Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-11-30

Brief Summary

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The purpose of this study is to determine whether massage therapy can improve immune status and enhance well-being in children living in the Dominican Republic who are infected with HIV.

Detailed Description

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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.

Conditions

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HIV Infections AIDS

Keywords

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Complementary Therapies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Massage therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Gail Shor-Posner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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CENISMI/Robert Reid Cabral Children's Hospital

Santo Domingo, , Dominican Republic

Site Status

Countries

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Dominican Republic

Other Identifiers

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R21AT001160-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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