N/A
N=89
Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT04528732 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: HIV Stigma (Child Reports) — 75.07; 73.0; 75.29 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group Cognitive Behavioral Therapy (G-CBT) (Behavioral); Multiple Family Group (MFG) (Behavioral)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HIV Stigma (Child Reports) |
75.07; 73.0; 75.29 | — |
| PRIMARY HIV Shame (Child Reports) |
0.72; 0.48; 0.82 | — |
| PRIMARY Stigma by Association (Child Reports) |
0.43; 1.44; 1.74 | — |
| PRIMARY HIV/AIDS Stigma and Discrimination (Caregiver Reports) |
37.36; 30.68; 33.52 | — |
| PRIMARY Stigma by Association (Caregiver Reports) |
3.43; 3.20; 2.58 | — |
| SECONDARY Child Depressive Symptoms (Child Reports) |
3.28; 3.10; 4.18 | — |
| SECONDARY Self-Concept (Child Reports) |
38.28; 34.61; 37.39 | — |
| SECONDARY Hopelessness (Child Reports) |
4.14; 4.55; 5.00 | — |
| SECONDARY Post-Traumatic Stress Disorder Symptoms (Child Reports) |
12.21; 9.24; 13.06 | — |
| SECONDARY Self-Reported Medication Adherence (Child Reports) |
93.14; 88.41; 91.37 | — |
| SECONDARY Engagement in Sexual Risk Behaviors (Child Reports) |
0; 0; 0 | — |
| SECONDARY Intentions to Engage in Sexual Risk Behaviors (Child Reports) |
5.43; 5.84; 5.52 | — |
| SECONDARY Child-Caregiver Support (Child Reports) |
57.93; 54.82; 59.77 | — |
| SECONDARY Friendship Quality (Child Reports) |
78.21; 83.45; 80.50 | — |
| SECONDARY Loneliness (Child Reports) |
27.50; 28.24; 30.52 | — |
| SECONDARY Caregiver Mental Health (Caregiver Reports) |
69.53; 65.88; 69.32 | — |
| SECONDARY Caregiver Parenting Stress (Caregiver Reports) |
61.96; 62.52; 62.00 | — |
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.
Eligibility Criteria
Inclusion Criteria for Children:
- 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
- Prescribed antiretroviral therapy
- Living within a family (defined broadly - not necessarily with biological parents)
- Ages 10 to 14 years.
Exclusion Criteria for Children:
- Unable to understand the study procedures and/or participant rights during the informed consent process
- Unwilling or unable to commit to completing the study.
- Presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation
Inclusion Criteria for Caregivers:
- Ages 18 and above
- Agree to participate in the study.
Exclusion Criteria for Caregivers
- Unable to understand the study procedures and/or participant rights during the informed consent process
- Unwilling or unable to commit to completing the study.
- Presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation
Data sourced from ClinicalTrials.gov (NCT04528732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.