Sarah E. Hill

Background: Nearly 40% of unplanned pregnancies in the USA are the result of inconsistent or incorrect contraceptive use. Finding ways to increase women’s comfort and satisfaction with contraceptive use is therefore critical to public health. One promising pathway for improving patient outcomes is through the use of digital decision aids that assist women and their physicians in choosing a contraceptive option that women are comfortable with. Testing the ability of these aids to improve patient outcomes is therefore a necessary first step toward incorporating this technology into traditional physician appointments. Purpose: To evaluate the effectiveness of a novel contraceptive decision aid at minimizing decisional conflict and increasing comfort with contraception among adult women. Methods: In total, 310 adult women were assigned to use either the Tuune contraceptive decision aid or a control aid modeled after a leading online contraceptive prescriber’s patient intake form. Participants then completed self-report measures of decisional conflict, contraceptive expectations, satisfaction, and contraceptive use intentions. Individual between-subjects analysis of variance (ANOVA) models were used to examine these outcomes. Results: Women using the Tuune decision aid (vs. those using the control aid) reported lower decisional conflict, more positive contraceptive expectations, greater satisfaction with the decision aid and recommendation, and more positive contraceptive use intentions. Conclusions: Use of Tuune improved each of the predicted patient outcomes relative to a control decision aid. Online decision aids, particularly when used alongside physician consultations, may be an effective tool for increasing comfort with contraceptive use. Clinical Trials Registration #: NCT05177783, ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT05177783

Background: Reproductive health literacy and menstrual health awareness play a crucial role in ensuring the health and well-being of women and people who menstruate. Further, awareness of one’s own menstrual cycle patterns and associated symptoms can help individuals identify and manage conditions of the menstrual cycle such as premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Digital health products, and specifically menstrual health apps, have the potential to effect positive change due to their scalability and ease of access. Objective: The primary aim of this study was to measure the efficacy of a menstrual and reproductive health app, Flo, in improving health literacy and health and well-being outcomes in menstruating individuals with and without PMS and PMDD. Further, we explored the possibility that the use of the Flo app could positively influence feelings around reproductive health management and communication about health, menstrual cycle stigma, unplanned pregnancies, quality of life, work productivity, absenteeism, and body image. Methods: We conducted 2 pilot, 3-month, unblinded, 2-armed, remote randomized controlled trials on the effects of using the Flo app in a sample of US-based (1) individuals who track their cycles (n=321) or (2) individuals who track their cycles and are affected by PMS or PMDD (n=117). Results: The findings revealed significant improvements at the end of the study period compared to baseline for our primary outcomes of health literacy (cycle tracking: D̄=1.11; t311=5.73, P<.001; PMS or PMDD: D̄=1.20; t115=3.76, P<.001) and menstrual health awareness (D̄=3.97; t311=7.71, P<.001), health and well-being (D̄=3.44; t311=5.94, P<.001), and PMS or PMDD symptoms burden (D̄=–7.08; t115=–5.44, P<.001). Improvements were also observed for our secondary outcomes of feelings of control and management over health (D̄=1.01; t311=5.08, P<.001), communication about health (D̄=0.93; t311=2.41, P=.002), menstrual cycle stigma (D̄=–0.61; t311=–2.73, P=.007), and fear of unplanned pregnancies (D̄=–0.22; t311=–2.11, P=.04) for those who track their cycles, as well as absenteeism from work and education due to PMS or PMDD (D̄=–1.67; t144=–2.49, P=.01). Conclusions: These pilot randomized controlled trials demonstrate that the use of the Flo app improves menstrual health literacy and awareness, general health and well-being, and PMS or PMDD symptom burden. Considering the widespread use and affordability of the Flo app, these findings show promise for filling important gaps in current health care provisioning such as improving menstrual knowledge and health. Trial Registration: OSF Registries osf.io/pcgw7; https://osf.io/pcgw7 ; OSF Registries osf.io/ry8vq; https://osf.io/ry8vq

BACKGROUND Reproductive health literacy and menstrual health awareness play a crucial role in ensuring the health and well-being of women and people who menstruate. Further, awareness of one’s own menstrual cycle patterns and associated symptoms can help individuals identify and manage conditions of the menstrual cycle such as premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Digital health products, and specifically menstrual health apps, have the potential to effect positive change due to their scalability and ease of access. OBJECTIVE The primary aim of this study was to measure the efficacy of a menstrual and reproductive health app, Flo, in improving health literacy and health and well-being outcomes in menstruating individuals with and without PMS and PMDD. Further, we explored the possibility that the use of the Flo app could positively influence feelings around reproductive health management and communication about health, menstrual cycle stigma, unplanned pregnancies, quality of life, work productivity, absenteeism, and body image. METHODS We conducted 2 pilot, 3-month, unblinded, 2-armed, remote randomized controlled trials on the effects of using the Flo app in a sample of US-based (1) individuals who track their cycles (n=321) or (2) individuals who track their cycles and are affected by PMS or PMDD (n=117). RESULTS The findings revealed significant improvements at the end of the study period compared to baseline for our primary outcomes of health literacy (cycle tracking: D̄=1.11; t311=5.73, P<.001; PMS or PMDD: D̄=1.20; t115=3.76, P<.001) and menstrual health awareness (D̄=3.97; t311=7.71, P<.001), health and well-being (D̄=3.44; t311=5.94, P<.001), and PMS or PMDD symptoms burden (D̄=–7.08; t115=–5.44, P<.001). Improvements were also observed for our secondary outcomes of feelings of control and management over health (D̄=1.01; t311=5.08, P<.001), communication about health (D̄=0.93; t311=2.41, P=.002), menstrual cycle stigma (D̄=–0.61; t311=–2.73, P=.007), and fear of unplanned pregnancies (D̄=–0.22; t311=–2.11, P=.04) for those who track their cycles, as well as absenteeism from work and education due to PMS or PMDD (D̄=–1.67; t144=–2.49, P=.01). CONCLUSIONS These pilot randomized controlled trials demonstrate that the use of the Flo app improves menstrual health literacy and awareness, general health and well-being, and PMS or PMDD symptom burden. Considering the widespread use and affordability of the Flo app, these findings show promise for filling important gaps in current health care provisioning such as improving menstrual knowledge and health. CLINICALTRIAL OSF Registries osf.io/pcgw7; https://osf.io/pcgw7 ; OSF Registries osf.io/ry8vq; https://osf.io/ry8vq

Background: Digital decision aids are becoming increasingly common in many areas of healthcare. These aids are designed to involve patients in medical decision making, with the aim of improving patient outcomes while decreasing healthcare burden. Previously developed contraceptive-based decision aids have been found to be effective at increasing women’s knowledge about reproductive health and contraception. Here, we sought to evaluate the effectiveness of a novel contraceptive-based decision aid at increasing women’s self-efficacy and knowledge about their reproductive health and contraceptive options, as well as their perceptions of their learning. This study was registered as a clinic trial at ClinicalTrials.gov (Contraception Decision Aid Use and Patient Outcomes, ID# NCT05177783) on 05/01/2022. Methods: The Tuune® contraceptive decision aid’s effectiveness was evaluated by conducting an experiment in which 324 women were assigned to use the Tuune® decision aid or a control decision aid. Primary outcomes included reproductive health self-efficacy, reproductive health and contraceptive knowledge, and perceptions of learning. Secondary analyses examined whether prior experience using hormonal contraceptives moderated the relationship between decision aid and each outcome measure. Results: Women assigned to use the Tuune® decision aid exhibited greater reproductive health self-efficacy, greater knowledge about reproductive health and contraception, and perceived having learned more than women assigned to use the control decision aid (ps ≤ .029). This pattern was also observed in women with previous contraceptive use experience, where women using Tuune® reported better outcomes than women using the control aid, regardless of their history of hormonal contraceptive use experience, although this interaction was not significant (p = .089). Conclusions: Use of the Tuune® contraceptive-based decision aid improved each of the predicted outcomes relative to a control decision aid. This suggests that use of the Tuune® contraceptive-based decision aid is well poised to increase women’s confidence and knowledge about contraceptive use and may also reduce burden on healthcare systems.

Background Digital decision aids are becoming increasingly common in many areas of healthcare. These aids are designed to involve patients in medical decision making, with the aim of improving patient outcomes while decreasing healthcare burden. Previously developed contraceptive-based decision aids have been found to be effective at increasing women’s knowledge about reproductive health and contraception. Here, we sought to evaluate the effectiveness of a novel contraceptive-based decision aid at increasing women’s self-efficacy and knowledge about their reproductive health and contraceptive options, as well as their perceptions of their learning. This study was registered as a clinic trial at ClinicalTrials.gov (Contraception Decision Aid Use and Patient Outcomes, ID# NCT05177783) on 01-05-2022. Methods The Tuune^→ contraceptive decision aid’s effectiveness was evaluated by conducting an experiment in which 324 women were assigned to use the Tuune^Ⓡ decision aid or a control decision aid. Primary outcomes included reproductive health self-efficacy, reproductive health and contraceptive knowledge, and perceptions of learning. Secondary analyses examined whether prior experience using hormonal contraceptives moderated the relationship between decision aid and each outcome measure. Results Women assigned to use the Tuune^→ decision aid exhibited greater reproductive health self-efficacy, greater knowledge about reproductive health and contraception, and perceived having learned more than women assigned to use the control decision aid. This pattern was also observed in women with previous contraceptive use experience, where women using Tuune^Ⓡ reported better outcomes than women using the control aid, regardless of their history of hormonal contraceptive use experience. Conclusions Use of the Tuune^→ contraceptive-based decision aid improved each of the predicted outcomes relative to a control decision aid. This suggests that use of the Tuune^Ⓡ contraceptive-based decision aid is well poised to increase women’s confidence and knowledge about contraceptive use and may also reduce burden on healthcare systems.

Early life stress increases one’s risk for health problems later in life, and many studies find that these effects are sex-differentiated. Here, we examined relationships between multiple sources of early life stress and adult immune function in humans across several functional assays. Adult participants provided retrospective information about their childhood (a) socioeconomic status, (b) household unpredictability, and (c) exposure to adverse experiences. Participants’ peripheral blood mononuclear cells (PBMCs) were then isolated for use in functional assays of immune performance: (a) tumor cell lysis by natural killer cells, (b) phagocytosis ofEscherichia colibioparticles, and (c) mitogen-induced leukocyte proliferation and cytokine release. In men, lower childhood socioeconomic status predicted decrements in immunological performance across functional assays, along with greater spontaneous cytokine release from PBMCs. These changes co-occurred with elevations in plasma testosterone levels. Similar effects were not observed for other sources of stress, nor were they found in women (with the exception of spontaneous cytokine release). These findings provide evidence that low childhood socioeconomic status has a lasting negative impact on multiple aspects of immune function, particularly in men.

We examined relationships between multiple sources of early life stress and adult immune function in humans. Adult participants provided retrospective information about their childhood a) socioeconomic status, b) household unpredictability, and c) exposure to adverse experiences. Participants’ peripheral blood mononuclear cells were then isolated for use in functional assays: a) tumor cell lysis by natural killer cells, and b) phagocytosis of Escherichia coli bioparticles, and c) mitogen-induced leukocyte proliferation and cytokine release. In men, lower childhood socioeconomic status predicted decrements in immunological performance across functional assays, along with greater spontaneous cytokine release from PBMCs. These changes co-occurred with elevations in plasma testosterone levels. Similar effects were not observed for other sources of stress, nor were they found in women (with the exception of spontaneous cytokine release). These findings provide evidence that low childhood socioeconomic status has a lasting negative impact on multiple aspects of immune function, particularly in men.