Kupambana: A Combined Microeconomic Strengthening and Stigma Reduction Intervention for Young People With HIV in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HIV Continuum of Care: Linkage, Receipt, Retention, and Viral Suppression
研究概览
简要总结
The goal of this clinical trial is to learn if a program called Kupambana can improve mental health and HIV care outcomes in young people with HIV in Zambia by combining stigma-reduction support with financial and job-skills training. The main questions it aims to answer are whether Kupambana is feasible and acceptable to young people with HIV and whether it improves mental health, reduces stigma, and improves progress along the HIV care continuum, such as staying in care and taking HIV medicine as prescribed. Researchers will compare young people who participate in Kupambana with those who receive a one-time financial literacy training session (usual care) to determine whether Kupambana leads to greater improvements in stigma, mental health, and HIV care outcomes. Participants will complete a baseline questionnaire and then be randomly assigned to either the Kupambana program or the one-time financial literacy training. Those assigned to Kupambana will attend eight weekly peer-led support group sessions focused on reducing HIV- and poverty-related stigma, receive a voucher for technical and vocational education and training, and attend a one-time financial literacy session. Those assigned to the comparison group will attend only the one-time financial literacy session. All participants will complete follow-up surveys at the end of the program and again 3 and 6 months later.
详细描述
This pilot randomized controlled trial is grounded in two theoretical frameworks: the Health Stigma and Discrimination Framework (HSDF), which addresses the intersection of HIV-related and poverty-related stigma as jointly shaped by structural, social, and individual-level factors, and Positive Youth Development (PYD), which emphasizes strengthening internal assets (such as socioemotional skills) and external assets (such as technical and vocational education and training and supportive relationships) to help young people thrive despite adversity. The intervention being tested was refined through a prior adaptation phase using the Assessment, Decision, Adaptation, Production, Topical experts-Integration, Training, and Testing (ADAPT-ITT) model and builds on two previously developed and tested livelihood interventions for people with HIV in Zambia.
Following completion of a baseline assessment, participants will be randomized in a 1:1 ratio using a computer-generated random allocation sequence implemented through sequentially numbered, opaque, sealed envelopes to minimize selection bias. To reduce the risk of treatment contamination between study arms, the study employs several mitigation strategies: differentiated staffing, in which the experimental intervention's stigma-reduction and financial literacy components are delivered by peer health educators while the technical and vocational education and training component is delivered by staff from a separate partner training institute; temporal separation of experimental and control group activities; blinding of data enumerators to participants' study arm assignment during data collection; and restricting participant information to only the intervention components to which they are assigned.
Data will be gathered through multiple methods, including participant self-report surveys administered electronically via tablet, abstraction of HIV clinical indicators from electronic and paper medical records with participant consent, structured intervention fidelity logs and attendance records completed by implementation staff, program cost and resource-use data gathered through administrative records and key-informant interviews, and qualitative exit interviews conducted with all experimental-arm participants as well as peer health educators and vocational training staff.
As a pilot study, the analytic approach is designed to generate feasibility benchmarks, acceptability estimates, implementation cost data, and preliminary effect estimates to inform a future, fully powered Type 1 hybrid effectiveness-implementation trial, rather than to test intervention efficacy through formal hypothesis testing. Quantitative analyses will rely primarily on descriptive statistics to characterize the sample and assess feasibility and acceptability against pre-specified benchmarks, and will use an intention-to-treat approach for exploratory between-group comparisons. Qualitative data will be analyzed using the framework method, with coder reliability checked across a subset of transcripts. The implementation cost analysis will be conducted from a community perspective to estimate the staff time, training, materials, transportation, and other resources required to deliver the intervention outside of a research context, informing future scale-up planning.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 24 years
- •Confirmed HIV-positive status, verified using health records obtained from health facilities with participant consent
- •Residing in the Chipata, Katete, or Lundazi Districts of Zambia's Eastern Province
- •Currently receiving HIV treatment, or previously initiated but disengaged from HIV treatment (stratified purposive sampling will be used to enroll roughly equal proportions of youth currently in care and those who have dropped out of care)
- •Reports at least one indicator of economic vulnerability, defined as any of the following: unemployed or without a regular source of income; not attending school or post-secondary education; or individual income below Zambia's national poverty line
排除标准
- •- HIV-negative or unknown status
研究组 & 干预措施
Kupambana
Participants receive the full Kupambana intervention package over approximately 9-12 weeks. All experimental participants attend one 2-hour group-based financial literacy training session (covering budgeting, savings, credit, and goal-setting) during week 1, delivered by peer health educators. Participants also attend eight weekly 2-hour peer-led stigma-reduction support group (SRSG) sessions addressing internalized, anticipated, and enacted HIV- and poverty-related stigma through socioemotional skill-building, including self-care, resilience, affirmation, and coping strategies. Additionally, participants receive a voucher for up to 12 weeks of technical and vocational education and training [TVET] (e.g., agriculture, mechanics, carpentry, tailoring) at a partner training institute, delivered by institute staff. Together, these components target intersecting HIV- and poverty-related stigma to improve mental health and HIV care continuum outcomes.
干预措施: Stigma Reduction Support Group (SRSG) (Behavioral)
Kupambana
Participants receive the full Kupambana intervention package over approximately 9-12 weeks. All experimental participants attend one 2-hour group-based financial literacy training session (covering budgeting, savings, credit, and goal-setting) during week 1, delivered by peer health educators. Participants also attend eight weekly 2-hour peer-led stigma-reduction support group (SRSG) sessions addressing internalized, anticipated, and enacted HIV- and poverty-related stigma through socioemotional skill-building, including self-care, resilience, affirmation, and coping strategies. Additionally, participants receive a voucher for up to 12 weeks of technical and vocational education and training [TVET] (e.g., agriculture, mechanics, carpentry, tailoring) at a partner training institute, delivered by institute staff. Together, these components target intersecting HIV- and poverty-related stigma to improve mental health and HIV care continuum outcomes.
干预措施: Technical and Vocational Education and Training (TVET) (Other)
Kupambana
Participants receive the full Kupambana intervention package over approximately 9-12 weeks. All experimental participants attend one 2-hour group-based financial literacy training session (covering budgeting, savings, credit, and goal-setting) during week 1, delivered by peer health educators. Participants also attend eight weekly 2-hour peer-led stigma-reduction support group (SRSG) sessions addressing internalized, anticipated, and enacted HIV- and poverty-related stigma through socioemotional skill-building, including self-care, resilience, affirmation, and coping strategies. Additionally, participants receive a voucher for up to 12 weeks of technical and vocational education and training [TVET] (e.g., agriculture, mechanics, carpentry, tailoring) at a partner training institute, delivered by institute staff. Together, these components target intersecting HIV- and poverty-related stigma to improve mental health and HIV care continuum outcomes.
干预措施: Financial Literacy (Behavioral)
Treatment-as-Usual
Participants attend one 2-hour group-based financial literacy training session (covering budgeting, savings, credit, and goal-setting) during week 1, delivered by peer health educators.
干预措施: Financial Literacy (Behavioral)
结局指标
主要结局
HIV Continuum of Care: Linkage, Receipt, Retention, and Viral Suppression
时间窗: Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program)
The proportion of participants meeting each of the following HIV care continuum indicators, assessed via self-report and medical record abstraction: linkage to care (connected to a clinic or health facility for HIV care); receipt of care (currently prescribed ART); retention in care (≥2 outpatient visits in the past year, with ≥90 days between the first and last visit); and viral suppression (viral load \<1000 copies/mL, per Zambia's national guidelines). Each indicator is reported separately rather than combined into a composite score. Higher proportions indicate better HIV care engagement and outcomes.
HIV Treatment Adherence
时间窗: Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program)
HIV treatment adherence will be measured with the Modified Medication Adherence Self-Report Inventory (M-MASRI), a brief self-report measure assessing ART adherence through multiple recall items, including missed doses in the past 1, 2, and 3 days, a 2-week recall of non-adherence, and a visual analogue scale (VAS) rating the percentage of prescribed doses taken over the past month (0% = "took none of my HIV medication" to 100% = "took all of my HIV medication"). Responses across items are combined to produce an overall adherence score, with higher scores indicating greater adherence.
Mental Health (Depression)
时间窗: Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program)
Depression will be measured with the 10-item Center for Epidemiologic Studies Depression Scale (CES-D-10), a brief screening measure assessing the frequency of depressive symptoms (e.g., sadness, hopelessness, restless sleep, loss of interest) experienced over the past week. Items are rated on a 4-point scale (0 = "rarely or none of the time" to 3 = "all of the time") and summed to produce a total score ranging from 0 to 30, with higher scores indicating greater depressive symptom severity.
Mental Health (Anxiety)
时间窗: Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program)
Anxiety will be measured with the 7-item Generalized Anxiety Disorder scale (GAD-7), which assesses the frequency of core anxiety symptoms (e.g., excessive worry, restlessness, difficulty relaxing) over the past two weeks. Items are rated on a 4-point scale (0 = "not at all" to 3 = "nearly every day") and summed to produce a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity.
Mental Health (Psychological Distress)
时间窗: Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program)
General psychological distress will be measured using the World Health Organization (WHO) Self-Reporting Questionnaire (SRQ-20), a 20-item screening tool for common mental disorders that covers somatic and psychological symptoms of distress (e.g., headaches, poor appetite, feeling nervous, tense, or worthless). Items are rated dichotomously (yes/no) and summed to produce a total score ranging from 0 to 20, with higher scores indicating greater psychological distress.
次要结局
- Internalized HIV Stigma(Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program))
- Internalized Poverty Stigma(Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program))
- Enacted HIV Stigma(Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program))
- Enacted Poverty Stigma(Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program))
- Intersectional Anticipated Discrimination(Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program))
- Resilience (Adult Resilience Measure-Revised (ARM-R))(Baseline; 7 months after baseline (end of program); 10 months after baseline (3 months after end of program); and 13 months after baseline (6 months after end of program))