Toward an intravaginal device to detect risk of preterm labor: a user-centered design approach in Sub-Saharan Africa.

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.

Prematurity and its complications are the leading cause of death and disability in children under 5 years of age. Up to ten percent of pregnancies in North America and Africa are affected. Screening tests to predict preterm birth (PTB) are insensitive, costly, and often unavailable in low resource settings. A U.S.-based study has developed an intravaginal device to detect preterm labor. In order to assess acceptability and guide development for a low-resource setting, a qualitative study was conducted in Kenya and South Africa. We conducted focus group discussions and interviews with pregnant women, male community members, health care providers and health systems experts. Participants with a personal history of PTB were almost unanimous in support of the proposed device; women with no experience of PTB expressed the greatest degree of reservation. Various potential challenges were identified: discomfort, hygiene, and sexual activity, the need for provider training and attention to country-specific regulatory processes. Design recommendations included preference for a small, soft, pliable device, with a shape that could facilitate easy removal. Stakeholders expressed a strong preference for insertion by providers. These findings reflect the significance of end-user consultation in device design and use.

Integrated Urology and Primary Care Model Improves Outcomes for Men With Testosterone Deficiency.

INTRODUCTION: Many men presenting with testosterone deficiency do not have access to a primary care provider. We sought to integrate primary care into initial urological evaluation to better identify and manage undertreated comorbidities. METHODS: New patients presenting with testosterone deficiency were offered primary care provider evaluation within a men's health center between October 2019 and 2022. Data collected from the electronic health record included age, race, BMI, access to prior primary care provider, new diagnoses, prescriptions, and referrals. RESULTS: Eighty-one men were evaluated over the 3-year study period. Thirty-three men (41%) did not have a preexisting primary care provider. Older men were significantly more likely to have a preexisting primary care provider (OR 1.06 [95% CI: 1.02-1.10], P < .001). Hispanic men were significantly less likely to have an existing primary care provider (OR 0.16 [95% CI: 0.03-0.84], P = .01). Forty-eight men (59%) established continuity of care. Newly diagnosed comorbidities included hypertension (41%), obesity (37%), hyperlipidemia (27%), obstructive sleep apnea (25%), depression (23%), and diabetes (14%). Forty-one patients (51%) were prescribed a new medication. Twenty-one patients (26%) were referred to nutrition, with mean BMI decrease of 1.75 kg/m2. Twenty-six patients (32%) underwent sleep medicine evaluation for obstructive sleep apnea. Twenty-seven (33%) and 37 patients (46%) received a flu vaccination and immunization updates. Eleven patients (14%) were referred for screening colonoscopy. CONCLUSIONS: This is the first report of integrated primary care and urology evaluation for testosterone deficiency. This comprehensive model results in improved outcomes including increased access to subspecialty referrals, objective weight loss, treatment of new diagnoses, updated immunizations, and cancer screening.