7 Participants Needed

Behavioral Activation for People with HIV

AG
LN
Overseen ByLaura Nnadi, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Maryland, Baltimore
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will explore if a behavioral intervention program to assist people aged 50 and older with HIV is practical. The program includes a coach who talks with participants, encouraging them to be more active, reduce loneliness, and eat healthier.

Will I have to stop taking my current medications?

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

Is Behavioral Activation safe 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 nutritional interventions and the challenges of managing nutrition-related issues in HIV treatment, but do not address the safety of Behavioral Activation directly.12345

How is the Behavioral Activation, Nutrition, and Activity Intervention treatment different from other treatments for HIV?

This treatment is unique because it combines behavioral activation therapy, which focuses on improving mental health by encouraging positive activities, with nutrition and physical activity interventions to address both psychological and physical health in people with HIV. Unlike standard treatments that primarily focus on medication, this approach aims to enhance overall well-being and quality of life through lifestyle changes.14678

What data supports the effectiveness of the treatment Behavioral Activation, Nutrition, and Activity Intervention for people with HIV?

Nutritional well-being is important for the survival and quality of life of people with HIV, and having access to nutrition services is vital. Registered dietitians play a key role in developing nutrition care protocols, which are essential for maintaining health in HIV patients.12478

Who Is on the Research Team?

AG

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.
See 3 more

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?
3Treatment groups
Experimental Treatment
Group I: Physical Activity CoachingExperimental Treatment1 Intervention
Group II: Nutritional AssessmentExperimental Treatment1 Intervention
Group III: Behavioral ActivationExperimental Treatment1 Intervention

Find a Clinic Near You

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

Citations

Management of antiretroviral-related nutritional problems: challenges and future directions. [2019]
Position of the American Dietetic Association and the Canadian Dietetic Association: nutrition intervention in the care of persons with human immunodeficiency virus infection. [2019]
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. [2022]
Position of The Canadian Dietetic Association and The American Dietetic Association: nutrition intervention in the care of persons with human immunodeficiency virus infection. [2009]
[Malnutrition--a clinically relevant problem in HIV-1 infection?]. [2006]
Nutrition and pharmacology: general principles and implications for HIV. [2023]
When is Enough, Enough? How the Absence of Dose-Determination Trials Impedes Implementation of HIV Behavioral Interventions. [2019]
Management of antiretroviral-related nutritional problems: state of the science. [2019]
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