Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents

NCT04528732 | Completed Results

• 1 other identifier: R21MH121141
• Study Type: interventional
• Target: 89
• Locations: 2 countries
• Sites: 3

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (5)

• HIV Stigma (Child Reports)

  Child HIV Stigma was measured by the HIV Stigma Scale (HSS). The 40-item scale measures stigma and psychosocial aspects of having HIV. Responses were rated on a 4-point scale with 1= strongly agree, 2= agree, 3=disagree and 4=strongly disagree. Items in the inverse direction were reverse coded to create summated scores, with higher scores indicating high levels of HIV-related stigma. Min/max values: 40-160. Scores at 6-months are reported.

  6 months

• HIV Shame (Child Reports)

  Child HIV Shame was measured by the Shame Questionnaire. The 8-item scale is used to assess child's feelings of shame on a 3-point scale, with 0 =not true, 1 = somewhat true and 2 =very true. Summated scores were created with higher scores representing high levels of HIV-associated shame. Min/max values: 0-16. Scores at 6-months are reported.

  6 months

• Stigma by Association (Child Reports)

  Stigma by association (Child reports) was measured using 10-items from the Brief Stigma-by Association Scale. The scale measures experiences and consequences of associated stigma, on a 3-point scale with 0= Not at all, 1= Sometimes and 2= All the time. Summated scores were created with higher scores indicating high levels of stigma-by association. Min/max values: 0-20. Scores at 6-months are reported.

  6 months

• HIV/AIDS Stigma and Discrimination (Caregiver Reports)

  The HIV/AIDS Stigma and Discrimination Scale was used. The 22-item scale assessed respondents about what they think about people living with HIV/AIDS. Responses were rated on a 4-point scale with 1= strongly agree, 2= agree, 3=disagree and 4=strongly disagree. Min/max values: 22- 88, with higher scores indicating higher levels of perceived HIV-related stigma and discriminatory attitudes among caregivers. Scores at 6-months are reported.

  6 months

• Stigma by Association (Caregiver Reports)

  Stigma by association was measured using 10-items from the Brief Stigma-by-Association Scale. The scale measures experiences and consequences of associated stigma, on a 3-point scale, with 0= Not at all, 1= Sometimes and 2= All the time. Min/max values: 0-20. Summated scores were created with higher scores indicating higher levels of stigma by association experienced by caregivers. Scores at 6-months are reported.

  6 months

Secondary Outcomes (12)

• Child Depressive Symptoms (Child Reports)

  6 months

• Self-Concept (Child Reports)

  6 months

• Hopelessness (Child Reports)

  6 months

• Post-Traumatic Stress Disorder Symptoms (Child Reports)

  6 months

• Self-Reported Medication Adherence (Child Reports)

  6 months

Study Arms (3)

Usual Care

NO INTERVENTION

Usual care consists of the traditional clinic intervention that focuses on testing services, ART treatment, and information about disease management.

Group-Cognitive Behavioral Therapy (G-CBT)

EXPERIMENTAL

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.

Behavioral: Group Cognitive Behavioral Therapy (G-CBT)

Multiple Family Group (MFG)

EXPERIMENTAL

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.

Behavioral: Multiple Family Group (MFG)

Interventions

Group Cognitive Behavioral Therapy (G-CBT) BEHAVIORAL

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.

Group-Cognitive Behavioral Therapy (G-CBT)

Multiple Family Group (MFG) BEHAVIORAL

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.

Multiple Family Group (MFG)

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Ages 18 and above
• Agree to participate in the study.
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

International Center for Child Health and Development Field Office

Masaka, Uganda

Location

Reach the Youth Uganda

Masaka, Uganda

Location

Related Publications (4)

• Nabunya P, Ssewamala FM, Kizito S, Mugisha J, Brathwaite R, Neilands TB, Migadde H, Namuwonge F, Ssentumbwe V, Najjuuko C, Sensoy Bahar O, Mwebembezi A, McKay MM. Preliminary Impact of Group-Based Interventions on Stigma, Mental Health, and Treatment Adherence Among Adolescents Living with Human Immunodeficiency Virus in Uganda. J Pediatr. 2024 Jun;269:113983. doi: 10.1016/j.jpeds.2024.113983. Epub 2024 Feb 23.

  PMID: 38401789 DERIVED

• Kizito S, Nabunya P, Ssewamala FM. Enhancing Adherence to Antiretroviral Therapy Among Adolescents Living With HIV Through Group-Based Therapeutic Approaches in Uganda: Findings From a Pilot Cluster-Randomized Controlled Trial. J Pediatr Psychol. 2023 Nov 16;48(11):907-913. doi: 10.1093/jpepsy/jsad081.

  PMID: 37935531 DERIVED

• Nabunya P, Namuwonge F, Sensoy Bahar O, Ssentumbwe V, Migadde H, Mugisha J, Ssewamala FM. Stigma by Association, Parenting Stress, and the Mental Health of Caregivers of Adolescents Living With HIV in Uganda. J Adolesc Health. 2023 May;72(5S):S18-S23. doi: 10.1016/j.jadohealth.2022.08.017.

  PMID: 37062579 DERIVED

• 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.

  PMID: 35488323 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

All study-related activities, including participant recruitment, data collection and intervention delivery, were conducted during the COVID-19 lockdown. The associated challenges may have impacted the study outcomes.

Results Point of Contact

• Title: Dr. Proscovia Nabunya
• Organization: Washington University in St. Louis

nabunyap@wustl.edu

3149359087

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 27, 2020
• Study Start: November 26, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 11, 2026
• Results First Posted: December 11, 2023

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

US (1); UG (2)