a randomized, controlled trial of a patient-centered disclosure...
TRANSCRIPT
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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
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Background
• For children living with HIV, learning about their HIV status (“disclosure”) is a critical process within the transition to adulthood
• Caregivers of perinatally HIV-infected children frequently worry about the impact of disclosure, particularly subsequent stigma
• Also report delayed disclosure can hurt medication adherence
• Social environment, perceived HIV-related stigma, and community beliefs shape caregivers’ disclosure decisions
• Prior work in western Kenya: only 55% disclosed by age 14 years in a sample of 748 children and youth across 4 large clinics
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Study ObjectiveTo evaluate the impact of a patient-centered, culturally-appropriate and age-appropriate disclosure counseling intervention in a cluster-randomized trial among Kenyan children and their caregivers
1R01MH099747-01 (Vreeman)
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Study Design• Prospective, cluster-randomized trial
• Enrolled child-caregiver dyads (children ages 10-14) attending eight clinics within the AMPATH HIV treatment program in Kenya
• Clinics were randomized to intervention or control
• Children and caregivers were followed for 24 months, with assessments every six months (0, 6, 12, 18, and 24 months)
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• Curriculum for disclosure and adherence counseling: video-taped narratives; animated, tablet-based educational modules; print resources
• Counseling: Family and one-on-one
• Facilitated peer support groups
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hiv-films.org
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Primary Outcome: Disclosure Status
• Treated as a time-to-event outcome
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Analyses• 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.
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Results: Participants• 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 already (no difference between control and intervention groups)
• Children from control clinics were significantly more likely to have been orphaned (p=0.011), but otherwise demographic and clinical characteristics between groups not statistically different
• Majority of caregiver participants were biological mother of child (54%), but also many aunt/uncle caregivers (19%) and biological fathers (17%)
• During 24 months of follow-up, 25 patients withdrew from study and 7 patients died, with no significant differences by treatment group
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Results: Impact on Disclosure
• Disclosures in both control and intervention arms increased over follow-up, but the intervention arm had significantly more disclosures
• Using child-reported disclosure, prevalence of disclosure increased significantly between the baseline and 24 months of follow-up from 29.2% to 58.5% in the control arm and from 33.2% to 74.0% in the intervention arm
• This was a significant difference in disclosure prevalence for the intervention group at 24 months (difference of 15.5%, 95% confidence interval: 3.7, 27.3)
• Both more disclosures and early disclosures for intervention group, with largest increase at 6 months
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Results: Caregiver vs. Child Reports
• Caregiver and child reports of the child’s disclosure status were somewhat inconsistent.
• At baseline, 19% of child-caregiver dyads gave different answers within the dyad as to whether child knew his or her HIV status.
• In the majority of cases of disagreement (89%), caregiver reported that the child’s HIV status had been disclosed to child, while the child reported that they did not know their HIV status.
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Results: Composite Measure of Disclosure
• Using a composite measure for positive disclosure (either caregiver or child reports disclosure), disclosure increased during study: • 47% to 85% in control arm
• 50% to 91% in the intervention arm
• Prevalence of disclosure was higher in intervention group at each time point, but these differences were only significant at the 6-month follow-up, when 70.0% of children in the intervention arm were disclosed after 6 months in the study, compared to 58.5% in the control arm (p=0.039).
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Results: Mental and Behavioral Health
• Overall, there were not significant differences in mental and behavioral health outcomes at 24 months
• Trends suggested mental and behavioral distress increased at month 6 in the intervention group as disclosures increased, and then decreased compared to controls thereafter
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Results: PHQ-9
• On the PHQ-9, children in intervention group had 2.1 times (95% CI 1.01, 4.25) odds of moving from a lower depression category to a higher (i.e., more severe) depression category compared to children in control group at month 6 (the same timepoint at which disclosures increased significantly)
• At months 12 and 18, children in intervention group had reduced odds of moving from a lower to higher depression category (though not statistically significant), and at month 24, the odds between intervention and controls were similar
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Results: SDQ
• On the SDQ, children in the intervention group had 1.2 times (95% CI 0.55, 2.55) the odds of moving from a normal to borderline or borderline to abnormal category at 6 months
• At months 12, 18, and 24, children in the intervention group had trend towards reduced odds (ORs between 0.80 and 0.87), though these were also not statistically significant
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Results: Viral Suppression
• Viral load measures drawn at 24-month final study visit
• 118/250 participants (47%) had detectable viral load (>40 copies/mL)
• In a comparison adjusted for CD4, individuals in the intervention group trended towards being less likely to have a detectable viral load (odds ratio = 0.80, 95% CI: 0.22-2.84) and more likely to achieve viral suppression (2.29, 95% CI: 0.89-5.39) but neither was statistically significant
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Conclusions
• This study provides evidence for an effective, clinic-based intervention to increase disclosure of HIV status to children living with HIV
• Key components: Dedicated counselor available at clinic, supported by narrative-based counseling curriculum
• Making mental health support and peer support available throughout the disclosure process may be particularly important to navigate increased psychological distress immediately after disclosure and move towards resilience
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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.