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ObjectiveTo present the stage distribution, patterns of care, and outcomes of patients from Botswana with invasive cervical cancer, living with or without HIV.MethodsBetween 2013 and 2020, women with cervical cancer were prospectively enrolled in an observational cohort study.ResultsA total of 1,043 patients were enrolled; 69% were women living with HIV. The median age of the cohort was 47 years (interquartile range [IQR] 40-58 years), with women living with HIV presenting at a younger age compared to women without HIV (44 versus 61 years, p  10 g/dL (HR 0.51, p

BackgroundChlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are extremely common sexually transmitted infections (STIs) that are associated with adverse birth and neonatal outcomes, and the risk of vertical transmission of CT and NG during delivery is high. The majority of CT and NG infections are asymptomatic and missed by the standard of care in most countries (treatment based on symptoms). Thus, it is likely that missed maternal CT and NG infections contribute to preventable adverse health outcomes among women and children globally. This study aims to assess the effectiveness of CT and NG testing for asymptomatic pregnant women to prevent adverse neonatal outcomes, understand the inflammatory response linking CT and NG infections to adverse neonatal outcomes, and conduct an economic analysis of the CT and NG testing intervention.MethodsThe Maduo ("results" in Setswana) is a prospective, cluster-controlled trial in Gaborone, Botswana to compare a near point-of-care CT and NG testing and treatment intervention implemented in "study clinics" with standard antenatal care (World Health Organization-endorsed "syndromic management" strategy based on signs and symptoms without laboratory confirmation) implemented in "standard of care clinics" among asymptomatic pregnant women. The primary outcome is vertical transmission of CT/NG infection. Secondary outcomes include preterm birth (delivery

BackgroundChlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are common sexually transmitted infections (STIs) associated with adverse outcomes, yet most countries do not test and conduct syndromic management, which lacks sensitivity and specificity. Innovations allow for expanded STI testing; however, cost is a barrier.MethodsUsing inputs from a pilot program in Botswana, we developed a model among a hypothetical population of 50,000 pregnant women to compare 1-year costs and outcomes associated with 3 antenatal STI testing strategies: (1) point-of-care, (2) centralized laboratory, and (3) a mixed approach (point of care at high-volume sites, and hubs elsewhere), and syndromic management.ResultsSyndromic management had the lowest delivery cost but was associated with the most infections at delivery, uninfected women treated, CT/NG-related low-birth-weight infants, disability-adjusted life years, and low birth weight hospitalization costs. Point-of-care CT/NG testing would treat and cure the most infections but had the highest delivery cost. Among the testing scenarios, the mixed scenario had the most favorable cost per woman treated and cured ($534/cure). Compared with syndromic management, the mixed approach resulted in a mean incremental cost-effectiveness ratio of $953 per disability-adjusted life years averted, which is cost-effective under World Health Organization's one-time per-capita gross domestic product willingness-to-pay threshold.ConclusionsAs countries consider new technologies to strengthen health services, there is an opportunity to determine how to best deploy resources. Compared with point-of-care, centralized laboratory, and syndromic management, the mixed approach offered the lowest cost per infection averted and is cost-effective if policy makers' willingness to pay is informed by the World Health Organization's gross domestic product/capita threshold.

ObjectivesVulvar cancer is a rare gynecological malignancy. However, the incidence of human papillomavirus (HPV)-associated vulvar disease is increasing, particularly in low- and middle-income countries. HIV infection is associated with an increased risk of HPV-associated vulvar cancer. We evaluated treatment patterns and survival outcomes in a cohort of vulvar cancer patients in Botswana. The primary objective of this study was to determine overall survival and the impact of treatment modality, stage, and HIV status on overall survival.MethodsWomen with vulvar cancer who presented to oncology care in Botswana from January 2015 through August 2019 were prospectively enrolled in this observational cohort study. Demographics, clinical characteristics, treatment, and survival data were collected. Factors associated with survival including age, HIV status, stage, and treatment were evaluated.ResultsOur cohort included 120 women with vulvar cancer. Median age was 42 (IQR 38-47) years. The majority of patients were living with HIV (89%, n=107) that was well-controlled on antiretroviral treatment. Among women with HIV, 54.2% (n=58) were early stage (FIGO stage I/II). In those without HIV, 46.2% (n=6) were early stage (stage I/II). Of the 95 (79%) patients who received treatment, 20.8% (n=25) received surgery, 67.5% (n=81) received radiation therapy, and 24.2% (n=29) received chemotherapy, either alone or in combination. Median follow-up time of all patients was 24.7 (IQR 14.2-39.1) months and 2- year overall survival for all patients was 74%. Multivariate analysis demonstrated improved survival for those who received surgery (HR 0.26; 95% CI 0.08 to 0.86) and poor survival was associated with advanced stage (HR 2.56; 95% CI 1.30 to 5.02). Survival was not associated with HIV status.ConclusionsThe majority of women with vulvar cancer in Botswana are young and living with HIV infection. Just under half of patients present with advanced stage, which was associated with worse survival. Improved survival was seen for those who received surgery.

ObjectiveCervical cancer remains the most common cancer among women in sub-Saharan Africa and is also a leading cause of cancer related deaths among these women. The benefit of chemoradiation in comparison with radiation alone for patients with stage IIIB disease has not been evaluated prospectively in women living with human immunodeficiency virus (HIV). We assessed the survival of chemoradiation versus radiation alone among stage IIIB cervical cancer patients based on HIV status.MethodsBetween February 2013 and June 2018, patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IIIB cervical cancer with or without HIV and treated with chemoradiation or radiation alone, were prospectively enrolled in an observational cohort study. Overall survival was evaluated using the Kaplan-Meier method. Cox proportional hazards modeling was used to analyze associations with survival.ResultsAmong 187 patients, 63% (n=118) of women had co-infection with HIV, and 48% (n=69) received chemoradiation. Regardless of HIV status, patients who received chemoradiation had improved 2 year overall survival compared with those receiving radiation alone (59% vs 41%, p

BackgroundA significant proportion (20-59%) of people living with HIV in sub-Saharan Africa desire childbearing, are of reproductive age, and are in sero-different relationships (~50%). Thus it is plausible that some portion of new HIV transmissions are due to attempts to become pregnant. Safer conception (SC) methods that effectively reduce the risk of HIV transmission exist and can be made available in resource-constrained settings. Few studies in the region, and none in Botswana, have quantitatively examined the correlates of information, motivation, and behavioral skills for SC uptake.MethodsWe surveyed 356 women living with HIV from 6/2018 to 12/2018 at six public-sector health clinics in Gaborone, Botswana. Participants were 18-40 years old, not pregnant, and desired future children or were unsure about their childbearing plans. We examined correlates of SC information, motivation, and behavioral skills using nested linear regression models, adjusting for socio-demographic, interpersonal, and structural variables.ResultsKnowledge of SC methods varied widely. While some SC methods were well known (medical male circumcision by 83%, antiretroviral therapy for viral suppression by 64%), most other methods were known by less than 40% of participants. Our final models reveal that stigma as well as relationship and partner factors affect SC information, motivation, and behavioral skills. Both internalized childbearing stigma (ß=-0.50, 95%CI:-0.17, -0.02) and perceived community childbearing stigma were negatively associated with SC information (ß=-0.09, 95%CI:-0.80, -0.21). Anticipated (ß=-0.06, 95%CI:-0.12, -0.003) and internalized stigma (ß=-0.27, 95%CI:-0.44; -0.10) were associated with decreased SC motivation, while perceived community childbearing stigma was associated with increased SC motivation (ß=0.07, 95%CI:0.02, 0.11). Finally, internalized childbearing stigma was associated with decreased SC behavioral skills (ß=-0.80, 95%CI: -1.12, -0.47) while SC information (ß=0.24, 95%CI:0.12, 0.36), motivation (ß=0.36, 95%CI:0.15, 0.58), and perceived partner willingness to use SC (ß=0.47, 95%CI:0.36, 0.57) were positively associated with behavioral skills CONCLUSIONS: Low SC method-specific information levels are concerning since almost half (47%) of the study participants reported they were in sero-different relationships and desired more children. Findings highlight the importance of addressing HIV stigma and partner dynamics in interventions to improve SC information, motivation, and behavioral skills.

Despite advances in clinical care, safer conception services are not utilised in many high HIV prevalence countries, including Botswana. We conducted in-depth interviews with 10 HIV healthcare providers and 10 women living with HIV to develop a deeper understanding of attitudes surrounding childbearing and pregnancy planning. Interviews were analysed using a phenomenological approach. Providers felt it was a human right and normative for women living with HIV to have children but also expressed concern about women living with HIV having children. Women themselves anticipated stigma from providers regarding childbearing, although most described supportive care and had not experienced stigmatising treatment. Although providers believed pregnancies amongst women living with HIV were unplanned, women described discussing pregnancy desires with sexual partners. Despite providers voicing a rights-based approach to childbearing amongst women living with HIV, hesitancy towards pregnancy remains. This is felt by women living with HIV and perceived as stigma, which may make them less likely to seek fertility and safer conception advice. Safer conception interventions are unlikely to be successful if women do not feel comfortable discussing childbearing with health-care providers.

Safe and effective low-cost safer conception (SC) methods are increasingly available and being integrated into national guidelines in sub-Saharan African contexts. Sero-different couples of childbearing age can benefit from such services and the routine provision of SC counselling. Pre-exposure prophylaxis (PrEP) to prevent HIV acquisition to uninfected partners can reduce the chances of HIV transmission when trying to achieve pregnancy. Botswana has a strong commitment to reducing new HIV infections but PrEP is not yet widely available and little guidance has been offered on counselling sero-different couples. We conducted qualitative in-depth interviews in Gaborone, Botswana with 10 HIV healthcare providers and 10 women living with HIV of childbearing age because they act as a key conduit for reaching sero-different partners with information about PrEP. We examined knowledge and attitudes towards PrEP to assess the viability and develop a deeper understanding of this SC option. Interviews were analysed using an interpretive phenomenological approach. Three themes emerged: (1) awareness of PrEP is limited, (2) providers and women overwhelmingly showed interest in PrEP and (3) women living with HIV and providers have concerns about PrEP use. With the correct support, PrEP could be a useful SC option for sero-different couples in Botswana and other sub-Saharan contexts.

Various safer conception methods to limit HIV transmission risks can be offered in resource-constrained settings. However, implementation of safer conception services remains limited in many countries, including Botswana. Understanding perceptions about safer conception methods and the benefits and challenges to use can help with the development of policies, interventions, and service delivery models. Forty-five women living with HIV in the greater Gaborone, Botswana area participated in focus group discussions. Themes were analyzed using interpretive phenomenology. Despite low knowledge of specific safer conception methods that can be used to prevent transmission of HIV when trying to achieve pregnancy, there was noted interest in pre-exposure prophylaxis and vaginal insemination. Challenges to greater uptake were noted including a lack of knowledge about a range of SC methods, limited partner support and communication, provider stigma, health systems barriers, current policies, and the cultural acceptability of methods. Interventions will need to address these challenges and be responsive to the needs and reflect the realities of WLHIV who desire pregnancy in order for safer conception uptake to become a common practice.

BackgroundPartner notification is an essential component of sexually transmitted infection (STI) management. The process involves identifying exposed sex partner(s), notifying these partner(s) about their exposure to a curable STI, and offering counselling and treatment for the STI as a part of syndromic management or after results from an STI test. When implemented effectively, partner notification services can prevent the index patient from being reinfected with a curable STI from an untreated partner, reduce the community burden of curable STIs, and prevent adverse health outcomes in both the index patient and his or her sex partner(s). However, partner notification and treatment rates are often low. This study seeks to explore experiences and preferences related to partner notification and treatment for curable STIs among pregnant women receiving care in an antenatal clinic with integrated HIV and curable STI testing. Results are intended to inform efforts to improve partner notification and treatment rates in Southern Africa.MethodsWe conducted qualitative interviews among women diagnosed with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and/or Trichomonas vaginalis (TV) infection while seeking antenatal care in Gaborone, Botswana. Semi-structured interviews were used to obtain women's knowledge about STIs and their experiences and preferences regarding partner notification.ResultsFifteen women agreed to participate in the study. The majority of women had never heard of CT, NG, or TV infections prior to testing. Thirteen out of 15 participants had notified partners about the STI diagnosis. The majority of notified partners received some treatment; however, partner treatment was often delayed. Most women expressed a preference for accompanying partners to the clinic for treatment. Experiences and preferences did not differ by HIV infection status.ConclusionsThe integration of STI, HIV, and antenatal care services may have contributed to most women's willingness to notify partners. However, logistical barriers to partner treatment remained. More research is needed to identify effective and appropriate strategies for scaling-up partner notification services in order to improve rates of partners successfully contacted and treated, reduce rates of STI reinfection during pregnancy, and ultimately reduce adverse maternal and infant outcomes attributable to antenatal STIs.

BackgroundCervical cancer is the leading cause of cancer death in Sub-Saharan Africa. The risk of developing cancer is increased for women living with human immunodeficiency virus (HIV) infection. It is unknown which factors predict the initiation of curative chemoradiotherapy (CRT) in resource-limited settings and whether HIV is associated with initiating curative CRT in settings with a high HIV burden.MethodsAll women living with and without HIV infection who were initiating curative and noncurative CRT for locally advanced cervical cancer in Botswana were prospectively enrolled in an observational study. The factors associated with receiving CRT were evaluated in all patients and the subgroup of women living with HIV.ResultsOf 519 enrolled women, 284 (55%) initiated CRT with curative intent. The curative cohort included 200 women (70.4%) who were living with HIV and had a median CD4 count of 484.0 cells/μL (interquartile range, 342.0-611.0 cells/μL). In the noncurative cohort, 157 of 235 women (66.8%) were living with HIV and had a median CD4 count of 476.5 cells/μL (interquartile range, 308.0-649.5 cells/μL). HIV status was not associated with initiating curative CRT (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.58-1.56). The factors associated with receiving curative CRT treatment on multivariable analysis in all patients included baseline hemoglobin levels ≥10 g/dL (OR, 1.80; 95% CI, 1.18-2.74) and stage I or II versus stage III or IV disease (OR, 3.16; 95% CI, 2.10-4.75). Women aged >61 years were less likely to receive curative treatment (OR, 0.43; 95% CI, 0.24-0.75). Among women who were living with HIV, higher CD4 cell counts were associated with higher rates of CRT initiation.ConclusionsThe initiation of CRT with curative intent does not depend on HIV status. Significant predictors of CRT initiation include baseline hemoglobin level, disease stage, and age.

Objective: To evaluate the impact of screening and treating asymptomatic pregnant women for Chlamydia (C.) trachomatis and Neisseria (N.) gonorrhoeae infections on the frequency of preterm birth or low birthweight infants in Botswana. Design: Non‐randomised, cluster‐controlled trial. Setting: Four antenatal care clinics in Gaborone, Botswana. Population: Pregnant women aged ≥15 years, attending a first antenatal care visit, ≤27 weeks of gestation and without urogenital symptoms were eligible. Methods: Participants in the intervention clinics received screening (GeneXpert®, Cepheid) during pregnancy and at the postnatal visit. Participants in the standard‐of‐care clinics received screening at the postnatal visit only. We used multivariable logistic regression and post‐estimation predictive margins analysis. Post‐hoc analysis was conducted among sub‐samples stratified by parity. Main outcome measures: Preterm birth (<37 weeks of gestation) and low birthweight (<2500 g). Results: After controlling for parity, hypertension, antenatal care visits and clinic site, the predicted prevalence of preterm birth or low birthweight was lower in the intervention arm (11%) compared with the standard‐of‐care arm (16%) (adjusted odds ratio [aOR] 0.59; 95% confidence interval [CI] 0.28–1.24). In post‐hoc analysis, the intervention was more effective than the standard‐of‐care (aOR 0.20; 95% CI 0.07–0.64) among nulliparous participants. Conclusion: A C. trachomatis and N. gonorrhoeae infection screening and treatment intervention among asymptomatic pregnant women may have reduced preterm birth or low birthweight outcomes, but results were not statistically significant. Post‐hoc analysis found that the intervention reduced adverse outcomes among nulliparous participants. [ABSTRACT FROM AUTHOR]

Objective: Guidelines for effective triage following positive primary high‐risk human papillomavirus (HPV) screening in low‐ and middle‐income countries with high human immunodeficiency virus (HIV)‐prevalence have not previously been established. In the present study, we evaluated the performance of three triage methods for positive HPV results in women living with HIV (WLHIV) and without HIV in Botswana. Methods: We conducted baseline enrollment of a prospective cohort study from February 2021 to August 2022 in South‐East District, Botswana. Non‐pregnant women aged 25 or older with an intact cervix and no prior diagnosis of cervical cancer were systematically consented for enrollment, with enrichment of the cohort for WLHIV. Those who consented completed a questionnaire and then collected vaginal self‐samples for HPV testing. Primary HPV testing for 15 individual genotypes was conducted using Atila AmpFire® HPV assay. Those with positive HPV results returned for a triage visit where all underwent visual inspection with acetic acid (VIA), colposcopy, and biopsy. Triage strategies with VIA, colposcopy and 8‐type HPV genotype restriction (16/18/31/33/35/45/52/58), separately and in combination, were compared using histopathology as the gold standard in diagnosing cervical intraepithelial neoplasia (CIN) 2 or worse (CIN2+). Results: Among 2969 women enrolled, 1480 (50%) tested HPV positive. The cohort included 1478 (50%) WLHIV; 99% were virologically suppressed after a mean of 8 years on antiretroviral therapy. In total, 1269 (86%) women had histopathology data for analysis. Among WLHIV who tested positive for HPV, 131 (19%) of 688 had CIN2+ compared with 71 (12%) of 581 in women without HIV. Screening by 8‐type HPV genotype restriction was more sensitive as triage to detect CIN2+ in WLHIV 87.79% (95% CI: 80.92–92.85) and women without HIV 85.92% (95% CI: 75.62–93.03) when compared with VIA (WLHIV 62.31% [95% CI: 53.39–70.65], women without HIV 44.29% [95% CI: 32.41–56.66]) and colposcopy (WLHIV 70.77% [95% CI: 62.15–78.41], women without HIV 45.71% [95% CI: 33.74–58.06]). However, 8‐type HPV genotype restriction had low specificity in WLHIV of 30.88% (95% CI: 27.06–34.90) and women without HIV 37.06% (95% CI: 32.85–41.41). These results were similar when CIN3+ was used as the outcome. When combining 8‐type HPV genotype restriction with VIA as the triage strategy, there was improved specificity to detect CIN2+ in WLHIV of 81.65% (95% CI: 78.18–84.79) but dramatically reduced sensitivity of 56.15% (95% CI: 47.18–64.84). Conclusions: Eight‐type HPV genotype restriction is a promising component of effective triage for HPV positivity. However, novel triage strategies in LMICs with high HIV prevalence may be needed to avoid the trade‐off between sensitivity and specificity with currently available options. Clinical trials registration: This study is registered on Clinicaltrials.gov no. NCT04242823, https://clinicaltrials.gov/ct2/show/NCT04242823. Synopsis: Triage of HPV positivity with 8‐type genotype restriction is more sensitive than visual triage methods, however, has low specificity to detect high‐grade cervical disease. [ABSTRACT FROM AUTHOR]

: Introduction: Antiretrovirals such as dolutegravir (DTG) and tenofovir alafenamide (TAF) have been associated with excessive weight gain. The objective of this study was to understand the potential impact of ART‐associated weight gain on pregnancy outcomes among women living with HIV. Methods: Using data from the Tsepamo birth outcomes surveillance study in Botswana, we evaluated the relationship between maternal weight (and weight gain) and severe birth outcomes (very preterm delivery 4000 g) and maternal hypertension. We estimated the relative risk of each outcome by baseline weight (first weight in pregnancy Results: Of 22,828 women on ART at conception with singleton deliveries between August 2014 and April 2020, 16,300 (71.4%) had a weight measured 90 kg) was associated with increased risk of macrosomia (aRR 3.24, 95% CI 2.36, 4.44) and maternal hypertension (aRR 1.79, 95% CI 1.62, 1.97). Baseline weight was not associated with stillbirth or early neonatal death. For all outcomes, second trimester weight gain showed weaker associations than did baseline weight. Duration of pre‐pregnancy ART (years) was associated with higher baseline weight for DTG but not for EFV, and the risk of maternal hypertension by baseline weight category was higher for DTG than EFV for all strata. Conclusions: ART regimens associated with weight gain may reduce the number of women at risk for certain severe adverse pregnancy outcomes associated with low weight but increase the number at risk of macrosomia and maternal hypertension. Further research could determine whether weight‐based ART treatment strategies improve maternal and child health., INTRODUCTION Multiple studies have reported that tenofovir alafenamide (TAF) and dolutegravir (DTG) are associated with clinically significant weight gain, with risk of treatment‐emergent obesity (body mass index, or BMI, >30) [...]