article · Health Science Reports
Adults living with human immunodeficiency virus and hepatitis B co-infection face elevated risks of liver complications and poor treatment outcomes when antiretroviral therapy adherence is inadequate. While patient-centred education shows promise for improving treatment adherence and self-management in chronic disease care, evidence regarding its effect on virological outcomes in resource-constrained settings remains limited. This protocol outlines a pilot quasi-experimental study designed to evaluate a structured, patient-centred educational programme integrated into routine antiretroviral therapy services in North-West Ethiopia. The trial involves 120 adult participants divided into an intervention group receiving the educational programme and a comparison group receiving standard care. Evaluated over six months, the primary outcome is the change in viral load, alongside secondary outcomes including medication adherence, disease knowledge, and retention in care. A qualitative assessment will also evaluate the feasibility and acceptability of the intervention.
Managing co-infections such as HIV and hepatitis B requires strict adherence to medication to prevent severe liver damage and treatment failure. In resource-limited settings, healthcare systems often lack structured educational tools tailored to these complex health needs. Developing and testing feasible educational programmes can help clinicians support patients in managing their medication effectively, ultimately improving survival and treatment outcomes.
This work describes an early-stage clinical trial protocol for an educational healthcare programme rather than a commercial product. If proven feasible and effective, the structured training model could be adopted by public health authorities, hospital managers, and non-governmental organisations delivering antiretroviral therapy services in resource-constrained environments. However, real-world deployment depends entirely on the future execution and results of this pilot evaluation, placing it at a pre-implementation research stage.
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ABSTRACT Background Human immunodeficiency virus (HIV) remains a major public health challenge in sub‐Saharan Africa, including Ethiopia. Adults living with HIV are at increased risk of liver‐related complications, poor treatment outcomes, and suboptimal virological control, particularly when adherence to antiretroviral therapy (ART) is inadequate. Patient‐centered education has emerged as a promising strategy for improving treatment adherence, self‐management, and health outcomes among individuals with chronic diseases. However, evidence on the effect of patient‐centered education on HIV virological outcomes among adults living with HIV remains limited, particularly in resource‐constrained settings such as North‐West Ethiopia. Furthermore, limited evidence exists regarding the feasibility and acceptability of structured educational interventions tailored to this vulnerable population. This pilot quasi‐experimental study therefore aims to assess the effect of a patient‐centered education intervention on HIV virological outcomes among adults living with HIV in North‐West Ethiopia. Objective To evaluate the feasibility and preliminary effectiveness of a patient‐centered educational intervention on HIV virological outcomes, medication adherence, and HIV‐related knowledge among 120 adult people living with HIV–HBV co‐infection receiving ART in North‐West Ethiopia. Methods and Analysis This pilot quasi‐experimental study will employ non‐randomized intervention and comparison groups with baseline and 6‐month follow‐up assessments. A total of 120 participants (60 per group) will be enrolled from selected hospitals in North‐West Ethiopia. Participants in the intervention group will receive a structured patient‐centered education program integrated into routine ART services, while the comparison group will continue receiving standard care. Quantitative data will be entered into EpiData version 4.6 and analyzed using STATA version 18. Descriptive statistics will summarize baseline characteristics. Baseline differences between groups will be assessed using chi‐square tests for categorical variables and independent t‐tests or non‐parametric equivalents for continuous variables. The primary outcome will be the change in log‐transformed HIV viral load (log 10 copies/mL) from baseline to the end of the 6‐month follow‐up period. The intervention effect will be evaluated using paired t‐tests, difference‐in‐differences analysis, and multivariable linear regression while adjusting for potential confounders, including age, sex, educational status, baseline viral load, duration of ART, and medication adherence. Virological suppression, defined as HIV viral load < 1000 copies/mL, will be assessed as a secondary clinical outcome. Secondary outcomes will include medication adherence, HIV‐HBV‐related knowledge, self‐management practices, and retention in care. Statistical significance will be declared at p < 0.05. A qualitative study will be conducted at the end of the intervention period to assess the feasibility, acceptability, and implementation potential of the intervention. Qualitative data will be collected through focus group discussions with adult people live with HIV, in‐depth interviews with healthcare providers, and key informant interviews with hospital leaders and program managers. Audio‐recorded interviews will be transcribed verbatim and analyzed using directed thematic analysis with MAXQDA version 20. International Trial Registration Number The intervention protocol was registered on 15 November 2025 with the Pan African Clinical Trials Registry under identification number PACTR202512648125852.
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DOI: 10.1002/hsr2.73167
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