A randomized, controlled trial of a patient-centered disclosure counseling intervention for Kenyan children living with HIV. Rachel C. Vreeman, MD, MS; Winstone M. Nyandiko, MBChB, MMED, MPH; Irene Marete, MBChB, MMED; Ann Mwangi, PhD; Carole I. McAteer, MS; Alfred Keter, MS; Michael L. Scanlon, MA, MPH; Samuel O. Ayaya, MBChB, MMED; Josephine Aluoch, MA; Joseph Hogan, ScD 1R01MH099747-01 (Vreeman)

Dedicated counselor: Family and one-on-one counseling Intervention Narrative-based curriculum for disclosure and adherence counseling: video-taped narratives; animated, tablet-based educational modules; print resources Dedicated counselor: Family and one-on-one counseling Facilitated peer support groups Standard of Care Protocol for disclosure, counseling Trained staff, but no dedicated time Primary Outcome: Disclosure Status Disclosure as time-to-event outcome Secondary outcomes: Clinical status, Mental Health, Adherence, Stigma Study Objective & Design To evaluate the impact of a patient- centered disclosure counseling intervention in a cluster-randomized trial among Kenyan children and their caregivers Enrolled child-caregiver dyads (children ages 10-14) attending 8 clinics within AMPATH HIV treatment program in Kenya Randomized by clinic Children and caregivers followed for 24 months, with assessments every six months Disclosure treated as time-to-event outcome, measured on discrete time scale Discrete-time random-effects hazard models Results are summarized using two measures: Time-specific hazard ratio: compares probability of new disclosure at each time point, where denominator is those who have not yet disclosed Time-specific prevalence of disclosure: compares cumulative proportion disclosed at each time point post-baseline Clinical, mental, and behavioral outcomes: Independent sample t-test to compare normally distributed continuous variables, two-sample Wilcoxon rank-sum test to compare non-normally distributed variables. Comparison of proportions done with Wald test. Effect of intervention on depression (score on PHQ-9), and on emotional and behavioral symptoms (SDQ) assessed using a mixed effects ordinal logistic regression model. Included clinic-specific and subject-specific random effects with participants nested within clinics. The treatment arm and time variable, as well as interaction of the two, were included as the main effects. 1R01MH099747-01 (Vreeman)

Disclosures in both control and intervention arms increased over follow-up, but intervention arm had significantly more Using child-reported disclosure, prevalence of disclosure increased significantly between baseline and 24 months 29.2% to 58.5% in control arm 33.2% to 74.0% in intervention arm Significant difference at 24 months: 15.5% difference, 95% confidence interval: 3.7, 27.3 Both more disclosures and early disclosures for intervention group, with largest increase at 6 months Trends suggested mental and behavioral distress increased at month 6 in intervention group as disclosures increased, and then decreased compared to controls thereafter (PHQ-9, SDQ) Results 285 children and their caregivers Mean age 12.3 years, 52% female Average time-on-treatment: 4.4 years; 95% on first-line ART At baseline, 32% of children reported knowing their HIV status (no difference between control and intervention) Disagreements in caregiver and child reports of disclosure: At baseline, 19% of child-caregiver dyads gave different answers In 89% of cases of disagreement, caregiver reported that child’s HIV status had been disclosed to child, while child reported that they did not know their HIV status

Acknowledgements This research was supported by a grant entitled “Patient-Centered Disclosure Intervention for HIV- Infected Children” (1R01MH099747-01) to Dr. Rachel Vreeman by the National Institute for Mental Health, Bethesda, Maryland, USA. We thank and acknowledge the many AMPATH patients and their families involved, as well as the HADITHI counselors and research assistants.