Bob Kronemyer

 also concluded that inadequate health literacy was associated with an Apgar score of less than 4 at 5 minutes after delivery.

“It is well known that health literacy is an important social determinant of health in the general adult population,” said Lynn M. Yee, MD, MPH, principal investigator of the analysis and an assistant professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine in Chicago. “But health literacy has been relatively understudied during 

Yee and her colleagues were particularly interested in understanding if the relationships that have been observed in non-obstetric medicine also are found in the obstetric population, such as whether inadequate health literacy is associated with suboptimal pregnancy outcomes.

“This issue is important because if health literacy is connected to adverse pregnancy outcomes, then addressing health literacy represents a potential area for future interventions to improve the health of pregnant people and newborns,” Yee told 

. “Differences in health literacy also likely contribute to health disparities, and thus confronting health literacy may be one understudied avenue to reduce health disparities.”

The Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be (nuMoM2b) from 2010 to 2013 included evaluating health literacy among 9,341 of the 10,038 participants. Health literacy was assessed between 16 and 21 weeks of gestation via the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF), a validated 7-item word recognition test. The mean age of participants who completed the form was 27 years, of whom 27.4% had publicly funded prenatal care.

Overall, 17.5% of pregnant individuals in the study had scores reflecting inadequate health literacy.

Participants with inadequate health literacy were significantly more likely to be younger, have less educational attainment or have publicly funded insurance. They were also significantly more likely to identify as non-Hispanic Black or Hispanic.

Likewise, individuals who had inadequate health literacy were 1.11 times more likely to have cesarean delivery, 1.44 times more likely to incur major perineal laceration and 1.34 time more likely to have small-for-gestational-age status neonates, compared with pregnant individuals with adequate health literacy.

They were also 1.33 times more likely to have a child with low birth weight and 2.78 times more likely for their child to score less than 4 on the 5-minute Apgar score.

“We were not surprised at the high prevalence of inadequate health literacy in the study, because this issue is common in the general adult population,” Yee said. “I was somewhat surprised, though, at the associations with perinatal outcomes. For example, I think it is logical that inadequate health literacy may be linked to birth outcomes like cesarean delivery, but I was surprised health literacy was not associated with gestational diabetes. This may be an important area for future study.”

In addition, many studies examine education level or patient language as a proxy for patient understanding or knowledge, according to Yee. “But this is a limited perspective on health education and communication,” she said. “Our analysis suggests health literacy is a different social determinant of health that acts independently from education and language.”

Strategies to improve health literacy in clinical practice include assuming that all patients may have low health literacy, using simple messages, checking for patient understanding, using easy-to-read written communication, limiting the number of messages delivered at once, and using written pictures and diagrams when possible.

“Studying the effectiveness of health literacy interventions to help improve perinatal health outcomes or the quality of patient-provider communication would be valuable,” Yee said.

Yee LM, Silver R, Haas DM, et al. Association of health literacy among nulliparous individuals and maternal and neonatal outcomes. 

. 2021;4(9):e2122576. doi:1001/jamanetworkopen.2021.22576

Articles

Pregnant individuals with inadequate health literacy have a greater risk of cesarean delivery, major perineal laceration, small-for-gestational-age status and low birth weight, compared to individuals with adequate heath literacy, according to an analysis of data from a large, multicenter cohort study of nulliparous individuals in the United States.

Health literacy and maternal/neonatal outcomes

 also found that the safety profile of the therapy is comparable to other PD-1 inhibitors that have been reported or approved.

Balstilimab is an investigational, fully human monoclonal antibody that binds with high affinity to PD-1 and is designed to prevent the interaction between this receptor and its ligands PD-L1 and PD-L2, according to principal investigator David M. O’Malley, MD, professor and director of gynecologic oncology at The Ohio State University and the James Cancer Center in Columbus, Ohio. “By functioning as a PD-1 antagonist, balstilimab enhances T-cell receptor (TCR) signaling and T-cell responsiveness under conditions of TCR stimulation,” he said.

The study comprised 161 women, 18 years or older (media age 53), with recurrent and/or metastatic cervical cancer and who had relapsed after a prior platinum-based treatment regimen for advanced disease. All enrollees were treated with balstilimab intravenously at 3 mg/kg once every 2 weeks, for up to 24 months.

The primary endpoint was the objective response rate (ORR), as assessed by an independent review committee.

“Of the entire cohort, 15% had an ORR and 4% had a complete response (CR) to balstilimab,” O’Malley told 

The median duration of response was 15.4 months, across the entire breadth of cervical cancer patients.

In patients with PD-L1-positive tumors the ORR was 20%. Patients with PD-L1-negative tumors also responded to balstilimab, for which the ORR was 7.9%.

In addition, responses were not restricted to tumors of squamous cell histology. For instance, an ORR of 12.5% was seen in patients with cervical adenocarcinoma.

“Overall, the duration of response was impressive, with over 50% of responses sustained at 12 months among those patients who had that length of follow-up,” O’Malley said.

The 2 most common grade 3 or higher treatment-related adverse events were immune-mediated enterocolitis (3.1%) and diarrhea (1.9%).

“The greatest surprise was the responses seen across all groups of patients with recurrent, progressive cervical cancer, including those who were PDL-1 negative, were adenocarcinoma histology or were pretreated with bevacizumab, as well as those previously described as having PDL-1+ and squamous histology,” O’Malley said.

In addition to a favorable tolerability profile, “balstilimab represents an attractive candidate for use as a backbone in combination-based therapeutic approaches,” O’Malley said.

Nonetheless, because there are known toxicities in patients treated with PD-1 intravenously, “it is important to have a high clinical suspicion,” O’Malley said. “Timely identification and treatment are key.”

Study results indicate that balstilimab might be a differentiated anti-PD-1 antibody as compared to currently approved PD-1 inhibitors. For instance, pembrolizumab in the same setting has been shown to have an ORR of 14.6% in the PD-L1 positive population, but no observed responses in the PD-L1 negative population.

An ongoing phase 2 study of balstilimab alone or in combination with the novel cytotoxic T-lymphocyte-associated protein 4 inhibitor zalifrelimab (NCT03495882) is assessing the feasibility of dual immune checkpoint blockade for further improving outcomes in this patient population.

O’Malley is a consultant and advisor to Agenus.

O’Malley DM, Oaknin A, Monk BJ, et al. Phase II study of the safety and efficacy of the anti-PD-1 antibody balstilimab in patients with recurrent and/or metastatic cervical cancer. 

 Published online August 25, 2021. doi:org/10.1016/j.ygyno.2021.08.018

Results of a phase 2 study demonstrate that the anti-programmed death-1 (PD-1) antibody balstilimab from Agenus Inc. provides meaningful and durable clinical activity in patients with previously treated, recurrent/metastatic cervical cancer.

Balstilimab for patients with metastatic cervical cancer

“Ten years ago, we published a study that found that 86% of a large sample of pregnant women using opioids reported that their pregnancies were unintended. That rate is nearly double that of the general population,” said principal investigator Sarah Heil, PhD, a professor of psychiatry and psychological science at the University of Vermont Larner College of Medicine in Burlington. “This suggested a substantial unmet contraceptive need among women with OUD, but there was very little in the scientific literature about how to address the gap between women’s reproductive intentions and their contraceptive behavior.”

The study consisted of 138 women, aged 20 to 44 years, who were receiving medication for OUD and at high risk for an unintended pregnancy at trial enrollment between May 2015 and September 2018. 

The women were randomly assigned to receive 1 of 3 conditions: usual care, such as information about contraceptive methods and community health care facilities (the control group, n = 48); onsite contraceptive services adapted from the WHO, including 6 months of follow-up visits to assess method satisfaction and delivered in a facility colocated with the Chittenden Clinic, an opioid treatment program in Burlington (n = 48); and the same on-site contraceptive services, plus financial incentives for attending the follow-up visits (n = 42).

“The incentives were gift cards, not cash, that progressively increased in value from a low of $15 to a high of $47.50,” Heil said. “Each participant could choose gift cards for retailers that she preferred. But the women were never required to use a method, and incentives were not linked in any way to contraceptive use.” 

Follow-up visits occurred once a week for 2 months, followed by every other week for 2 months, then monthly for the last 2 months, “because data shows prescription contraceptive discontinuation is highest right after initiation and then progressively decreases over time,” Heil said. 

The percentage of participants with verified prescription contraceptive use at the 6-month end-of-treatment assessment was 10.4% for usual care, 29.2% for contraceptive services without incentives, and 54.8% for contraceptive services with incentives (

 < .001). Those effects also were sustained at the 12-month final assessment: 6.3%, 25.0%, and 42.9%, respectively (

The percentage of participants with an unintended pregnancy during the 12-month trial was 22.2%, 16.7%, and 4.9%, respectively (

 = .03). Each dollar invested also yielded an estimated $5.59 in societal cost-benefits for contraceptive services vs usual care, $6.14 for contraceptive services plus incentives vs usual care, and $6.96 for combining incentives with contraceptive services vs contraceptive services alone. 

Clinicians should be aware that many women with OUD at risk for unintended pregnancy are interested in more effective contraceptive methods, including LARCs, but rarely are able to secure them in the current health care system. 

“Colocating contraceptive services with an opioid treatment program, with or without the addition of incentives, helps decrease unmet contraceptive need, so we encourage contraceptive service providers to look for opportunities to work with opioid treatment programs in their community,” she said. 

Heil SH, Melbostad HS, Matusiewicz AK, et al. Efficacy and cost-benefit of onsite contraceptive services with and without incentives among women with opioid use disorder at high risk for unintended pregnancy: a randomized clinical trial. 

Published online July 14, 2021. doi:10.1001/jamapsychiatry.2021.1715

Among women with opioid use disorder (OUD) at high risk for unintended pregnancy, on-site contraceptive services coupled with financial incentives to attend follow-up visits to assess contraceptive satisfaction was a significantly more effective and cost-beneficial intervention than without incentives or with usual care, according to a prospective randomized clinical trial in JAMA Psychiatry.

Certain incentives may help those with OUD prevent unintended pregnancy

“While the contribution of MG to symptoms in men is well described, less is known about its association with common genital symptoms in women,” wrote the authors.

The study comprised 1318 women who attended the Melbourne Sexual Health Centre (MSHC) between April 2017 and April 2019.

The 3 most frequently self-reported symptoms on a questionnaire were abnormal vaginal discharge (34%), abnormal vaginal odor (24%), and vulvovaginal itch (21%).

Compared with asymptomatic women, symptomatic women were nearly twice as likely to report inconsistent condom use in the prior 12 months and nearly 2.5 times more likely to have had a sexually transmitted infection (STI) in the past 6 months.

Participants were tested for MG and macrolide resistance, CT, 

, bacterial vaginosis (BV), and vulvovaginal candidiasis (VVC).

Among the entire cohort, 6% (n = 83) had MG, of whom 48% (n = 39) had macrolide-resistant MG. Similarly, 8% (n = 103) had CT. The incidence of MG was comparable in asymptomatic and symptomatic women: 5% (10 of 195) and 7% (73 of 1108), respectively (

However, MG was 4.38 times more likely to be associated with mucopurulent cervicitis on examination (

 = .002). But MG was not linked to other specific genital symptoms or signs.

“These data provide evidence that routine testing for MG in women with common genital symptoms is not indicated,” the authors wrote.

BV and VVC were the only infections detected more frequently in symptomatic women than in asymptomatic women: 33% vs 17% for BV (

This finding reflects how frequent the symptoms of vaginal discharge, odor, and itch were in female STI clinic attendees. All women with MG were symptomatic.

One challenge in treating MG is increasing antimicrobial resistance. Recent Australian studies have found that 50% to 60% of MG infections in heterosexuals are macrolide resistant, with resistance exceeding 80% in men who have sex with men.

Treatment strategies for MG also are more complex and costly. Nonetheless, up to 50% of women patients at MSHC can avoid quinolone therapy, while attaining 95% first-line cure with a doxycycline-2.5 g azithromycin regimen.

Because recruitment for the study was limited to a single sexual health clinic and non–English-speaking women were excluded, prevalence estimates are not generalizable.

The investigators also were unable to approach all women attending the clinic because only select doctors recruited symptomatic women. In addition, women with marked pelvic inflammatory disease (PID) were not recruited in order to expedite clinical care.

Therefore, the study did not assess the connection between MG and PID, thus probably resulting in more women with milder symptoms.

Furthermore, vaginal symptoms are less likely to be linked to cervical STIs, which may have affected the authors’ ability to evaluate associations between other relevant symptoms and signs.

“As a consequence, our findings are most relevant to women with mild to moderate genitourinary symptoms attending outpatient STI services and general practices,” they wrote. 

Latimer RL, Vodstrcil LA, Plummer EL, et al. The clinical indications for testing women for 

. Published online July 1, 2021. doi:10.1136/sextrans-2020-054818

A cross-sectional study in the journal Sexually Transmitted Infections has found that Mycoplasma genitalium (MG) is just as prevalent as Chlamydia trachomatis (CT) among women seen at a sexual health center in Australia.

Bob Kronemyer

Articles

Health literacy and maternal/neonatal outcomes

Balstilimab for patients with metastatic cervical cancer

Certain incentives may help those with OUD prevent unintended pregnancy

Study finds Mycoplasma genitalium just as prevalent as Chlamydia trachomatis at health center