NCT00070980

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
Last Updated

August 18, 2006

Status Verified

July 1, 2006

First QC Date

October 9, 2003

Last Update Submit

August 17, 2006

Conditions

HIV InfectionsAIDS

Keywords

Complementary Therapies

Interventions

Massage therapyPROCEDURE

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • HIV infection
  • Parent/caregiver signature on consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CENISMI/Robert Reid Cabral Children's Hospital

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Massage

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gail Shor-Posner, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 9, 2003

First Posted

October 13, 2003

Study Start

March 1, 2003

Study Completion

November 1, 2004

Last Updated

August 18, 2006

Record last verified: 2006-07

Locations

DO(1)