1. 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
1R01MH (Vreeman)

2. 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.
1R01MH (Vreeman)

3. 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

4. Acknowledgements
This research was supported by a grant entitled “Patient-Centered Disclosure Intervention for HIV- Infected Children” (1R01MH ) 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.