Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
Condition: HIV Infection
MeSH terms: HIV Infections; HIV Seropositivity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): N'ap Grandi; N'ap Grandi - A; Health Promotion - A
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Adolescence; Adherence