Translation Validation, Software Adaptation, and Usability Testing of a Spanish Contraception Decision Tool: Protocol for a Mixed Methods Pilot Study.

Abstract

Background: Contraceptive care is complex, especially for individuals with health conditions (eg, diabetes, depression, and cardiovascular disease) who must consider how and to what extent their condition may be affected by contraception or vice versa. My Health, My Choice (MHMC) is a novel, web-based contraceptive decision support tool designed in English for patients with health conditions and is currently being tested in a cluster randomized controlled trial in the United States. MHMC is not available in Spanish, creating linguistic barriers to trial participation for those who prefer to read and learn in Spanish.

Objective: This protocol describes a 3-stage process to create a medically accurate, linguistically and culturally acceptable Spanish version of MHMC called Mi salud, mi decisión.

Methods: The pilot study combines an iterative, convergent mixed methods design with an innovative translation process and user experience methodology. In stage 1 (translation validation), a bilingual 8-person translation team will conduct the Team-Driven, Person-Centered Translation Process, a 7-step innovative process developed for this study: (1) resource and team preparation; (2) forward translations; (3) synthesis of translations; (4) back translation; (5) consensus (harmonizing) of translations; (6) review and proofreading; and (7) pretest or pilot of the translated adaptation. In stage 2 (software adaptation), we will work with a professional software team to internationalize MHMC (prepare it to technically support multiple languages) and then localize MHMC (prepare it for a specific language or region) for use in Spanish. In stage 3, we will conduct usability testing with a nonprobability sample of 12 to 20 Spanish-speaking individuals (aged 18-49, who can get pregnant and want contraceptive decision support) who vary in reading levels and Spanish dialects. Quantitative usability data will be collected via electronic survey with an adapted version of the Spanish System Usability Scale (SUS). Qualitative data will be collected via "think aloud" cognitive interviews during which participants navigate the tool in real-time. We will conduct iterative cycles of rapid qualitative analysis and software revisions to identify and resolve user-interface problems and improve the Spanish text for medical accuracy, linguistic acceptability, and cultural acceptability. Usability testing will stop when data no longer yield substantive feedback.

Results: As of September 7, 2026, we have enrolled 5 participants to date and anticipate completion of the pilot by November 1, 2026. We anticipate completion of qualitative analysis by December 2026 and publication of results in 2027. The final product, Mi salud, mi decisión, will be a contraceptive decision tool in Spanish with semantic equivalence (similar meanings of words) and conceptual equivalence (similar meanings of concepts) to the original English MHMC.

Conclusions: This protocol describes translation validation, software adaptation, and usability testing of a novel web-based contraceptive decision tool in Spanish. Upon completion of this project, Mi salud, mi decisión will be ready for efficacy testing in a cluster randomized controlled trial.