Suubi4Stigma: Addressing HIV-Associated Stigma Among Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 3
- 主要终点
- HIV Stigma (Child Reports)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Children:
- •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.
排除标准
- •for Children:
- •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
- •Inclusion Criteria for Caregivers:
- •Ages 18 and above
- •Agree to participate in the study.
- •Exclusion Criteria for Caregivers
- •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
研究组 & 干预措施
Usual Care
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)
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.
干预措施: Group Cognitive Behavioral Therapy (G-CBT) (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.
干预措施: Multiple Family Group (MFG) (Behavioral)
结局指标
主要结局
HIV Stigma (Child Reports)
时间窗: 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)
时间窗: 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.
HIV/AIDS Stigma and Discrimination (Caregiver Reports)
时间窗: 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 (Child Reports)
时间窗: 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.
Stigma by Association (Caregiver Reports)
时间窗: 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.
次要结局
- Post-Traumatic Stress Disorder Symptoms (Child Reports)(6 months)
- Self-Reported Medication Adherence (Child Reports)(6 months)
- Child Depressive Symptoms (Child Reports)(6 months)
- Hopelessness (Child Reports)(6 months)
- Engagement in Sexual Risk Behaviors (Child Reports)(6 months)
- Self-Concept (Child Reports)(6 months)
- Child-Caregiver Support (Child Reports)(6 months)
- Caregiver Mental Health (Caregiver Reports)(6 months)
- Caregiver Parenting Stress (Caregiver Reports)(6 months)
- Intentions to Engage in Sexual Risk Behaviors (Child Reports)(6 months)
- Friendship Quality (Child Reports)(6 months)
- Loneliness (Child Reports)(6 moths)
研究者
Fred Ssewamala
Professor
Washington University School of Medicine