HIVNCT07732660
Reducing Stigma and Building Employability Skills for Young People With HIV in Zambia
A study testing Stigma Reduction Support Group (SRSG), Financial Literacy and Technical and Vocational Education and Training (TVET) in people with HIV and Mental Health, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- HIV, Mental Health, Treatment Adherence
- What is being tested?
- Stigma Reduction Support Group (SRSG), Financial Literacy and Technical and Vocational Education and Training (TVET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteZambia
- Study dates
- 13 Sep 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- HIV-negative or unknown status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, Mental Health, Treatment Adherence
- Being tested
- Stigma Reduction Support Group (SRSG), Financial Literacy, Technical and Vocational Education and Training (TVET)
- Keywords
- HIV Infections, Social Stigma, Poverty, Young Adult, Zambia, Vocational Education
- Medical subject headings
- Psychological Well-Being, Treatment Adherence and Compliance, HIV Infections, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stigma Reduction Support Group (SRSG)Behavioural
Also called Stigma Mitigation, Anti-stigma Interventions, Stigma Elimination Initiatives, Social Inclusion Interventions
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.
Financial LiteracyBehavioural
Also called Financial Inclusion, Financial Capability, Money Management
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.
Technical and Vocational Education and Training (TVET)Other
Also called Vocational Skills Training, Technical Skills Training, Job Skills Training, Career Skills Training
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.
| Study group | Role | What they receive |
|---|---|---|
| Kupambana | Experimental | 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. Receives: Behavioral: Stigma Reduction Support Group (SRSG); Behavioral: Financial Literacy; Other: Technical and Vocational Education and Training (TVET) |
| Treatment-as-Usual | Other | 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. Receives: Behavioral: Financial Literacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Continuum of Care: Linkage, Receipt, Retention, and Viral Suppression
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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 outcomes (6)
Internalized HIV Stigma
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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))
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start13 Sep 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Rainier D Masa, PhD, MSW, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732660
- Sponsor's protocol ID
- 24-1712
- Other IDs
- R01TW012676
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kupambana: A Combined Microeconomic Strengthening and Stigma Reduction Intervention for Young People With HIV in Zambia
- ClinicalTrials.gov ID
- NCT07732660
- Acronym / sponsor ID
- 24-1712
- Conditions
- HIV, Mental Health, Treatment Adherence
- Keywords
- HIV Infections, Social Stigma, Poverty, Young Adult, Zambia, Vocational Education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 13 Sep 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kupambana | Experimental | Behavioral: Stigma Reduction Support Group (SRSG), Behavioral: Financial Literacy, Other: Technical and Vocational Education and Training (TVET)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. |
| Treatment-as-Usual | Other | Behavioral: Financial LiteracyParticipants 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- HIV-negative or unknown status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stigma Reduction Support Group (SRSG)Also: Stigma Mitigation, Anti-stigma Interventions, Stigma Elimination Initiatives, Social Inclusion InterventionsEight 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. | Behavioural | Kupambana |
| Financial LiteracyAlso: Financial Inclusion, Financial Capability, Money ManagementA 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. | Behavioural | Kupambana, Treatment-as-Usual |
| Technical and Vocational Education and Training (TVET)Also: Vocational Skills Training, Technical Skills Training, Job Skills Training, Career Skills TrainingA 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 | Kupambana |
Primary outcome
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.
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.
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.
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.
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.
6 secondary outcomes
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 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 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 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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainier D Masa, PhD, MSW principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stigma Reduction Support Group (SRSG), Financial Literacy and Technical and Vocational Education and Training (TVET) in people with HIV and Mental Health, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.