people with HIV. Studies have found that this method encourages greater activity and social involvement, crucial for well-being.

For Physical Activity Coaching, another intervention in this trial, studies suggest it increases walking and improves overall health in people with HIV. Regular exercise enhances physical fitness and might strengthen the immune system.

Regarding Nutritional Assessment, the third intervention under study, research indicates that personalized nutrition plans improve the quality of life for those with HIV. These plans address specific dietary needs, enhance nutritional health, and provide more energy.

Together, these approaches aim to help people with HIV live healthier, more active lives. ^{2 6 7 8 9}

Who Is on the Research Team?

Ann Gruber-Baldini, PhD

Principal Investigator

UMB

Are You a Good Fit for This Trial?

This trial is for people aged 50 or older who are living with HIV. Participants should be able to think clearly (as shown by a cognitive test), feel some loneliness, isolation, or depression, and must speak English. They need to be getting care at the UM THRIVE Center or another HIV center in Baltimore.

Inclusion Criteria

My memory and thinking test score is above 13.

I am diagnosed with HIV.

I am 50 years old or older.

Exclusion Criteria

I do not have severe memory or thinking problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Behavioral Activation Program

Participants engage in a 12-week Behavioral Activation program with remote coaching to reduce loneliness and boost social engagement, including physical activity and nutrition guidance.

12 weeks

Remote interactions (phone or videoconference)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessments of social isolation, sleep efficiency, and physical activity.

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation, Nutrition, and Activity Intervention

Trial Overview The study tests a program where coaches encourage participants to increase social connections, physical activity, and improve their diet. It aims to see if this approach is practical for enhancing the well-being of older adults with HIV.

How Is the Trial Designed?

Group I: Physical Activity Coaching Experimental Treatment 1 Intervention

The intervention involves physical activity sessions tailored for people with HIV. Participants engage in physical activities targeting health improvement and fall prevention, promoting physical activity self-efficacy and outcome expectations. Coaches identify individual exercise goals, assess access to physical activity options, and focus on safe, unsupervised strength and balance physical activities at home. Tailored exercise materials, including handouts and videos, are accessible through a website. Additionally, participants are encouraged to follow a structured walking program.

Group II: Nutritional Assessment Experimental Treatment 1 Intervention

Participants will complete a mini nutritional assessment and keep a food diary. Each participant will meet with a registered dietician for an evaluation. The coaching will be personalized based on the dietician's advice and will include information about community resources for food, making sure health options are available, and suggesting diets and recipes for better eating options.

Group III: Behavioral Activation Experimental Treatment 1 Intervention

Participants receive brief BA (Behavioral Activation) coaching through remote interactions (phone or videoconference) with lay coaches. The structured behavioral approach focuses on identifying and scheduling values-based, rewarding social engagements and activities. Coaches assist in overcoming barriers to social connectedness, involving a review of daily activity patterns, setting activity goals, creating implementation plans, and assessing successes and areas for improvement. The program is adapted for individuals aging with HIV, with community collaboration to tailor content and delivery methods.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Effective treatment of HIV has significantly improved survival rates, but maintaining nutritional well-being is crucial for both survival and quality of life.

Antiretroviral therapies can negatively impact nutrition, creating challenges for healthcare providers in identifying and addressing these issues, which affects treatment recommendations and patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of antiretroviral-related nutritional problems: challenges and future directions. Fields-Gardner, C., Keithley, JK.[2019]

Medical nutrition therapy is crucial for individuals with HIV/AIDS, focusing on assessing nutrient deficiencies, restoring lean body mass, and enhancing quality of life, highlighting the importance of registered dietitians in the healthcare team.

There is a need for ongoing research and development of nutrition care protocols specific to HIV/AIDS, with calls for dietitians to lead these efforts and for increased funding from health organizations to support nutrition-related research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the American Dietetic Association and the Canadian Dietetic Association: nutrition intervention in the care of persons with human immunodeficiency virus infection. [2019]

Nutrition intervention is crucial for individuals with HIV/AIDS, focusing on early detection and treatment of nutrient deficiencies, restoring lean body mass, and enhancing quality of life, highlighting the importance of registered dietitians in the healthcare team.

There is a need for further research in nutrition interventions for HIV/AIDS, and registered dietitians are encouraged to lead these efforts to develop effective nutrition care protocols and guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of The Canadian Dietetic Association and The American Dietetic Association: nutrition intervention in the care of persons with human immunodeficiency virus infection. [2009]

HIV-infected individuals are at a high risk of malnutrition due to various factors, similar to patients with cancer, highlighting the need for early nutritional assessment and education.

For managing HIV-associated malnutrition, oral nutrition is preferred, but in cases of severe malabsorption, such as with opportunistic gastrointestinal infections, total parenteral nutrition may be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Malnutrition--a clinically relevant problem in HIV-1 infection?]. Ollenschläger, G., Schrappe-Bächer, M., Fätkenheuer, G., et al.[2006]

In a study involving 1815 malnourished HIV-infected patients starting antiretroviral therapy (ART), those receiving lipid-based nutritional supplements with added vitamins and minerals (LNS-VM) showed greater improvements in nutritional measures compared to those receiving supplements without added vitamins and minerals (LNS).

The LNS-VM group experienced significant increases in weight, body mass index, and mid-upper arm circumference after starting ART, indicating that vitamin and mineral supplementation can enhance nutritional recovery, although it did not affect appetite.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on anthropometry and appetite of vitamins and minerals given in lipid nutritional supplements for malnourished HIV-infected adults referred for antiretroviral therapy: results from the NUSTART randomized controlled trial. Rehman, AM., Woodd, S., PrayGod, G., et al.[2022]

Food and nutrition significantly influence the metabolism, safety, and effectiveness of antiretroviral therapies (ART) for HIV, highlighting the need for integrated nutritional considerations in treatment plans.

Research has shown that nutritional status affects drug bioavailability and metabolism, and there is a growing concern about the interactions between ART and traditional therapies, necessitating further investigation in low- and middle-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and pharmacology: general principles and implications for HIV. Raiten, DJ.[2023]

Behavioral interventions delivered by trained professionals have been shown to improve adherence to antiretroviral therapy (ART) and achieve better viral suppression in patients, but the optimal amount of intervention needed for different patient populations is not well understood.

The lack of empirical data on intervention dosing limits the ability to interpret trial results and implement effective strategies, highlighting the need for further studies to determine the appropriate dosage of behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When is Enough, Enough? How the Absence of Dose-Determination Trials Impedes Implementation of HIV Behavioral Interventions. Kalichman, SC.[2019]

HIV-infected individuals on antiretroviral therapy face new nutritional challenges, but there is limited research on effective management strategies.

Current studies primarily focus on drug therapy, highlighting the need for controlled trials to explore the benefits of lifestyle changes and alternative therapies in addressing these nutritional issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of antiretroviral-related nutritional problems: state of the science. Keithley, JK.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6576263/

Applying behavioral activation to sustain and enhance ... This study provides preliminary evidence that a combined CM-BA intervention for this population was feasible (100% retention at 6-months), acceptable.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02140775?cond=HIV%2FAIDS&page=3&rank=22

Return to Work Randomized Controlled Trial: Counseling ... The current study is a randomized clinical trial comparing Behavioral Activation counseling with supportive counseling for HIV+ participants presenting with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422001689

Improving functioning in HIV+ patients with chronic pain ... In this paper, we describe our protocol for a multisite, randomized controlled trial of the effectiveness of a collaborative behavioral intervention, called HIV ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8808422/

Act Healthy: A Randomized Clinical Trial Evaluating ... This randomized clinical trial evaluated the effectiveness of Act Healthy (AH), a behavioral activation (BA) plus Life-Steps, a medication adherence and HIV ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.990994/full

Effects of cognitive behavioral therapy on improving ... Cognitive behavioral therapy is effective in improving depressive symptoms in people living with HIV, with better long-term (>6 months) results than short-term ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06239961

Behavioral Activation, Nutrition, and Activity Intervention This study aims to see if a 12-week program called Behavioral Activation (BA) can help people aged 50 and above with HIV by reducing loneliness and boosting ...

7. withpower.com withpower.com/trial/phase-human-immunodeficiency-virus-hiv-infections-2-2024-20a66

Behavioral Activation for People with HIV The research articles reviewed do not provide specific safety data for Behavioral Activation or related interventions for people with HIV. They focus on ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796713001228

A randomized clinical trial of Behavioral Activation (BA) ... Biological assessments included CVD risk markers Interleukin-6 (IL-6) and D-dimer. Psychosocial outcomes included depressive symptoms, positive affect, and ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10073275/

HIV-PASS (Pain and Sadness Support): Randomized ... Secondary outcomes included pain severity, depression symptoms, anxiety, overall mental health, and perception of overall physical health. HIV-PASS is a CBT ...