Offering extended use of the contraceptive implant via an implementation science framework: a qualitative study of clinicians' perceived barriers and facilitators.

BACKGROUND: The etonogestrel contraceptive implant is currently approved by the United States Food and Drug Administration (FDA) for the prevention of pregnancy up to 3 years. However, studies that suggest efficacy up to 5 years. There is little information on the prevalence of extended use and the factors that influence clinicians in offering extended use. We investigated clinician perspectives on the barriers and facilitators to offering extended use of the contraceptive implant. METHODS: Using the Consolidated Framework for Implementation Research (CFIR), we conducted semi-structured qualitative interviews. Participants were recruited from a nationwide survey study of reproductive health clinicians on their knowledge and perspective of extended use of the contraceptive implant. To optimize the diversity of perspectives, we purposefully sampled participants from this study. We used content analysis and consensual qualitative research methods to inform our coding and data analysis. Themes arose deductively and inductively. RESULTS: We interviewed 20 clinicians including advance practice clinicians, family medicine physicians, obstetrician/gynecologist and complex family planning sub-specialists. Themes regarding barriers and facilitators to extended use of the contraceptive implant emerged. Barriers included the FDA approval for 3 years and clinician concern about liability in the context of off-label use of the contraceptive implant. Educational materials and a champion of extended use were facilitators. CONCLUSIONS: There is opportunity to expand access to extended use of the contraceptive implant by developing educational materials for clinicians and patients, identifying a champion of extended use, and providing information on extended use prior to replacement appointments at 3 years.

Understanding feasibility and acceptability of implementation of linking delivery of family planning and infant vaccination care in rural Maharashtra, India: a qualitative study.

BACKGROUND: Linking family planning with infant vaccination care has the potential to increase contraceptive use among postpartum women in rural settings. We explored the multilevel factors that can facilitate or impede uptake of contraception at the time of infant vaccination among postpartum women and couples in rural Maharashtra, India. METHODS: We conducted 60 semi-structured interviews with key stakeholders including: postpartum married women (n = 20), husbands (n = 10), and mothers-in-law (n = 10) of postpartum women, frontline healthcare workers (auxiliary nurse midwives (ANMs) and Accredited Social Health Activists (ASHAs), (n = 10), and community leaders (physician medical officers and village panchayat leaders) (n = 10). We sought to assess the feasibility and acceptability of delivering community-based postpartum family planning care in rural India at the time of infant vaccination. The Consolidated Framework for Implementation Research (CFIR) was used to design a structured interview guide and codebook. Data were analyzed via directed content analysis. RESULTS: Three major themes emerged: (1) Social fertility and gender norms including son preference and male control over contraceptive decision-making influence postpartum contraceptive access and choice. (2) Linking contraceptive care and infant vaccination is perceived as potentially feasible and acceptable to implement by families, health workers, and community leaders. The intervention provides care to women and families in a convenient way where they are in their community. (3) Barriers and facilitators to linked infant postpartum contraception and infant vaccination were identified across the five CFIR domains. Key barriers included limited staff and space (inner setting), and contraceptive method targets for clinics and financial incentives for clinicians who provide specific methods (outer setting). Key facilitators included convenience of timing and location for families (intervention characteristics), the opportunity to engage husbands in decision-making when they attend infant vaccination visits (participant characteristics), and programmatic support from governmental and community leaders (process of implementation). CONCLUSIONS: Linked provision of family planning and infant vaccination care may be feasible and accessible in rural India utilizing strategies identified to reduce barriers and facilitate provision of care. A gender-transformative intervention that addresses gender and social norms has greater potential to impact reproductive autonomy and couples' contraceptive decision-making.

A qualitative analysis of pharmacists' attitudes towards provision of medication abortion.

BACKGROUND: 90% of United States' counties do not have a single clinic offering abortion care, and barriers to care disproportionately affect low-income families. Novel models of abortion care delivery, including provision of medication abortion in pharmacies, with pharmacists prescribing medication, have the potential to expand access to abortion care. Pharmacists are well-positioned to independently provide abortion care and are highly accessible to patients, however medication abortion provision by pharmacists is not currently legal or available in the United States. To assess the potential acceptability of pharmacist provision of medication abortion and to identify anticipated barriers and facilitators to this model of care, we explored pharmacists' attitudes towards providing medication abortion, inclusive of patient selection, counseling, and medication prescribing. METHODS: From May to October 2021, we conducted 20 semi-structured qualitative interviews with pharmacists across the United States, guided by the domains of the Consolidated Framework for Implementation Science Research. RESULTS: Major themes included there is a need for pharmacist provision of medication abortion and pharmacists perceive provision of medication abortion to be potentially acceptable if anticipated barriers are addressed. Anticipated barriers identified included personal, religious, and political beliefs of pharmacists and lack of space and systems to support the model. Ensuring adequate staffing with pharmacists willing to participate, private space, time for counseling, safe follow-up, training, and reimbursement mechanisms were perceived strategies to facilitate successful implementation. CONCLUSIONS: Pharmacist identified implementation strategies are needed to reduce anticipated barriers to pharmacist provision of medication abortion.

Association of traditional marital practices with contraceptive decision-making, couple communication, and method use among couples in rural Maharashtra, India.

In India, traditional social practices around marriage, such as non-involvement of prospective brides in choice of partner and timing of marriage, child/early marriage, dowry and purdah, compromise women's agency at the time of marriage and may also affect contraceptive practices in marriage. This paper examines the associations between traditional marital practices and contraceptive behaviours, including women's control over contraceptive decision-making, couples' communication about contraception, and ever use of contraceptives, among married women aged 18-29 years (N = 1,200) and their husbands in rural Maharashtra, India. Multivariable logistic regression was used to examine the association between these marginalising social practices and family planning behavioural outcomes, adjusting for demographic and parity confounders. Wives who were the primary decision-makers on who to marry had higher odds of ever having communicated with their husband on pregnancy prevention (AOR 1.76, 95% CI 1.16-2.68), and ever using modern contraceptives (AOR 2.19, 95% CI 1.52-3.16). Wives who were the primary decision-makers on when to marry also had higher odds of ever having used modern contraceptives (AOR 1.86, 95% CI 1.21-2.93). Women's involvement in marital choice may facilitate couples' engagement related to family planning, possibly via the establishment of better communication between partners.

Early vs Interval Postpartum Intrauterine Device Placement: A Randomized Clinical Trial.

Importance: The early postpartum period, 2 to 4 weeks after birth, may be a convenient time for intrauterine device (IUD) placement; the placement could then coincide with early postpartum or well-baby visits. Objective: To determine expulsion rates for IUDs placed early postpartum compared with those placed at the standard interval 6-week visit. Design, Setting, and Participants: In this randomized noninferiority trial, people who had a vaginal or cesarean birth were randomly assigned to undergo early (14-28 days) or interval (42-56 days) postpartum IUD placement. Clinicians blinded to participant study group used transvaginal ultrasonography to confirm IUD presence and position at the 6-month postpartum follow-up. The study assessed 642 postpartum people from 4 US medical centers, enrolled a consecutive sample of 404 participants from March 2018 to July 2021, and followed up each participant for 6 months postpartum. Interventions: Early postpartum IUD placement, at 2 to 4 weeks postpartum, vs standard interval placement 6 to 8 weeks postpartum. Main Outcomes and Measures: The primary outcome was complete IUD expulsion by 6 months postpartum; the prespecified noninferiority margin was 6%. Secondary outcomes were partial IUD expulsion, IUD removal, pelvic infection, patient satisfaction, uterine perforation, pregnancy, and IUD use at 6 months postpartum. IUD malposition was an exploratory outcome. Results: Among 404 enrolled participants, 203 participants were randomly assigned to undergo early IUD placement and 201 to undergo interval IUD placement (mean [SD] age, 29.9 [5.4] years; 46 [11.4%] were Black, 228 [56.4%] were White, and 175 [43.3%] were Hispanic). By 6 months postpartum, 53 participants (13%) never had an IUD placed and 57 (14%) were lost to follow-up. Among the 294 participants (73%) who received an IUD and completed 6-month follow-up, complete expulsion rates were 3 of 149 (2.0% [95% CI, 0.4%-5.8%]) in the early placement group and 0 of 145 (0% [95% CI, 0.0%-2.5%]) in the interval placement group (between-group difference, 2.0 [95% CI, -0.5 to 5.7] percentage points). Partial expulsion occurred in 14 (9.4% [95% CI, 5.2%-15.3%]) participants in the early placement group and 11 (7.6% [95% CI, 3.9%-13.2%]) participants in the interval placement group (between-group difference, 1.8 [95% CI, -4.8 to 8.6] percentage points). IUD use at 6 months was similar between the groups: 141 (69.5% [95% CI, 62.6%-75.7%]) participants in the early group vs 139 (67.2% [95% CI, 60.2%-73.6%]) in the interval group. Conclusions and Relevance: Early IUD placement at 2 to 4 weeks postpartum compared with 6 to 8 weeks postpartum was noninferior for complete expulsion, but not partial expulsion. Understanding the risk of expulsion at these time points may help patients and clinicians make informed choices about the timing of IUD placement. Trial Registration: ClinicalTrials.gov Identifier: NCT03462758.

Complications after interval postpartum intrauterine device insertion.

BACKGROUND: In the United States, up to 57% of women report resumption of sexual activity by the 6 week postpartum visit. Effective contraception should be addressed and provided at that time, to avoid unintended pregnancies and optimize interpregnancy intervals. Long-acting reversible contraceptives are the most effective forms of reversible contraception and are increasingly popular during the postpartum period. However, timing of postpartum intrauterine device (IUD) placement varies among providers and many delay insertion due to concerns for uterine perforation or expulsion of the IUD. OBJECTIVE: This study aimed to evaluate uterine perforation and expulsion rates with IUD insertion at 4-8 weeks postpartum vs 9-36 weeks postpartum. STUDY DESIGN: We performed a retrospective cohort study using the Kaiser Permanente Southern California electronic medical record from 2010 to 2016. We calculated the proportion of perforations and expulsions with IUD insertion at 4-8 weeks vs 9-36 weeks postpartum. Our primary outcome was the perforation rate. Secondarily, we evaluated the expulsion rate. For our minimum sample size calculation, to detect a difference of 0.5% in the perforation rate, with a baseline perforation rate of 0.5% for the 9-36 week postpartum IUD placement group, 80% power, and 5% alpha error rate, we would need at least 4221 participants per group, 8442 in total. RESULTS: A total of 24,959 patients met inclusion criteria (n=13,180 in the 4-8 week group, n=11,777 in the 9-36 week group). Of 430 patients with a confirmed complication, 157 uterine perforations and 273 IUD expulsions were identified. Perforation rates were significantly higher with placement at 4-8 weeks than at 9-36 weeks (0.78% vs 0.46%; P=.001). After adjusting for race and ethnicity, breastfeeding, IUD type, provider type, parity, most recent delivery, and body mass index, the odds of perforation remained higher with placement at 4-8 weeks than at 9-36 weeks (adjusted odds ratio, 1.92; 95% confidence interval, 1.28-2.89). Our Kaplan-Meier survival curve showed that the risk of uterine perforation remained elevated until approximately 22-23 weeks postpartum. Expulsion rates were similar between the 2 groups (1.02 vs 1.17; P=.52). CONCLUSION: Uterine perforation after interval postpartum IUD insertion is greater at 4-8 weeks than at 9-36 weeks, although perforation rates remain low at <1%. Expulsion rates did not differ between the groups. Because overall rates of uterine perforation are low, women can safely be offered IUDs at any interval beyond 4 weeks with minimal concern for perforation.

Associations between Contraceptive Decision-Making and Marital Contraceptive Communication and use in Rural Maharashtra, India.

Women's contraceptive decision-making control is crucial for reproductive autonomy, but research largely relies on the Demographic and Health Survey (DHS) measure which asks who is involved with decision-making. In India, this typically assesses joint decision-making or male engagement. Newer measures emphasize female agency. We examined three measures of contraceptive decision-making, the DHS and two agency-focused measures, to assess their associations with marital contraceptive communication and use in rural Maharashtra, India. We analyzed follow-up survey data from women participating in the CHARM2 study (n = 1088), collected in June-December 2020. The survey included the DHS (measure 1), Reproductive Decision-Making Agency (measure 2), and Contraceptive Final Decision-Maker measures (measure 3). Only Measure 1 was significantly associated with contraceptive communication (adjusted odds ratio [AOR]: 2.75, 95 percent confidence interval [CI]: 1.69-4.49) and use (AOR: 1.73, 95 percent CI: 1.14-2.63). However, each measure was associated with different types of contraceptive use: Measure 1 with condom (adjusted relative risk ratio [aRRR]: 1.99, 95 percent CI: 1.12-3.51) and intrauterine device (IUD) (aRRR: 4.76, 95 percent CI: 1.80-12.59), Measure 2 with IUD (aRRR: 1.64, 95 percent CI: 1.04-2.60), and Measure 3 with pill (aRRR: 2.00, 95 percent CI: 1.14-3.52). Among married women in Maharashtra, India, male engagement in decision-making may be a stronger predictor of contraceptive communication and use than women's agency, but agency may be predictive of types of contraceptives used.

Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception.

BACKGROUND: Long-acting reversible contraception (LARC), including intrauterine devices (IUDs) and contraceptive implants, are highly effective, reversible methods of contraception. Providing LARC methods during the postpartum period is important to support contraceptive choice, and to prevent unintended pregnancy and short interpregnancy intervals. Delaying offering contraception to postpartum people until the first comprehensive postpartum visit, traditionally at around six weeks postpartum, may put some postpartum people at risk of unintended pregnancy, either due to loss to follow-up or because of initiation of sexual intercourse prior to receiving contraception. Therefore, immediate provision of highly effective contraception, prior to discharge from hospital, has the potential to improve contraceptive use and prevent unintended pregnancies and short interpregnancy intervals. OBJECTIVES: To compare the initiation rate, utilization rates (at six months and 12 months after delivery), effectiveness, and adverse effects of immediate versus delayed postpartum insertion of implants and IUDs for contraception. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and POPLINE for eligible studies up to December 2020. We examined review articles and contacted investigators. We checked registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies. SELECTION CRITERIA: We sought randomized controlled trials (RCTs) that compared immediate postpartum versus delayed insertion of contraceptive implant and IUDs for contraception. DATA COLLECTION AND ANALYSIS: Two review authors (JS, SK) independently screened titles and abstracts of the search results, and assessed the full-text articles of potentially relevant studies for inclusion. They extracted data from the included studies, assessed risk of bias, compared results, and resolved disagreements by consulting a third review author (PL, SA or PP). We contacted investigators for additional data, where possible. We computed the Mantel-Haenszel or inverse variance risk ratio (RR) with 95% confidence interval (CI) for binary outcomes and the mean difference (MD) with 95% CI for continuous variables. MAIN RESULTS: In this updated review, 16 studies met the inclusion criteria; five were studies of contraceptive implants (715 participants) and 11 were studies of IUDs (1894 participants). We identified 12 ongoing studies. We applied GRADE judgements to our results; the overall certainty of the evidence for each outcome ranged from moderate to very low, with the main limitations being risk of bias, inconsistency, and imprecision. Contraceptive implants Immediate insertion probably improves the initiation rate for contraceptive implants compared with delayed insertion (RR 1.48, 95% CI 1.11 to 1.98; 5 studies, 715 participants; I2 = 95%; moderate-certainty evidence). We are uncertain if there was a difference between the two groups for the utilization rate of contraceptive implants at six months after delivery (RR 1.16, 95% CI 0.90 to 1.50; 3 studies, 330 participants; I2 = 89%; very low-certainty evidence) or at 12 months after insertion (RR 0.98, 95% CI 0.93 to 1.04; 2 studies, 164 participants; I2 = 0%; very low-certainty evidence). People who received an immediate postpartum contraceptive implant insertion may have had a higher mean number of days of prolonged vaginal bleeding within six weeks postpartum (mean difference (MD) 2.98 days, 95% CI -2.71 to 8.66; 2 studies, 420 participants; I2 = 91%; low-certainty evidence) and a higher rate of other adverse effects in the first six weeks after birth (RR 2.06, 95% CI 1.38 to 3.06; 1 study, 215 participants; low-certainty evidence) than those who received a delayed postpartum insertion. We are uncertain if there was a difference between the two groups for prolonged bleeding at six months after delivery (RR 1.19, 95% CI 0.29 to 4.94; 2 studies, 252 participants; I2 = 0%; very low-certainty evidence). There may be little or no difference between the two groups for rates of unintended pregnancy at six months (RR 0.20, 95% CI 0.01 to 4.08; one study, 205 participants; low-certainty evidence). We are uncertain whether there was a difference in rates of unintended pregnancy at 12 months postpartum (RR 1.82, 95% CI 0.38 to 8.71; 1 study, 64 participants; very low-certainty evidence). There may be little or no difference between the two groups for any breastfeeding rates at six months (RR 0.97, 95% CI 0.92 to 1.01; 2 studies, 225 participants; I2 = 48%; low-certainty evidence). IUDs Immediate insertion of IUDs probably improves the initiation rate compared with delayed insertion, regardless of type of IUD (RR 1.27, 95% CI 1.07 to 1.51; 10 studies, 1894 participants; I2 = 98%; moderate-certainty evidence). However, people who received an immediate postpartum IUD insertion may have had a higher expulsion rate at six months after delivery (RR 4.55, 95% CI 2.52 to 8.19; 8 studies, 1206 participants; I2 = 31%; low-certainty evidence) than those who received a delayed postpartum insertion. We are uncertain if there was a difference between the two groups in the utilization of IUDs at six months after insertion (RR 1.02, 95% CI 0.65 to 1.62; 6 studies, 971 participants; I2 = 96%; very low-certainty evidence) or at 12 months after insertion (RR 0.86, 95% CI 0.5 to 1.47; 3 studies, 796 participants; I2 = 92%; very low-certainty evidence). Immediate IUDs insertion may reduce unintended pregnancy at 12 months (RR 0.26, 95% CI 0.17 to 0.41; 1 study, 1000 participants; low-certainty evidence). We are uncertain whether there was difference in any breastfeeding rates at six months in people receiving progestin-releasing IUDs (RR 0.90, 95% CI 0.63 to 1.30; 5 studies, 435 participants; I2 = 54%; very low-certainty evidence). AUTHORS' CONCLUSIONS: Evidence from this updated review indicates that immediate postpartum insertion improves the initiation rate of both contraceptive implants and IUDs by the first postpartum visit compared to delayed insertion. However, it is not clear whether that there are differences in utilization rates at six and 12 months postpartum. We are uncertain whether there is any difference in the unintended pregnancy rate at 12 months. Provision of progestin-releasing implants and IUDs immediately postpartum may have little or no negative impact on breastfeeding. However, the expulsion rate of IUDs and prolonged vaginal bleeding associated with immediate implants appears to be higher.

FundAl Retroflexion (FAR) Angle is a Novel Sonographic Marker Associated With Cesarean Scar Pregnancies in the First Trimester: A Case-Control Study.

OBJECTIVES: Early diagnosis of Cesarean scar pregnancies (CSP) remains difficult. This study describes a novel sonographic marker, the FundAl Retroflexion (FAR) angle, that may be used in the first trimester. The objective of the study is to compare the FAR angle between CSP and normal pregnancies. METHODS: For this case-control study, we reviewed images from our institution's database that were acquired from January 2016 to December 2019. All cases of CSP and randomly selected controls, defined as patients with history of Cesarean delivery and normal implantation, that underwent ultrasound evaluation at <14 weeks were included. The FAR angle, defined as the acute angle created between the endometrial echo and cervical canal, was measured. The mean FAR angle was then compared between the two groups and a receiver operating characteristic (ROC) curve was generated. RESULTS: We identified 15 cases of CSP during the study period and were able to measure the FAR angle in 14 of the cases. The mean FAR angle was larger in CSP than in normal control pregnancies (45° versus 27°, respectively, P < 0.001). Using an ROC curve, a FAR angle cut off of 40° maximizes the ability to distinguish between CSP from normal pregnancies. CONCLUSIONS: The FAR angle provides an easily obtainable and numerical measurement. CSP have larger FAR angle compared to normal controls with a distinguishing cut off of 40°. Larger studies are needed to determine if using the FAR angle can improve first trimester diagnosis for CSP.

PrEP University: A Multi-Disciplinary University-Based HIV Prevention Education Program.

The introduction of emtricitabine/tenofovir diphosphate (FTC/TDF) as pre-exposure prophylaxis (PrEP) for HIV prevention has raised questions regarding which clinicians will serve as prescribers and how providers will be educated about this HIV prevention strategy. We piloted an HIV Prevention Education Program called PrEP University (PrEP U) to address knowledge gaps in HIV prevention among medical trainees. We examined PrEP awareness and assessed learning as a result of the program, measuring knowledge before and after the lectures with an anonymous 5-question multiple choice test. A total of 198 learners participated in PrEP University, which included 127 first year medical students, and post-graduate trainees in internal medicine (n = 23), family medicine (n = 16), OBGYN (n = 13) and pharmacy (n = 19). Prior to PrEP U, 27% of all participants were not aware of PrEP and an additional 8% were unsure if they had heard of it. Knowledge increased significantly after the education program among trainees in OBGYN (2.3 vs 3.8, p < 0.001), pharmacy (1.4 vs 2.5, p = 0.012) and school of medicine (3.3 vs 4.4, p < 0.001), with a trend seen in family medicine (2.7 vs. 3.7, p = 0.067) and internal medicine (2.7 vs 3.4, p = 0.068). Overall, an HIV Prevention Education Program was successfully administered to nearly 200 participants and resulted in improved knowledge of HIV prevention and PrEP across. Pharmacists and OBGYN physicians are two groups with an expanding role in the use of PrEP. Similar programs at other medical schools should be implemented to ensure that future physicians and pharmacists are comfortable with PrEP prescription.

Out-of-clinic and self-managed abortion in Bangladesh: menstrual regulation provider perspectives.

BACKGROUND: In Bangladesh, abortion is illegal except to save a woman's life, though menstrual regulation (MR) is permitted. MR involves the use of manual uterine aspiration or Misoprostol (with or without Mifepristone) to induce menstruation up to 10-12 weeks from the last menstrual period. Despite the availability of safe and legal MR services, abortions still occur in informal setttings and are associated with high complication rates, causing women to then seek post abortion care (PAC). The objective of this study is to contextualize MR in Bangladesh and understand systemic barriers to seeking care in formal settings and faciltators to seeking care in informal settings via the perspective of MR providers in an effort to inform interventions to improve MR safety. METHODS: Qualitative individual semi-structured interviews were conducted with 25 trained MR providers (doctors and nurses) from urban tertiary care facilities in six different cities in Bangladesh from April to July, 2018. Interviews explored providers' knowledge of MR and abortion in Bangladesh, knowledge/experience with informal MR providers, knowledge/experience with patients attempting self-managed abortion, personal attitudes and moral perspectives of MR/abortion in general, and barriers to formal MR. Team based coding and a directed content analysis approach was performed by three researchers. RESULTS: There were three predominant yet overlapping themes: (i) logistics of obtaining MR/PAC/abortion, (ii) provider attitudes, and (iii) overcoming barriers to safe MR. With regards to logistics, lack of consensus among providers revealed challenges with defining MR/abortion gestational age cutoffs. Increasing PAC services may be due to patients purchasing Mifepristone/Misoprostol from pharmacists who do not provide adequate instruction about use, but are logistically easier to access. Patients may be directed to untrained providers by brokers, who intercept patients entering the hospitals/clinics and receive a commission from informal clinics for bringing patients. Provider attitudes and biases about MR can impact who receives care, creating barriers to formal MR for certain patients. Attitudes to MR in informal settings was overwhelmingly negative, which may contribute to delays in care-seeking and complications which endanger patients. Perceived barriers to accessing formal MR include distance, family influence, brokers, and lack of knowledge. CONCLUSIONS: Lack of standardization among providers of MR gestational age cutoffs may affect patient care and MR access, causing some patients to be inappropriately turned away. Providers in urban tertiary care facilities in Bangladesh see primarily the complicated MR/PAC cases, which may impact their negative attitude, and the safety of out-of-clinic/self-managed abortion is unknown. MR safety may be improved by eliminating brokers. A harm reduction approach to improve counseling about MR/abortion care in pharmacies may improve safety and access. Policy makers should consider increasing training of frontline health workers, such as Family Welfare Visitors to provide evidence-based information about Mifepristone/Misoprostol.

Male-female concordance in reported involvement of women in contraceptive decision-making and its association with modern contraceptive use among couples in rural Maharashtra, India.

OBJECTIVE: Women's involvement in contraceptive decision-making increases contraceptive use and reduces unmet need, but study of this has been limited to women's self-reports. Less research is available examining couple concordance and women's involvement in contraceptive decision-making as reported by both men and women. STUDY DESIGN: We carried out a cross-sectional study using data from rural India (N = 961 young married couples). Using multivariable regression we examined the association between concordance or discordance in spousal reports of wife's involvement in contraceptive decision-making and modern contraceptive use, adjusting for demographics, intimate partner violence, and contraceptive use discussion. RESULTS: More than one third (38.3%) of women reported current modern contraceptive use. Report of women's involvement in contraceptive decision-making showed 70.3% of couples agreed that women were involved, jointly or alone (categorized as Concordant 1), 4.2% agreed women were not involved (categorized at Concordant 2), 13.2% had women report involvement but men report women were uninvolved (categorized as Discordant 1), and 12.2% had women report uninvolvement but men report that women were involved (categorized as Discordant 2). Discordant 2 couples had lower odds of modern contraceptive use relative to Concordant 1 couples (adjusted RR = 0.61, 95% CI 0.45-0.83). No other significant differences between Concordant 1 couples and other categories were observed. CONCLUSION: One in four couples indicated discordance on women's involvement in contraceptive decision making, with Discordant 2 category having lower odds of contraceptive use. Couples' concordance in women's involvement in contraceptive decision-making offers a target for family planning research and interventions to better meet their needs. Trial registration ClinicalTrial.gov, NCT03514914. https://clinicaltrials.gov/ct2/show/NCT03514914.

Evidence on women's involvement in decision-making are limited to women's self reports and often not specific to contraceptive decision-making. This study uses couples dyadic data to assess male­female concordance on women's involvement in contraceptive decision-making and contraceptive use outcomes. Couple's concordance on women's involvement in contraceptive decision-making is associated with contraceptive use. There is potential in couple-focused family planning counseling that enhances women's contraceptive decision-making agency to improve women's contraceptive use.

Pharmacists' knowledge, perspectives, and experiences with mifepristone dispensing for medication abortion.

BACKGROUND: The U.S. Food and Drug Administration (FDA) restricts dispensing of mifepristone for medication abortion to certified health care providers at clinical facilities, thus prohibiting pharmacist dispensing. Allowing mifepristone dispensing by pharmacists could improve access to medication abortion. OBJECTIVE: To assess the feasibility of pharmacists dispensing mifepristone to patients who have undergone evaluation for eligibility and counseling for medication abortion by a clinician. METHODS: Before providing a study training on medication abortion, we administered baseline surveys to pharmacists who participated in a multisite mifepristone-dispensing intervention. The survey assessed medication abortion knowledge-using a 15-item score-and perceptions about the benefits and challenges of the model. We administered follow-up surveys in the study's final month that also assessed the pharmacists' satisfaction and experiences with mifepristone dispensing. To investigate the association of the study intervention with the pharmacists' knowledge, perceptions, and experiences dispensing mifepristone, we conducted multivariable linear regression analyses using generalized estimating equation models, accounting for clustering by individual. RESULTS: Among the 72 pharmacists invited from 6 pharmacies, 47 (65%) completed the baseline surveys, and 56 (78%) received training. At the study's end (mean 18 months later), 43 of the 56 pharmacists who received training (77%) completed the follow-up surveys. At follow-up, 36 (83%) respondents were very or somewhat satisfied with mifepristone dispensing, and 24 (56%) reported experiencing no challenges dispensing mifepristone. Four (6%) of the 72 pharmacists invited objected to participating in mifepristone dispensing. In regression analyses, average knowledge scores, perceived ease of implementation, and level of support for the pharmacist-dispensing model were higher at follow-up (P < 0.001). CONCLUSION: Most pharmacists were willing to be trained, dispensed mifepristone with few challenges when given the opportunity, were satisfied with the model, and had higher knowledge levels at follow-up. Our findings support removal of FDA's restriction on pharmacist dispensing of mifepristone.

Expulsion of intrauterine devices after postpartum placement by timing of placement, delivery type, and intrauterine device type: a systematic review and meta-analysis.

OBJECTIVES: To provide updated and more detailed pooled intrauterine device expulsion rates and expulsion risk estimates among women with postpartum intrauterine device placement by timing of insertion, delivery type, and intrauterine device type to inform current intrauterine device insertion practices in the United States. DATA SOURCES: We searched PubMed, Cochrane Library, and ClinicalTrials.gov through June 2019. STUDY ELIGIBILITY CRITERIA: We included all studies, of any study design, that examined postpartum placement of Copper T380A (copper) or levonorgestrel-containing intrauterine devices that reported counts of expulsion. STUDY APPRAISAL AND SYNTHESIS METHODS: We evaluated intrauterine device expulsion among women receiving postpartum intrauterine devices in the "immediate" (within 10 minutes), "early inpatient" (>10 minutes to <72 hours), "early outpatient" (72 hours to <4 weeks), and interval (≥4 weeks) time periods after delivery. We assessed study quality using the US Preventive Services Task Force evidence grading system. We calculated pooled absolute rates of partial and complete intrauterine device expulsion separately and estimated adjusted relative risks by the timing of postpartum placement, delivery type, and intrauterine device type using log-binomial multivariable regression. RESULTS: We identified 48 level I to II-3 studies of poor to good quality that reported a total of 7661 intrauterine device placements. Complete intrauterine device expulsion rates varied by timing of placement as follows: 10.2% (range, 0.0-26.7) for immediate; 13.2% (3.5-46.7) for early inpatient; 0% for early outpatient; and 1.8% (0.0-4.8) for interval placements. Complete intrauterine device expulsion rates also varied by delivery type: 14.8% (range, 4.8-43.1) for vaginal and 3.8% (0.0-21.1) for cesarean deliveries. Among immediate postpartum vaginal placements, the expulsion rate for levonorgetrel intrauterine devices was 27.4% (range, 18.8-45.2) and 12.4% (4.8-43.1) for copper intrauterine devices. Compared with interval placement, immediate and early postpartum placements (inpatient and outpatient combined) were associated with greater risk of complete expulsion (adjusted risk ratio, 8.33; 95% confidence interval, 4.32-16.08, and adjusted risk ratio, 5.27; 95% confidence interval, 2.56-10.85, respectively). Among immediate postpartum placements, risk of expulsion was greater for placement after vaginal compared with cesarean deliveries (adjusted risk ratio, 4.57; 95% confidence interval, 3.49-5.99). Among immediate placements at the time of vaginal delivery, levonorgestrel intrauterine devices were associated with a greater risk of expulsion compared with copper intrauterine devices (adjusted risk ratio, 1.90; 95% confidence interval, 1.36-2.65). CONCLUSION: Although intrauterine device expulsion rates vary by timing of placement, type, and mode of delivery, intrauterine device insertion can take place at any time. Understanding the risk of intrauterine device expulsion at each time period will enable women to make an informed choice about when to initiate use of an intrauterine device in the postpartum period based on their own goals and preferences.

Family planning counseling and its associations with modern contraceptive use, initiation, and continuation in rural Uttar Pradesh, India.

BACKGROUND: We examine the association between the quality of family planning (FP) counseling received in past 24 months, and current modern contraceptive use, initiation, and continuation, among a sample of women in rural Uttar Pradesh, India. METHODS: This study included data from a longitudinal study with two rounds of representative household survey (2014 and 2016), with currently married women of age 15-49 years; the analysis excluded women who were already using a permanent method of contraceptive during the first round of survey and who reported discontinuation because they wanted to be pregnant (N = 1398). We measured quality of FP counseling using four items on whether women were informed of advantages and disadvantages of different methods, were told of method(s) that are appropriate for them, whether their questions were answered, and whether they perceived the counseling to be helpful. Positive responses to every item was categorized as higher quality counseling, vs lower quality counseling for positive response to less than four items. Outcome variables included modern contraceptive use during the second round of survey, and a variable categorizing women based on their contraceptive use behavior during the two rounds: continued-users, new-users, discontinued-users, and non-users. RESULTS: Around 22% had received any FP counseling; only 4% received higher-quality counseling. Those who received lower-quality FP counseling had 2.42x the odds of reporting current use of any modern contraceptive method (95% CI: 1.56-3.76), and those who received higher quality FP counseling at 4.14x the odds of reporting modern contraceptive use (95% CI: 1.72-9.99), as compared to women reporting no FP counseling. Women receiving higher-quality counseling also had higher likelihood of continued use (ARRR 5.93; 95% CI: 1.97-17.83), as well as new use or initiation (ARRR: 4.2; 95% CI: 1.44-12.35) of modern contraceptives. Receipt of lower-quality counseling also showed statistically significant associations with continued and new use of modern contraceptives, but the effect sizes were smaller than those for higher-quality counseling. CONCLUSIONS: Findings suggest the value of FP counseling. With a patient-centered approach to counseling, continued use of modern contraceptives can be supported among married women of reproductive age. Unfortunately, FP counseling, particularly higher-quality FP counseling remains rare.

A gender synchronized family planning intervention for married couples in rural India: study protocol for the CHARM2 cluster randomized controlled trial evaluation.

BACKGROUND: Prior research from India demonstrates a need for family planning counseling that engages both women and men, offers complete family planning method mix, and focuses on gender equity and reduces marital sexual violence (MSV) to promote modern contraceptive use. Effectiveness of the three-session (two male-only sessions and one couple session) Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention, which used male health providers to engage and counsel husbands on gender equity and family planning (GE + FP), was demonstrated by increased pill and condom use and a reduction in MSV. However, the intervention had limited reach to women and was therefore unable to expand access to highly effective long acting reversible contraceptives such as the intrauterine device (IUD). We developed a second iteration of the intervention, CHARM2, which retains the three sessions from the original CHARM but adds female provider- delivered counseling to women and offers a broader array of contraceptives including IUDs. This protocol describes the evaluation of CHARM2 in rural Maharashtra. METHODS: A two-arm cluster randomized controlled trial will evaluate CHARM2, a gender synchronized GE + FP intervention. Eligible married couples (n = 1200) will be enrolled across 20 clusters in rural Maharashtra, India. Health providers will be gender-matched to deliver two GE + FP sessions to the married couples in parallel, and then a final session will be delivered to the couple together. We will conduct surveys on demographics as well as GE and FP indicators at baseline, 9-month, and 18-month follow-ups with both men and women, and pregnancy tests at each time point from women. In-depth interviews will be conducted with a subsample of couples (n = 50) and providers (n = 20). We will conduct several implementation and monitoring activities for purposes of assuring fidelity to intervention design and quality of implementation, including recruitment and tracking logs, provider evaluation forms, session observation forms, and participant satisfaction surveys. DISCUSSION: We will complete the recruitment of participants and collection of baseline data by July 2019. Findings from this work will offer important insight for the expansion of the national family planning program and improving quality of care for India and family planning interventions globally. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03514914 .

Menstrual cycle-dependent alterations in glycosylation: a roadmap for defining biomarkers of favorable and unfavorable mucus.

OBJECTIVE: To understand glycosylation of endocervical proteins at different times throughout the menstrual cycle in naturally cycling women and in women using hormonal or non-hormonal contraceptive methods, in order to characterize biochemical fingerprints of favorable and unfavorable cervical mucus. DESIGN: Lectin/antibody-probed protein blot analysis of endocervical mucus samples collected onto ophthalmologic sponges (wicks) from two groups: a longitudinal cohort of naturally cycling women at three time points in their menstrual cycles (discovery cohort), and a cross-sectional cohort of women on hormonal or non-hormonal contraceptive methods (validation cohort). SETTING: Participants were recruited from the San Francisco Bay Area from 2010 to 2016. PATIENT(S): Women with regular cycles not using hormonal or intrauterine device (IUD) contraceptives were recruited for the longitudinal cohort (n = 8). Samples from women using levonorgestrel-containing combined oral contraceptives (n = 16), levonorgestrel containing IUDs (n = 14), copper IUDs (n = 17), depo-medroxyprogesterone acetate (DMPA) (n = 15), and controls (n = 13) were used for validation. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Detection of specific glycosylation patterns on lectin/antibody probed protein blots. RESULT(S): Two lectins (Lens culinaris agglutinin and Lycopersicon esculentum [tomato lectin]), and the antibody MECA-79 demonstrated consistent cycle-dependent changes in protein binding. The glycan-binding patterns of the levonorgestrel-containing contraceptives were generally similar to each other and to those from women in the luteal phase. The DMPA samples showed slightly different binding patterns. CONCLUSION(S): We identified molecular signatures of unfavorable mucus from women in the luteal phase and on hormonal contraceptives. Further characterization of these biomarkers may be useful in contraceptive development and in evaluation of infertility.

The effect of intrauterine devices on acquisition and clearance of human papillomavirus.

BACKGROUND: Previous studies have shown a decrease in cervical cancer associated with intrauterine device use. It has been hypothesized that intrauterine device use may alter the natural history of human papillomavirus infections, preempting development of precancerous lesions of the cervix and cervical cancer, but the effect of intrauterine devices on the natural history of human papillomavirus infection and subsequent development of cervical cancer is poorly understood. OBJECTIVE: The purpose of this study was to evaluate the association between intrauterine device use and cervical high-risk human papillomavirus acquisition and clearance. STUDY DESIGN: This is a prospective cohort study conducted from October 2000 through June 2014 among 676 sexually active young women and girls enrolled from family planning clinics in San Francisco, CA. Data were analyzed using a Cox proportional hazards model, including time-varying indicators of intrauterine device use, and adjusting for fixed and time-dependent predictor variables. RESULTS: A total of 85 women used an intrauterine device at some time during follow-up. Among 14,513 study visits, women reported intrauterine device use at 505 visits. After adjusting for potential behavioral confounders, there was no association between intrauterine device use and human papillomavirus acquisition (hazard ratio, 0.50; 95% confidence interval, 0.20-1.23; P = .13) or clearance of human papillomavirus infection (hazard ratio, 1.44; 95% confidence interval, 0.76-2.72; P = .26). CONCLUSION: Current intrauterine device use is not associated with acquisition or persistence of human papillomavirus infection. Intrauterine device use is safe among women and girls with human papillomavirus infections and at risk for human papillomavirus acquisition. Intrauterine device use may play a role further downstream in the natural history of cervical cancer by inhibiting the development of precancerous lesions of the cervix in human papillomavirus-infected women, or enhancing clearance of established precancerous lesions.