Patient-Centered Disclosure Intervention for HIV-Infected Children (HADITHI)
|ClinicalTrials.gov Identifier: NCT01947764|
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: HADITHI Intervention||Not Applicable|
Access to highly active antiretroviral therapy (ART) transforms HIV/AIDS management from responding to an acute infection and its co-morbidities into coordinating the care of a complex chronic disease. Ninety percent of the world's 2.3 million HIV-infected children live in sub-Saharan Africa. As HIV-infected children receiving ART grow and thrive, clinicians in these resource-limited settings face new challenges. As children age, they need to be transitioned into taking responsibility for their own care. Central to this transition is the process of telling children that they are infected with HIV. The most effective strategies for disclosing HIV status to children in resource-limited settings are not known. Moreover, parents and healthcare providers often fear disclosure, worrying about the personal and social impact on the child and the family. To date, only a modicum of research describes the prevalence of pediatric disclosure, effective disclosure processes, or the impact of disclosure in resource-limited settings.
The long-term goal of our research team is to provide evidence to improve the chronic care and disease management of HIV-infected children in resource-limited settings. We have evaluated the experience of medication-taking and ART adherence for children in Kenya and East Africa, and we are currently carrying out a validation study developing pediatric ART adherence measurement strategies that include disclosure assessment.(1K23MH087225-01) We have conducted a systematic review of disclosure to children in resource-limited settings, implemented a clinical training program in pediatric disclosure in Kenya, and have done pilot work to evaluate the prevalence and impact of disclosure within the AMPATH HIV care system in western Kenya. Our results consistently demonstrate the importance of disclosure for pediatric adherence and the sustained daily care of children with HIV, and yet disclosure rates remain low with standard care, particularly because parents and guardians fear disclosure. We now propose a cluster randomized trial to assess the effectiveness of a patient-centered disclosure intervention for HIV-infected Kenyan children and their families. In the HADITHI (Helping AMPATH Disclose Information and Talk about HIV Infection) trial, the objective is to evaluate the efficacy of an intensive, culturally adapted, narrative-based disclosure intervention for HIV-infected Kenyan children compared to the less intensive disclosure process currently used as the standard of care. Our primary endpoint will be disclosure status over two-years follow-up, with secondary endpoints related to clinical, psychological, and social outcomes. The central hypothesis is that an intensive disclosure intervention based on culture-specific qualitative work and a patient-centered approach will allow for higher rates of disclosure and allow children not only to know their HIV status, but also to have improved medication adherence, improved medical outcomes, unimpaired psychological and/or behavioral outcomes, and no increase in experienced stigma or social isolation over time. The rationale for evaluating this disclosure intervention is to provide a robust test of efficacy for a disclosure process in a resource-limited setting.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Patient-Centered Disclosure Intervention for HIV-Infected Children|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
No Intervention: Usual Care
The Usual Care components for the control clinics will include the following:
In Usual Care clinics, no specific personnel will be dedicated to disclosure.
Experimental: HADITHI Intervention
In addition to the Usual Care components, the HADITHI Intervention clinics will include:
The disclosure counselors will avail themselves for conducting disclosure with any families referred to them by the AMPATH clinicians. They will post fliers that describe their services for parents and caregivers so that families can self-refer for disclosure counseling. Similarly, the post-disclosure support groups for children will be available for anyone enrolled in the clinic and families will be able to self-refer or to be referred by the clinicians.
Behavioral: HADITHI Intervention
The HADITHI Intervention consists of a culturally adapted, multi-component clinic-based intervention designed to support families in pediatric HIV disclosure in Kenya.
In addition to the Usual Care components, the HADITHI Intervention clinics will have the following intervention components:
Culturally modified curricula materials, including videotaped narratives, to guide counseling and group sessions.
Dedicated disclosure counselors to initiate and conduct disclosure, with one-on-one counseling for caregivers and children, as well as family-based sessions.
Post-disclosure peer support groups, facilitated by the disclosure counselors, for children who have gone through disclosure.
- Disclosure Status [ Time Frame: 2 years ]Percent of children (ages 10-15) documented as knowing their HIV status; Percent knowing why they take medicines; Percent knowing why they attend AMPATH clinic
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947764
|Moi Teaching and Referral Hospital - AMPATH Center|
|Eldoret, Kenya, 30100|
|Principal Investigator:||Rachel C Vreeman, MD, MS||Indiana University|
|Principal Investigator:||Winstone Nyandiko, MBChB, MPH||Moi University|