Clinical trial NCT04528732: Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents
Official title: Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-08-27
Enrollment: 89
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria for Children:

1. HIV+ status - defined as a child who has been tested for HIV with confirmation by medical report and has been disclosed to, i.e. know their status
2. Prescribed antiretroviral therapy
3. Living within a family (defined broadly - not necessarily with biological parents)
4. Ages 10 to 14 years.

   Exclusion Criteria for Children:
5. Unable to understand the study procedures and/or participant rights during the informed consent process
6. Unwilling or unable to commit to completing the study.
7. Presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation

Inclusion Criteria for Caregivers:

1. Ages 18 and above
2. Agree to participate in the study.

   Exclusion Criteria for Caregivers
3. Unable to understand the study procedures and/or participant rights during the informed consent process
4. Unwilling or unable to commit to completing the study.
5. Presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation

Primary outcomes:
measure: HIV Stigma (Child Reports)
timeFrame: 6 months
measure: HIV Shame (Child Reports)
timeFrame: 6 months
measure: Stigma by Association (Child Reports)
timeFrame: 6 months
measure: HIV/AIDS Stigma and Discrimination (Caregiver Reports)
timeFrame: 6 months
measure: Stigma by Association (Caregiver Reports)
timeFrame: 6 months
Secondary outcomes:
measure: Child Depressive Symptoms (Child Reports)
timeFrame: 6 months
measure: Self-Concept (Child Reports)
timeFrame: 6 months
measure: Hopelessness (Child Reports)
timeFrame: 6 months
measure: Post-Traumatic Stress Disorder Symptoms (Child Reports)
timeFrame: 6 months
measure: Self-Reported Medication Adherence (Child Reports)
timeFrame: 6 months
measure: Engagement in Sexual Risk Behaviors (Child Reports)
timeFrame: 6 months
measure: Intentions to Engage in Sexual Risk Behaviors (Child Reports)
timeFrame: 6 months
measure: Child-Caregiver Support (Child Reports)
timeFrame: 6 months
measure: Friendship Quality (Child Reports)
timeFrame: 6 months
measure: Loneliness (Child Reports)
timeFrame: 6 moths
measure: Caregiver Mental Health (Caregiver Reports)
timeFrame: 6 months
measure: Caregiver Parenting Stress (Caregiver Reports)
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Masaka
country: Uganda
facility: International Center for Child Health and Development Field Office
city: Masaka
country: Uganda
facility: Reach the Youth Uganda
Study officials:
References:
citation: Nabunya P, Ssewamala FM, Bahar OS, Michalopoulos LTM, Mugisha J, Neilands TB, Trani JF, McKay MM. Suubi4Stigma study protocol: a pilot cluster randomized controlled trial to address HIV-associated stigma among adolescents living with HIV in Uganda. Pilot Feasibility Stud. 2022 Apr 29;8(1):95. doi: 10.1186/s40814-022-01055-7.