Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents

NCT ID: NCT04528732

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-26
• Study Completion Date: 2022-06-30

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group-Cognitive Behavioral Therapy (G-CBT)

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 Type: EXPERIMENTAL

Group Cognitive Behavioral Therapy (G-CBT)

Intervention Type: 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.

Multiple Family Group (MFG)

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.

Group Type: EXPERIMENTAL

Multiple Family Group (MFG)

Intervention Type: 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.

Interventions

Group Cognitive Behavioral Therapy (G-CBT)

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.

Intervention Type: BEHAVIORAL

Multiple Family Group (MFG)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

1. Ages 18 and above

2. Agree to participate in the study.

Exclusion Criteria

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

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Washington University in St. Louis

St Louis, Missouri, United States

International Center for Child Health and Development Field Office

Masaka, , Uganda

Reach the Youth Uganda

Masaka, , Uganda

Countries

United States; Uganda

References

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.

Reference Type: DERIVED

PMID: 38401789 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37935531 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37062579 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35488323 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21MH121141

Identifier Type: NIH

Identifier Source: org_study_id

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