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NCT Number: NCT07732660

Reducing Stigma and Building Employability Skills 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stigma Reduction Support Group (SRSG)

Behavioral

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.

Other names: Stigma Mitigation, Anti-stigma Interventions, Stigma Elimination Initiatives, Social Inclusion Interventions, Stigma Awareness and Education Programs

Financial Literacy

Behavioral

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.

Other names: Financial Inclusion, Financial Capability, Money Management

Technical and Vocational Education and Training (TVET)

Other

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.

Other names: Vocational Skills Training, Technical Skills Training, Job Skills Training, Career Skills Training, Employment Skills Training, Workforce Skills Development, Trade Skills Training, Career and Livelihood Training

Primary outcomes

  1. HIV Continuum of Care: Linkage, Receipt, Retention, and Viral Suppression

    Time frame: 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.

  2. HIV Treatment Adherence

    Time frame: 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.

  3. Mental Health (Depression)

    Time frame: 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.

  4. Mental Health (Anxiety)

    Time frame: 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.

  5. Mental Health (Psychological Distress)

    Time frame: 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.

Secondary outcomes

  1. Internalized HIV Stigma

    Time frame: 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 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.

  2. Internalized Poverty Stigma

    Time frame: 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 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.

  3. Enacted HIV Stigma

    Time frame: 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 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.

  4. Enacted Poverty Stigma

    Time frame: 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.

  5. Intersectional Anticipated Discrimination

    Time frame: 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 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.

  6. Resilience (Adult Resilience Measure-Revised (ARM-R))

    Time frame: 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 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rainier D Masa, PhD, MSW

CONTACT

[email protected]

919-962-6531

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study title

Kupambana: A Combined Microeconomic Strengthening and Stigma Reduction Intervention for Young People With HIV in Zambia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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