Integrating Project YES! With WHO-Endorsed Mental Health Approaches Among Youth Living With HIV
NCT ID: NCT07221201
Last Updated: 2025-11-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
400 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-10-25
Study Completion Date
2026-06-30
Brief Summary
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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.
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Detailed Description
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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.
Phase two is the focus of this registration with clinicaltrials.gov. For phase two, the study team will address Aim 3: to pilot test the intervention, collecting pilot Project YES+ outcomes by conducting an RCT with 50 intervention and 50 comparison AYALHIV and their caregivers who attend HIV care at the Arthur Davison Children's Hospital (ADCH) in Ndola, Zambia (expanding to other clinics if needed to reach the sample size). Individual-level AYA study measures, including stigma, depression, violence, ART adherence, and blood draws for viral testing, will occur at baseline and endline. This data will advance our knowledge on stigma measures and the integration of mental health care in an effective HIV stigma reducing intervention to address the bi-directional associations among HIV, depression, violence victimization, and various internalized stigmas. This data will provide the foundation for a future impact study of Project YES+ on AYALHIV stigmas and HIV outcomes. The specific aim 3 is detailed below:
Aim 3: The purpose of Aim 3 is to test the feasibility of conducting Project YES+ among AYALHIV to prepare preliminary evidence and working knowledge to test the intervention impact in the future. To assess whether 90% of AYAHLIV will attend at least 80% of the intervention sessions with a 90% confidence interval and a margin of error + 10, the investigators will need a minimum sample size of 25 AYALHIV in each study arm. A group sample size of 50 though, will allow us to achieve 74% power to detect a two-sided difference with an alpha of 0.05 of 25 points between the two groups on internalized stigma related to HIV, violence or depression. The investigators know from Project YES! data that a reduction of this size in HIV-internalized stigma is possible. In addition, this sample size will provide valuable data on the proportion of participants reducing psychological distress. At baseline 100% of all AYALHIV participants will have have a positive screen for the Kessler 6 measure of psychological distress and the investigators assume some variability in the proportion with a positive Kessler 6 score in the control group at endline. Group sizes of 50 will achieve 80% power to detect a 20% difference in the Kessler 6 from 95% to 75% between the control and intervention group for a two-sided comparison with alpha=0.05.
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.
Phase two is the focus of this registration with clinicaltrials.gov. For phase two, the study team will address Aim 3: to pilot test the intervention, collecting pilot Project YES+ outcomes by conducting an RCT with 50 intervention and 50 comparison AYALHIV and their caregivers who attend HIV care at the Arthur Davison Children's Hospital (ADCH) in Ndola, Zambia (expanding to other clinics if needed to reach the sample size). Individual-level AYA study measures, including stigma, depression, violence, ART adherence, and blood draws for viral testing, will occur at baseline and endline. This data will advance our knowledge on stigma measures and the integration of mental health care in an effective HIV stigma reducing intervention to address the bi-directional associations among HIV, depression, violence victimization, and various internalized stigmas. This data will provide the foundation for a future impact study of Project YES+ on AYALHIV stigmas and HIV outcomes. The specific aim 3 is detailed below:
Aim 3: The purpose of Aim 3 is to test the feasibility of conducting Project YES+ among AYALHIV to prepare preliminary evidence and working knowledge to test the intervention impact in the future. To assess whether 90% of AYAHLIV will attend at least 80% of the intervention sessions with a 90% confidence interval and a margin of error + 10, the investigators will need a minimum sample size of 25 AYALHIV in each study arm. A group sample size of 50 though, will allow us to achieve 74% power to detect a two-sided difference with an alpha of 0.05 of 25 points between the two groups on internalized stigma related to HIV, violence or depression. The investigators know from Project YES! data that a reduction of this size in HIV-internalized stigma is possible. In addition, this sample size will provide valuable data on the proportion of participants reducing psychological distress. At baseline 100% of all AYALHIV participants will have have a positive screen for the Kessler 6 measure of psychological distress and the investigators assume some variability in the proportion with a positive Kessler 6 score in the control group at endline. Group sizes of 50 will achieve 80% power to detect a 20% difference in the Kessler 6 from 95% to 75% between the control and intervention group for a two-sided comparison with alpha=0.05.
Conditions
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HIV - Human Immunodeficiency Virus
Mental Health
Anxiety
Depression in Adolescence
Stigma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized Controlled Trial (Individual Level)
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Standard of Care
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).
Group Type
NO_INTERVENTION
No interventions assigned to this group
Project YES+ intervention arm
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.
Group Type
EXPERIMENTAL
Project YES+ intervention arm
Intervention Type
BEHAVIORAL
Project YES+ integrates Project YES!
Interventions
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Project YES+ intervention arm
Project YES+ integrates Project YES!
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
For youth
* 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
* 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
Exclusion Criteria
For youth,
* 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.
* 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.
Minimum Eligible Age
15 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fogarty International Center of the National Institute of Health
NIH
Sponsor Role
collaborator
Arthur Davison Children's Hospital
OTHER
Sponsor Role
collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
Johns Hopkins Bloomberg School of Public Health
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Julie A Denison, PhD
Role: PRINCIPAL_INVESTIGATOR
JHBSPH
Sam Miti, BSc HB, MBcHB, MeMMed-PEDS
Role: STUDY_DIRECTOR
Arthur Davison Children's Hospital
Locations
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Arthur Davison Children's Hospital
Ndola, Copperbelt, Zambia
Site Status
RECRUITING
Countries
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Zambia
Central Contacts
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Facility Contacts
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Sam Miti, Sc HB, MBcHB, MMed-PEDS, FZCO
Role: primary
References
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Reference Type
BACKGROUND
Parker R, Aggleton P. HIV and AIDS-related stigma and discrimination: a conceptual framework and implications for action. Soc Sci Med. 2003 Jul;57(1):13-24. doi: 10.1016/s0277-9536(02)00304-0.
Reference Type
BACKGROUND
4. Goffman E. Stigma: Notes on the management of spoiled identity: Simon and Schuster; 2009
Reference Type
BACKGROUND
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Other Identifiers
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IRB00024597
Identifier Type: -
Identifier Source: org_study_id
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