Reducing Stigma and Building Employability Skills for Young People With HIV in Zambia
2026年8月11日 更新者：University of North Carolina, Chapel Hill
Kupambana: A Combined Microeconomic Strengthening and Stigma Reduction Intervention for Young People With HIV in Zambia
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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Rainier D Masa, PhD, MSW
- 電話番号：919-962-6531
- メール：rmasa@email.unc.edu
研究場所
-
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Lusaka Province
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Lusaka、Lusaka Province、ザンビア
- 募集
- University of Zambia
-
コンタクト：
- Joseph M Zulu, PhD
- 電話番号：260 771514511
- メール：joseph.zulu@unza.zm
-
主任研究者：
- Joseph M Zulu, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- HIV-negative or unknown status
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Eight weekly, 2-hour, peer-led SRSG sessions delivered only to participants in the experimental condition.
Sessions address internalized, anticipated, and enacted HIV- and poverty-related stigma through socioemotional skill-building activities, including self-care, resilience, affirmation, and coping strategies.
Unlike the financial literacy training, this component is recurring (8 sessions vs. 1) and focuses on psychosocial and stigma-related content rather than financial knowledge.
Unlike the TVET voucher, it is delivered directly by study-affiliated peer health educators rather than an external training partner, and does not involve vocational skill acquisition.
他の名前：
A single, one-time, 2-hour group-based session covering budgeting, savings, credit, and financial goal-setting, delivered by peer health educators during week 1.
This is the only intervention component common to both study arms: it is administered identically to participants in the experimental (Kupambana) and control (usual care) conditions to increase comparability between groups and isolate the effects of the additional experimental components.
Unlike the SRSG, it is a single session rather than a recurring series, and unlike the TVET voucher, it involves no referral to an external training institute or ongoing skills instruction.
他の名前：
A voucher, provided only to participants in the experimental condition, covering enrollment in a vocational or entrepreneurship training course of the participant's choosing (e.g., agriculture, mechanics, carpentry, tailoring) at a partner training institute for up to 12 weeks.
Unlike the financial literacy training and SRSG, this component is delivered by staff external to the research team at a separate partner institute, allows participants to choose their trade/course, and provides a direct economic asset (subsidized access to training) rather than group-based instruction or peer support.
他の名前：
|
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他の：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.
|
A single, one-time, 2-hour group-based session covering budgeting, savings, credit, and financial goal-setting, delivered by peer health educators during week 1.
This is the only intervention component common to both study arms: it is administered identically to participants in the experimental (Kupambana) and control (usual care) conditions to increase comparability between groups and isolate the effects of the additional experimental components.
Unlike the SRSG, it is a single session rather than a recurring series, and unlike the TVET voucher, it involves no referral to an external training institute or ongoing skills instruction.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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HIV Continuum of Care: Linkage, Receipt, Retention, and Viral Suppression
時間枠：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.
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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)
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HIV Treatment Adherence
時間枠：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.
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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)
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Mental Health (Depression)
時間枠：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)
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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.
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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)
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Mental Health (Anxiety)
時間枠：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)
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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.
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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)
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Mental Health (Psychological Distress)
時間枠：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)
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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.
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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)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Internalized HIV Stigma
時間枠：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)
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Internalized HIV stigma will be measured with a 9-item scale assessing the extent to which participants have accepted and internalized negative HIV-related beliefs and feelings about themselves (e.g., feeling ashamed of having HIV, feeling that HIV makes them dirty inside, feeling like a bad person because of their HIV status, feeling they are not as good as other young people because of their HIV status).
Items are rated on a 3-point scale (0 = "never" to 2 = "most of the time") and summed to produce a total score ranging from 0 to 18, with higher scores indicating greater 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)
|
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Internalized Poverty Stigma
時間枠：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)
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Internalized poverty stigma will be measured with a 6-item scale assessing the extent to which participants internalize negative beliefs and stereotypes about poverty (e.g., associating low income with personal failure, laziness, or shame; feeling like a lesser person because of one's economic situation).
Items are rated on a 5-point Likert-type scale (1 = "strongly disagree" to 5 = "strongly agree") and summed to produce a total score, with higher scores indicating greater internalized poverty stigma.
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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)
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Enacted HIV Stigma
時間枠：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)
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Enacted HIV stigma will be measured with a 13-item scale assessing participants' actual experiences of HIV-related discrimination and mistreatment, including verbal abuse and social isolation.
Items are rated on a 4-point frequency scale (0 = "never," 1 = "once or twice," 2 = "several times," 3 = "most of the time"), consistent with the response format used for internalized HIV stigma, and summed to produce a total score ranging from 0 to 39, with higher scores indicating greater enacted HIV stigma.
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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)
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Enacted Poverty Stigma
時間枠：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 will be measured with a 5-item scale assessing participants' experiences of poverty-related mistreatment (e.g., people making negative assumptions about them, treating them badly, speaking down to them, or blaming them because they don't have much money; being excluded by family or friends because of their economic situation).
Items are rated on a 5-point scale (0 = "never" to 4 = "very often") and summed to produce a total score ranging from 0 to 20, with higher scores indicating greater experienced poverty stigma.
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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)
|
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Intersectional Anticipated Discrimination
時間枠：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)
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Intersectional anticipated discrimination will be measured with an 8-item scale assessing participants' anticipation of future unfair treatment attributed to HIV status, economic situation, or both.
Adapted items are rated on a 5-point agreement scale (0 = "strongly disagree" to 4 = "strongly agree") and summed to produce a total score ranging from 0 to 32, with higher scores indicating greater anticipated discrimination.
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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)
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Resilience (Adult Resilience Measure-Revised (ARM-R))
時間枠：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)
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Resilience will be measured with the 17-item Adult Resilience Measure-Revised (ARM-R), a self-report measure of social-ecological resilience assessing individual, relational, and community/contextual protective resources available to support positive coping and adaptation in the face of adversity.
Items are rated on a 5-point scale (1 = "not at all" to 5 = "a lot") and summed to produce a total score ranging from 17 to 85, with higher scores reflecting greater access to protective resources.
|
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)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Rainier D Masa, PhD, MSW、University of North Carolina, Chapel Hill
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月3日
一次修了 (推定)
2027年10月1日
研究の完了 (推定)
2027年10月1日
試験登録日
最初に提出
2026年7月23日
QC基準を満たした最初の提出物
2026年7月23日
最初の投稿 (実際)
2026年7月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月12日
QC基準を満たした最後の更新が送信されました
2026年8月11日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 24-1712
- R01TW012676 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD 共有時間枠
Beginning 9 and continuing for 36 months following publication
IPD 共有アクセス基準
Investigator has approved IRB, IEC, or REB and has an executed data use/sharing agreement with UNC.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。