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

NCT01922882 | Completed DMC

• 1 other identifier: 1R01HD074267-01
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Disclosure

Keywords

HIV; Maternal disclosure; Health promotion; Maternal mental health; Child behavior

Outcome Measures

Primary Outcomes (1)

• Change in disclosure

  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.

  Baseline, 3 months, 6 months and 9 month post baseline

Secondary Outcomes (7)

• Change in health promotion

  Baseline, 3 months, 6 months, 9 months post baseline

• Change in custody planning

  Baseline, 3 months, 6 months and 9 month post baseline

• Change in maternal depression scores

  Baseline, 3 months, 6 months and 9 month post baseline

• Change in maternal anxiety scores

  Baseline, 3 months, 6 months and 9 month post baseline

• Change in child mental health scores

  Baseline, 6 months and 9 month post baseline

Other Outcomes (1)

• Change in health perceptions

  Baseline and 9 months post baseline

Study Arms (2)

Amagugu Counseling Intervention

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Amagugu Counseling Intervention BEHAVIORAL

6-session home-based counseling intervention delivered by lay counselors at mothers' homes

Amagugu Counseling Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of KwaZulu: lead

Study Sites (1)

Africa Centre for Health and Population Studies

Somkele, KwaZulu-Natal, 3935, South Africa

Location

Related Publications (9)

• Rochat TJ, Mkwanazi N, Bland R. Maternal HIV disclosure to HIV-uninfected children in rural South Africa: a pilot study of a family-based intervention. BMC Public Health. 2013 Feb 18;13:147. doi: 10.1186/1471-2458-13-147.

  PMID: 23418933 BACKGROUND

• Rochat TJ, Arteche AX, Stein A, Mkwanazi N, Bland RM. Maternal HIV disclosure to young HIV-uninfected children: an evaluation of a family-centred intervention in South Africa. AIDS. 2014 Jul;28 Suppl 3:S331-41. doi: 10.1097/QAD.0000000000000333.

  PMID: 24991906 BACKGROUND

• Rochat TJ, Arteche AX, Stein A, Mitchell J, Bland RM. Maternal and child psychological outcomes of HIV disclosure to young children in rural South Africa: the Amagugu intervention. AIDS. 2015 Jun;29 Suppl 1:S67-79. doi: 10.1097/QAD.0000000000000668.

  PMID: 26049540 BACKGROUND

• Mkwanazi NB, Rochat TJ, Bland RM. Living with HIV, disclosure patterns and partnerships a decade after the introduction of HIV programmes in rural South Africa. AIDS Care. 2015;27 Suppl 1(sup1):65-72. doi: 10.1080/09540121.2015.1028881.

  PMID: 26616127 BACKGROUND

• Rochat TJ, Bland R, Coovadia H, Stein A, Newell ML. Towards a family-centered approach to HIV treatment and care for HIV-exposed children, their mothers and their families in poorly resourced settings. Future Virol. 2011 Jun;6(6):687-696. doi: 10.2217/fvl.11.45.

  PMID: 22003360 BACKGROUND

• Rochat TJ, Mitchell J, Stein A, Mkwanazi NB, Bland RM. The Amagugu Intervention: A Conceptual Framework for Increasing HIV Disclosure and Parent-Led Communication about Health among HIV-Infected Parents with HIV-Uninfected Primary School-Aged Children. Front Public Health. 2016 Aug 31;4:183. doi: 10.3389/fpubh.2016.00183. eCollection 2016.

  PMID: 27630981 BACKGROUND

• Mkwanazi N., Rochat T.J, Coetzee B., Bland R. (2013) Mothers' and health workers' perceptions of participation in a child-friendly health initiative in rural South Africa. Health, 5(12), 2137-2145. doi: 10.4236/health.2013.512291 NO PMID

  BACKGROUND

• Mkwanazi, N. B., Rochat, T. J., Imrie, J., & Bland, R. M. (2012). Disclosure of maternal HIV status to children: considerations for research and practice in sub-Saharan Africa. Future Virology, 7(12), 1159-1182. NO PMID

  BACKGROUND

• Rochat TJ, Stein A, Cortina-Borja M, Tanser F, Bland RM. The Amagugu intervention for disclosure of maternal HIV to uninfected primary school-aged children in South Africa: a randomised controlled trial. Lancet HIV. 2017 Dec;4(12):e566-e576. doi: 10.1016/S2352-3018(17)30133-9. Epub 2017 Aug 23.

  PMID: 28843988 DERIVED

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: August 14, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 23, 2016

Record last verified: 2016-08

Locations

ZA (1)