Abstract
PURPOSE: The main objective of this research is to develop and validate a comprehensive self-management tool for PLWH (HIV-SM LMIC tool) in Ethiopia. METHOD: Item development followed a recommended procedure. Item concepts were based on two previously published articles by the same authors, guided by the Individual Family Self-management (IFSMT) theoretical framework. The developed items were translated from English into Amharic (a local language in Ethiopia). Two rounds of face and content validation were conducted with HIV program experts, academics, people outside the health sector, and HIV patients. A total of 61 participants (52 in the first round and 9 in the second round) participated in the validation process. All participants evaluated the content and face validity of each item and provided qualitative judgments, comments, and suggestions. RESULTS: In the first round of validation, most participants were health professionals (53.8%), followed by HIV patients (19.2%) and HIV program experts/researchers (9.6%). Nine participants took part in the second round. Initially, 117 draft items were refined into 63 for validation. I-FVI (individual face validity index) values ranged from 0.56 to 0.98, with 43 items (68%) scoring ≥ 0.80, indicating high face validity. I-CVI (individual content validity index) values ranged from 0.76 to 1.00, with 61 items (97%) scoring ≥ 0.80, demonstrating high content validity. Common qualitative feedback highlighted translation and contextualization issues in the Amharic version and overlapping concepts. Based on FVI, CVI, and qualitative feedback, particularly patient comments, 26 items were dropped or merged, resulting in a 37-item tool. In the second round, 31 items scored above 0.80 on the CVI. Three items were removed due to low CVI (< 0.70) and redundancy, while two were dropped based on participant feedback. The remaining 32 items had kappa values > 0.74, indicating excellent relevance. Both English and Amharic versions were revised. CONCLUSION: A comprehensive 32-item HIV-SM LMIC tool tailored to HIV patients in low- and middle-income countries was developed following a rigorous psychometric evaluation process. Further research on its construct validity, criterion validity and reliability are recommended before its use. In addition, future studies should assess the cross-cultural validity of the final instrument.