Part 1: Formative study for developing patient-reported outcomes (PROs) for measuring contraceptive-induced menstrual changes (CIMCs)

Harvard Dataverse 2026 Dataset Open access

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Authors: Amelia C. L. Mackenzie, Jenni A. Smit, Marija Mirić, Alison B. Edelman, Mags E. Beksinska, Angely Catano, Stephanie R. Chung, Eunice Cuevas, Maddison Delacerda, Marci Messerle Forbes, Emily Hoppes, Leah Ingeno
+15 more Laura Jacobson, Mbali Khoma, Thandiwe Majola, Melissa Matos, Mbali Mavundla, Sarah McCaffrey, Alicia Mendez, Massiel Mendez, Nothando Mhlaba, Fortunate Nzwakie Mosery, Lungelo Keith Ndlovu, Bongeka Qiya, Kayla Stankevitz, Alexis Sullivan, Bongiwe Zulu
DOI: 10.7910/dvn/of8n4o
Cited by: 2

Abstract

This formative qualitive study was designed to produce data to develop and refine a patient-reported outcome mesure (PROM) to measure contraceptive-induced menstrual changes (CIMCs) for future contraceptive clinical trials. Focus group discussions were conducted with women of reproductive age (18-49-yrs-old) who report experiencing contraceptive-induced menstrual changes (CIMCs) in three sites – 1) Portland, Oregon, United States, 2) Santo Domingo, Dominican Republic, and 3) Durban, South Africa. 18 Focus group discussions were conducted with 102 women (4-7 per group) from 11/21/24 to 2/28/2025 in South Africa ; 1/24/25 to 2/6/25 in Dominican Republic; 8/26/25 to 9/18/25 in United States. This work was supported, in whole by the Gates Foundation [INV-062479]. The conclusions and opinions expressed in this work are those of the author(s) alone and shall not be attributed to the Foundation.

Publication details

Journal / source
Harvard Dataverse
Publication date
19 February 2026
Document type
Dataset