Pregnant Women Living With HIV Research Articles

Efficacy and safety of DTG plus 3TC for prophylaxis of perinatal transmission of HIV infection in pregnant women who have detectable viral load after 14 weeks of gestation: A pilot study (PREGNANCY)

Abstract Background The prevention of perinatal HIV transmission depends on the safe and effective use of antiretroviral therapy (ART). Simplifying treatment reduces drug exposure for both mother and child. We evaluated the safety and efficacy of DTG/3TC for antiretroviral-naïve pregnant women living with HIV (PWLHIV). Methods This proof-of-concept trial enrolled ART-naïve pregnant women over 15 years old with HIV infection and a gestational age between 14 and 28 weeks. Participants received a fixed-dose combination of DTG/3TC. Baseline HIV genotyping was performed. Participants were monitored at baseline, every 4 weeks, and at delivery. Infants were assessed at birth, 4 weeks, and 6 weeks of age. Outcomes included the proportion of women achieving an undetectable HIV-1 plasma viral load (<50 copies/mL) at delivery, therapy modification frequency, perinatal HIV transmission rate, and adverse events. Results Between January 2019 and March 2021, 20 women were enrolled. At baseline, the median CD4 cell count was 401.6 ± 113.6 cells/μL, increasing to 690.2 ± 266 cells/μL at delivery. Median viral load was 9,514 copies/mL. All women achieved an undetectable viral load after an average of 40 days. No cases of perinatal HIV transmission were detected. No therapy modifications were necessary during the study, and no adverse events were related to the ART. Conclusion In this pilot trial, DTG/3TC demonstrated safety and efficacy, with all participants achieving viral suppression before delivery. There were no cases of perinatal HIV transmission and no drug-related adverse events. DTG/3TC can be an option for initial treatment of drug-naïve PWLHIV.

Impact of HIV infection on cervical intraepithelial neoplasia detection in pregnant and non-pregnant women in Germany: a cross-sectional study.

Women living with HIV (WLWH) are frequently affected by cervical dysplasia caused by Human Papillomavirus (HPV) and invasive cervical cancer (CxCa). CxCa screening programs can include colposcopy, cytology, and HPV testing. These methods, however, have limitations in effectively stratifying cervical dysplasia. This study aimed to evaluate the applicability of an innovative mRNA-based multiplexed expression-quantifying assay in the detection and assessment of cervical dysplasia in WLWH. The QuantiGene-Molecular-Profiling-Histology Assay (QG-MPH) was used to detect and quantify HPV oncogene and cellular biomarker mRNA expression. These results were included in the Risk Score (QG-MPH RS) calculations that inform about the presence and severity of dysplasia. QG-MPH RS results were compared to the highly sensitive Multiplexed Papillomavirus Genotyping (MPG) Assay and clinical results obtained by cytology, colposcopy and histology. For a standardized nomenclature of clinical results, the clinical ASSIST Score was used. Of 241 WLWH, including 96 pregnant women, a concordance between the QG-MPH RS and the ASSIST Score was found to 36.3% (49/135) in non-pregnant WLWH and 67.1% (57/85) in pregnant WLWH. The QG-MPH method demonstrated high specificity for detecting high-risk HPV (HR-HPV) genotypes and high-grade cervical dysplasia, achieving 89.6% and 82.4%, respectively, including pregnant and non-pregnant WLWH. The QG-MPH assay shows potential for improving the detection and management of HPV-related cervical dysplasia in WLWH, including pregnant women. Its high specificity, however, is tempered by its tendency to overestimate dysplasia severity in certain cases, indicating that further research is needed to refine its use as a reliable diagnostic tool for this high-risk population.

Vaginal Microbiome and the Risk of Preterm Birth in Women Living With HIV: A Scoping Review.

There are sparse data on the role of thevaginal microbiome (VMB) in pregnancy among pregnant women living with HIV (PWLWH) and its association with spontaneous preterm birth (sPTB). We conducted a scoping review to assess associations between vaginal microbiota and sPTB among PWLWH. Three studies were included, representing a total of 180 PWLWH out of 652 total pregnancies. All studies used modern DNA sequencing methods (16S rRNA amplification, metagenomics, or metatranscriptomics). PWLWH had higher VMB richness and diversity compared to HIV-uninfected pregnant women and higher sPTB rates in two of three studies. A higher proportion of sPTB among PWLWH was observed in those with Lactobacillus-deficient, anaerobe-dominant vaginal microbiota. In two of three studies, higher concentrations of vaginal inflammation markers were associated with increased VMB richness and diversity. HIV status was independently associated with sPTB. It is unclear if increased vaginal microbial diversity among PWLWH or increased vaginal inflammation contributes more to PTB, but HIV does appear to alter the VMB in pregnant individuals and may also affect PTB rates in microbiome-independent pathways. Given the limited number of studies, heterogeneity in sample size, sample collection methods, and inconsistent results it is difficult to causally link HIV, VMB, inflammatory cytokines, and sPTB.

The Childbirth Experiences of Pregnant Women Living with HIV Virus: Scoping Review.

Understand and explore the childbirth experiences of pregnant women living with HIV (PWLWHIV). With the advent of several measures to decrease the intrapartum HIV infection and a strong emphasis on the humanization of childbirth, there is a growing focus on providing positive childbirth experiences for pregnant women. Indeed, a positive childbirth experience is even more important in the group of pregnant women living with HIV (PWLWHIV) as it plays a pivotal role in enhancing the mother's adherence to her postpartum treatment and the newborn's engagement in Infectious Disease services. A scoping review was conducted. Searches were performed on databases, such as MEDLINE, PUBMED, WEB OF SCIENCE and Cochrane Library, using the following keywords: childbirth, birth, parturition, HIV, humaniz*, perceived safety, experience, maternal satisfaction, healthcare professional and midwi*. Articles meeting pre-established criteria were selected within the timeframe of 2013 to 2023 for inclusion in the review. Out of a total of 2,340,391 articles, 4 were chosen based on our defined criteria. Three primary themes emerged from the selected articles: the assessment of childbirth experience quality, vulnerability and autonomy. The four studies identified had a small sample size and were not adequately conducted with a specific focus on studying the childbirth experience of pregnant women living with HIV (PWLWHIV). This scoping review revealed a gap in the existing literature, indicating a need for further research and clarification in the identified area.

HIV-related immune activation attenuates polyfunctional IgG and memory B-cell responses to Tdap immunization during pregnancy

Maternal pertussis vaccination with Tdap vaccine is recommended to protect newborns from severe postnatal infection. HIV-exposed uninfected (HEU) infants have a higher incidence of pertussis infection and may particularly benefit from maternal immunization. The impact of HIV infection on the quality of IgG and memory B cell (MBC) responses to Tdap vaccination in pregnant women (PW) living with HIV (PWH) is unknown. In this observational study, humoral immune responses to Tdap vaccination, including IgG levels, Fc-dependent effector functions, and MBC frequencies, were measured before and after vaccination in 40 PWH and 42 HIV-uninfected PW. Placental transfer of IgG and avidity were assessed in cord blood (CB). Soluble and cellular immune activation markers were quantified at baseline. One month after vaccination, PWH had lower frequencies of MBC compared with HIV-uninfected PW. At delivery, PWH had attenuated pertussis-specific IgG levels and Fc-dependent effector functions. Reduced levels of maternal vaccine polyfunctional IgG and IgG avidity were transferred to HEU as compared to HIV-unexposed newborns. After adjustment with ethnicity, maternal antibody levels and gestational age at vaccination, HIV infection was independently associated with decreased levels of PT specific-IgG in CB. Both maternal and neonatal pertussis-specific IgG responses as well as PT-specific IgG avidity were inversely correlated with maternal sCD14 levels before vaccination among PWH. Maternal HIV infection is associated with attenuated humoral immune responses to Tdap vaccination that correlate with sCD14. Suboptimal transfer of maternal immunity may further increase the risk of severe pertussis infection in HEU infants. This work was supported by IRIS Fund managed by the Foundation Roi Baudouin [2017J1820690206902], Association Vésale pour la Recherche Médicale and the Medical Council of CHU Saint-Pierre and has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, US Department of Health and Human Services, under Award No. U19AI145825. N.D. is a clinical researcher and A.M. is Research Director at the Fonds de la Recherche Scientifique (F.R.S.-FNRS), Belgium. M.E.A. was partially supported by NIHNIAID1U19AI14825. This article is published with the support of the Fondation Universitaire of Belgium.

Retrospective Cohort Study on the Impact of the COVID-19 Pandemic on Pregnancy Outcomes for Women Living With HIV in British Columbia.

For pregnant women living with HIV (WLWH), engagement in care is crucial to maternal health and reducing the risk of perinatal transmission. To date, there have been no studies in Canada examining the impact of the COVID-19 pandemic on pregnant WLWH. This was a retrospective cohort study assessing the impact of the pandemic on perinatal outcomes for pregnant WLWH using data from the Perinatal HIV Surveillance Program in British Columbia, Canada. We compared maternal characteristics, pregnancy outcomes, and clinical indicators related to engagement with care between a prepandemic (January 2017-March 2020) and pandemic cohort (March 2020-December 2022). We investigated preterm birth rates with explanatory variables using logistic regression analysis. The prepandemic cohort (n = 87) had a significantly (P < 0.05) lower gestational age at the first antenatal encounter (9.0 vs 11.8) and lower rates of preterm births compared with the pandemic cohort (n = 56; 15% vs 37%). Adjusted odds of preterm birth increased with the presence of substance use in pregnancy (aOR = 10.45, 95% confidence interval: 2.19 to 49.94) in WLWH. There were 2 cases of perinatal transmission of HIV in the pandemic cohort, whereas the prepandemic cohort had none. The pandemic had pronounced effects on pregnant WLWH and their infants in British Columbia including higher rates of preterm birth and higher gestational age at the first antenatal encounter. The nonstatistically significant increase in perinatal transmission rates is of high clinical importance.

HIV-related Shame among Women Giving Birth in Tanzania: A Mixed Methods Study.

Women living with HIV (WLHIV) commonly experience HIV-related shame which can interfere with HIV care-seeking behavior and lead to poor clinical outcomes. HIV-related shame may be particularly heightened during the pregnancy and postpartum periods. This study aimed to describe HIV-related shame among WLHIV giving birth, identify associated factors, and qualitatively examine the impacts of HIV-related shame on the childbirth experience. Postpartum WLHIV (n = 103) were enrolled in the study between March and July 2022 at six clinics in the Kilimanjaro Region, Tanzania. Participants completed a survey within 48h after birth, prior to being discharged. The survey included a 13-item measure of HIV-related shame, which assessed levels of HIV-related shame(Range: 0-52). Univariable and multivariable regression models examined factors associated with HIV-related shame. Qualitative in-depth interviews were conducted with pregnant WLHIV (n = 12) and postpartum WLHIV (n = 12). Thematic analysis, including memo writing, coding, and synthesis, was employed to analyze the qualitative data. The survey sample had a mean age of 29.1 (SD = 5.7), and 52% were diagnosed with HIV during the current pregnancy. Nearly all participants (98%) endorsed at least one item reflecting HIV-related shame, with an average endorsement of 9 items (IQR = 6). In the final multivariable model, HIV-related shame was significantly associated with being Muslim vs. Christian (ß = 6.80; 95%CI: 1.51, 12.09), attending less than four antenatal care appointments (ß = 5.30; 95%CI: 0.04, 10.55), and reporting experiences of HIV stigma in the health system (ß = 0.69; 95%CI: 0.27, 1.12). Qualitative discussions revealed three key themes regarding the impact of HIV-related shame on the childbirth experience: reluctance to disclose HIV status, suboptimal adherence to care, and the influence on social support networks. WLHIV giving birth experience high rates of HIV-related shame, and social determinants may contribute to feelings of shame. HIV-related shame impacts the childbirth experience for WLHIV, making the labor and delivery setting an important site for intervention and support.The study is funded by the National Institutes of Health (R21 TW012001) and is registered on clinicaltrials.gov (NCT05271903).

Metabolic Alterations in Mothers Living with HIV and Their HIV-Exposed, Uninfected Infants.

HIV-exposed, uninfected (HEU) children present with suboptimal growth and a greater susceptibility to infection in early life when compared to HIV-unexposed, uninfected (HUU) children. The reasons for these findings are poorly understood. We used a metabolomics approach to investigate the metabolic differences between pregnant women living with HIV (PWLWH) and their HEU infants compared to the uninfected and unexposed controls. Untargeted metabolomic profiling was performed using 1H-NMR spectroscopy on maternal plasma at 28 weeks' gestation and infant plasma at birth, 6/10 weeks, and 6 months. PWLWH were older but, apart from a larger 28 week mid-upper-arm circumference, anthropometrically similar to the controls. At all the time points, HEU infants had a significantly reduced growth compared to HUU infants. PWLWH had lower plasma 3-hydroxybutyric acid, acetoacetic acid, and acetic acid levels. In infants at birth, threonine and myo-inositol levels were lower in the HEU group while formic acid levels were higher. At 6/10 weeks, betaine and tyrosine levels were lower in the HEU group. Finally, at six months, 3-hydroxyisobutyric acid levels were lower while glycine levels were higher in the HEU infants. The NMR analysis has provided preliminary information indicating differences between HEU and HUU infants' plasma metabolites involved in energy utilization, growth, and protection from infection.

"It Soothes Your Heart": A Multimethod Study Exploring Acceptability of Point-of-Care Viral Load Testing among Ugandan Pregnant and Postpartum Women Living with HIV.

High adherence to antiretroviral therapy (ART) is critical for achieving viral suppression and preventing onward HIV transmission. ART continuation can be challenging for pregnant women living with HIV (PWLHIV), which has critical implications for risk of vertical HIV transmission. Point-of-care viral load (POC VL) testing has been associated with improved treatment and retention outcomes. We sought to explore acceptability of POC VL testing among Ugandan PWLHIV during pregnancy and postpartum. This multimethod analysis drew on quantitative and qualitative data collected between February and December 2021. Quantitatively, we used an intent-to-treat analysis to assess whether randomization to clinic-based POC VL testing during pregnancy and infant testing at delivery was associated with improved viral suppression (≤50 copies/mL) by 3 months postpartum compared to standard-of-care (SOC) VL testing through a central laboratory, adjusting for factorial randomization for the male partner testing strategy. Additionally, a subset of 22 PWLHIV in the POC VL arm participated in in-depth qualitative interviews. We inductively analyzed transcripts to develop categories representing concepts that characterized women's perceptions of POC VL testing during pregnancy and at delivery and ways that POC VL testing may have impacted their ART adherence and viral suppression. Key themes around women's perceptions of POC VL testing were then organized into main categories. Overall, 151 PWLHIV were enrolled into the study, 77 (51%) of whom were randomized to receive POC VL testing during pregnancy and at delivery. Women reported in qualitative interviews that POC VL testing had (1) motivated their ART adherence during pregnancy and postpartum and that they felt this testing method had (2) helped them protect their infants from acquiring HIV and (3) improved their emotional wellbeing. POC VL testing was highly acceptable among Ugandan PWLHIV and was viewed as an important tool that women believed improved their ART adherence, gave them information necessary to protect their infants from vertical HIV acquisition, and improved their emotional wellbeing. These findings support the global scale-up of POC VL testing in settings with high HIV burden, especially for PWLHIV who may be at risk of treatment disruptions or loss to follow-up.

The effect of antenatal isoniazid preventive therapy on birth outcomes in Western Kenya.

BACKGROUND: Pregnant women living with HIV (WLHIV) are at high risk for TB. There are limited data to inform whether TB preventive therapy is safe in pregnancy.METHODS: We completed a retrospective study of antenatal and birth records of mother-infant dyads at two health care facilities in Kisumu, Kenya. Among pregnant WLHIV, we assessed the relationship of antenatal isoniazid preventive therapy (IPT) with birth outcomes (preterm birth, low birth weight [LBW], congenital anomalies, and perinatal death).RESULTS: Of 576 mother-infant pairs, most women were on antiretroviral therapy (574, 99.7%) with viral suppression (518, 89.9%) and one-quarter had IPT exposure during pregnancy (152, 26.4%). The prevalence of preterm birth was lower among women with antenatal IPT exposure (21% vs. 30%; P = 0.03). LBW, congenital anomaly and perinatal death were not associated with antenatal IPT; however, we observed a trend toward fewer composite poor birth outcomes among women taking antenatal IPT (26% vs 33%; P = 0.08). Controlling for maternal age and viral load, IPT use during pregnancy was associated with lower odds of preterm birth (aOR 0.62, 95% CI 0.40-0.98; P = 0.04).CONCLUSION: In a programmatic setting in Western Kenya, IPT use was not associated with adverse birth outcomes.

Prenatal ultrasound screening and pregnancy outcomes in HIV-positive women in Germany: results from a retrospective single-center study at the Charité-Universitätsmedizin Berlin.

The aim of this study was to investigate the rate of Mother-to-child-transmission (MTCT) in women living with HIV (WLWH) in a tertiary care institution. Furthermore, we aimed to assess prenatal ultrasound screening for fetal anomalies and outcomes in high-risk pregnancies due to maternal HIV infection." In this single-center study, retrospective data related to pregnancy and childbirth were collected from 420 WLWH. All data were evaluated descriptively. From January 2014 to December 2020, a total number of 420 pregnant WLWH delivered 428 newborns. 415 (98.8%) were receiving antiretroviral therapy (ART) and 88.8% had a viral load of < 50 cop/ml prior delivery. 46 (11%) of the newborns were born prematurely. Low birth weight < 2500g occurred in 38 (9.1%) of the children. 219 (52.1%) caesarean sections (CS) were performed. The most frequent indication for an elective CS was a previous CS (70.2%). 8 severe malformations were detected using first and second trimester ultrasound. In one child, MTCT was detected postpartum, resulting in an HIV transmission rate of 0.2% in the presented cohort. The low rate of vertical HIV-transmission in our cohort of 0.2% is the result of interdisciplinary prenatal care and high experience of healthcare providers in treatment of WLWH. Despite high ART coverage and adherence, good maternal immune system and very low vertical HIV transmission rate, maternal HIV infection remains a challenge in obstetric care. First and second ultrasound screening should be a part of prenatal care for HIV-infected women and should also be offered to HIV-negative women. A reduction of the rate of unnecessary elective caesarean deliveries in WLWH is necessary to reduce complications in subsequent pregnancies.

Psychological distress, anxiety, depression, stress level, and coping style in HIV-pregnant women in Mexico.

To evaluate the presence of psychological distress (PD) and its association with the mental health and coping styles of pregnant women living with HIV (PWLWH). An observational, cross-sectional descriptive study was performed. Seventy-three PWLWH were included. Patients responded to a psychometric battery for PD, depression, anxiety, stress, and coping style evaluation. The scales used in the study were: Goldberg's 30-item General Health Questionnaire (GHQ-30), State-Trait Anxiety Inventory (STAI), Zung Depression Self-Measurement Scale (ZDS), Nowack Stress Profile, Lazarus and Folkman's Coping Styles Questionnaire. PD was observed in 31.5% of the participants. PD-positive patients showed a higher probability of presenting traits of depression and anxiety and medium/high stress levels. Besides, they preferentially used emotion-focused coping styles. PD is associated with a higher probability of presenting anxiety and depression in PWLWH. Emotion-focused coping style could be a factor in decision-making associated with risk behaviors in PWLWH.

Immunogenicity of tetanus, diphtheria and acellular pertussis vaccination among pregnant women living with and without HIV.

Vaccination during pregnancy with tetanus-diphtheria-acellular pertussis (Tdap) vaccine is recommended to protect the young infants against pertussis. There is a paucity of data on immune responses to Tdap in pregnant women living with HIV (PWLWH), and its impact on the protection of their infants has not been described. In an open label phase IV clinical trial in South Africa, we evaluated the immunogenicity and safety of Tdap in PWLWH compared with HIV-uninfected women. Antigen-specific immunoglobulin G (IgG) to pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae, diphtheria and tetanus were measured by electrochemiluminescence-based multiplex assay. Overall 91 PWLWH and 136 HIV-uninfected pregnant women were enrolled. All PWLWH were on antiretroviral treatment and 94.5% had HIV viral loads <40 copies per millilitre. Antibody levels pre-vaccination were lower among PWLWH compared with HIV-uninfected women for all antigens. At one-month post-vaccination PWLWH compared with HIV-uninfected women had lower fold-increase and antibody concentrations for all epitopes. Also, a lower proportion of PWLWH achieved ≥4-fold increase from pre to post-vaccination for pertussis toxoid and pertactin, or diphtheria IgG levels ≥0.1IU/mL and ≥1IU/mL post-vaccination. Adverse events post-vaccination were similar in PWLWH and HIV-uninfected. Tdap vaccination was safe and immunogenic. PWLHW had, however, attenuated humoral immune responses, which could affect the effectiveness of protecting their infants against pertussis compared with those born to women without HIV. ClinicalTrials.gov identifier: NCT05264662.

Assessment of Health-Related Quality of Life Using EQ-5D-5L Tool With Indian Tariffs Among Reproductive Age Group Women Living With HIV in India

ObjectiveIndia is witnessing declining HIV prevalence because of dedicated efforts by the government. The highly active antiretroviral therapy has improved life span of people living with HIV but bearing many side effects. Women living with HIV (WLHIV) in reproductive age group have additional burden of pregnancy-related issues. This study aimed to estimate the health utility score among WLHIV in India, particularly in context of their contraceptive use, during pregnancy and postpartum period. MethodsA primary cross-sectional study was conducted among 195 WLHIV availing antiretroviral treatment services at public health facilities of Mumbai. The EQ-5D-5L interview-based questionnaire in local language and Indian value set was used to estimate health-related quality of life (QOL) reported as mean (± SD) utility and visual analog scale (VAS) scores. The relationship between utility values and VAS scores was assessed. ResultsThe WLHIV with mean age of 31.6 (6.4) years were on antiretroviral medication for nearly 7 years, and 63% had CD4+ cell count > 500 cells/mm3. Response of “11111,” that is, in full health state, was reported by 66.7%. The mean utility and VAS scores were 0.976 (± 0.0519) and 82.21 (± 15.77). Reduced health-related QOL scores were associated with pain and discomfort dimension. Utility scores among contraceptive users (0.986 [± 0.029]) was higher than nonusers (0.976 [± 0.028]). Currently pregnant WLHIV had least utility score (0.959 [± 0.088]). ConclusionsWLHIV had better QOL while using contraceptives more so when they were sterilized. Pregnancy reduces the QOL. This emphasizes the need to promote effective contraceptive methods among WLHIV and prevent unintended pregnancies.

Adverse perinatal outcomes attributable to HIV in sub-Saharan Africa from 1990 to 2020: Systematic review and meta-analyses

BackgroundMaternal HIV infection and antiretroviral drugs (ARVs) are associated with increased risks of adverse perinatal outcomes. The vast majority of pregnant women living with HIV (WLHIV) reside in sub-Saharan Africa. We aimed to determine the burden of adverse perinatal outcomes attributable to HIV and ARVs in sub-Saharan Africa between 1990 and 2020.MethodsWe conduct a systematic review of studies on the association of pregnant WLHIV with adverse perinatal outcomes in sub-Saharan Africa. We perform random-effects meta-analyses to determine the risk difference (attributable risk, AR) of perinatal outcomes among WLHIV receiving no ARVs, monotherapy, or combination antiretroviral therapy (cART) initiated antenatally or preconception, compared to HIV-negative women. We estimate numbers of perinatal outcomes attributable to HIV and ARVs by combining the AR values with numbers of WLHIV receiving different ARV regimens in each country in sub-Saharan Africa annually between 1990 and 2020.ResultsWe find that WLHIV receiving no ARVs or cART initiated antenatally or preconception, but not monotherapy, have an increased risk of preterm birth (PTB), low birthweight (LBW) and small for gestational age (SGA), compared to HIV-negative women. Between 1990 and 2020, 1,921,563 PTBs, 2,119,320 LBWs, and 2,049,434 SGAs are estimated to be attributable to HIV and ARVs in sub-Saharan Africa, mainly among WLHIV receiving no ARVs, while monotherapy and preconception and antenatal cART averted many adverse outcomes. In 2020, 64,585 PTBs, 58,608 LBWs, and 61,112 SGAs were estimated to be attributable to HIV and ARVs, the majority among WLHIV receiving preconception cART.ConclusionsAs the proportion of WLHIV receiving preconception cART increases, the burden of adverse perinatal outcomes among WLHIV in sub-Saharan Africa is likely to remain high.Systematic review registration numberCRD42021248987

Treatment of Perinatal Depression and Correlates of Treatment Response Among Pregnant Women Living with HIV in Uganda.

Perinatal depression is common among women living with HIV, but depression care is limited in low-resource settings. We examined (1) characteristics of women receiving Problem Solving Therapy (PST) versus antidepressant therapy (ADT), (2) treatment response by modality, and (3) correlates of treatment response. This analysis used data from 191 Ugandan women in the intervention arm of a cluster randomized controlled trial of task-shifted, stepped-care depression treatment for pregnant women living with HIV (PWLWH). Treatment response was defined as scoring < 5 on the nine-item Patient Health Questionnaire (PHQ-9). Bivariate analysis and multivariable logistic regression were used to examine characteristics of women by treatment group and correlates of treatment response. Of 134 participants with depression, 129 (96%) were treated: 84 (65%) received PST and 45 (35%) received ADT. Severe depression at treatment initiation was more common in those receiving ADT (28.9% versus 4.8%, Fischer's Exact Test < 0.001). Treatment response was higher for PST (70/84; 83.3%) than ADT (30/45; 66.7%; p = .03). ADT side effects were rare and minor; no infants had serious congenital defects. Of 22 participants (19%) who did not respond to treatment, only five received intensified management. Social support and interpersonal violence were associated with treatment response (adjusted odds ratio, [aOR] = 3.06, 95% CI = 1.08-8.66 and aOR = 0.64, 95% CI = 0.44-0.93). Both depression treatment modalities yielded high response rates in Ugandan PWLWH; ADT was well-tolerated. Our results highlight a need to build capacity to implement the stepped-care protocol for non-responders and screen for social support and interpersonal violence.

Adverse pregnancy outcomes associated with antiretroviral therapy initiated before pregnancy and during pregnancy: a retrospective study in Hubei province, China.

Antiretroviral therapy (ART) initiation before pregnancy was reported to have an increased risk of adverse pregnancy outcomes (APOs) than ART initiation during pregnancy. However, the risks of APOs associated with different ART regimens initiated before or during pregnancy remain unknown. Pregnant women living with HIV (PWLHIV) from Hubei Province, China, were retrospectively enrolled between January 1, 2004, and December 31, 2021. The trends of ART initiation time and application of different ART regimens were evaluated over time, separately. Using no ART exposure before and during pregnancy as control, the risks of APOs associated with protease inhibitor (PI) based regimens and non-nucleoside reverse transcriptase inhibitors (NNRTIs) based regimens initiated before pregnancy were analyzed; and the risks of APOs associated with PI-based regimens, NNRTIs based regimens and zidovudine (AZT) monotherapy initiated during pregnancy were analyzed. APOs, including low birthweight (LBW), stillbirth, preterm birth (PTB) and early miscarriage, were reviewed. Among 781 PWLHIV including 1,010 pregnancies, 522 pregnancies (51.7%) were exposed to ART before or during pregnancy. Of them, the proportion of ART initiation before pregnancy per year increased from around 20% in the early period to more than 60% after 2019. Efavirenz (EFV)-nucleoside reverse transcriptase inhibitors (NRTIs) (32.2%), LPV/r-NRTIs (31.2%), and nevirapine (NVP)-NRTIs (27.4%) were the most commonly used regimens, and the proportion of LPV/r-NRTIs used per year has increased to around 50.0% in recent years. LPV/r-NRTIs was associated with higher risks of LBW whether initiated before pregnancy [adjusted OR (aOR) = 2.59, 95%CI 1.04-6.45, p = 0.041] or during pregnancy (aOR = 2.19, 95%CI 1.03-4.67, p = 0.041), compared with no exposure to ART before and during pregnancy. However, no matter initiated before or during pregnancy, LPV/r-NRTIs had no significantly increased risks of stillbirth, PTB and early miscarriage, and EFV /NVP-NRTIs and AZT monotherapy had no significantly increased risks of LBW, stillbirth, PTB and early miscarriage when compared with no exposure to ART before and during pregnancy. Our data suggests that LPV/r-NRTIs has been widely used among PWLHIV in recent years. However, the potential risk of LBW should be continuously monitored among PWLHIV whether LPV/r-NRTIs is initiated before or during pregnancy.

The effects of revised peer-counselor support on the PMTCT cascade of care: results from a cluster-randomized trial in Kenya (the EMMA study)

BackgroundThis study evaluated the effect of revisions to existing peer-counselor services, called Mentor Mothers (MM), at maternal and child health clinics on medication adherence for women living with HIV (WLWH) in Kenya and on early infant HIV testing.MethodsThe Enhanced Mentor Mother Program study was a 12-site, two-arm cluster-randomized trial enrolling pregnant WLWH from March 2017 to June 2018 (with data collection through September 2020). Six clinics were randomized to continued MM-supported standard care (SC). Six clinics were randomized to the intervention arm (INT = SC plus revised MM services to include more one-on-one interactions). Primary outcomes for mothers were defined as: (PO1) the proportion of days covered (PDC) with antiretroviral therapy (ART) ≥ 0.90 during the last 24-weeks of pregnancy; and (PO2) ≥ 0.90 PDC during the first 24-weeks postpartum. Secondary outcomes were infant HIV testing according to national guidelines (at 6, 24, and 48 weeks). Crude and adjusted risk differences between study arms are reported.ResultsWe enrolled 363 pregnant WLHV. After excluding known transfers and subjects with incomplete data extraction, data were analyzed for 309 WLWH (151 SC, 158 INT). A small share achieved high PDC during the prenatal and postnatal periods (0.33 SC/0.24 INT achieved PO1; 0.30 SC/0.31 INT achieved PO2; crude or adjusted risk differences were not statistically significant). In addition, ~ 75% in both study arms completed viral load testing during year two after enrollment, with > 90% suppressed in both arms. For infants, ≥ 90% in both arms had at least one HIV test through study follow up (76 weeks) but testing on schedule according to PMTCT guidelines was uncommon.ConclusionsWhile national guidelines in Kenya recommended that all HIV-infected pregnant women take a daily antiretroviral regimen for life following a HIV diagnosis, results presented here indicate that a minor share achieved high medication coverage during the prenatal and postnatal periods analyzed. In addition, adjustments to Mentor-Mother services showed no improvement in study outcomes. The lack of effect for this behavioral intervention is relatively consistent with the existing literature to improve mother-infant outcomes along the PMTCT care cascade.Clinical Trial NumberNCT02848235. Date of first trial registration 28/07/2016.

Pregnant women and male partner perspectives of secondary distribution of HIV self-testing kits in Uganda: A qualitative study.

HIV self-testing (HIVST) is a promising strategy to increase awareness of HIV status among sub-Saharan African (SSA) men. Understanding user perspectives on HIVST secondary distribution from pregnant women attending antenatal care (ANC) to their male partners is crucial to optimizing delivery strategies. We sampled pregnant women attending ANC without their partners and purposively oversampled pregnant women living with HIV (PWHIV) to understand their unique views. We recruited male partners after obtaining contact information from women. We conducted 14 focus group discussions and 10 in-depth interviews with men and pregnant women. We assessed acceptability of HIVST secondary distribution, barriers, facilitators, and interventions to increase HIVST uptake. Participants felt that HIVST secondary distribution was acceptable, particularly for women in stable relationships. However, many expressed concerns about accusations of mistrust, relationship dissolution, fear of discovering serodifference, and lack of counseling associated with HIVST. PWHIV reported hesitation about secondary distribution, citing fears of unintended HIV status disclosure and abandonment resulting in financial hardship for themselves and their infant. Some participants preferred that providers contact men directly to offer HIVST kits instead of distribution via women. Participants reported that community sensitization, availability of phone-based counseling, male clinic staff, extended clinic hours, and financial incentives could increase men's HIVST use and linkage to care. Participants expressed high interest in using HIVST, but secondary distribution was not universally preferred. We identified potential strategies to increase HIVST acceptability, particularly among PWHIV and those in unstable partnerships which can inform strategies to optimize HIVST distribution.

No increased in utero and peripartum HIV acquisition risk in HIV-exposed preterm infants.

Limited data exist on the differential risk of HIV acquisition between infants born preterm versus those born at term to women living with HIV (WLHIV). With a reported increase in preterm delivery among pregnant WLHIV, understanding the risk of vertical transmission of HIV in preterm infants can inform strategies to optimise the timing of diagnostic testing, antiretroviral prophylaxis, and infant feeding. To describe the prevalence and timing of HIV acquisition, in utero versus perinatal, among infants with perinatal HIV exposure born prior to 37 weeks completed gestation age compared to those born at term in the Botswana-based Mpepu study and explore predictors of infant HIV acquisition. Using data extracted from the Mpepu study, we describe the prevalence, timing and risk factors for HIV acquisition in infants born preterm versus those born at term. Fisher exact testing was used to test for differences in prevalence and timing of HIV and a multivariable logistic regression model was used to assess risk factors for infant HIV acquisition. 2866 infants born to WLHIV were included in this secondary analysis. 532 (19%) were born preterm. There was no observed difference in the prevalence of HIV acquisition among infants born preterm versus at term overall (0.8% vs 0.6%, P = 0.54), at birth (0.2% vs 0.3%, P = 1.00) or between 14 and 34 days post-delivery (0.6% vs 0.3%, P = 0.41). The absence of maternal antiretroviral use during pregnancy significantly predicted infant HIV acquisition, with the risk of HIV acquisition reduced by 96% among infants whose mothers were taking antiretroviral treatment (ART) during pregnancy (adjusted odds ratio: 0.003, confidence interval: 0.01-0.02, P < 0.001). There was no observed increase of in utero and peripartum HIV acquisition among infants born preterm following foetal exposure to HIV compared to those born at term.