Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Massage to Enhance Well-Being in HIV-Positive Dominican Children|
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||November 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070980
|CENISMI/Robert Reid Cabral Children's Hospital|
|Santo Domingo, Dominican Republic|
|Principal Investigator:||Gail Shor-Posner, MD||University of Miami|