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Toward an intravaginal device to detect risk of preterm labor: a user-centered design approach in Sub-Saharan Africa
Emma Smith1, Cecilia Milford2, Kenneth Ngure3
1Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.
Insights
A new intravaginal device to predict preterm birth (PTB) risk shows promise. Stakeholders preferred provider insertion, highlighting the need for user-centered design in developing PTB prediction tools.
Area of Science:
- Obstetrics and Gynecology
- Global Health
- Medical Device Development
Background:
- Preterm birth (PTB) and its complications are a leading cause of child mortality in Africa and North America.
- Current PTB screening tests are often ineffective, expensive, and inaccessible in low-resource settings.
- A novel self-placed intravaginal device is being developed to predict PTB risk.
Purpose of the Study:
- To gather stakeholder input from Kenya and South Africa on a novel intravaginal device for PTB risk prediction.
- To ensure local contextual factors inform the device's future development and acceptability.
- To assess user-centered design preferences for the PTB risk prediction device.
Main Methods:
- Qualitative study involving focus group discussions and in-depth interviews in Kenya and South Africa.
- Participants included pregnant women, community males, women with a history of PTB, healthcare providers, and health system experts.
- Thematic analysis of transcribed interviews and user-centered design sessions for prototype preferences.
Main Results:
- Women with a history of PTB strongly supported the device; others expressed reservations.
- Healthcare providers anticipated acceptance from women with a PTB history.
- Identified challenges included insertion comfort, hygiene, sexual activity concerns, provider training needs, and regulatory processes. A preference for provider insertion was noted.
Conclusions:
- An intravaginal device for PTB risk detection is generally acceptable.
- Stakeholders strongly preferred provider insertion, emphasizing the importance of end-user consultation.
- Device modifications, educational messaging, and provider training are recommended for successful utilization.
Background:
Prematurity and its complications are the leading cause of death and disability in children under five in Africa and North America, affecting as many as one in ten pregnancies. Screening tests to predict preterm birth (PTB) are insensitive, costly, and often unavailable in low resource settings. In parallel with early-stage U.S.-based testing of a novel self-placed intravaginal device to predict PTB risk, we elicited key stakeholder input from two sub-Saharan African countries to ensure local contextual factors inform future development of the device and its acceptability.
Methods:
A qualitative study was conducted in Kiambu County, Kenya and KwaZulu-Natal Province, South Africa. We conducted 26 focus group discussions with pregnant women (n = 132) and males from the community (n = 54); in-depth interviews with women who had a history of PTB (n = 10), healthcare providers (n = 16), and health system experts (n = 10). Interviews were transcribed and thematic analysis was performed using an iterative coding technique. In addition, we facilitated user-centered design sessions to generate prototype preferences.
Results:
Women with a personal history of PTB were almost unanimous in support of the proposed device, whereas those with no experience of PTB expressed the greatest degree of reservation. Healthcare providers anticipated that women with a history of PTB would accept the device. However, various potential challenges were identified, including potential discomfort with device insertion, hygiene, and sexual activity, as well as need for provider training, and attention to country-specific regulatory processes. Both community participants and providers expressed a preference for a provider inserted device. Design recommendations included preference for a small, soft, pliable device, with a shape that could facilitate easy removal.
Conclusions:
Use of an intravaginal device to detect risk of PTB was generally acceptable, however stakeholders expressed a notable preference for insertion by providers. This reflects the significance of end-user consultation in device design and use. Recommended device modifications as well as educational messaging and provider technical assistance may facilitate utilization.
