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HIV Symptom Management Program for African American Mothers

HIV Symptom Management With African American Mothers

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7460
        • University of North Carolina at Chapel Hill

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 sekund og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria

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

Exclusion Criteria

  • Diagnosis of AIDS

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Margaret S. Miles, RN, PhD, University of North Carolina, Chapel Hill

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 1996

Studieafslutning

1. august 1999

Datoer for studieregistrering

Først indsendt

1. august 2003

Først indsendt, der opfyldte QC-kriterier

1. august 2003

Først opslået (Skøn)

4. august 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2005

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2005

Sidst verificeret

1. juni 2003

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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