Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

Tracking Information
First Submitted Date ICMJE	October 15, 2007
First Posted Date ICMJE	October 17, 2007
Results First Submitted Date	July 25, 2014
Results First Posted Date	September 3, 2014
Last Update Posted Date	September 3, 2014
Study Start Date ICMJE	April 2007
Actual Primary Completion Date	September 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 31, 2014)	Changes in GI Symptom Per Intervention Session [ Time Frame: 8 weeks ]; We used the GI symptom subscale of the Revised HIV Sign and Symptom Checklist (SSC-HIV) to measure the intensity (0-10) of the six targeted GI symptoms: diarrhea, loose stools, gas/bloating, abdominal pain, nausea and vomiting, with 0 indicating no symptom and 10 indicating most sever symptom. Rating changes per intervention session were estimated using a mixed effects regression model controlling for baseline ratings. Data of loose stools are presented here.
Original Primary Outcome Measures ICMJE; (submitted: October 16, 2007)	GI symptoms and HIV medication adherence [ Time Frame: 6 months ]
Change History	Complete list of historical versions of study NCT00545623 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE; (submitted: October 16, 2007)	Quality of Life [ Time Frame: 6 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
Official Title ICMJE	Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
Brief Summary	The aims of the study are to investigate individual, combined and added effects of acupuncture and the relaxation response in reducing gastrointestinal symptoms, improving medication adherence and quality of life among people living with HIV/AIDS. The study will also explore the mechanism of these therapeutic effects of acupuncture and the relaxation response.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	HIV Infections
Intervention ICMJE	Procedure: Acupuncture acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks; Behavioral: Relaxation Response listening to CDs with verbal instructions of techniques to elicit relaxation response; Other: sham acupuncture sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Study Arms	Active Comparator: ACU+RR acupuncture + relaxation response CD Interventions: Procedure: Acupuncture Behavioral: Relaxation Response; Active Comparator: SHAM+RR sham acupuncture + relaxation response CD Intervention: Behavioral: Relaxation Response; Active Comparator: ACU+EDU acupuncture+control CD Intervention: Procedure: Acupuncture; Sham Comparator: SHAM+EDU sham acupuncture+control CD Intervention: Other: sham acupuncture
Publications *	Chang BH, Sommers E. Acupuncture and the relaxation response for treating gastrointestinal symptoms in HIV patients on highly active antiretroviral therapy. Acupunct Med. 2011 Sep;29(3):180-7. doi: 10.1136/acupmed-2011-010026. Epub 2011 Jun 24.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 6, 2012)	130
Original Estimated Enrollment ICMJE; (submitted: October 16, 2007)	80
Actual Study Completion Date	September 2010
Actual Primary Completion Date	September 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Confirmed HIV-positive status or AIDS diagnosis; Self report of having at least one of the 6 GI symptoms: diarrhea, loose stools, gas/flatulence or bloating, abdominal pain, nausea, or vomiting that have persisted for at least 8 weeks.; Being on a stable antiretroviral regimen containing Nucleoside/nucleotide reverse transcriptase inhibitors and/or protease inhibitors- for at least 8 weeks. Exclusion Criteria: Incident diagnosis of any of the following conditions within the past month or during study period: Pneumocystis carinii pneumonia, Kaposi's sarcoma, Mycobacterium avian complex, Cytomegalovirus, Non-Hodgkins lymphoma, Lymphoma or other cancer, Pelvic inflammatory disease, AIDS-related dementia, Bacterial or other infection, Diabetes, Acute moderate or severe neutropenia, Cryptococcus, Progressive multifocal leukoencephalopathy, Idiopathic thrombocytopenic purpura. All of these conditions are major opportunistic infections or medical complications that may require hospitalization and additional pharmaceutical intervention.; GI diagnoses of irritable bowel syndrome, Crohn's Disease, parasites, any type of gastric ulcer or ulcerative colitis or cancer in any part of the gastrointestinal system. These are conditions not related to HIV diagnosis and could result in digestive problems similar to those we are investigating.; Onset of acute opportunistic infection.; Hemophilia or other bleeding disorder since that will make acupuncture treatment unsafe.; Pregnant women will be excluded since, although none of the acupuncture points or combinations are contraindicated in pregnancy, the presence of morning sickness could serve as a potential confounding factor.; Current users of acupuncture for treating GI symptoms.; Current practice of relaxation response.; Current enrollment in another clinical intervention study.; Cognitive impairment as measured by Mini Mental Status Examination (MMSE), a reliable and valid screening instrument for the detection of cognitive impairment, using a commonly used cut-off point of 24.; If use of Chinese herbs has been recently discontinued, a potential participant must have at least 2 weeks without herb use to be eligible for the study. Because use of herbs is occasionally accompanied by digestive disorders,a period of stabilizing is required before acupuncture treatment can be initiated. This washout period has been conservatively estimated by ACP staff herbalists to constitute a sufficient time for effects of herbs to cease.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00545623
Other Study ID Numbers ICMJE	R21AT003377-01( U.S. NIH Grant/Contract ); R21AT003377-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bei-Hung Chang, Boston University
Study Sponsor ICMJE	Boston University
Collaborators ICMJE	National Center for Complementary and Integrative Health (NCCIH)
Investigators ICMJE	Principal Investigator: Bei-Hung Chang, Sc.D. Boston University
PRS Account	Boston University
Verification Date	August 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP