An interventional study of N'ap Grandi and N'ap Grandi - A in HIV Infection, sponsored by Florida International University. Completed at 1 site in Haiti. Open to participants aged 15 Years to 19 Years. Per ClinicalTrials.gov, last updated 2018-07-11.
Sponsored by Florida International University · Not applicable, Interventional, and Supportive care
Despite overall declines in HIV incidence and mortality since ART scale-up in low and middle income countries, both have risen among youth. In addition, HIV-infected youth achieve inferior treatment outcomes compared to their adult counterparts in both high- and low-income countries, and these poorer outcomes are generally attributed to suboptimal adherence. Thus, there is a critical need for the development of adherence and risk reduction interventions for the growing cohort of these youth, and the proposed cognitive behavioral N'ap Grandi is one such intervention.
As pediatric HIV infection has shifted from being a fatal disease to a chronic illness, a growing cohort of young people are moving through adolescence with all the challenges of the adult HIV-infected population but largely without comparable treatment outcomes or an evidence base to improve adherence to antiretroviral treatment (ART) and preventive behavior. Despite overall declines in HIV incidence and mortality since the ART scale-up, both have risen among youth. The goal of the proposed 3-year R34 developmental study is to respond to this need for tailored research, in particular among HIV+ older adolescents, and contribute to understanding the added value in resource-limited settings of including caregivers in an adherence and risk reduction program. Although caregiver involvement is a recognized correlate of outcomes in HIV+ youth, there are no rigorous studies of the role of caregivers in outcomes among HIV+ older adolescents.This project will integrate caregiver involvement and cognitive behavioral intervention (CBI) elements to improve ART adherence and HIV risk reduction for HIV+ older adolescents treated in resource-poor clinical settings.Our proposed study population will include caregivers and 15 to 19 year-old HIV+ youth who know their status and are receiving ART in Port-au-Prince, Haiti. Guided by the theoretical framework of the developmentally sensitive Information-Motivation-Behavioral Skills for Pediatric Adherence (IMB-PED), we will develop Growing Up (N'ap Grandi, in Haitian Creole) as a collaborative model of caregiver-adolescent engagement in the key informational, motivational, and behavioral skills antecedents of ART adherence and risk reduction. The study will utilize qualitative and quantitative methods to: identify barriers and facilitators to adherence and risk reduction (Aim 1); develop and pretest N'ap Grandi, including developmentally-appropriate manuals, training materials, procedures, and psychometric adequacy of measures (Aim 2); and assess feasibility and preliminary efficacy in a 3-arm randomized controlled trial (RCT), in which 120 youth will be assigned to three groups: the experimental caregiver-adolescent N'ap Grandi, an adolescent-only version (N'ap Grandi-A) and an adolescent-only health promotion group (HP-A), examining ART adherence and virologic response, HIV risk behaviors, positive communication and monitoring, stress and mood, and costs from the health center perspective (Aim 3).
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 278 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
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Exclusion Criteria:
Both Adolescent and Caregiver participate in assessment and intervention groups. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention.
Behavioral: N'ap Grandi
Adolescents participate in assessment and intervention groups, Caregivers participate in assessment only. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention.
Behavioral: N'ap Grandi - A
Adolescents participate in assessment and intervention groups, Caregivers participate in assessment only. Adolescent assessments will be administered at baseline, 3 months- and 6 months-post intervention. Caregiver assessments will be administered at baseline and 6 months-post intervention.
Behavioral: Health Promotion - A
Eight 90-minute adolescent cognitive behavioral modules and four 90-minute caregiver cognitive behavioral modules, delivered in weekend workshops over a 1 month period, with the last two modules for joint participation of adolescents and caregivers.
Eight 90-minute adolescent cognitive behavioral modules delivered in weekend workshops over a 1 month period.
Eight 90-minute adolescent health promotion modules delivered in weekend workshops over a 1 month period.
ART Adherence and response
Data from self report questionnaire (percent medications taken), medication possession ratio (percent completed), and virologic suppression (percent improvement) will be aggregated into a composite measure of adherence.
Time frame: 6 months
HIV sexual transmission risk reduction
Increase in self-reported safer sex behavior via questionnaire
Time frame: 6 months
Caregiver supportive communication
Increase in self-reported positive caregiver-adolescent communication and monitoring via questionnaire
Time frame: 6 months
Psychosocial health
Improvement in self-reported stress and mood via questionnaire
Time frame: 6 months
Cost of intervention from the health center perspective
Provide data on the economic feasibility of broader scale up of these interventions
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Florida International University