Study of SystemCHANGE-HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01256814
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : August 30, 2011
Association of Nurses in AIDS Care
Information provided by (Responsible Party):
Allison Webel, Case Western Reserve University

December 8, 2010
December 9, 2010
August 30, 2011
January 2011
Not Provided
Sleep quantity and quality [ Time Frame: 15 weeks ]
Same as current
Complete list of historical versions of study NCT01256814 on Archive Site
  • Physical Activity [ Time Frame: 15 weeks ]
  • Mental Wellness [ Time Frame: 15 weeks ]
Same as current
Not Provided
Not Provided
Study of SystemCHANGE-HIV
SystemCHANGE-HIV: A Pilot Study Exploring the Effect of a Systems-based Intervention to Increase Physical Activity, Sleep Behavior, and Mental Wellness
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Behavioral: SystemCHANGE-HIV
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.
  • Experimental: Behaviorial Intervention
    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
    Intervention: Behavioral: SystemCHANGE-HIV
  • Active Comparator: Control
    The control group will receive the manual "Symptom Management Manual: Strategies for People Living with HIV/AIDS".
    Intervention: Behavioral: SystemCHANGE-HIV

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2011
Not Provided

Inclusion Criteria:

  • documented HIV diagnosis
  • adult (21 years old or greater)
  • English speaking

Exclusion Criteria:

Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Allison Webel, Case Western Reserve University
Case Western Reserve University
Association of Nurses in AIDS Care
Not Provided
Case Western Reserve University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP