Objective: The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children.
Design: This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms.
Setting: The study occurred at an outpatient HIV primary care centre in Shanghai, China.
Participants: Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis.
Intervention: The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays.
Main outcome measure(s): Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV.
Results: In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size.
Conclusion: Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.