Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Group Cognitive Behavioral Therapy (G-CBT); Behavioral: Multiple Family Group (MFG)

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Masaka, Uganda
    • International Center for Child Health and Development Field Office
  • Masaka, Uganda
    • Reach the Youth Uganda
• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Usual care consists of the traditional clinic intervention that focuses on testing services, ART treatment, and information about disease management.
Experimental: 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.	Behavioral: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Depressive Symptoms (Child Reports)	The Child Depression Inventory (CDI) was used to measure children's depressive symptoms. Respondents were asked to mark a statement that best described their feelings during the past 2 weeks. Each of the 14-items on the CDI has three response options that correspond to varying levels of symptomology for clinical depression. Min/max: 0-28, with higher scores representing high levels of depressive symptoms. Scores at 6-months are reported.	6 months
Self-Concept (Child Reports)	Self-concept was measured using the Tennessee Self-Concept Scale (TSCS). The 20-item scale measures children's perception of identity, self-satisfaction and other behaviors. Each item was rated on a 5-point scale: 1= always false, 2=usually false, 3=sometimes true/sometimes false, 4=usually true and 5= always true. Min/max values: 20-100. Ten items in the inverse direction were reverse coded to create summated scores, with higher scores indicating higher levels of child self-concept. Scores at 6-months are reported.	6 months
Hopelessness (Child Reports)	Hopelessness was measured using the Beck Hopelessness Scale (BHS). The 20-item scale measures children's hopelessness and pessimistic attitudes toward the future. Items have a "true" or "false" response coded as "1" or "0" respectively. Nine items with positive wording were reverse coded to create a summated score for the entire scale. Min/max values: 0-20, with higher scores indicating higher levels of hopelessness. Scores at 6-months are reported.	6 months
Post-Traumatic Stress Disorder Symptoms (Child Reports)	Child PTSD was measured using 31 items from the abbreviated Childhood post-traumatic Stress Reaction Index (CPTS-RI). Participants were asked about reactions people sometimes have after very bad things happen and how this was applicable to them in the past month. Responses were rated on a 5-point Likert scale, with 0= None, 1= Little (1-2 days a week), 2 = some (2-3 days a week), 3 =Much (2 days a month) and 4 =most (Almost every day). Min/max values: 0-124. Summated scores were created with higher scores indicating higher levels of child PTSD symptoms. Scores at 6-months are reported.	6 months
Self-Reported Medication Adherence (Child Reports)	Child self-reported adherence was assessed using three items: 1) "In the last 30 days, on how many days did you miss at least one dose of your HIV medications (range: 0-30 days)?" 2) "In the last 30 days, how often did you take your HIV medicine in the way you were supposed to (never to always)?" and 3) "In the last 30 days, how good a job did you do at taking your HIV medicine in the way you were supposed to (very poor - excellent)"? Responses were linearized into a continuous scale ranging from 0-100, with low scores representing poor adherence and 100 representing perfect adherence. Scores at 6-months are reported.	6 months
Engagement in Sexual Risk Behaviors (Child Reports)	Engagement in sexual risk behaviors was measured by asking a respondent whether they had engaged in unprotected sex, coded as "yes" or "no". Number of participants who responded "yes" at 6-months are reported.	6 months
Intentions to Engage in Sexual Risk Behaviors (Child Reports)	Intentions to engage in sexual risk behaviors were assessed by asking respondents to rate how 5 sexual activity-related statements applied to them. Items were rated on a 5-point Likert scale, with 1=never, 2=sometimes, 3=about half of the time, 4=most of the time and 5=always. Min/max values: 5-25, with higher scores indicating high intentions to engage in sexual risk-taking behaviors. Scores at 6-months are reported.	6 months
Child-Caregiver Support (Child Reports)	Child-caregiver support was measured using 17 items from the Social Support Behaviors Scale (SS-BS) scale. Respondents were asked to rate the adults they live with, on a 5-point Likert scale, with 1= never, 2 = sometimes, 3=about half of the time, 4=most of the time, and 5= always. Min/max values: 17-85. Summated scores were created with high scores indicating high levels of perceived support from caregivers. Scores at 6-months are reported.	6 months
Friendship Quality (Child Reports)	Child's quality of friendships was measured using 21-items from the Friendship Qualities Scale. This multidimensional measurement scale assesses the quality of children's relationships with their best friends via several aspects, including closeness, help, safety and closeness. Respondents were asked to rate how each statement applied to them. Responses were rated on a 5- point Likert scale, with 1=never, 2=sometimes, 3=about half of the time, 4=most of the time, and 5= always. Min/max values: 21-105, with high scores indicating high quality friendship levels. Scores at 6-months are reported.	6 months
Loneliness (Child Reports)	Child loneliness was assessed using the UCLA Loneliness Scale. The 20-item scale measures one's subjective feelings of loneliness as well as feelings of social isolation. Responses were rated on 4-point Likert scale with 3= I often feel this way, 2= I sometimes feel this way, 1 = I rarely feel this way, and 0=I never feel this way. Min/max values: 0-60, with high scores indicating higher levels of social isolation. Scores at 6-months are reported.	6 moths
Caregiver Mental Health (Caregiver Reports)	Caregiver mental health functioning was assessed using 34-items from the Brief Symptom Inventory (BSI). The scale measures symptoms of anxiety, somatization and depression. Respondents were asked to rate how they felt emotionally, on a 5-point Likert scale, with 1=Never true, 2=rarely true, 3= true sometimes, 4= true most of the time and 5=always true. Min/max values: 34-170, with higher scores representing higher levels of caregiver mental distress. Scores at 6-months are reported.	6 months
Caregiver Parenting Stress (Caregiver Reports)	Parenting stress was measured by 33 items from the Parenting Stress Index (PSI). The 33-item scale assesses symptoms related to parental distress, difficult child, and caregiver-child dysfunctional relationships. Respondents were asked to rate their parenting stress, on a 4-point Likert scale, with 1=strongly disagree, 2=somewhat disagree, 3=somewhat agree and 4=strongly agree. The theoretical range for this scale is 33-132, with high scores indicating high levels of parenting stress. Score at 6-months are reported.	6 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R21MH121141 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per Code of Federal Regulations Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No