Tamsen J Rochat1, Alan Stein2, Mario Cortina-Borja3, Frank Tanser4, Ruth M Bland5. 1. Africa Health Research Institute, Durban, South Africa; Human and Social Development Research Program, Human Science Research Council, Durban, South Africa; MRC/Developmental Pathways to Health Research Unit, Department of Paediatrics, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Psychiatry, Oxford University, Oxford, UK. Electronic address: trochat@hsrc.ac.za. 2. Agincourt MRC/Wits Rural Public Health and Health Transitions Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Psychiatry, Oxford University, Oxford, UK. 3. Population, Policy and Practice Programme, University College London, Great Ormond Street Institute of Child Health, London, UK. 4. Africa Health Research Institute, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; CAPRISA Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa. 5. Africa Health Research Institute, Durban, South Africa; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Institute of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK; Royal Hospital for Sick Children, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Abstract
BACKGROUND: Increasing populations of children who are HIV-exposed but uninfected will face the challenge of disclosure of parental HIV infection status. We aimed to test the efficacy of an intervention to increase maternal HIV-disclosure to primary school-aged HIV-uninfected children. METHODS: This randomised controlled trial was done at the Africa Health Research Institute in KwaZulu-Natal, South Africa. Women who had tested HIV positive at least 6 months prior, had initiated HIV treatment or been enrolled in pretreatment HIV care, and had an HIV-uninfected child (aged 6-10 years) were randomly allocated to either the Amagugu intervention or enhanced standard of care, using a computerised algorithm based on simple randomisation and equal probabilities of being assigned to each group. Lay counsellors delivered the Amagugu intervention, which included six home-based counselling sessions of 1-2 h and materials and activities to support HIV disclosure and parent-led health promotion. The enhanced standard of care included one clinic-based counselling session. Outcome measures at 3 months, 6 months, and 9 months post baseline were done by follow-up assessors who were masked to participants' group and counsellor allocation. The primary outcome was maternal HIV disclosure (full [using the word HIV], partial [using the word virus], or none) at 9 months post baseline. We did the analysis in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT01922882). FINDINGS: Between July 1, 2013, and Dec 31, 2014, we randomly assigned 464 participants to the Amagugu intervention (n=235) or enhanced standard of care (n=229). 428 (92%) participants completed the 9 month assessment by Sept 3, 2015. Disclosure at any level was more common in the Amagugu intervention group (n=204 [87%]) than in the enhanced standard-of-care group (n=128 [56%]; adjusted odds ratio 9·88, 95% CI 5·55-17·57; p<0·0001). Full disclosure was also more common in the Amagugu intervention group (n=150 [64%]) than in the enhanced standard-of-care group (n=98 [43%]; 4·13, 2·80-6·11; p<0·0001). Treatment-unrelated adverse effects were reported for 17 participants in the Amagugu intervention group versus six in the enhanced standard-of-care group; adverse effects included domestic violence (five [2%] in the Amagugu intervention group vs one [<1%] in the enhanced standard-of-care group), sexual assault (four [2%] vs one [<1%]), participant illness or death (four [2%] vs four [2%]), and family member illness or death (four [2%] vs none). No treatment-related deaths occurred. INTERPRETATION: The lay-counsellor-driven Amagugu intervention to aid parental disclosure has potential for wide-scale implementation after further effectiveness research and could be adapted to other target populations and other diseases. Further follow-up and effectiveness research is required. FUNDING: National Institutes of Health.
RCT Entities:
BACKGROUND: Increasing populations of children who are HIV-exposed but uninfected will face the challenge of disclosure of parental HIV infection status. We aimed to test the efficacy of an intervention to increase maternal HIV-disclosure to primary school-aged HIV-uninfectedchildren. METHODS: This randomised controlled trial was done at the Africa Health Research Institute in KwaZulu-Natal, South Africa. Women who had tested HIV positive at least 6 months prior, had initiated HIV treatment or been enrolled in pretreatment HIV care, and had an HIV-uninfectedchild (aged 6-10 years) were randomly allocated to either the Amagugu intervention or enhanced standard of care, using a computerised algorithm based on simple randomisation and equal probabilities of being assigned to each group. Lay counsellors delivered the Amagugu intervention, which included six home-based counselling sessions of 1-2 h and materials and activities to support HIV disclosure and parent-led health promotion. The enhanced standard of care included one clinic-based counselling session. Outcome measures at 3 months, 6 months, and 9 months post baseline were done by follow-up assessors who were masked to participants' group and counsellor allocation. The primary outcome was maternal HIV disclosure (full [using the word HIV], partial [using the word virus], or none) at 9 months post baseline. We did the analysis in the intention-to-treat population. This study is registered with ClinicalTrials.gov (NCT01922882). FINDINGS: Between July 1, 2013, and Dec 31, 2014, we randomly assigned 464 participants to the Amagugu intervention (n=235) or enhanced standard of care (n=229). 428 (92%) participants completed the 9 month assessment by Sept 3, 2015. Disclosure at any level was more common in the Amagugu intervention group (n=204 [87%]) than in the enhanced standard-of-care group (n=128 [56%]; adjusted odds ratio 9·88, 95% CI 5·55-17·57; p<0·0001). Full disclosure was also more common in the Amagugu intervention group (n=150 [64%]) than in the enhanced standard-of-care group (n=98 [43%]; 4·13, 2·80-6·11; p<0·0001). Treatment-unrelated adverse effects were reported for 17 participants in the Amagugu intervention group versus six in the enhanced standard-of-care group; adverse effects included domestic violence (five [2%] in the Amagugu intervention group vs one [<1%] in the enhanced standard-of-care group), sexual assault (four [2%] vs one [<1%]), participantillness or death (four [2%] vs four [2%]), and family member illness or death (four [2%] vs none). No treatment-related deaths occurred. INTERPRETATION: The lay-counsellor-driven Amagugu intervention to aid parental disclosure has potential for wide-scale implementation after further effectiveness research and could be adapted to other target populations and other diseases. Further follow-up and effectiveness research is required. FUNDING: National Institutes of Health.
Authors: Judith J Toromo; Edith Apondi; Winstone M Nyandiko; Mark Omollo; Salim Bakari; Josephine Aluoch; Rami Kantor; J Dennis Fortenberry; Kara Wools-Kaloustian; Batya Elul; Rachel C Vreeman; Leslie A Enane Journal: BMC Public Health Date: 2022-06-04 Impact factor: 4.135
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