- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00070980
Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV
Massage to Enhance Well-Being in HIV-Positive Dominican Children
Study Overview
Detailed Description
The incidence of pediatric HIV in the Dominican Republic has been rapidly rising, while antiretroviral therapies are not yet readily available to slow disease progression. There is compelling evidence that massage therapy may enhance immune status and alter the course of HIV disease. Increased immune capacity and improvement in HIV disease progression markers have been demonstrated following massage therapy in HIV infected adolescents and adults, even in the absence of antiretroviral treatments. In studies with premature newborns, increased weight gain, decreased stress behavior, and more optimal cognitive and motor development have been reported following massage treatment. This study will examine the efficacy of massage therapy, an affordable and potentially beneficial complementary/alternative treatment, to promote health and enhance well-being in HIV infected children in the Dominican Republic.
Children will be randomly assigned to receive either massage therapy or standard care/friendly visits twice weekly for 12 weeks. Data will be gathered to assess acceptance, safety, and compliance to massage therapy and to examine whether massage treatment has improved immune function, developmental performance, and behavioral function.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Santo Domingo, Dominican Republic
- CENISMI/Robert Reid Cabral Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV infection
- Parent/caregiver signature on consent form
Exclusion criteria:
- Unknown HIV status
- Fever, new opportunistic infection, or acute hospitalization within 30 days prior to study entry
- Massage therapy within 30 days prior to study entry
- Unable to have massage (e.g., extensive skin lesions)
- Symptoms of child abuse
- Child born drug-addicted
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Collaborators and Investigators
Investigators
- Principal Investigator: Gail Shor-Posner, MD, University of Miami
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT001160-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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