跳至主要内容
临床试验/NCT07221201
NCT07221201已完成不适用

Reducing the Intersecting Stigmas of HIV, Violence Victimization, and Mental Health: a Randomized Controlled Pilot Integrating Project YES! Youth Engaging for Success With WHO-Endorsed Mental Health Approaches Among Youth Living With HIV in Ndola, Zambia

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2025年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
323
试验地点
1
主要终点
Feasibility of intervention as assessed by percentage of sessions attended

研究概览

简要总结

The proposed study will address the intersecting stigmas of HIV, violence and depression among adolescents and young adults (15-24) living with HIV (AYALHIV) in Zambia. The study will integrate a WHO-endorsed mental health approach into an existing HIV-stigma-reducing intervention, and refine measures of internalized and intersecting stigmas, to create and test the feasibility of Project YES+- a combined youth peer mentoring and lay mental health intervention. This research aims to shift HIV care and treatment for AYALHIV by addressing the multiple internalized and intersecting stigmas that impeded antiretroviral adherence and HIV viral suppression.

详细描述

Nine out of ten AIDS-related deaths among adolescents occur in sub-Saharan Africa (SSA). Despite advances in antiretroviral combination therapy (ART), AIDS-related mortality among adolescents has only decreased 33% since 2010, compared to 66% among children. This slow decline in adolescent deaths is attributed in part to incomplete adherence to ART and subsequent viral failure. Only an estimated 34% of AYALHIV in Zambia, ages 15-24 years, have achieved viral suppression (<1000 copies/mL).

Stigma is increasingly recognized as a modifiable factor impacting ART adherence and viral suppression. Stigma as defined by Goffman is the social devaluation of a person due to an attribute discredited by society, with Parker and Aggleton critically examining stigma as a tool that reinforces inequalities. Different frameworks, such as the mental illness stigma framework and the HIV stigma framework, further delineate stigma into mechanisms experienced by people without the attribute, with the mechanisms being stereotypes, discrimination, and prejudice leading to social rejection, and those with the attribute, with the mechanisms being enacted (experienced), anticipated (beliefs about how others will treat you) and internalized stigma (accepting negative views and devaluing one's self) impacting physical, mental and social health. In this proposed research the investigators focus on internalized HIV stigma among AYALHIV, as well as internalized stigma related to the prevalent youth experiences of violence and depression. Further, the investigators also focus on intersectional stigma, capturing anticipated stigma associated with the complex reality of AYALHIV's multiple social identities instead of one specific attribute. This focus responds directly to this RFA and priority NIH/NIMH future directions for stigma-related research. Evidence shows that internalized stigma is related to viral failure and ART adherence among adults in SSA. Systematic review articles have also examined HIV-internalized stigma interventions; however, a 2019 systematic review of HIV self-stigma interventions in low- and middle-income countries found only one youth focused study from Thailand. In a more recent narrative review, two articles were AYALHIV specific, with only one measuring internalized stigma. In response to this distinct gap in stigma-reducing interventions, and informed by our team's preliminary studies, the investigators developed and tested Project YES! Youth Engaging for Success, to address internalized stigma and HIV outcomes among AYALHIV.

Project YES! is a peer-led facility-based youth mentoring program and is the only CDC evidence-based intervention (EBI) developed in SSA that reduced HIV-internalized stigma among AYALHIV ages 15-24. This RCT found that peer mentoring versus standard of care (SOC) decreased the relative odds of HIV-related internalized stigma (feelings of shame, guilt and worthlessness) by a factor of 0.39 (95% CI:0.21,0.73).) In a stratified analysis, intervention versus SOC participants from a pediatric clinic had a relative increase in the odds of viral suppression (VS) by a factor of 4.7 (95% CI:1.84, 11.78). However, study data also highlighted critical intervention gaps: 74% of AYALHIV experienced physical, sexual and/or emotional violence in the past year, with those experiencing violence at greater risk of viral failure (see preliminary studies).(17) Additionally, AYALHIV who screened positive for depression were less likely to achieve VS (53% vs 62%). Research among South African AYALHIV identified significant, multidirectional pathways linking HIV status and internalized stigma through violence victimization, depression and anticipated stigma, and mental health research clearly links internalized stigma with depression. Few studies, however, examined the relationship between internalized stigma and HIV outcomes, with one finding the impact of discrimination on reduced HIV care retention heightened by internalized stigma. With an estimated 25% of AYALHIV experiencing depression, and the high levels of violence in this population, the investigators must effectively intervene on these pathways to improve HIV outcomes during a developmental stage when youth are "developing and consolidating their sense of self".

To address these gaps the investigators propose integrating WHO-endorsed and lay delivered mental health approaches (e.g. PM+, SH+ and EASE) into our peer mentoring EBI (Project YES!) to create and test Project YES+. The World Health Organization, has various psychological management programs to address mental health conditions through lay workers. Examples of these mental health approaches include Project Management Plus (PM+) and Self Help+, both designed for adults 18+ years, and the Early Adolescent Skills for Emotions (EASE) program designed for young adolescents 10-14 years. While efficacious, the targeted age groups leave a clear gap in service options for 15-19 year olds. By adapting and integrating these mental health approaches into Project YES+, the investigators will specifically provide AYALHIV with problem-management skills through lay peer mentors shown to reduce depression and anxiety. The investigators hypothesize that Project YES+ will also reduce related internalized and intersecting stigmas and improve HIV outcomes. Our refinement of stigma measures will also advance the field's ability to test stigma-reducing interventions to disrupt the pathways among violence, depression, internalized stigma and HIV-related health outcomes. This proposed research will contribute to the field of HIV empirical research and care practices by refining measures and pilot testing a feasible peer led intervention designed to reduce stigma and achieve undetectable viral loads among AYALHIV 15-24 years of age.

STUDY DESIGN The development and pilot testing of Project YES+ will occur in two phases. Phase one has been completed and addressed Aim 1: to integrate an adapted WHO endorsed mental health intervention into Project YES! and Aim 2: to refine stigma measures. To achieve aim 1 the study team first worked with WHO to identify the most promising packages and components to adapt (e.g. PM+, SH+, EASE). After honing in on the key approaches, the investigators then held co-design workshops with AYA and caregivers to refine the Project YES+ To achieve Aim 2, to refine stigma measures, the team conducted cognitive interviewing with youth and caregivers. This phase 1 produced: 1) an age-and-culturally relevant AYALHIV stigma reduction intervention linked to mental health and HIV outcomes, and 2) adapted measures of intersectional, violence-, and depression-related stigmas for AYALHIV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Be between ages 15-21
  • •living within 30-minutes, by personal transportation, of the clinic by self-report,
  • •and being available to attend sessions and data collection over a 4-8 month time period On ART for at least 6 months
  • •On first-line ART
  • •Speaks Bemba
  • •For caregivers
  • •Being 25 years of age or older
  • •Caring for an AYALHIV who meets the study eligibility criteria
  • •Speaks Bemba
  • •Living within 30-minutes, by personal transportation, of the clinic by self-report
  • •Being available to attend sessions and data collection over a 4-8 month time period

排除标准

  • •only one youth per household may join.
  • •Also participants will be excluded from joining the RCT if they are at imminent risk of suicide based on WHO guidance on the Self Help plus program.

研究组 & 干预措施

Standard of Care

No Intervention

The comparison group will receive the standard of care. Standard of care at ADCH includes an optional monthly AYALHIV youth group. The comparison arm participants will also be offered referrals to health care providers if they screen positive for depression or have experienced severe forms of violence (a process the investigators utilized and refined during the Project YES! study).

Project YES+ intervention arm

Experimental

Project YES+ will be about 4 months and will consist of an orientation meeting with the youth client, their caregiver, the healthcare worker and the youth peer mentor to introduce the intervention. Youth clients will then meet with their YPM individually and in groups with other youth living with HIV in the intervention, and go through the WHO- Self Help plus group meetings. Caregivers will also attend three different caregiver group meetings. At the end, there will be a transition group meeting with youth and caregivers together, followed by one last individual mentoring meeting with the youth. All individual and group meetings are facilitated by the youth peer mentor. Study team members will provide reminder calls for youth and their caregivers before intervention meetings and data collection points.

干预措施: Project YES+ intervention arm (Behavioral)

结局指标

主要结局

Feasibility of intervention as assessed by percentage of sessions attended

时间窗: Up to 4 months

Feasibility of 90% of AYAHLIV attending at least 80% of the intervention sessions with a 90% confidence interval and a margin of error + 10.

Number of intervention participants who report they would recommend Project YES+ to their peers

时间窗: up to 4 months

The endline question is "Overall, you would recommend/not recommend this program to another youth living with HIV" with the response options would recommend, would not recomment, decline to answer"

Number of intervention participants who would recommend Project YES+ for caregivers

时间窗: up to four months

This outcome will be assessed during endline with the question "Overall, you would recommend/not recommend this program to a caregiver of a another youth living with HIV"

次要结局

  • Number of youth participants with a positive composite score consisting of psychological distress (Kessler 6) and one positive stigma score (internalized, violence, mental health and intersectional stigma).(Baseline up to approximately 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验