Reducing Stigma and Building Employability Skills for Young People With HIV in Zambia

August 11, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Zambia
    • Lusaka Province
      • Lusaka, Lusaka Province, Zambia
        • Recruiting
        • University of Zambia
        • Contact:
        • Principal Investigator:
          • Joseph M Zulu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Stigma Reduction Support Group (SRSG)
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
Behavioral: Financial Literacy
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
Other: Technical and Vocational Education and Training (TVET)
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
Other: 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.
Behavioral: Financial Literacy
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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)
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.
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)
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.
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)
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.
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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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))
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fogarty International Center of the National Institute of Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rainier D Masa, PhD, MSW, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-1712
  • R01TW012676 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

Beginning 9 and continuing for 36 months following publication

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and has an executed data use/sharing agreement with UNC.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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