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HIV Symptom Management Program for African American Mothers

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HIV Symptom Education Program
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, African American, Symptom Management

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria African American HIV infected Primary caregiver of child(ren) under the age of 9 Exclusion Criteria Diagnosis of AIDS

Sites / Locations

  • University of North Carolina at Chapel Hill

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 1, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00065819
Brief Title
HIV Symptom Management Program for African American Mothers
Official Title
HIV Symptom Management With African American Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2003
Overall Recruitment Status
Completed
Study Start Date
September 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 1999 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, African American, Symptom Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
HIV Symptom Education Program

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria African American HIV infected Primary caregiver of child(ren) under the age of 9 Exclusion Criteria Diagnosis of AIDS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret S. Miles, RN, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7460
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12465865
Citation
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.
Results Reference
background
PubMed Identifier
11840408
Citation
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.
Results Reference
background
PubMed Identifier
11486719
Citation
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.
Results Reference
background

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HIV Symptom Management Program for African American Mothers

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