Journal of women's health
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Journal of women's health · Oct 2022
Randomized Controlled TrialA Home-Mailed Versus General Practitioner-Delivered Vaginal Self-Sampling Kit for Cervical Cancer Screening: A Cluster Randomized Controlled Trial with a Cost-Effectiveness Analysis.
Objective: We assessed whether general practitioner (GP) delivery of a vaginal self-sampling kit was non-inferior to home-mailed delivery on cervical cancer screening (CCS) participation. Methods: Two hundred and ten French GPs from Indre-et-Loire French department were randomized into two groups, and their unscreened women patients aged 30-65 were included in February-March 2015. In the GP delivery group (n = 105 GPs; 1,806 women), women were sent a reminder letter inviting them to collect a vaginal self-sampling kit at their regular GP's practice. ⋯ Home-mailed delivery of a vaginal self-sampling kit is a cost-effective way to increase CCS in that the additional cost of this strategy seems acceptable. This study is registered at www. Clinicaltrials.gov NCT02255084.
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Journal of women's health · Sep 2022
Randomized Controlled TrialAcceptability of a Long-Acting, Multipurpose Vaginal Ring: Findings from a Phase I Trial in the U.S. and Dominican Republic.
Background: Women worldwide face risks from pregnancy, HIV, and other sexually transmitted infections (STIs). To date, highly effective contraceptive methods provide no HIV/STI protection, and HIV prevention products, excluding condoms, provide no pregnancy protection. Intravaginal rings (IVRs) delivering antiretrovirals and contraceptives are a promising multipurpose prevention technology (MPT). ⋯ In qualitative interviews, women were willing to continuously use an IVR for 6-12 months, providing it did not "degrade" inside the body. Reasons for trial participation and prevention preferences, menstrual attitudes, and perceived IVR benefits and doubts varied by site. Conclusions: Findings provide strong evidence of demand for an MPT IVR that protects from pregnancy and HIV/STIs, lasts longer than 1 month, minimally disrupts menstrual bleeding, and is in women's control. numberClinicalTrials.gov: #NCT03279120.
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Journal of women's health · Aug 2022
Randomized Controlled TrialRemotely Educating Young Women About Alcohol: A Randomized Trial of the PartyWise Intervention.
Background: Alcohol and binge drinking pose significant health risks, especially for underage women; nonetheless, binge drinking is common. Materials and Methods: To evaluate the effectiveness of the PartyWise intervention in increasing awareness of sex differences in the risks of binge drinking, we used social media to enroll 520 female adolescents aged 15-19 years in a randomized controlled trial. Intervention participants received telephone screening, a brief counseling intervention with web-based resources (http://www.partywise.org), and up to 8 weekly text messages. ⋯ Although rates of any binge drinking in the past month remained similar between groups, intervention recipients were less likely to report binge drinking more than once in the past 30 days (22% vs. 32%, adj OR 0.58, 95% CI 0.35-0.99 at 3 months; 27% vs. 30%, adj OR 0.97, 95% CI 0.60-1.55 at 9 months). Conclusions: The PartyWise intervention is a promising approach to increasing awareness of the risks of binge drinking for underage women in a remotely delivered platform. Clinical Trials Registration: The Share Health Study: Teen Social Connections and Health (Phase 2), NCT03842540, https://clinicaltrials.gov/ct2/show/NCT03842540?id=NCT03842540&draw=2&rank=1.
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Journal of women's health · Jul 2022
Randomized Controlled TrialAcceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial.
Background: The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined acceptability and preference for 3-month versus 1-month rings for HIV-1 risk reduction in a phase 1 clinical trial. Materials and Methods: In Microbicide Trials Network-036/International Partnership for Microbicides 047, 49 HIV-negative participants aged 18-45 were randomized to one of two 3-month rings or the 1-month ring. ⋯ Conclusions: Both ring durations were highly acceptable at study exit. Although most participants preferred a 3-month ring, preference was more divided in certain subgroups, highlighting the benefit of offering different duration options. Providing additional support to address concerns about hygiene and safety may improve acceptability of a 3-month vaginal ring.
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Journal of women's health · Jun 2022
Randomized Controlled TrialThe Impact of Caffeine Intake on Mental Health Symptoms in Postmenopausal Females with Overactive Bladder Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial.
Background: Caffeine has been associated with a dose-dependent variety of mental health changes, which have been found to precede or be a complication of overactive bladder (OAB) symptoms after menopause. The current study examines the effects of low and moderate caffeine intake on anxiety, depression, sleep, and stress in postmenopausal females with OAB. Materials and Methods: Eighty-one females were randomized in a prospective, double-blind, placebo-controlled study. ⋯ Conclusions: Moderate caffeine use may decrease anxiety in postmenopausal patients with underlying OAB, whereas depression, insomnia, and perceived stress were not affected by low-to-moderate caffeine intake. Our results support that counseling efforts on moderate caffeine consumption in postmenopausal patients underline that low-to moderate caffeine intake may be appropriate and possibly beneficial unless contraindicated due to other underlying conditions. Clinical Trials Registration: clinicaltrials.gov (NCT02180048).