Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- HIV Stigma Measure for Children [Every assessment time point (baseline, 3months, 6months)]
HIV-associated stigma for children will be measured using the HIV Stigma Measure. We will measure the mean score over time. The total score range between 40- 160 with a high score indicating higher levels of perceived HIV-associated stigma.
- The Shame Questionnaire for Children [Every assessment time point (baseline, 3months, 6months)]
Shame related to living with HIV will be measured using the Shame Questionnaire. We will measure the mean score over time. The total score range between 0 and 16 with a higher score indicating higher levels of HIV-associated shame.
- Stigma By Association Scale for Children [Every assessment time point (baseline, 3months, 6months)]
Stigma by association for children will be measured using the Stigma By Association Scale. We will measure the mean score over time. The total score range between 0 and 20 with a high score indicating higher levels of perceived stigma by association.
- Stigma By Association Scale for Caregivers [Every assessment time point (baseline, 3months, 6months)]
Stigma by association for caregivers will be measured using the Stigma By Association Scale. We will measure the mean score over time. The total score range between 0 and 20 with a high score indicating higher levels of perceived stigma by association.
- HIV/AIDS Stigma and Discrimination Scale for Caregivers [Every assessment time point (baseline, 3months, 6months)]
HIV stigma and discrimination for caregivers will be measured using the HIV/AIDS Stigma and Discrimination Scale. We will measure the mean score over time. The total score range between 22 and 88 with a high score indicating higher levels of perceived HIV/AIDS stigma and discrimination.
Secondary Outcome Measures
- Child Depression Inventory (CDI) [Every assessment time point (baseline, 3months, 6months)]
Depressive Symptoms will be measured using the Child Depression Inventory (CDI) scale. We will measure the mean score on the CDI scale over time. The total score range between 0 and 28 with a high score indicating higher levels of depressive symptoms.
- Tennessee Self-Concept Scale (TSCS) [Every assessment time point (baseline, 3months, 6months)]
Self concept will be measured using the Tennessee Self-Concept Scale (TSCS). We will measure the mean score on the TSCS over time. The total score range between 20 and 100 with a high score indicating higher levels of self-concept.
- Beck Hopelessness Scale (BHS) [Every assessment time point (baseline, 3months, 6months)]
Hopelessness will be measured using the Beck Hopelessness Scale (BHS). We will measure the mean score on the BHS over time. The total score range between 0 and 20 with a high score indicating higher levels of hopelessness.
- Post-Traumatic Stress Disorder (PTSD) [Every assessment time point (baseline, 3months, 6months)]
Post-Traumatic Stress Disorder (PTSD) will be measured using the Child PTSD Reaction Scale. We will measure the mean score on the Child PTSD Reaction Scale over time. The total score range between 0 and 120, with a high score indicating higher levels of PTSD.
- Self-Reported Medication Adherence [Every assessment time point (baseline, 3months, 6months).]
Self reported medication adherence will be measured by the number of times a child missed taking medication in the past 30 days, and number of days took medication the way they were supposed to.
- Viral Suppression [Every 6 months.]
Viral suppression will be assessed using viral load (VL) data collected from health clinic records. VL will be dichotomized between undetectable /suppression (VL< 40 copies/ml) and detectable/failed viral suppression (VL > =40 copies/ml) levels.
- Self-Reported Engagement in Sexual Risk Behaviors [Every assessment time point (baseline, 3months, 6months)]
Engagement in sexual risk behavior will be measured by whether the child engaged in sexual activity (Yes/No) and whether they practiced protected sex (Yes/No).
- Intentions to Engage in Sexual Risk Behaviors [Every assessment time point (baseline, 3months, 6months)]
Intentions to engage in sexual risk behaviors will be measured 5-item scale. We will measure the mean score on the scale measuring intentions to engage in sexual activity.
- Friendship Qualities Scale (FQS) [Every assessment time point (baseline, 3months, 6months)]
Friendship quality will be measured using the Friendship Qualities Scale (FQS). We will measure the mean score on the FQS over time. The total score range between 21- 105 with a higher score indicating higher levels of friendship quality.
- Social Support Behaviors Scale (SSBS) [Every assessment time point (baseline, 3months, 6months)]
Social support from family members and friends will be measured using the Social Support Behaviors Scale (SSBS). We will measure the mean score on the SSBS over time. The total score ranges between 45-225, with higher score indicating higher levels of social support.
- UCLA Loneliness Scale [Every assessment time point (baseline, 3months, 6months)]
Loneliness will be measured using the UCLA Loneliness Scale. We will measure the mean score on the UCLA Loneliness Scale over time. The total score ranges between 0 to 60 with a higher score indicating higher levels of loneliness.
Eligibility Criteria
Criteria
Inclusion Criteria for Children:
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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
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Prescribed antiretroviral therapy
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Living within a family (defined broadly - not necessarily with biological parents)
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Ages 10 to 14 years.
Exclusion Criteria for Children:
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Unable to understand the study procedures and/or participant rights during the informed consent process
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Unwilling or unable to commit to completing the study.
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Presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation
Inclusion Criteria for Caregivers:
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Ages 18 and above
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Agree to participate in the study.
Exclusion Criteria for Caregivers
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Unable to understand the study procedures and/or participant rights during the informed consent process
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Unwilling or unable to commit to completing the study.
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Presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University in St. Louis | Saint Louis | Missouri | United States | 63130 |
| 2 | International Center for Child Health and Development Field Office | Masaka | Uganda | ||
| 3 | Reach the Youth Uganda | Masaka | Uganda |
Sponsors and Collaborators
- Washington University School of Medicine
- National Institute of Mental Health (NIMH)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R21MH121141