Scale-up of a paediatric HIV disclosure intervention in Ghana using a stepped wedge cluster randomised trial design: Sankofa 2 protocol and implementation.
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| Title: | Scale-up of a paediatric HIV disclosure intervention in Ghana using a stepped wedge cluster randomised trial design: Sankofa 2 protocol and implementation. |
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| Authors: | Reynolds NR; Johns Hopkins University, Baltimore, Maryland, USA nancy.reynolds@jhu.edu., Shabanova V; Yale University, New Haven, Connecticut, USA., Renner L; University of Ghana, Accra, Greater Accra Region, Ghana., Antwi S; Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti Region, Ghana., Ayisi Addo S; Ghana Health Service, Accra, Greater Accra Region, Ghana., Enimil AK; Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti Region, Ghana., Lartey M; University of Ghana, Accra, Greater Accra Region, Ghana., Gan G; Yale University, New Haven, Connecticut, USA., Parziale S; Yale University, New Haven, Connecticut, USA., Aikins Amissah K; Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti Region, Ghana., Kusah JT; University of Ghana, Accra, Greater Accra Region, Ghana., Ofori-Atta AL; University of Ghana, Accra, Greater Accra Region, Ghana., Slade E; Johns Hopkins University, Baltimore, Maryland, USA., Agyarko-Poku T; Ghana Health Service, Accra, Greater Accra Region, Ghana., Paintsil E; Yale University, New Haven, Connecticut, USA.; University of Ghana, Accra, Greater Accra Region, Ghana.; Boston Medical Center, Boston, Massachusetts, USA. |
| Source: | BMJ open [BMJ Open] 2025 Nov 13; Vol. 15 (11), pp. e099681. Date of Electronic Publication: 2025 Nov 13. |
| Publication Type: | Journal Article; Clinical Trial Protocol |
| Language: | English |
| Journal Info: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| MeSH Terms: | HIV Infections*/psychology , Caregivers*/psychology , Truth Disclosure* , Disclosure*, Humans ; Ghana ; Child ; Adolescent ; Randomized Controlled Trials as Topic ; Female ; Male ; Cost-Benefit Analysis ; Child, Preschool ; Research Design |
| Abstract: | Competing Interests: Competing interests: None declared. Introduction: There is a pressing need for effective interventions that can support healthcare workers and caregivers in the challenging yet crucial task of disclosing the HIV status to infected children and adolescents. Previously, we developed and tested a successful disclosure intervention called Sankofa in Ghana. In an ongoing 5-year follow-up study, Sankofa 2, we aim to build on the successful Sankofa trial by testing the intervention on a larger scale. Methods and Analysis: This study is a pragmatic, stepped-wedge cluster randomised trial. Setting: It is being conducted in 12 HIV paediatric clinics in Ghana to examine the effectiveness, health benefits, cost and implementation of the Sankofa intervention. Caregiver-child dyads (n=700) will be enrolled. Evaluation of effectiveness, health benefits, cost and implementation of the Paediatric HIV disclosure intervention, Sankofa 2, is posed to offer valuable insights for scale-up and sustainability. Ethics and Dissemination: Ethical clearance has been obtained from the Ghana Health Service Ethics Review Committee, the University of Ghana Ethical and Protocol Review Committee, the Committee on Human Research Publication and Ethics of the Kwame Nkrumah University of Science and Technology, the Johns Hopkins Medicine Institutional Review Board and the Yale School of Medicine Human Investigation Committee. The clinical trial was registered on ClinicalTrials.gov on 5 March 2021. All caregiver participants are required to provide written informed consent and the children assent before enrolment. If either the child or caregiver says no to the study, the dyad is not eligible for the study. No study-related procedures are performed until consent is obtained. The results of the trial will be added on ClinicalTrials.gov, published in peer-reviewed journals and presented at international conferences. Trial Registration Number: NCT04791865. (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.) |
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| Grant Information: | R01 HD103512 United States HD NICHD NIH HHS |
| Contributed Indexing: | Keywords: Adolescent; Clinical Trial; Implementation Science |
| Molecular Sequence: | ClinicalTrials.gov NCT04791865 |
| Entry Date(s): | Date Created: 20251114 Date Completed: 20251114 Latest Revision: 20251122 |
| Update Code: | 20251122 |
| PubMed Central ID: | PMC12625916 |
| DOI: | 10.1136/bmjopen-2025-099681 |
| PMID: | 41238360 |
| Database: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstract: | Competing Interests: Competing interests: None declared.<br />Introduction: There is a pressing need for effective interventions that can support healthcare workers and caregivers in the challenging yet crucial task of disclosing the HIV status to infected children and adolescents. Previously, we developed and tested a successful disclosure intervention called Sankofa in Ghana. In an ongoing 5-year follow-up study, Sankofa 2, we aim to build on the successful Sankofa trial by testing the intervention on a larger scale.<br />Methods and Analysis: This study is a pragmatic, stepped-wedge cluster randomised trial.<br />Setting: It is being conducted in 12 HIV paediatric clinics in Ghana to examine the effectiveness, health benefits, cost and implementation of the Sankofa intervention. Caregiver-child dyads (n=700) will be enrolled. Evaluation of effectiveness, health benefits, cost and implementation of the Paediatric HIV disclosure intervention, Sankofa 2, is posed to offer valuable insights for scale-up and sustainability.<br />Ethics and Dissemination: Ethical clearance has been obtained from the Ghana Health Service Ethics Review Committee, the University of Ghana Ethical and Protocol Review Committee, the Committee on Human Research Publication and Ethics of the Kwame Nkrumah University of Science and Technology, the Johns Hopkins Medicine Institutional Review Board and the Yale School of Medicine Human Investigation Committee. The clinical trial was registered on ClinicalTrials.gov on 5 March 2021. All caregiver participants are required to provide written informed consent and the children assent before enrolment. If either the child or caregiver says no to the study, the dyad is not eligible for the study. No study-related procedures are performed until consent is obtained. The results of the trial will be added on ClinicalTrials.gov, published in peer-reviewed journals and presented at international conferences.<br />Trial Registration Number: NCT04791865.<br /> (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.) |
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| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2025-099681 |