Pharmacist provision of medication abortion: A pilot study.

OBJECTIVES: This study aimed to perform a "proof of concept" pilot and assess patient satisfaction of pharmacist provision of medication abortion utilizing an implementation toolkit. STUDY DESIGN: Pharmacists completed an online and in-person training followed by an online assessment prior to participating in the pilot. Pharmacists provided medication abortion care using a "no-test" protocol and an implementation toolkit. Participants were administered 200 mg of mifepristone orally on the day of their abortion visit and instructed to take 800 mcg of misoprostol buccally 24 to 48 hours later (with an additional 800 mcg buccally 4 hours after the first dose for patients 63-70 days' gestation). Visits were completed in person in a private room adjacent to the pharmacy. We assessed the rate of completed abortions and any complications. Following their abortion, patients completed a brief interviewer-administered survey and semistructured qualitative interview. RESULTS: Ten patients completed medication abortion visits. Nine of 10 participants had complete abortions. One participant identified that she did not pass her pregnancy and underwent an in-office aspiration. One participant visited an emergency department for pain and received pain medication. No serious adverse events occurred. All patients completed the postabortion survey, and all were "very satisfied" with their abortion experience. Nine patients completed postabortion interviews. CONCLUSIONS: In this pilot study, pharmacists were successful at providing medication abortion to patients. Satisfaction was high, and complications were uncommon. IMPLICATIONS: Patients were highly satisfied with pharmacist provision of medication abortion and are likely to utilize this service if available.

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.

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.

Effect of Paracervical Block Volume on Pain Control for Dilation and Aspiration: A Randomized Controlled Trial.

OBJECTIVE: To compare pain scores during office dilation and aspiration between low-volume and high-volume paracervical block of the same dose. METHODS: We conducted a multi-site, randomized, single-blind, placebo-controlled trial from October 2018 to December 2020. We randomized participants presenting for office dilation and aspiration under minimal sedation stratified by procedural indication (induced abortion vs early pregnancy loss) to a 20-mL buffered 1% lidocaine paracervical block or a 40-mL buffered 0.5% lidocaine paracervical block, both with two units of vasopressin in a standardized technique. To detect a 15-mm or greater difference in pain at the time of cervical dilation with 80% power and a two-sided alpha of 0.05, a total of 104 participants was required. The study was also powered to detect a 20-mm or greater difference in pain at the time of cervical dilation within each stratum (induced abortion and early pregnancy loss). The primary outcome was pain with cervical dilation on a 100-mm visual analog scale in the overall cohort. Secondary outcomes included pain with cervical dilation within each stratum. We used a Wilcoxon rank-sum test to compare median pain scores between groups. RESULTS: We enrolled 114 participants. There was no difference in median pain scores between low-volume and high-volume groups during dilation (62 mm vs 59 mm, P=.94), aspiration (69.5 mm vs 70 mm, P=.47), postprocedure (25 mm vs 25 mm, P=.76), or overall (60 mm vs 60 mm, P=.23). Stratified by indication, there were no significant differences in scores at any time point between the low-volume and high-volume paracervical block groups. There was decreased overall pain in patients with induced abortion who received the higher volume paracervical block, though this did not reach statistical significance (67.5 mm vs 60.5 mm, P=.08). Pain during paracervical block administration was similar between groups (55 mm vs 45 mm, P=.24) and there was no difference in occurrence of side effects (P=.63). CONCLUSION: We found no difference in pain with cervical dilation among participants who received the low-volume compared with high-volume paracervical block when studied alone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03636451.

Time from first clinical contact to abortion in Texas and California.

OBJECTIVE: To assess whether having an abortion in Texas, a U.S. state with many restrictive abortion laws, is associated with increased time between contacting an abortion provider and receiving an abortion, compared to having an abortion in California, a less restrictive U.S. state. STUDY DESIGN: This is a multisite, cross-sectional survey of 434 patients in 12 abortion facilities (ambulatory surgical centers and clinics) in Texas (n = 291) and three abortion clinics in California (n = 143) from 2018 to 2019. At 11 facilities in Texas the response rate was 76%. The response rate was not collected at other sites. We compare the clinical-contact-to-abortion time interval between the facilities in these two states using mixed-effects multivariable logistic regression, adjusting for age, race, education, household income, parity, marital status, and insurance status. We also compare barriers to scheduling and traveling to abortion appointments. RESULTS: Median clinical-contact-to-abortion time is similar among respondents in Texas and California [(9 vs 8 days, p = 0.86). The odds of having a clinical-contact-to-abortion time ≥7 days is similar among respondents in Texas compared to California (adjusted odds ratio 1.0 (95% confidence interval, 0.4-2.6, p = 0.98). Respondents in Texas travel farther for their abortion (mean 22.1 vs 13.5 miles, p < 0.01), are more likely to sell something of value or delay paying another expense to pay for their abortion (49.7% vs 11.4%, p < 0.01), and to miss work to attend their abortion (73.9% vs 61.3%, p = 0.03). CONCLUSIONS: In this study, we found no difference in clinical-contact-to-abortion time between respondents in Texas and those in California. Respondents in Texas, however, face other significant barriers in obtaining abortion care, which result in life disruptions and financial hardship. IMPLICATIONS: Patients face greater financial barriers when seeking abortion in Texas compared to California. Though we found no significant difference in clinical-contact-to-abortion time in this sample between the two states, clinical-contact-to-abortion time may be a useful measure of facility congestion and the obstacles patients face obtaining abortion care.

An Examination of Misconceptions and Their Impact on Cervical Cancer Prevention Practices among Sub-Saharan African and Middle Eastern Refugees.

Objective: The purpose of the study was to understand cervical cancer screening and prevention practices of refugee women in San Diego, California and identify desired components of a cervical cancer screening toolkit. Methods: We conducted a qualitative study utilizing semi-structured focus groups and identified common themes via grounded theory analysis. Results: There were 53 female refugee participants from Sub-Saharan Africa and the Middle East. Over half of all women surveyed expressed a fear of pelvic exams and loss of modesty as barriers to seeking gynecologic care, with nearly 34% avoiding routine pap tests. Of the 18 participants who were asked if they were aware of the Human Papilloma Virus (HPV) vaccination, only one had heard of the vaccine and none had received it for themselves or their children. Over 60% of participants were interested in educational materials surrounding HPV and pap tests. Conclusion: There is a significant lack of knowledge regarding cervical cancer screening and HPV vaccination among refugee women in San Diego, California. Refugee women in this study were interested in multi-modal educational materials as part of a cervical cancer screening toolkit.

Validation of the Interpersonal Quality of Family Planning Scale in a rural Indian setting.

OBJECTIVES: The provision of high-quality family planning (FP) counseling can both enhance clients' experience of care and improve their ability to make and act on their contraceptive decisions. The Interpersonal Quality of Family Planning (IQFP) scale measures FP counseling quality and has been validated in the United States. We aimed to explore whether it remains appropriate for use in a low-/middle-income country (LMIC). STUDY DESIGN: We surveyed 1201 nonsterilized married women ages 18-29 in Maharashtra, India, between September 2018 and June 2019. Respondents rated their FP provider from "poor" (1) to "excellent" (5) across 11 IQFP items. We assessed scale reliability via Cronbach's α test and used exploratory factor analysis to evaluate unidimensionality and regression models of plausibly related outcomes to assess construct validity. RESULTS: Five hundred four women (42%) had seen an FP provider within the past year, 491 (97%) of whom answered all items. Mean IQFP score was 2.62 out of 5 (SD 0.94, range 1-5). Scale reliability was high (α = 0.97). Exploratory factor analyses support unidimensionality (all factor loadings > 0.4). A 1-point increase in average IQFP score was associated with nearly double the odds of current modern contraceptive use (adjusted odds ratio = 1.73, 95% confidence interval = 1.36-2.19). CONCLUSIONS: The IQFP scale shows good reliability and construct validity in this context, and its use in LMIC settings should be broadly considered. A higher IQFP score was associated with greater odds of contraceptive use. The reported FP counseling quality was low, so future public health efforts should aim to increase counseling quality to better meet the needs of women in low-resource settings like rural India. Measurement tools like IQFP can support success evaluation of the quality of care provided by family planning programs. IMPLICATIONS: The Interpersonal Quality of Family Planning scale is a useful tool in rural India, a different context than the one in which it was developed. Use of the IQFP scale should be considered in other low-/middle-income countries to better measure the quality of family planning care provided.

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 .