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

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.