Healthy Living for Better Days

Investigator: John Lewis

Institutional Protocol #: 20121029

National Clinical Trials Identifier: N/A

Funding Agency/Sponsor: Intramural

Division: Psychiatry

Therapeutic Area:

Phase: N/A

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 3/20/2013


Purpose/Abstract:

Each year, close to 50,000 Americans become newly infected with HIV and recent reports indicate that Miami Dade County, Florida has the highest number of new HIV cases in the country. Furthermore, women constitute the fastest growing group of new HIV/AIDS diagnoses, and all groups that lack accessibility to health care, such as African Americans and Hispanics, have been disproportionately affected by HIV/AIDS. Since its introduction in the mid-1990s, the potent antiretroviral therapy (ART) has resulted in substantial reduction in HIV-associated morbidity and mortality, making this disease chronic and manageable. Consequently, today’s standard care of HIV-infected individuals is focused more on long-term adverse effects related to both infection and pharmacological treatment. However, despite the clear benefits, the previously unknown adverse effects of ART have been emerging, representing a major health concern for this patient population. Treating HIV with ART can result in a number of physical and psychological adverse effects. Common but often mild undesirable effects include disorders of the gastrointestinal tract (bloating, nausea, and diarrhea), nervous system (headache, pain/neuropathy, and fatigue), and integumentary system (rash and dry skin). Lipodystrophy, a visible condition characterized by abnormalities in the body’s production, utilization, and distribution of fat, can result in negative psychosocial implications in HIV-infected individuals. Because of the lack of a standardized definition for HIV-associated lipodystrophy, prevalence rates may vary from 11% to 83% and risk factors include longer duration on ART therapy, increasing age, and advanced HIV disease. Furthermore, lipodystrophy, not just a cosmetic concern, can be associated with endocrine and metabolic abnormalities leading to increased risk for cardiovascular disease (CVD) and diabetes mellitus. Other serious but less prevalent adverse effects associated with ART may include anemia, renal, liver, and mitochondrial toxicity, lactic acidosis, and osteopenia/osteoporosis. In addition to physical adverse effects, patients receiving ART may also experience negative psychological responses, such as agitation, confusion, anxiety, nightmares, mania, and depression. Finally, any of these physical and psychological adverse reactions may result in poor adherence to treatment that requires daily dosing at the appropriate times for the remainder of the patient’s life. Ultimately, low adherence rates can develop drug resistance and consequently compromise a patient’s immunity. Thus, any intervention that helps improve the general health status of HIV-infected individuals is important for the public health.
"Healthy Living for Better Days" is a community program aiming to combine exercise intervention and healthy eating education into a community program to improve overall and cardiovascular health status, among persons living with HIV and of primarily low socioeconomic status. Furthermore, we plan to evaluate the program effectiveness through the assessments protocol at months 0,3,6, and 12.
We anticipate that HIV-individuals involved in this project will improve their fitness and strength levels, cardiovascular health, immune functioning and the overall quality of life (QoL).

Eligibility Criteria:

Inclusion Criteria:

Confirmed HIV infection, older than 18 years and able to provide signature on consent form.

Exclusion Criteria:

Non-confirmed HIV infection, medical issues precluding exercise, and pregnancy.
Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Eduard Tiozzo, Instructor
(305) 243 6912
etiozzo@miami.edu

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