iCOPE, a multi-level, cluster randomized, 36-month, parallel-group study to assess the efficacy of HIV disclosure intervention in HIV parental disclosure among parents living with HIV in China

Objectives: Parents living with HIV who disclose their HIV status to their children could benefit from the parental HIV disclosure. However, it is also very challenging because of persistent stigma and discrimination against HIV. This report describes the study design and protocol of the "Interactive Communication with Openness, Passion, and Empowerment (iCOPE)" randomized controlled trial aimed at assisting parents living with HIV in conducting culturally and developmentally appropriate disclosure to their uninfected children in China through trainings among both parents living with HIV and healthcare providers. Methods: A total of 791 parents living with HIV with children aged between 6 and 15 years and 357 healthcare providers were randomized into either the intervention group or control group. Intervention package for parents consisted of five 2-h sessions focusing on positive coping, disclosure decision making, developing a developmentally appropriate disclosure plan, and accessing social support and post-disclosure counseling. The intervention for healthcare providers was made up of two 45-min sessions organized around two primary themes: knowledge of child cognitive development and effective parent-child communication skills in the context of parental disclosure. The control group received nutritional education of either five 2-h sessions (parents) or two 45-min sessions (healthcare providers). The outcome assessments were conducted at baseline, 6, 12, 18, 24, 30, and 36 months. Conclusion: The iCOPE study is among the first efforts to develop and evaluate a theory-based and multi-level intervention to promote culturally and developmentally appropriate parental HIV disclosure in China. It has implications for healthcare providers, social workers, and policy makers as it will provide efficacy data on how to enhance appropriate parental HIV disclosure and will shed light on developing a clinical guideline regarding parental HIV disclosure in China and other low- and middle-income countries.