NCT00065819

Brief Summary

African American mothers infected with HIV face unique challenges in management of their disease. The goal of this study was to determine the effectiveness of an HIV self-care and symptom management program designed to help low-income African American mothers with HIV.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1996

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

September 1, 1996

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1999

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2003

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2003

First QC Date

August 1, 2003

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIVAfrican AmericanSymptom Management

Interventions

HIV Symptom Education ProgramBEHAVIORAL

Eligibility Criteria

Age0 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • African American
  • HIV infected
  • Primary caregiver of child(ren) under the age of 9

You may not qualify if:

  • Diagnosis of AIDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7460, United States

Location

Related Publications (3)

  • Black BP, Miles MS. Calculating the risks and benefits of disclosure in African American women who have HIV. J Obstet Gynecol Neonatal Nurs. 2002 Nov-Dec;31(6):688-97. doi: 10.1177/0884217502239211.

    PMID: 12465865BACKGROUND

  • Mallory C, Miles MS, Holditch-Davis D. Reciprocity and retaining African-American women with HIV in research. Appl Nurs Res. 2002 Feb;15(1):35-41. doi: 10.1053/apnr.2002.29529.

    PMID: 11840408BACKGROUND

  • Miles MS, Gillespie JV, Holditch-Davis D. Physical and mental health in African American mothers with HIV. J Assoc Nurses AIDS Care. 2001 Jul-Aug;12(4):42-50. doi: 10.1016/S1055-3290(06)60215-X.

    PMID: 11486719BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Margaret S. Miles, RN, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 4, 2003

Study Start

September 1, 1996

Study Completion

August 1, 1999

Last Updated

June 24, 2005

Record last verified: 2003-06

Locations

US(1)