JMIR Publications

ABSTRACT

Background:

Choosing contraception is a highly personal and often complex decision. People with acute and chronic health conditions (e.g. pulmonary embolism, diabetes, hypertension)have additional factors to deliberate, such as if and to what extent a contraceptive method may affect their health conditions or interact with their medications. My Health My Choice (MHMC) is a web-based decision support tool that helps patients understand their contraceptive options in context of their health conditions, medications, and personal priorities.

Objective:

This study will evaluate the efficacy of MHMCuse among people with diverse health conditions who seek contraceptive counseling in U.S. outpatient clinics.

Methods:

This study is a mixed methods cluster randomized controlled trial (RCT) comparing MHMC and usual contraceptive care (intervention arm) to usual contraceptive care only (control arm). A total of 14 clinics that specialize in primary care or obstetrics and gynecology will be enrolled with 7 clinics in each arm. We aim to enroll a total of 725 patients (363 in each group) who are 18-49 years old, able to speak and read English, seeking contraception for pregnancy prevention, and have at least one health condition among 60 eligible health conditions and characteristics (e.g. cigarette smoking, postpartum state). Aim 1 (quantitative) is to assess the primary outcome of patient-reported contraceptive nonuse (yes/no) at 3 months. Aim 2 (mixed methods) starts with a quantitative summary of patient-reported contraceptive use by method type (e.g. pills, shot, implant) and corresponding Medical Eligibility Risk Category (Category 1, 2, 3, or 4) per the Centers for Disease Control and Prevention (CDC) U.S. Medical Eligibility Criteria (US MEC) Guidelines. We will then conduct exit interviews of a sub-sample of approximately 30 patients and 30 clinicians to qualitatively understand how MHMC and other contextual factors influenced perceptions about contraceptive risk and contraceptive decisions. Aim 3 (quantitative) is to explore patient-reported contraceptive decisional conflict (measured by the Decisional Conflict Scale) and patient-reported quality of interaction with their contraceptive provider (measured by the Interpersonal Quality of Family Planning Scale) as mediators of the effects of MHMC on the primary outcome. This paper describes the study protocol per the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials).

Results:

This study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD110570, PI Wu) in 2023. The study team is collaborating with the DARTNet Institute (Aurora, Colorado, USA) to enroll and prepare health clinics for trial launch. Fourteen clinics have enrolled in the trial and are in various stages of study preparation and regulatory approval. We anticipate patient enrollment to run from October 2025-September 2028.

Conclusions:

This protocol summarizes the first mixed methods cluster RCT of MHMC, a novel web-based decision support tool for people with health conditions. Clinical Trial: NCT07075536