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Abstract Introduction Viral suppression is a critical component for preventing mother-to-child transmission of HIV(MTCT). Mothers’ perceptions of viral load suppression is crucial in the attainment of successful outcomes in preventing mother to child transmission of HIV. We therefore aimed to explore the experiences and perceptions of women on viral suppression. Methods This was a qualitative sub-study embedded in a cluster-randomized trial (NCT04122144) designed to improve viral load outcomes among pregnant and breastfeeding mothers living with HIV in four level III/IV health facilities in South-western Uganda. Thirty-two in-depth interviews were conducted with pregnant and breastfeeding women with HIV from 1st March 2020 to 30th September 2020 to explore their understanding and interpretation of viral suppression. Interviews were audio-recorded, transcribed, and coded in Dedoose software for analysis. Results A total of 32 Women living with HIV were enrolled in this qualitative study. WLHIV explained viral suppression in the context of attaining good health and having HIV-free babies. Adherence to ART was presented as a key avenue to viral suppression. The level of engagement with providers was presented as a key attribute of attaining viral suppression. The participants narrated their experiences with viral load testing within the routine services. However, they revealed experiencing some proximate barriers to suppression including anticipated stigma, challenges with non-disclosure of HIV status, pregnancy distress, and distance to the health facility. Conclusion The understanding and interpretation of viral suppression among pregnant and breastfeeding mothers living with HIV provides a basis for adopting behaviors leading to prevention of vertical transmission of HIV. Health care workers can support women by providing clear and culturally appropriate education about viral suppression, adherence strategies and creating a supportive and non-judgmental environment.

Abstract Pregnant and breastfeeding women are often under-represented in clinical research, including pharmacokinetic studies, due to ethical and logistical challenges. This paper examines strategies to improve the recruitment and retention of this demographic in pharmacokinetic research, drawing on experiences from five studies conducted at the Infectious Diseases Institute, Makerere University, Uganda. Key strategies implemented include Community Advisory Board meetings, the involvement of Peer Mothers as Co-Investigators, established recruitment sites, the use of safety protocols, and the utilization of diverse communication platforms, including social media and stakeholder meetings. Despite these efforts, substantial barriers, such as scheduling conflicts and frequent staff turnover at recruitment sites, continue to threaten progress. The paper recommends flexible scheduling, strengthening public engagement, and transparent demonstration of adherence to ethical principles; justice, non-maleficence, respect, and beneficence to ensure the safety and inclusivity of pregnant and breastfeeding women. The inclusion of this population in pharmacokinetic studies is essential for providing evidence-based care that meets their unique health needs.

Introduction: Viral suppression is a critical component for preventing mother-to-child transmission of HIV(MTCT). Mothers' perceptions of viral load suppression is crucial in the attainment of successful outcomes in preventing mother to child transmission of HIV. We therefore aimed to explore the experiences and perceptions of women on viral suppression. Methods: This was a qualitative sub-study embedded in a cluster-randomized trial (NCT04122144) designed to improve viral load outcomes among pregnant and breastfeeding mothers living with HIV in four level III/IV health facilities in South-western Uganda. Thirty-two in-depth interviews were conducted with pregnant and breastfeeding women with HIV from 1st March 2020 to 30th September 2020 to explore their understanding and interpretation of viral suppression. Interviews were audio-recorded, transcribed, and coded in Dedoose software for analysis. Results: A total of 32 Women living with HIV were enrolled in this qualitative study. WLHIV explained viral suppression in the context of attaining good health and having HIV-free babies. Adherence to ART was presented as a key avenue to viral suppression. The level of engagement with providers was presented as a key attribute of attaining viral suppression. The participants narrated their experiences with viral load testing within the routine services. However, they revealed experiencing some proximate barriers to suppression including anticipated stigma, challenges with non-disclosure of HIV status, pregnancy distress, and distance to the health facility. Conclusion: The understanding and interpretation of viral suppression among pregnant and breastfeeding mothers living with HIV provides a basis for adopting behaviors leading to prevention of vertical transmission of HIV. Health care workers can support women by providing clear and culturally appropriate education about viral suppression, adherence strategies and creating a supportive and non-judgmental environment. [ABSTRACT FROM AUTHOR]

Pregnant and breastfeeding women are often under-represented in clinical research, including pharmacokinetic studies, due to ethical and logistical challenges. This paper examines strategies to improve the recruitment and retention of this demographic in pharmacokinetic research, drawing on experiences from five studies conducted at the Infectious Diseases Institute, Makerere University, Uganda. Key strategies implemented include Community Advisory Board meetings, the involvement of Peer Mothers as Co-Investigators, established recruitment sites, the use of safety protocols, and the utilization of diverse communication platforms, including social media and stakeholder meetings. Despite these efforts, substantial barriers, such as scheduling conflicts and frequent staff turnover at recruitment sites, continue to threaten progress. The paper recommends flexible scheduling, strengthening public engagement, and transparent demonstration of adherence to ethical principles; justice, non-maleficence, respect, and beneficence to ensure the safety and inclusivity of pregnant and breastfeeding women. The inclusion of this population in pharmacokinetic studies is essential for providing evidence-based care that meets their unique health needs. [ABSTRACT FROM AUTHOR]

Abstract Background The COVID-19 pandemic highlights vaccination’s critical role in reducing morbidity and mortality, depending on public attitude. This study aims to identify the estimates of COVID-19 vaccine acceptance in pregnant and lactating women, as well as associated potential factors. Methods A cross-sectional study was conducted between August and September 2021, through an online survey and with a paper survey distributed in gynecology and pediatric clinics. Pregnant and breastfeeding women aged 18 years and above were recruited. The attitude scale was created specifically for evaluating attitudes towards the COVID-19 vaccine. Results In total, 207 women participated, with 132 breastfeeding, 74 pregnant and 1 experiencing both conditions. Of these, one hundred and twenty women (58%) considered themselves at risk for COVID-19 infection. In addition, 51.7% (n = 107) of women expressed the intent to receive the vaccine once available. A multivariable linear regression was conducted taking the COVID-19 vaccination attitude scale as a dependent variable. The results revealed an R-squared value of 0.558, indicating that approximately 55.8% of the variance in the attitude scale was accounted for by the included predictors. The results showed that preventive measures (ß=2.25, 95% Confidence Interval (CI) [1.02; 3.48], p

Background: The COVID-19 pandemic highlights vaccination's critical role in reducing morbidity and mortality, depending on public attitude. This study aims to identify the estimates of COVID-19 vaccine acceptance in pregnant and lactating women, as well as associated potential factors. Methods: A cross-sectional study was conducted between August and September 2021, through an online survey and with a paper survey distributed in gynecology and pediatric clinics. Pregnant and breastfeeding women aged 18 years and above were recruited. The attitude scale was created specifically for evaluating attitudes towards the COVID-19 vaccine. Results: In total, 207 women participated, with 132 breastfeeding, 74 pregnant and 1 experiencing both conditions. Of these, one hundred and twenty women (58%) considered themselves at risk for COVID-19 infection. In addition, 51.7% (n = 107) of women expressed the intent to receive the vaccine once available. A multivariable linear regression was conducted taking the COVID-19 vaccination attitude scale as a dependent variable. The results revealed an R-squared value of 0.558, indicating that approximately 55.8% of the variance in the attitude scale was accounted for by the included predictors. The results showed that preventive measures (ß=2.25, 95% Confidence Interval (CI) [1.02; 3.48], p < 0.001), preference for vaccines made in Europe and America (ß=1.23; 95% CI [0.69–1.77], p < 0.001), protect yourself for getting sick (ß=4.22, 95% Confidence Interval (CI) [2.83; 5.61], p < 0.001) and belief in the importance of vaccination for themselves and their baby (ß=3.49; 95% CI [2.01; 4.98], p < 0.001) were associated with a positive attitude towards vaccination. Conversely, experiencing a previous bad reaction to a vaccine (ß= -1.35; 95% CI [0.85–1.85], p < 0.001) and concerns regarding COVID-19 vaccine safety (ß= -4.09; 95% CI [-5.98; -2.21], p < 0.001) were associated with a negative attitude towards vaccination. Conclusion: Our findings reveal that COVID-19 vaccine acceptability among pregnant and breastfeeding women, amidst the pandemic was insufficient to meet community immunity. The identified reasons for vaccine reluctance, notably concerns about safety for both personal health and the health of their pregnancy or newborns, along with insufficient information about the vaccine, underscore the pressing need to address these factors to improve immunization rates. [ABSTRACT FROM AUTHOR]

Abstract Background This exploratory analysis investigates the prevalence and risk factors of neurocognitive toxicity in postpartum women on HIV treatment in response to a concern of an Isoniazid Preventive Therapy (IPT)/Efavirenz interaction. Trial Design Pregnant women on HIV treatment from countries with high TB prevalence were randomized in IMPAACT P1078 to 28 weeks of IPT started either during pregnancy or at 12 weeks postpartum. Partway through study implementation, the Patient Health Questionnaire 9, the cognitive complaint questionnaire, and the Pittsburg Sleep Quality Index were added to evaluate depression, cognitive function, and sleep quality at postpartum weeks. Screening for peripheral neuropathy was conducted throughout the study. Methods We summarized percentages of women with depression symptoms, cognitive dysfunction, poor sleep quality and peripheral neuropathy and assessed the association of 11 baseline risk factors of neurotoxicity using logistic regression, adjusted for gestational age stratum. Results Of 956 women enrolled, 749 (78%) had at least one neurocognitive evaluation. During the postpartum period, the percentage of women reporting at least mild depression symptoms, cognitive complaint and poor sleep quality peaked at 13%, 8% and 10%, respectively, at 12 weeks, and the percentage of women reporting peripheral neuropathy peaked at 13% at 24 weeks. There was no evidence of study arm differences in odds of all four neurotoxic symptoms. Conclusions Timing of IPT initiation and EFV use were not associated with symptoms of neurotoxicity. Further study is advised to formally assess risk factors of neurotoxicity.

No abstract available.

Introduction: Daily oral pre-exposure prophylaxis (PrEP) is a safe and effective HIV prevention method for pregnant and postpartum women, but adherence barriers exist. Understanding the role of male partners in supporting PrEP use may inform strategies to support PrEP adherence among pregnant and breastfeeding women. Methods: To understand male partners’ involvement in women’s use of PrEP, we conducted in-depth interviews with pregnant women in Lilongwe, Malawi who had recently decided to use PrEP (n = 30) and their male partners (n = 20) in the context of a PrEP adherence trial. Women were purposively recruited to ensure variation in their partners’ HIV status. Interviews were conducted in Chichewa using a semistructured guide. We followed a thematic approach to analyze the interview data. Results: Most male partners were receptive to women using PrEP during pregnancy because it eased their fears of the woman and baby acquiring HIV. Men often played a key role in women’s PrEP adherence by providing daily reminders and encouragement to adhere to their medication. The majority of women appreciated this support from the men as it lessened the burden of remembering to take their medications daily on their own and aided their adherence. However, several women who lacked male partner support spoke of wanting their partners to be more involved. Many men living with HIV found the mutual support beneficial for their antiretroviral therapy adherence, while men without HIV or with status unknown appreciated knowing that the family was protected. While most men were open to women continuing PrEP beyond the current study, some would only support it if women were still at risk for acquiring HIV. Conclusion: In this study, male partners were strongly motivated to support the PrEP adherence of their female partners as a way of ensuring that the pregnant women and unborn babies were protected against HIV. Promoting disclosure and tangible support that arises organically among men may be helpful, but programs to enhance this support and identify ways to support women who do not receive support from their partners or do not wish to disclose their PrEP use to partners may be needed. [ABSTRACT FROM AUTHOR]

IntroductionDaily oral pre-exposure prophylaxis (PrEP) is a safe and effective HIV prevention method for pregnant and postpartum women, but adherence barriers exist. Understanding the role of male partners in supporting PrEP use may inform strategies to support PrEP adherence among pregnant and breastfeeding women.MethodsTo understand male partners’ involvement in women's use of PrEP, we conducted in-depth interviews with pregnant women in Lilongwe, Malawi who had recently decided to use PrEP (n = 30) and their male partners (n = 20) in the context of a PrEP adherence trial. Women were purposively recruited to ensure variation in their partners’ HIV status. Interviews were conducted in Chichewa using a semistructured guide. We followed a thematic approach to analyze the interview data.ResultsMost male partners were receptive to women using PrEP during pregnancy because it eased their fears of the woman and baby acquiring HIV. Men often played a key role in women's PrEP adherence by providing daily reminders and encouragement to adhere to their medication. The majority of women appreciated this support from the men as it lessened the burden of remembering to take their medications daily on their own and aided their adherence. However, several women who lacked male partner support spoke of wanting their partners to be more involved. Many men living with HIV found the mutual support beneficial for their antiretroviral therapy adherence, while men without HIV or with status unknown appreciated knowing that the family was protected. While most men were open to women continuing PrEP beyond the current study, some would only support it if women were still at risk for acquiring HIV.ConclusionIn this study, male partners were strongly motivated to support the PrEP adherence of their female partners as a way of ensuring that the pregnant women and unborn babies were protected against HIV. Promoting disclosure and tangible support that arises organically among men may be helpful, but programs to enhance this support and identify ways to support women who do not receive support from their partners or do not wish to disclose their PrEP use to partners may be needed.

Abstract Background Most medications lack evidence-based information about its safety and efficacy during pregnancy and breastfeeding, because pregnant women are often not included in clinical research. Another way to generate evidence is by using a Learning Healthcare System (LHS) approach. In an LHS, care and research are aligned in such a way that it can accelerate evidence generation and outcomes for patients, based on real-life medication use. For the development of an ethically responsible and sustainable LHS, it is of crucial importance to understand what women think of such an alternative approach to knowledge generation. Therefore, this paper explores their views on an LHS for pregnant and breastfeeding women. Method For this qualitative study, we interviewed 20 women during preconception, pregnancy, or nursing to explore their views on an ethically responsible LHS for pregnant and breastfeeding women. The pseudonymized transcripts were analyzed thematically. Results We identified four main themes describing women’s views on LHSs. The first theme describes that respondents were positive about learning healthcare systems, and considered them to function as a central point for information about their medication, which they felt is currently lacking. The second theme shows that respondents want to contribute to and engage in generating new information because they want to help others and contribute to scientific research. Respondents also mentioned that, currently, not every woman is aware of the risks of the lack of evidence for medication used in pregnancy. The third theme shows that respondents regard their healthcare professional as essential for the translation and interpretation of information, regardless of a learning healthcare system. The last theme describes that respondents will trust a learning healthcare system more if the medical community supports it, and when data collection and processing is transparent. Conclusion Women during preconception, pregnancy and nursing agree that an LHS could be a viable alternative to help close the knowledge gap on the safety of medication used during pregnancy and breastfeeding. The obtained insights from our interviews provide valuable stepping-stones for the development of an ethically responsible and sustainable LHS, as well as for the engagement of women in an LHS.

Background: This exploratory analysis investigates the prevalence and risk factors of neurocognitive toxicity in postpartum women on HIV treatment in response to a concern of an Isoniazid Preventive Therapy (IPT)/Efavirenz interaction. Trial Design: Pregnant women on HIV treatment from countries with high TB prevalence were randomized in IMPAACT P1078 to 28 weeks of IPT started either during pregnancy or at 12 weeks postpartum. Partway through study implementation, the Patient Health Questionnaire 9, the cognitive complaint questionnaire, and the Pittsburg Sleep Quality Index were added to evaluate depression, cognitive function, and sleep quality at postpartum weeks. Screening for peripheral neuropathy was conducted throughout the study. Methods: We summarized percentages of women with depression symptoms, cognitive dysfunction, poor sleep quality and peripheral neuropathy and assessed the association of 11 baseline risk factors of neurotoxicity using logistic regression, adjusted for gestational age stratum. Results: Of 956 women enrolled, 749 (78%) had at least one neurocognitive evaluation. During the postpartum period, the percentage of women reporting at least mild depression symptoms, cognitive complaint and poor sleep quality peaked at 13%, 8% and 10%, respectively, at 12 weeks, and the percentage of women reporting peripheral neuropathy peaked at 13% at 24 weeks. There was no evidence of study arm differences in odds of all four neurotoxic symptoms. Conclusions: Timing of IPT initiation and EFV use were not associated with symptoms of neurotoxicity. Further study is advised to formally assess risk factors of neurotoxicity. [ABSTRACT FROM AUTHOR]

Background: Most medications lack evidence-based information about its safety and efficacy during pregnancy and breastfeeding, because pregnant women are often not included in clinical research. Another way to generate evidence is by using a Learning Healthcare System (LHS) approach. In an LHS, care and research are aligned in such a way that it can accelerate evidence generation and outcomes for patients, based on real-life medication use. For the development of an ethically responsible and sustainable LHS, it is of crucial importance to understand what women think of such an alternative approach to knowledge generation. Therefore, this paper explores their views on an LHS for pregnant and breastfeeding women.Method: For this qualitative study, we interviewed 20 women during preconception, pregnancy, or nursing to explore their views on an ethically responsible LHS for pregnant and breastfeeding women. The pseudonymized transcripts were analyzed thematically.Results: We identified four main themes describing women's views on LHSs. The first theme describes that respondents were positive about learning healthcare systems, and considered them to function as a central point for information about their medication, which they felt is currently lacking. The second theme shows that respondents want to contribute to and engage in generating new information because they want to help others and contribute to scientific research. Respondents also mentioned that, currently, not every woman is aware of the risks of the lack of evidence for medication used in pregnancy. The third theme shows that respondents regard their healthcare professional as essential for the translation and interpretation of information, regardless of a learning healthcare system. The last theme describes that respondents will trust a learning healthcare system more if the medical community supports it, and when data collection and processing is transparent.Conclusion: Women during preconception, pregnancy and nursing agree that an LHS could be a viable alternative to help close the knowledge gap on the safety of medication used during pregnancy and breastfeeding. The obtained insights from our interviews provide valuable stepping-stones for the development of an ethically responsible and sustainable LHS, as well as for the engagement of women in an LHS. [ABSTRACT FROM AUTHOR]

No abstract available.

This paper analyzes the ways in which pregnant and breastfeeding women perceive the presence of chemical substances in food products. It also deals with how they reflect on the effects of those substances on their own health and that of the baby and the foetus when they think about processes of accumulation, transmission and elimination of those substances inside their bodies. Our first hypothesis is that women's discourses about the health effects of Persistent Toxic Substances (PTS) is related to the social distance of the social actors that reproduce these discourses. The acceptability of these discourses is more evident the greater is the trust in the social actors who transmit this information. This paper analyzes the discourses of health workers and the close social environment of these women, since both play an essential role in the transmission of these discourses. Despite the fact that the dietary advice received by women is strongly medicalized, the information provided on chemical substances in food in the medical environment is scarce and not homogeneous. Thus, this type of risk is made invisible in the doctor-patient relationship, and the responsibility for managing it usually falls on women. [ABSTRACT FROM AUTHOR]

INTRODUCTION: With the rapid scale-up of antiretroviral treatment (ART) in the "Treat All" era, there has been increasing emphasis on using differentiated models of HIV service delivery. The gaps within the clinical cascade for mothers and their infants suggest that current service delivery models are not meeting families' needs and prompt re-consideration of how services are provided. This article will explore considerations for differentiated care and encourage the ongoing increase of ART coverage through innovative strategies while also addressing the unique needs of mothers and infants. DISCUSSION: Service delivery models should recognize that the timing of the mother's HIV diagnosis is a critical aspect of determining eligibility. Women newly diagnosed with HIV require a more intensive approach so that adequate counselling and monitoring of ART initiation and response can be provided. Women already on ART with evidence of virologic failure are also at high risk of transmitting HIV to their infants and require close follow-up. However, women stable on ART with a suppressed viral load before conception have a very low likelihood of HIV transmission and thus are strong candidates for multi-month ART dispensing, community-based distribution of ART, adherence clubs, community adherence support groups and longer intervals between clinical visits. A number of other factors should be considered when defining eligibility of mothers and infants for differentiated care, including location of services, viral load monitoring and duration on ART. To provide differentiated care that is client-centred and driven while encompassing a family-based approach, it will be critical to engage mothers, families and communities in models that will optimize client satisfaction, retention in care and quality of services. CONCLUSIONS: Differentiated care for mothers and infants represents an opportunity to provide client-centred care that reduces the burden on clients and health systems while improving the quality and uptake of services for families. However, with decreasing funding, stable HIV incidence, and aspirations for sustainability, it is critical to consider efficient, customized and cost-effective models of care for these populations as we aspire to eliminate mother-to-child transmission of HIV. [ABSTRACT FROM AUTHOR]