HIV Symptom Management Program for African American Mothers

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00065819
First received: August 1, 2003
Last updated: June 23, 2005
Last verified: June 2003
  Purpose

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.


Condition Intervention Phase
HIV Infections
Behavioral: HIV Symptom Education Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HIV Symptom Management With African American Mothers

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Study Start Date: September 1996
Estimated Study Completion Date: August 1999
Detailed Description:

Infection with the human immunodeficiency virus (HIV) poses a growing threat to the health of women in childbearing years and occurs disproportionately among lower socioeconomic populations and minority women. Early identification of HIV infection and advances in antiretroviral therapies have begun to prolong the lives of infected individuals. However, women with HIV appear to have more rapid disease progression and shorter survival after diagnosis than men. Evidence is emerging that women are less likely to use health services, are more likely to present at clinical facilities with advanced disease, and are less likely to receive antiretroviral therapy.

To date, little attention has focused on the prevention and management of symptoms experienced by women with HIV before they develop AIDS. The primary aim of this randomized clinical study was determine the efficacy of an HIV self-care and symptom management intervention designed to help low-income African American mothers with HIV. The study was based on the Maternal HIV Self-Care Symptom Management framework, which postulates that helping mothers to cope with their emotional responses to HIV diagnosis and to reframe their understanding of HIV from an immediate life-threatening illness to a chronic disease decreases emotional distress and improves health.

One hundred and nine African American mothers, including 17 grandmothers who were primary caregivers for children, participated in the trial. Women were randomized to either the intervention or the control group. The intervention focused on the mother’s responses to her HIV diagnosis and helped her understand, manage, and prevent selected HIV-related symptoms, using her concern about her child(ren) as a motivator. The intervention used a cognitive reframing educational approach based within a therapeutic relationship with an advanced practice nurse. The nurse provided a culturally sensitive milieu designed to help the woman feel safe in exploring her feelings and expressing her needs. Eight teaching modules provided basic information to improve knowledge about HIV and help the mother identify self-care strategies related to general health promotion. Data were collected using self-report measures assessing emotional distress and health.

Mothers in the intervention group reported fewer feelings of stigma 6 months after the intervention ended than did mothers in the control group. Within the intervention group, there was a reduction in two aspects of affective state (depression/dejection and tension/anxiety) and in stigma. However, most outcomes did not differ significantly. There was no reduction in depressive symptoms, in other aspects of affective state, or in HIV worry. Mothers in the intervention group reported higher physical function scores 6 months after the intervention ended compared to control mothers. Other aspects of health-related quality of life, such as perception of health, health distress, energy/fatigue, and role function, did not improve. Within the intervention group, mothers reported fewer infections from enrollment to 1 month after the intervention ended. In contrast, mothers in the control group reported a decline in physical function and overall role function. There was a high drop-out for mothers in both groups. Analysis of enrollment data comparing the mothers who dropped out and mothers who remained in the study indicated that drop-out mothers had significantly higher scores on emotional distress variables and social conflict and lower perceptions of health, suggesting the need for a more targeted intervention with a stronger focus on mental health.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Diagnosis of AIDS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065819

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7460
Sponsors and Collaborators
Investigators
Principal Investigator: Margaret S. Miles, RN, PhD University of North Carolina, Chapel Hill
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00065819     History of Changes
Other Study ID Numbers: R01NR04416, RR000466GCRC
Study First Received: August 1, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HIV
African American
Symptom Management

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 01, 2014