Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The study seeks to reduce HIV/AIDS-associated stigma and its negative impact on adolescent
      health and psychosocial well-being. This study will examine two evidence-informed
      interventions: 1) group cognitive behavior therapy (G-CBT) that aims at cognitive
      restructuring and strengthening coping skills at the individual level, and 2) multiple family
      group (MFG) that strengthens family relationships intended to address HIV/AIDS-associated
      stigma at the individual level and within families. Adolescents between 10-14 years, will be
      randomly assigned -at the clinic level, to one of three study arms: 1) Usual care to receive
      the currently implemented usual care addressing HIV/AIDS-associated stigma (educational
      materials from the Ugandan Ministry of Health); 2) G-CBT intervention + Usual care; and 3)
      MFG intervention + Usual care. The interventions will be delivered over a 3-month period.
      Assessments will be collected at baseline, 3 months and 6 months post intervention
      initiation. The study will also explore participants, caregivers and facilitators'
      intervention experiences, as well as multi-level facilitators and barriers to intervention
      implementation and participation.
    

Detailed description: 
      Sub-Saharan Africa (SSA) is heavily burdened by HIV, with 85% of new infections among
      adolescents and youth globally happening in the region. Recent statistics indicate that HIV
      prevalence among adolescents and young people is rising in Uganda. While availability and
      access to free antiretroviral therapy (ART) has decreased child mortality, it has increased
      the likelihood that a number of children living with HIV (CLWH) will transition into
      adulthood, with HIV as a chronic, highly stigmatized illness. Unfortunately, the stigma this
      group experiences results in much lower quality of life. Stigma, a common experience
      characterized by public blame, moral condemnation and discrimination, has been documented to
      be one of the greatest challenges to slowing the spread of HIV&AIDS. It perpetuates the
      culture of silence and fear and prevents individuals from testing and seeking health care.
      Research has shown that HIV/AIDS-associated stigma predicts depression and PTSD, poor
      treatment and adherence, loneliness and social isolation, HIV-related physical health, and
      HIV sexual risk behavior. It is critical for HIV interventions to target stigma in order to
      reduce HIV spread. Yet, stigma-reduction interventions targeting children and adolescents
      living with HIV/AIDS in SSA are almost non-existent. Thus, there is a need for research that
      will generate knowledge to address HIV/AIDS-associated stigma, especially among CLWH as they
      transition to adolescence. The proposed exploratory study (R21) will: Aim 1: Pilot test the
      feasibility, acceptability, and preliminary impact of an innovative Group Cognitive Behavior
      Therapy (G-CBT) and Multiple Family Group (MFG) interventions on reducing HIV/AIDS-associated
      stigma and its impact on targeted participant outcomes (stigma, post-trauma symptoms,
      depression, sexual risk behavior, family/social support, and adherence to medication) in
      comparison to: 1a) usual care vs G-CBT; 1b) Usual care vs MFG; 1c) G-CBT vs. MFG. Aim 2:
      Qualitatively examine participants' and facilitators' intervention experiences and identify
      individual, family and institutional-level facilitators and barriers to G-CBT and MFG
      intervention implementation and participation. The study will be conducted in 9 health
      clinics (n = 90 children, ages 10-14) and their caregivers (total 90 child- caregiver dyads)
      in Masaka. Clinics will be randomized to one of three study arms (n=3 clinics; 30
      child-caregiver dyads each arm): 1) Usual care to receive the currently implemented usual
      care addressing HIV/AIDS-associated stigma (educational materials developed by the Ugandan
      Ministry of Health); 2) G-CBT intervention + usual care; and 3) MFG intervention + usual
      care. Participants will be followed over a 6-month period, with data collected at baseline, 3
      months and 6 months post intervention initiation to assess feasibility, acceptability, and
      preliminary impact. The long-term goal of the proposed research is to develop culturally
      appropriate, feasible, acceptable and effective interventions that address
      HIV/AIDS-associated stigma and its impact on CLWH's wellbeing and their families in SSA.
    

Intervention name(s): Group Cognitive Behavioral Therapy (G-CBT); Multiple Family Group (MFG)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): G-CBT consists of 10-session for HIV/AIDS-associated stigma, utilizing core components of CBT, including psychoeducation, cognitive restructuring, and skill-building to increase adaptive coping mechanisms.; MFG consists of 10-sessions that strengthen family relationships intended to address HIV/AIDS-associated stigma at the individual level and within families. The core components of MFG are known as 4Rs and 2S's: rules, responsibility, relationships, respectful communication, stress and social support.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adolescents will be randomly assigned to one of three study arms: 1) Usual care to receive the currently implemented usual care addressing HIV/AIDS-associated stigma (educational materials from the Ugandan Ministry of Health); 2) G-CBT intervention + Usual care; and 3) MFG intervention + Usual care.
Masking: None (Open Label)
Primary purpose: Treatment