Abstract
Background In sub-Saharan Africa, HIV care is dependent on informal caregiving, typically by female family members. Informal caregiving has been associated with numerous negative effects on caregivers (i.e. depression, intimate partner violence (IPV), financial insecurity). These factors impact both caregivers’ ability to provide care and their own wellbeing. South Africa is home to approximately 17% of the world’s children and adolescents living with HIV (CALHIV), making the development of initiatives that mitigates the negative effects of caregiving critical. This protocol details the design of a cluster randomised trial seeking to assess the feasibility, preliminary effectiveness, cost-effectiveness, and acceptability of a cash transfer plus gender transformative economic empowerment intervention for improving psychological wellbeing, depressive symptoms, gender equality, and economic outcomes of caregivers of CALHIV.Methods Caregivers of CALHIV will be recruited from public sector HIV clinics within the eThekwini municipality, KwaZulu-Natal, South Africa. Clusters will be randomly assigned to the intervention or control groups. Participants in the intervention arm (n = 120) will receive cash transfers (ZAR350, USD $18,79) and enrol in a programme (10 workshop sessions) over a 6-month period. Participants in the control arm (n = 120) will receive a monthly cash transfer (ZAR350, USD $18,79) for a 6-month period and a once-off standard mobile message at the beginning of the trial, encouraging linkage to healthcare services. Participants will be interviewed at baseline and endline, at the 7-month mark, to collect socio-demographic, health and wellbeing status, IPV, costs and earnings, and food security data. The primary outcomes (psychological wellbeing, depressive symptoms, IPV) will be measured using the Mental Health Continuum Short Form, the CES-D-10 scale, and the WHO’s Violence Against Women scale. A qualitative study and economic evaluation will be conducted alongside the main trial to probe participants perceptions on the intervention and assess economic cost and costs-effectiveness.Discussion This trial has the potential to inform a larger confirmatory trial which will be valuable for informing post-pandemic recovery efforts for caregivers of CALHIV and others disproportionally burdened by compounding health and social crises.Trial registration PACTR202311618532061. Registry name: Pan African Clinical Trial Registry (PACTR); URL: https://pactr.samrc.ac.za/; Registration date: 21-November-2023 (retrospectively registered); Date first participant enrolled: 24-August-2023