Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065819
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-08-01
Brief Title:
HIV Symptom Management Program for African American Mothers
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
HIV Symptom Management With African American Mothers
Status:
COMPLETED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mothers responses to her HIV diagnosis and helped her understand manage and prevent selected HIV-related symptoms using her concern about her children 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 depressiondejection and tensionanxiety 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 energyfatigue 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
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 mothers responses to her HIV diagnosis and helped her understand manage and prevent selected HIV-related symptoms using her concern about her children 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 depressiondejection and tensionanxiety 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 energyfatigue 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RR000466GCRC | None | None | None |