Positive narratives regarding men's support for the abortion decisions of their partners provide a counterpoint to commonly held negative narratives. Future research should explore how supportive men who accompany partners at the time of an abortion may improve women's abortion experiences.
5505 Background: Platinum-resistant ovarian cancer (PROC) continues to have a poor prognosis. Maveropepimut-S (MVP-S, namely DPX-Survivac) leverages the lipid-based DPX delivery platform to educate a specific and persistent T cell-based immune response to 5 HLA-restricted peptides from survivin, a cancer-related protein commonly upregulated in several cancers. MVP-S in combination with Pembrolizumab (Pemb) and low-dose Cyclophosphamide (CPA) is expected to enhance immune response. This trial aims to assess the safety and efficacy of this regimen in patients (pts) with PROC. Methods: Phase 1 escalation cohort allowed all PROC subtypes and comprised 2 dose levels (DL) of MVP-S with 1 initial dose 0.25 mL followed by boosters of 0.25 mL (DL1) or 0.5mL (DL2) SC q6w, combined with CPA (50 mg BID every other week) and Pemb (200 mg q3w). Dose escalation was performed using 3+3 design. Dose-limiting toxicities (DLT) were defined as G4 non-hematologic, ≥G3 persistent non-hematologic toxicity, laboratory value or febrile neutropenia; ≥G2 persistent injection site skin ulceration ( > 1wk) or allergic/immune reactions by CTCAE v4.03. DL was considered safe if ≤1 DLT occurred in 6 pts until 21 days after initial and first boosting dose. Pts with high-grade serous (HGSOC) or endometrioid ovarian cancer were allowed in the Phase 2 expansion cohort (P2EC) and treated with the Recommended Phase 2 Dose (RP2D). Response was assessed every 6 wks. Activity in P2EC was defined as at least 2/10 partial response (PR) or stable disease (SD) for 12 wks according to RECIST 1.1. Primary endpoint is overall response rate (ORR), and secondary includes safety, PFS, and OS. Biopsies and blood draws were performed prior to and on treatment for genomic analysis, immune profiling and ctDNA. Results: Twenty-six pts were enrolled, 24 were evaluable for safety (8 DL1, 6 DL2, and 10 in P2EC). HGSOC represented 62% of phase I and 100% of P2EC. Median age was 61y (49-78). Pts received a median of 4 (1-7) prior lines of therapy. Median cycles of MVP-S were 2 (1-8). Toxicity G4/G3/G2 occurred in 1/3/7 pts of DL1 and 0/3/6 of DL2. G3/G2 immune-related AE (irAE) and injection site reactions (ISR) were observed in 1/1 and 1/3 pts treated at DL1, and in 1/0 and 2/2 pts at DL2, respectively. DL1 was selected as RP2D due to the occurrence of nephritis and ISR G3 at DL2. No AEs were qualified as DLT. On the P2EC, 5 G3 (1 irAE, 0 ISR) and 28 G2 (0 irAE, 3 ISR) toxicities were observed. At Phase 1, one pt with MSI-High clear cell subtype has ongoing CR after 26 mos of follow-up, 2 pts had PR and 6 SD.There were 1 PR and 3 SD on P2EC, of which 1 and 2, respectively, achieved response > 12wks. Conclusions: The combination of MVP-S, low-dose CPA, and Pemb was tolerable and met the efficacy endpoint in the expansion cohort in heavily treated PROC. Immuno-genomic correlative analyses are ongoing. Clinical trial information: NCT03029403. [Table: see text]
Introduction. Although pre-exposure prophylaxis (PrEP) is recommended by the Centers for Disease Control and Prevention, there is a practice gap in treatment at Planned Parenthood of Illinois. This project evaluated a clinical practice alert and evidence-based patient education script to determine if the intervention increased the number of appointments to discuss or initiate PrEP in patients at risk for acquiring HIV. Method. From October to December 2018, a clinical practice alert and evidence-based patient education script were implemented at one Planned Parenthood of Illinois health center. Aggregate data collected included the number of times the clinical alert was generated, the number of times staff read the script, the number of scheduled appointments to discuss PrEP, and the number of times PrEP was prescribed. Qualitative data were collected from clinic staff to further evaluate the intervention. Results. Eleven patients triggered the alert and staff read the education script nine times during the 8-week implementation period. One patient scheduled an appointment to discuss PrEP; no new prescriptions were initiated. One identified patient scheduled an appointment with a provider to initiate PrEP on a date after the implementation period ended. Staff found the alert and script helpful to initiate conversations with patients. Conclusions. This intervention established a system for clinic staff to identify patients at risk for acquiring HIV in order to discuss accurate, evidence-based PrEP information. Findings are limited to this particular setting due to a small sample size, which eliminated the possibility for statistical analysis.
ObjectiveTo evaluate the effect of a narrative intervention on individual-level abortion stigma in patients undergoing abortion.Study designThis randomised controlled trial examined individual-level abortion stigma and psychological distress among patients undergoing outpatient abortion. Patients were randomised to a narrative intervention verus usual care. The intervention consisted of viewing a digital narrative and responding to a writing prompt. Abortion stigma was measured using the Individual Level Abortion Stigma Scale (ILAS) and psychological distress was assessed with a modified Profile of Mood States-Short Form (POMS-SF) at baseline and after 2 weeks. The primary outcome compared change in ILAS score from baseline to follow-up between groups. The secondary outcome compared change in the modified POMS-SF score.ResultsWe randomised 215 participants. Baseline characteristics were similar between groups. Overall baseline stigma scores were low. The study groups did not differ significantly in the primary ILAS outcome (mean change=0.07 in both groups with score range 0 to 3.5, 95% CI -0.11 to 0.11, p=0.98). There was also no significant difference in the secondary modified POMS-SF outcome (mean change −0.64 for the intervention group and −0.65 for the control group with score range −8 to 8, 95% CI -1.10 to 1.12, p=0.98). Black participants, comprising the majority, demonstrated lower levels of individual-level abortion stigma and psychological distress at baseline than participants identifying with any other race (mean baseline ILAS score of 0.70 vs 1.00 and mean modified POMS-SF score of −3.00 vs −1.45, 95% CI 0.12 to 0.46 and 95% CI 0.28 to 2.01, p=0.001 and p=0.02, respectively).ConclusionsPatients who participated in a narrative intervention did not score lower on an individual-level abortion stigma scale compared with a control group at 2-week follow-up. Demographic characteristics may predict levels of individual-level abortion stigma and psychological distress among patients seeking abortion.
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