Maternal HIV Disclosure to School Children: RCT of Family-based Intervention (Amagugu)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of KwaZulu
Sponsor:
Information provided by (Responsible Party):
University of KwaZulu
ClinicalTrials.gov Identifier:
NCT01922882
First received: July 8, 2013
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The purpose of this trial is to test whether, compared to the normal Standard of Care at primary health care clinics, a home-based counseling intervention ( the 'Amagugu' Counseling Intervention), will increase the number of HIV-infected mothers who are able to disclose their own HIV status to their primary school-aged children. The investigators also wish to examine whether the intervention improves the quality of the maternal-child relationship, emotional and well-being of the child and social support.


Condition Intervention
HIV
Disclosure
Behavioral: Amagugu Counseling Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Maternal HIV Disclosure to School Children: RCT of Family-based Intervention (Amagugu)

Resource links provided by NLM:


Further study details as provided by University of KwaZulu:

Primary Outcome Measures:
  • Change in disclosure [ Time Frame: Baseline, 3 months, 6 months and 9 month post baseline ] [ Designated as safety issue: No ]
    Measures the proportion of HIV-infected women in the intervention and control arms who, within 3, 6 and 9-months disclose their HIV status to their 6-9 year old HIV-uninfected child.


Secondary Outcome Measures:
  • Change in health promotion [ Time Frame: Baseline, 3 months, 6 months, 9 months post baseline ] [ Designated as safety issue: No ]
    Measures the proportion of HIV-infected women in the intervention and control arms who, within 3, 6 and 9-months take their child on a health promotion visit to a clinic.

  • Change in custody planning [ Time Frame: Baseline, 3 months, 6 months and 9 month post baseline ] [ Designated as safety issue: No ]
    Measures the proportion of HIV-infected women in the intervention and control arms who, within 3, 6 and 9-months develop, together with their child, a clear custody care plan.

  • Change in maternal depression scores [ Time Frame: Baseline, 3 months, 6 months and 9 month post baseline ] [ Designated as safety issue: No ]
    Measures changes in maternal depression scores using the Patient Health Questionnaire -PHQ-9.

  • Change in maternal anxiety scores [ Time Frame: Baseline, 3 months, 6 months and 9 month post baseline ] [ Designated as safety issue: No ]
    Measures changes in maternal anxiety scores using the General Anxiety Questionnaire-GAD-7

  • Change in child mental health scores [ Time Frame: Baseline, 6 months and 9 month post baseline ] [ Designated as safety issue: No ]
    Measures changes in child mental health using the Child Behaviour Check-list (CBCL).

  • Change in quality of the parent-child relationship [ Time Frame: Baseline, 3 months, 6 months and 9 month post baseline ] [ Designated as safety issue: No ]
    Measure changes in the parent-child relationship using the Parenting Stress Index (SF36).

  • Change in the quality of family functioning [ Time Frame: Baseline, 3 months, 6 months and 9 month post baseline ] [ Designated as safety issue: No ]
    Measures changes in the quality of family support and family functioning using the Family Assessment Device (FAD)


Other Outcome Measures:
  • Change in health perceptions [ Time Frame: Baseline and 9 months post baseline ] [ Designated as safety issue: No ]
    Measure baseline health perceptions and changes in health perceptions at the study endpoint using the Medical Outcomes Study (MOS-36)


Estimated Enrollment: 600
Study Start Date: May 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amagugu Counseling Intervention

The 'Amagugu' intensive 6 session home-based intervention. All 6 visits will be undertaken by a lay counsellor over a period of 8-10 weeks. The intervention includes 3 stages linked to the outcomes of the intervention:

  • family engagement, personal preparation, disclosure practice using intervention materials
  • health promotion training and a mother-child visit
  • play-for-communication and custody care planning
Behavioral: Amagugu Counseling Intervention
6-session home-based counseling intervention delivered by lay counselors at mothers' homes
No Intervention: Standard of Care

There is currently no Standard of Care in the South African DoH addressing the issue of parental disclosure of HIV status to HIV-uninfected children, beyond a recommendation to 'counsel to disclose'.

Therefore, for women who are randomized to the control group, we will ensure a Standard of Care for all mothers including a one-hour counselling session, focused specifically on disclosure, delivered at the primary health care facility as part of the HIV Programme.

We will orientate all health professionals in the enrolment clinic, including nurses, counsellors and community health care workers, on parental HIV disclosure, and provide a one-day training workshop (including training manual, role-plays and competency testing.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mother tested HIV-positive at least 6 months prior to the enrolment date
  • Mother has initiated HIV treatment or is established in pre-ART care
  • Mother has an HIV-uninfected child aged 6-9 years resident in her home
  • Mother has not yet disclosed to this child or other children in the household under 9 years of age
  • Mother has the physical and mental capacity for participation as assessed by the Clinic Research Assistant and Department of Health Staff

Exclusion Criteria:

  • Mother received her HIV-positive result less than 6 months ago
  • Mother has not yet undergone or received results of her first CD4 test to confirm pre-ART status
  • Mother does not have an HIV-uninfected child or other children under the age of 9 years resident in the home
  • Mother has previously participated in the Amagugu intervention
  • Mother is resident in the home, but migrates for work on more than five consecutive days of each week
  • Mother is identified as psychotic or delusional based on the study staffs' judgement, or is unable to give signed informed consent
  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: NCT01922882

Contacts
Contact: Tamsen J Rochat, PhD +27355507500 trochat@africacentre.ac.za
Contact: Suzette Grobler +27355507500 sgrobler@africacentre.ac.za

Locations
South Africa
Africa Centre for Health and Population Studies Recruiting
Somkele, KwaZulu-Natal, South Africa, 3935
Principal Investigator: Tamsen J Rochat, PhD         
Principal Investigator: Ruth M Bland, MD         
Sponsors and Collaborators
University of KwaZulu
Investigators
Principal Investigator: Ruth M Bland, MD Africa Centre for Health and Population Studies, University of KwaZulu-Natal
Principal Investigator: Tamsen J Rochat, PhD Africa Centre for Health and Population Studies, University of KwaZulu-Natal
  More Information

Additional Information:
Publications:
Responsible Party: University of KwaZulu
ClinicalTrials.gov Identifier: NCT01922882     History of Changes
Other Study ID Numbers: 1R01HD074267-01
Study First Received: July 8, 2013
Last Updated: February 19, 2014
Health Authority: South Africa: Department of Health

Keywords provided by University of KwaZulu:
HIV
Maternal disclosure
Health promotion
Maternal mental health
Child behavior

ClinicalTrials.gov processed this record on September 15, 2014