HIV/AIDSNCT04528732

Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents

A study testing Group Cognitive Behavioral Therapy (G-CBT) and Multiple Family Group (MFG) in people with HIV/AIDS, run by Washington University School of Medicine at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 10 to 14 years
Conditions the study is for: HIV/AIDS
What is being tested?: Group Cognitive Behavioral Therapy (G-CBT) and Multiple Family Group (MFG)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 3 sitesin 2 countries
Study dates: 26 Nov 2020to 30 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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
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

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Uganda2 sites

International Center for Child Health and Development Field Office
Masaka
Reach the Youth Uganda
Masaka

Other trials in Uganda

United States1 site

Washington University in St. Louis
St Louis, Missouri, 63130

Other trials in United States

About this study

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.

Read the 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
Being tested: Group Cognitive Behavioral Therapy (G-CBT), Multiple Family Group (MFG)
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group Cognitive Behavioral Therapy (G-CBT)Behavioural
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)Behavioural
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.

Study groups in NCT04528732
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Multiple Family Group (MFG)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months

Secondary outcomes (12)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 202030 Jun 2022

First posted27 Aug 2020
Study start26 Nov 2020
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04528732
Sponsor's protocol ID: R21MH121141
Status last verified: Mar 2026
First submitted: 3 Aug 2020
Last updated: 11 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 38401789
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.
PubMed 37935531
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.
PubMed 37062579
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.
PubMed 35488323

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents
ClinicalTrials.gov ID: NCT04528732
Acronym / sponsor ID: R21MH121141
Conditions: HIV/AIDS
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 26 Nov 2020 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 27 Aug 2020 (actual)
Results: Posted 11 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
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.

Arm	Type	Receives
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	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.
Multiple Family Group (MFG)	Experimental	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.

Who may qualify

Ages: 10 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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.
Ages 18 and above

Key exclusion criteria (6 listed)

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
Unable to understand the study procedures and/or participant rights during the informed consent process
Unwilling or unable to commit to completing the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Group-Cognitive Behavioral Therapy (G-CBT)
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.	Behavioural	Multiple Family Group (MFG)

Primary outcome

HIV Stigma (Child Reports)
Time frame: 6 months
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.
HIV Shame (Child Reports)
Time frame: 6 months
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.
Stigma by Association (Child Reports)
Time frame: 6 months
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.
HIV/AIDS Stigma and Discrimination (Caregiver Reports)
Time frame: 6 months
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.
Stigma by Association (Caregiver Reports)
Time frame: 6 months
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.

12 secondary outcomes

Child Depressive Symptoms (Child Reports)
Time frame: 6 months
Self-Concept (Child Reports)
Time frame: 6 months
Hopelessness (Child Reports)
Time frame: 6 months
Post-Traumatic Stress Disorder Symptoms (Child Reports)
Time frame: 6 months
Self-Reported Medication Adherence (Child Reports)
Time frame: 6 months
Engagement in Sexual Risk Behaviors (Child Reports)
Time frame: 6 months
Intentions to Engage in Sexual Risk Behaviors (Child Reports)
Time frame: 6 months
Child-Caregiver Support (Child Reports)
Time frame: 6 months
Friendship Quality (Child Reports)
Time frame: 6 months
Loneliness (Child Reports)
Time frame: 6 moths
Caregiver Mental Health (Caregiver Reports)
Time frame: 6 months
Caregiver Parenting Stress (Caregiver Reports)
Time frame: 6 months

Results and safety

Results posted to the registry on 11 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	29	28
Group-Cognitive Behavioral Therapy (G-CBT)	26	25
Multiple Family Group (MFG)	34	31

Primary outcome: HIV Stigma (Child Reports)

Time frame: 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Usual Care n = 28	Group-Cognitive Behavioral Therapy (G-CBT) n = 25	Multiple Family Group (MFG) n = 31
Value	75.07 (15.35)	73.0 (16.90)	75.29 (18.77)

Population analysed: Only child reports were analyzed.

Primary outcome: HIV Shame (Child Reports)

Time frame: 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Usual Care n = 28	Group-Cognitive Behavioral Therapy (G-CBT) n = 25	Multiple Family Group (MFG) n = 31
Value	0.72 (1.44)	0.48 (1.12)	0.82 (1.15)

Population analysed: Only child reports were analyzed.

Primary outcome: Stigma by Association (Child Reports)

Time frame: 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Usual Care n = 28	Group-Cognitive Behavioral Therapy (G-CBT) n = 25	Multiple Family Group (MFG) n = 31
Value	0.43 (0.74)	1.44 (2.99)	1.74 (3.04)

Population analysed: Only child reports were analyzed.

Primary outcome: HIV/AIDS Stigma and Discrimination (Caregiver Reports)

Time frame: 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Usual Care n = 28	Group-Cognitive Behavioral Therapy (G-CBT) n = 25	Multiple Family Group (MFG) n = 31
Value	37.36 (10.80)	30.68 (8.88)	33.52 (8.90)

Population analysed: Only caregiver reports were analyzed.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care: Children	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Group-Cognitive Behavioral Therapy (G-CBT): Children	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Multiple Family Group (MFG): Children	0 of 34 (0%)	0 of 34 (0%)	1 of 34
Usual Care: Caregivers	0 of 29 (0%)	0 of 29 (0%)	1 of 29
Group-Cognitive Behavioral Therapy (G-CBT): Caregivers	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Multiple Family Group (MFG): Caregivers	0 of 34 (0%)	0 of 34 (0%)	0 of 34

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38401789Nabunya 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.
Derived from this study: PubMed 37935531Kizito 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.
Derived from this study: PubMed 37062579Nabunya 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.
Derived from this study: PubMed 35488323Nabunya 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group Cognitive Behavioral Therapy (G-CBT) and Multiple Family Group (MFG) in people with HIV/AIDS, run by Washington University School of Medicine at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Uganda, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV Stigma (Child Reports) (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04528732, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.