Study of SystemCHANGE-HIV

Study Overview
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Brief Summary
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The purpose of this study is to assess a new behavioral intervention to help how people living with HIV/AIDS practice self-management skills. Specifically, we want to see if a new educational intervention can improve physical activity, sleep, mental wellness and quality of life in HIV(Human Immunodeficiency Virus)-infected men and women. We hypothesize that those who are in the intervention group will practice more self-management skills than those in the control group.

Detailed Description
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Sample: The study sample will include 40 HIV+ men and women. Inclusion criteria include: a documented HIV diagnosis; adult (18 years old or greater); and English speaking. Design: The SystemCHANGE-HIV study will be a 15-week, randomized, two-group experimental design including a 10-week behavioral intervention. In the experimental group, one half of the participants (n=20) will receive the intervention; and in the control group, the other half of the participants will undergo usual care. Both the experimental and control group will complete the same psychometric instrument packet, three times, to give a comparison of self-management before and after intervention and at a four-week follow up visit. This packet includes information on medical history, demographics, HIV self-management,physical activity, social support, social capital, mental wellness, and quality of life.Additionally, all participants will wear an actigraph for seven consecutive days, at each data collection point, to assess sleep. Analysis:Preliminary data analysis will include descriptive statistics and scatter plots to examine the distribution of each outcome at each time point, as well as each covariate of interest. Although our randomization scheme will ensure balance of baseline variables between the two arms (other than that due to chance alone), we will estimate the standardized magnitude of each baseline difference as well as the correlation between each baseline variable and each outcome of interest at 10 weeks or at 15 weeks to objectively determine baseline variables that will be needed to estimate the unbiased effect of the intervention on each outcome. The primary analysis will be based on intent to treat approach and will investigate the effect of the intervention on continuous outcomes at 10 weeks or 15 weeks. In particular, an Analysis of Covariance model will be used that adjusts for treatment arm and the baseline level of the outcome variable. Such a model will allow us to estimate the effect of the intervention on each outcome, adjusting for the baseline outcome.In addition, linear mixed models will be used to determine if the effect of the intervention on the outcome at 10 weeks differs from the effect of the intervention on the outcome at 15 weeks. If needed, all analyses will be repeated using an as-treated approach. All analyses will be performed using a two-sided significance of 0.05.

Official Title
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SystemCHANGE-HIV: A Pilot Study Exploring the Effect of a Systems-based Intervention to Increase Physical Activity, Sleep Behavior, and Mental Wellness

Conditions
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HIV

Intervention / Treatment
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* Behavioral: SystemCHANGE-HIV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documented HIV diagnosis adult (21 years old or greater) English speaking Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behaviorial Intervention<br>SystemCHANGE-HIV is a 10-week, small-group intervention that will promote behavior changes to improve the following: physical activity, sleep behaviors and mental wellness. S | Behavioral: SystemCHANGE-HIV<br>* SystemCHANGE, is based on social ecological theory and focuses on redesigning the family environment and daily routines that are linked to health behavior. This framework emphasizes context and specifies that change is best accomplished by: identifying a measurable goal, examining the system processes surrounding attainment of that goal, listing several ideas that may improve the system, engaging in a series of experiments to test the best ideas to improve the process, implementing the most successful ideas based on data from the experiments, and monitoring the system to maintain the gains. The SystemCHANGE-HIV intervention works to help participants make small environmental changes made in family daily routines that will eventually construct an environment.<br>|
| Active Comparator: Control<br>The control group will receive the manual Symptom Management Manual: Strategies for People Living with HIV/AIDS. | Behavioral: SystemCHANGE-HIV<br>* SystemCHANGE, is based on social ecological theory and focuses on redesigning the family environment and daily routines that are linked to health behavior. This framework emphasizes context and specifies that change is best accomplished by: identifying a measurable goal, examining the system processes surrounding attainment of that goal, listing several ideas that may improve the system, engaging in a series of experiments to test the best ideas to improve the process, implementing the most successful ideas based on data from the experiments, and monitoring the system to maintain the gains. The SystemCHANGE-HIV intervention works to help participants make small environmental changes made in family daily routines that will eventually construct an environment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quantity and quality |  | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity |  | 15 weeks | 
| Mental Wellness |  | 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, Adult, Behavioral Intervention, Sleep, Physical Activity