Scale-up of a paediatric HIV disclosure intervention in Ghana using a stepped wedge cluster randomised trial design:
Nancy R Reynolds1, Veronika Shabanova2, Lorna Renner3
1Johns Hopkins University, Baltimore, Maryland, USA nancy.reynolds@jhu.edu.
Insights
The Sankofa 2 study is evaluating an intervention to help healthcare workers disclose HIV status to children and adolescents in Ghana. This larger trial builds on previous success to assess effectiveness, benefits, and costs for wider implementation.
Area of Science:
- Public Health
- Clinical Trials
- HIV/AIDS Research
Background:
- A significant need exists for interventions supporting healthcare workers and caregivers in disclosing HIV status to infected children and adolescents.
- The Sankofa intervention was previously developed and tested successfully in Ghana.
- The Sankofa 2 study aims to scale up and further evaluate this intervention.
Purpose of the Study:
- To examine the effectiveness, health benefits, cost, and implementation of the Sankofa intervention in pediatric HIV care.
- To provide insights for the scale-up and sustainability of the intervention.
- To support healthcare workers and caregivers in the critical process of HIV status disclosure.
Main Methods:
- A pragmatic, stepped-wedge cluster randomized trial design.
- Conducting the study across 12 HIV pediatric clinics in Ghana.
- Enrolling 700 caregiver-child dyads.
Main Results:
- The study is ongoing, and results are pending.
- Evaluation of effectiveness, health benefits, cost, and implementation are key objectives.
- Insights for scale-up and sustainability are anticipated.
Conclusions:
- The Sankofa 2 trial is expected to yield valuable data on the Sankofa intervention's impact.
- Findings will inform strategies for improving pediatric HIV disclosure support.
- The study aims to contribute to the long-term sustainability of effective HIV care practices.
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.
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