Accuracy of self-assessment of gestational duration among people seeking abortion.

BACKGROUND: Mifepristone, used together with misoprostol, is approved by the United States Food and Drug Administration for medication abortion through 10 weeks' gestation. Although in-person ultrasound is frequently used to establish medication abortion eligibility, previous research demonstrates that people seeking abortion early in pregnancy can accurately self-assess gestational duration using the date of their last menstrual period. OBJECTIVE: In this study, we establish the screening performance of a broader set of questions for self-assessment of gestational duration among a sample of people seeking abortion at a wide range of gestations. STUDY DESIGN: We surveyed patients seeking abortion at 7 facilities before ultrasound and compared self-assessments of gestational duration using 11 pregnancy dating questions with measurements on ultrasound. For individual pregnancy dating questions and combined questions, we established screening performance focusing on metrics of diagnostic accuracy, defined as the area under the receiver operating characteristic curve, sensitivity (or the proportion of ineligible participants who correctly screened as ineligible for medication abortion), and proportion of false negatives (ie, the proportion of all participants who erroneously screened as eligible for medication abortion). We tested for differences in sensitivity across individual and combined questions using McNemar's test, and for differences in accuracy using the area under the receiver operating curve and Sidak adjusted P values. RESULTS: One-quarter (25%) of 1089 participants had a gestational duration of >70 days on ultrasound. Using the date of last menstrual period alone demonstrated 83.5% sensitivity (95% confidence interval, 78.4-87.9) in identifying participants with gestational durations of >70 days on ultrasound, with an area under the receiver operating characteristic curve of 0.82 (95% confidence interval, 0.79-0.85) and a proportion of false negatives of 4.0%. A composite measure of responses to questions on number of weeks pregnant, date of last menstrual period, and date they got pregnant demonstrated 89.1% sensitivity (95% confidence interval, 84.7-92.6) and an area under the receiver operating curve of 0.86 (95% confidence interval, 0.83-0.88), with 2.7% of false negatives. A simpler question set focused on being >10 weeks or >2 months pregnant or having missed 2 or more periods had comparable sensitivity (90.7%; 95% confidence interval, 86.6-93.9) and proportion of false negatives (2.3%), but with a slightly lower area under the receiver operating curve (0.82; 95% confidence interval, 0.79-0.84). CONCLUSION: In a sample representative of people seeking abortion nationally, broadening the screening questions for assessing gestational duration beyond the date of the last menstrual period resulted in improved accuracy and sensitivity of self-assessment at the 70-day threshold for medication abortion. Ultrasound assessment for medication abortion may not be necessary, especially when requiring ultrasound could increase COVID-19 risk or healthcare costs, restrict access, or limit patient choice.

Linkage to Care Following an HIV Diagnosis in Three Public Sector Clinics in eThekwini (Durban), South Africa: Findings from a Prospective Cohort Study.

Linkage to care following an HIV diagnosis remains an important HIV care continuum milestone, even in the era of universal ART eligibility. In an 8-month prospective cohort study among 459 (309 women, 150 men) newly-diagnosed HIV-positive individuals in three public-sector clinics in Durban metropolitan region, South Africa, from 2010 to 2013, median time to return to clinic for CD4+ results (linkage) was 10.71 weeks (95% CI 8.52-12.91), with 54.1% 3-month cumulative incidence of linkage. At study completion (9.23 months median follow-up), 26.2% had not linked. Holding more positive outcome-beliefs about enrolling in care was associated with more rapid linkage [adjusted hazard ratio (AHR)each additional belief 1.31; 95% CI 1.05-1.64] and lower odds of never linking [adjusted odds ratio (AOR) 0.50; 95% CI 0.33-0.75]. Holding positive ARV beliefs was strongly protective against never linking to care. Age over 30 years (AHR 1.59; 95% CI 1.29-1.97) and disclosing one's HIV-positive status within 30 days of diagnosis (AHR 1.52; 95% CI 1.10-2.10) were associated with higher linkage rates and lower odds of never linking. Gender was not associated with linkage and did not alter the effect of other predictors. Although expanded access to ART has reduced some linkage barriers, these findings demonstrate that people's beliefs and social relations also matter. In addition to structural interventions, consistent ART education and disclosure support, and targeting younger individuals for linkage are high priorities.

Social Support and Violence-prone Relationships as Predictors of Disclosure of HIV Status Among Newly Diagnosed HIV-positive South Africans.

Despite the salience of social support and violence as potential outcomes of disclosure, how pre-existing social support and relationship violence among people living with HIV shapes and influences HIV status disclosure has received limited attention. Following the Disclosure Process Model, this study investigated pre-disclosure support and violence-prone relationships as predictors of disclosure using data from a prospective study of 459 newly diagnosed South African women and men. Most (88%) disclosed their status to at least one person by their 8-month interview. Level of social support was unrelated to disclosure to a partner. However, those with higher levels of support had higher odds of disclosing to family and to others. Women in violence-prone relationships were more likely to report disclosure to a partner than were those not in such relationships, counter to expectations. The findings suggest that the same mechanisms may not explain processes of disclosure across all relationship types.

"I did not see a need to get tested before, everything was going well with my health": a qualitative study of HIV-testing decision-making in KwaZulu-Natal, South Africa.

Few studies have examined HIV-testing decision-making since the South African national HIV counseling and testing campaign in 2010-2011 and subsequent expansion in antiretroviral therapy (ART) eligibility in 2012. We describe HIV-testing decision-making and pathways to testing among participants in Pathways to Care, a cohort study of newly-diagnosed HIV-positive adults in KwaZulu-Natal. Our analysis is embedded within a theoretical framework informed by Arthur Kleinman's work on pluralistic healthcare systems, and the concept of diagnostic itineraries (i.e., the route taken to HIV testing). We conducted 26 semi-structured interviews in 2012, within one month of participants' diagnosis. Most (n = 22) deferred testing until they had developed symptoms, and then often sought recourse in non-biomedical settings. Of the eleven symptomatic participants who accessed professional medical services prior to testing, only three reported that a healthcare professional had offered or recommended an HIV test. Although ART emerged as an important motivator, offering hope of health and normalcy, fear of death and HIV-related stigma remained key barriers. Despite national policy changes in testing and treatment, health system and individual factors contributed to ongoing high levels of late diagnosis of HIV in this study population. Encouraging local health systems to direct clients toward HIV testing, and continuing to raise awareness of the benefits of routine testing remain important strategies to reduce delayed diagnoses.

Sexual Risk and Intravaginal Practice Behavior Changes During Pregnancy.

Data suggest that pregnant women in some settings have high prevalence of HIV and other sexually transmitted infections (STI). We examined changes in sexual risk behaviors and intravaginal practices during pregnancy that may contribute to HIV and STI incidence using data from the Methods for Improved Reproductive Health in Africa study conducted in South Africa and Zimbabwe 2003-2006. We used a crossover design and modified Poisson regression to compare behaviors among HIV negative women 18-45 years during pregnant and non-pregnant periods. Among the 4802 women <45 years at enrollment, 483 (10.1 %) had a pregnancy and were included in the analysis. Compared to non-pregnant periods, pregnancy was associated with fewer than 3 sex acts per week (adjusted risk ratio [ARR] 0.89; 95 % CI 0.79-0.99) but more sex acts without condoms (ARR 1.32; 95 % CI 1.15-1.51). Pregnancy was also associated with decreased reporting of other sexual risk behaviors including any anal sex, multiple sexual partners, and/or sex in exchange for drugs or money. Women also reported less intravaginal wiping during pregnancy (ARR 0.84; 95 % CI 0.76-0.93). We found pregnancy decreased sexual activity and some high-risk sexual behaviors but increased the risk of sex without a condom.

Contraceptive Use among Women in Accra, Ghana: 2003 and 2008.

Despite a relatively low fertility rate, maternal mortality in Ghana still remains high. According to the Ghana Demographic and Health Surveys, about 22% of Ghanaian women of reproductive age currently use contraception. We analyzed contraceptive use among a representative sample of women in Accra, Ghana, to better understand contraceptive use patterns. We used data from two cross-sectional surveys of a representative cohort of women in Accra. In 2003, 28.9% of sexually active women used a contraceptive method. In 2008, 31.5% of sexually active women used a contraceptive method. Additionally, we observed high rates of discontinuation-from 64.1% among those using longer-acting methods to 82.1% among those using traditional methods-between years. Further research on women's contraceptive decision-making is needed to explain these patterns and to ensure that family planning interventions meet the needs of women in Ghana.

Do miscarriage care practice recommendations align with individuals' needs?: A scoping review.

OBJECTIVES: Miscarriage is a common occurrence; yet individuals often have negative experiences when receiving miscarriage care, signaling a gap in the quality of miscarriage care. We explore the literature on individuals' experiences with miscarriage care across a variety of dimensions and assess how these experiences align with practice recommendations. STUDY DESIGN: We conducted a scoping review of peer-reviewed studies in PubMed published in English through April 30, 2022, and focused on individuals' experiences with miscarriage care in healthcare settings and on practice recommendations for providing care in a variety of countries. The search returned 1812 studies; after screening, 41 studies were included in the analysis. RESULTS: Included studies reported on individuals' experiences with miscarriage care settings and accessibility, information provision, emotional support, decision-making and follow-up. Overall, individuals are often dissatisfied with their miscarriage care experiences. Practice recommendations are generally responsive to these issues. CONCLUSIONS: Individuals experiencing miscarriage are best served by care that is patient-centered, involves shared decision-making, and addresses individuals' informational and emotional needs. However, the prevalence of individuals' negative experiences with miscarriage care points to the need to address key gaps in and improve the implementation of practice recommendations. IMPLICATIONS: Future research should focus on documenting the miscarriage experiences of and developing relevant practice recommendations for communities that face the greatest barriers to care, generating evidence on the dimensions that constitute high-quality miscarriage care from patients' perspectives and assessing the barriers and facilitators to effectively implementing existing practice recommendations.

Do goals of care documentation reflect the conversation?: Evaluating conversation-documentation accuracy.

BACKGROUND: Documenting goals of care in the electronic health record is meant to relay patient preferences to other clinicians. Evaluating the content and documentation of nurse and social worker led goals of care conversations can inform future goals of care initiative efforts. METHODS: As part of the ADvancing symptom Alleviation with Palliative Treatment trial, this study analyzed goals of care conversations led by nurses and social workers and documented in the electronic health record. Informed by a goals of care communication guide, we identified five goals of care components: illness understanding, goals and values, end of life planning, surrogate, and advance directives. Forty conversation transcripts underwent content analysis. Through an iterative team process, we defined documentation accuracy as four categories: (1) Complete-comprehensive accurate documentation of the conversation, (2) Incomplete-partial documentation of the conversation, (3) Missing-discussed and not documented, and (4) Incorrect-misrepresented in documentation. We also defined-Not Discussed-for communication guide questions that were not discussed nor documented. A constant comparative approach was used to determine the presence or absence of conversation content in the documentation. RESULTS: All five goals of care components were discussed in 67% (27/40) of conversation transcripts. Compared to the transcripts, surrogate (37/40, 93%) and advance directives (36/40, 90%) were often documented completely. Almost 40% of goals and values (15/40, 38%) and half of end of life planning (19/40, 48%) were incomplete. Illness understanding was missing (13/40, 33%), not discussed (13/40, 33%), or incorrect (2/40, 5%). CONCLUSION: Nurse and social worker led goals of care conversations discussed and documented most components of the goals of care communication guide. Further research may guide how best to determine the relative importance of accuracy, especially in the broad setting of incomplete, missing, and incorrect EHR documentation.

What happens to the women who fall through the cracks of health care reform? Lessons from Massachusetts.

We investigated the impact of Massachusetts health care reform on low-income women's experiences accessing insurance and health services, specifically reproductive health services such as contraception. Our findings suggest that concentrated efforts are needed to make sure that health services are available and accessible to populations who fall through the cracks of health care reform, including immigrants, minors and young adults, and women living outside urban areas. In addition, systems changes are needed to ensure that women going through common life transitions, such as pregnancy, marriage, moving, or graduating from school, have continuous access to insurance, and therefore health services, as their lives change. These groups face barriers enrolling in and maintaining their insurance coverage as well as obtaining timely health care benefits they are eligible for through their insurance benefits or public health programs. Without intervention, many in these groups may delay or avoid seeking health care altogether, which may increase health care disparities in the long term. Family planning providers in Massachusetts have played a critical role in mitigating barriers to insurance and health care. However, recent threats to defund family planning providers call into question the ability of these providers to continue providing much-needed services.

A commentary on progestin-only pills and the "three-hour window" guidelines: Timing of ingestion and mechanisms of action.

Clinical guidelines for progestin-only pills (POPs) state that each pill should be taken at the same time each day, with only a "three-hour window" of tolerance before back-up contraception should be used. In this commentary, we summarize studies examining the timing of ingestion and mechanisms of action for various POP formulations and dosages. We found that different progestins have different properties that determine the effect of delayed or missed pills on effectiveness at preventing pregnancy. Our findings highlight that there is more margin for error for some POPs than guidelines suggest. The three-hour window recommendation should be re-evaluated in light of these findings. Since clinicians, potential POP users, and regulatory bodies rely on current guidelines to make decisions about POP use, a critical evaluation and update of these guidelines are urgently needed.

Experiences using a progestin-only pill in an over-the-counter environment in the United States: a cross-sectional survey.

BACKGROUND: Efforts are underway to make a progestin-only pill (POP) over the counter (OTC) in the United States (US); however, little is known about POP user experiences, which could impact uptake and continuation. METHODS: From January 2020-September 2021, we conducted a cross-sectional online survey with individuals who used OTC POPs in a US trial. We calculated descriptive statistics and Pearson chi-square and Fisher's exact tests to assess menstrual bleeding acceptability, how OTC POP experiences compared with prior contraceptive methods, and preferred ways to get answers to questions during OTC POP use. RESULTS: Among 550 adult and 115 adolescent participants, 80% (n=531) felt their menstrual bleeding was acceptable. Participants reported a range of menstrual bleeding experiences compared with prior long-acting or hormonal methods used; 58% (n=84) said the POP bleeding was similar or better and 36% (n=53) said it was worse. Among participants who used contraception in the month prior to the trial, 77% (n=201) said their overall OTC POP experience was similar or better. Top benefits compared with prior methods included less worry about pregnancy, ease of access, fewer side effects, and greater decision-making power. Adults preferred to get answers about OTC POPs via webpage or app, whereas teens preferred asking pharmacists or other healthcare providers. CONCLUSIONS: Overall, OTC POP users in a trial setting found the menstrual bleeding acceptable and the method similar to or better than previous methods. POP labelling should provide clear messaging about bleeding changes users may experience.

Effectiveness and efficacy rates of progestin-only pills: A comprehensive literature review.

OBJECTIVES: To synthesize published literature on POP effectiveness and efficacy. STUDY DESIGN: We searched PubMed Central, PubMed, and the Cochrane library through March 07, 2022. We included articles written in English reporting a Pearl Index or life table rate for pregnancy. We excluded articles only assessing formulations that: were never marketed globally, are only sold in combination with estrogen, are currently sold only for noncontraceptive purposes, or were not given to participants continuously. Four researchers independently extracted data and two analyzed data using Excel and R. RESULTS: We included 54 studies. Among studies at low or moderate risk of bias, the median Pearl Index rate (the failure rate during typical use) was 1.63 (range 0.00-14.20, IQR 4.03) and the median method failure Pearl Index rate (the failure rate during perfect use) was 0.97 (range 0.40-6.50, IQR 0.68). Excluding the newer formulations, Desogestrel and Drospirenone, which are closer to combined oral contraceptives in that they prevent pregnancy by inhibiting ovulation, the median Pearl Index rate is 2.00 (range 0.00-14.12, IQR 2.5) and the median method failure Pearl Index rate is 1.05 (range 0.00-10.90, IQR 1.38). CONCLUSIONS: Among studies at low or moderate risk of bias, the median Pearl Index rate during typical POP use was much lower than currently estimated (7.00), while the median perfect use rate was similar to current estimates. IMPLICATIONS: Future research should investigate the possibility that POPs may be much more effective during typical use than currently believed.

Pilot label comprehension study for an over-the-counter combined oral contraceptive pill in the United States.

CONTEXT: A growing body of evidence supports over-the-counter access to oral contraceptives in the United States. An important consideration for over-the-counter approval is consumers' ability to understand key package label messages related to safety and effectiveness without clinician involvement. We developed a prototype over-the-counter Drug Facts Label for a combined oral contraceptive pill and conducted a pilot label comprehension study to evaluate consumer understanding of key messages for use. METHODS: In November-December 2020, we conducted interviews with 163 adults and teens in the United States who were aged 12-49 years and identified as female or another gender but had a uterus and the ability to become pregnant. We developed 11 primary endpoints based on assessment of clinical risks that could occur if consumers fail to heed them, including messages about contraindications and directions for use; 11 secondary endpoints represented additional important information but with lower potential for clinical consequences if not understood. We evaluated endpoint comprehension by computing frequencies, percentages, and 2-sided Exact (Clopper-Pearson) 95% confidence intervals for observed proportions. RESULTS: Ten of the 11 primary endpoints and 10 of the 11 secondary endpoints were each understood by ≥95% of participants. The remaining primary endpoint on use with prior blood clots was understood by 89% of participants. The remaining secondary endpoint on the product being designed for "people who have the ability to become pregnant" was understood by 83% of participants. CONCLUSION: Participants understood the key label information required for safe and effective combined oral contraceptive use without clinician involvement.

Male circumcision for HIV prevention: clinical practices and attitudes among healthcare providers in South Africa and Zimbabwe.

BACKGROUND: This study aimed to document the clinical practices and attitudes of health care providers in South Africa and Zimbabwe on male circumcision for human immunodeficiency virus (HIV) prevention. METHODS: We conducted national surveys of physicians and nurses in both countries in 2008-2009 (N = 1444). Data on male circumcision for HIV prevention were analyzed; outcomes were patient counseling, provision of services, and desire for training. We used multivariable logistic regression to examine associations between these outcomes and clinician, practice, and attitudinal variables. RESULTS: Overall, 57% of clinicians reported counseling male patients on male circumcision, 17% were offering services (49% referrals), and 61% desired training. In the multivariable analyses, provision of services was more common in South Africa (P ≤ 0.001) but desire for training higher in Zimbabwe (P ≤ 0.01). Provision of services was highest among physicians (P ≤ 0.01) and in hospital settings (P ≤ 0.001). However, nurses had greater desire for training (P ≤ 0.05) as did younger clinicians (P ≤ 0.001). Clinicians in rural and clinic settings were just as likely to express training interest. Clinician attitudes that patients would be upset due to cultural beliefs and would increase risky behaviors were associated with less counseling and service provision (P ≤ 0.05). CONCLUSIONS: Many clinicians in South Africa and Zimbabwe showed willingness to integrate new HIV prevention evidence into practice and to become trained to offer the procedure to patients. Results suggest that both countries should consider involving nurses in male circumcision for HIV prevention, including those in rural areas, and should help clinicians to address cultural concerns.

Willingness of clinicians to integrate microbicides into HIV prevention practices in southern Africa.

The first vaginal microbicide was recently proven effective in clinical trials. We assessed the willingness of clinicians to integrate microbicides into HIV prevention practices in Southern Africa, where women face elevated HIV risks. We conducted in-depth interviews (n = 60) and nationally representative surveys (n = 1,444) in South Africa and Zimbabwe with nurses and physicians. Over half of clinicians (58%) were aware of microbicides, with physicians far more likely than nurses to be familiar. Clinicians, including those in rural areas, were generally willing to discuss microbicides, a female-initiated method less effective than the condom, particularly when condom use was unlikely (70%). Fewer would include microbicides while counseling adolescents (51%). Most clinicians (85%) thought their patients would use microbicides; greater clinician familiarity with microbicides was significant for support. Training for both nurses and physicians prior to introduction is critical, so they have sufficient knowledge and skills to offer a microbicide upon availability.

Assessment of service availability and health care workers' opinions about young women's sexual and reproductive health in Soweto, South Africa.

Young women in South Africa experience high HIV and unintended pregnancy rates. Health care workers' (HCWs') opinions about sexual and reproductive health (SRH) issues impact young women's ability to access SRH services. We explored HCW opinions through interviews with a purposive sample of 29 HCWs in three primary health clinics in Soweto, South Africa and examined service availability through facility assessments. Most HCWs believed young women should not have sex before marriage and thought that young women ignore information they receive about HIV and pregnancy prevention. HCWs acknowledged outside factors influencing young women's ability to protect themselves. Most thought injectables were the most appropriate contraception for young women; all recognized the importance of condoms for dual protection. Some services were only reported to be provided to those over 18 years. HCWs may benefit from workshops providing technical and policy information and values clarification exercises highlighting the impact of opinions on service provision.

Pain, Side Effects, and Abortion Experience Among People Seeking Abortion Care in the Second Trimester.

Background: There is limited documentation about pain and side effects associated with dilation and evacuation (D&E) abortion, yet, pain and side effects are important factors that can affect a client's abortion experience. In 2016, Hope Clinic for Women, an independent abortion clinic in Illinois, altered its cervical preparation protocols before D&E to reduce the total time of the abortion process and improve the client experience. This analysis addresses the gap in data on client experience of abortion in the later second trimester by evaluating pain, side effects, and acceptability by gestational age. Methods: Abortion clients obtaining services at the clinic between March 2017 and June 2018 were eligible to participate if they had viable singleton pregnancies of 16-23.6 weeks' gestation, spoke English, and were at least 18 years old. Eligible participants completed a two-part survey about their abortion experience. Results: We found that respondents seeking abortion care at later gestations in the second trimester were more likely to report pain during their abortions. We did not find any association between side effects and gestational age. Conclusion: Although most respondents were prepared for the pain they experienced, some reported experiencing more pain than they expected, and more effective pain relief was commonly reported as a way to improve the service. More research on patient experiences of later abortion is needed, particularly on experiences of pain and options for pain management.

Interest in Continued Use After Participation in a Study of Over-the-Counter Progestin-Only Pills in the United States.

Objective: To assess interest in continued use of over-the-counter progestin-only pills among individuals who used them in a trial. Methods: From January 2020 to September 2021, we conducted a cross-sectional online survey with individuals who completed participation in a trial evaluating over-the-counter use of norgestrel 0.075 mg tablets in the United States. We calculated descriptive statistics, Pearson's chi-square and Fisher's exact tests, and logistic regression models to assess likelihood of future over-the-counter progestin-only pill use, reasons for interest/noninterest, situations for over-the-counter progestin-only pill use, willingness to pay for an over-the-counter progestin-only pill, likelihood of future preventive health screenings, prior difficulties getting prescription contraception, and background characteristics. Results: Among 550 adult and 115 adolescent participants (75% response rate), 83% reported likelihood of future over-the-counter progestin-only pill use. Hispanic/Latinx and Black participants and adults with public insurance, prior pregnancies, and some college reported higher likelihood of future use compared with their counterparts. Among likely users, 90% were interested in long-term use and 79 % ≥ 25 years of age reported they would get future preventive screenings; participants would pay up to $20/month on average. Primary reasons for interest included convenience (81%), ease of access (80%), and saving time (77%) and money (64%). The primary reason for noninterest was bleeding associated with progestin-only pill use (52%). Conclusion: There was high interest in continuing to use over-the-counter progestin-only pills among individuals who had used them in a study. These findings highlight the real-world acceptability of taking a progestin-only pill without a prescription, and contribute to evidence supporting over-the-counter access.