Comparative evaluation of three different regression-equation-based mixed dentition analysis of children for prediction of the mesiodistal width of permanent canine and premolars.

BACKGROUND: Dental malocclusion is common all over the world, and it is caused by a difference in arch length and tooth size. This necessitates mixed dentition analysis for early intervention treatment planning such as eruption guiding, serial extraction, space maintainer, space regainer, and jaw extension. The aim of the study is to comparatively evaluate three different regression equation based mixed dentition analysis of children for prediction of the mesiodistal width of permanent canine and premolars in population of Vidarbha region. METHODS: This study comprised of 300 patients aged 13 to 16 years old. The impressions of patients were poured, and the mesiodistal width of their teeth was measured and documented. Three independent analyses were performed using the Ling and Wong method (L&W), the Bernabe and Flores-Mir method (B&F), and the Tanaka and Johnston method (T&J), and the results were compared to the sum of permanent canine and premolar teeth (SPCP). ANOVA with post hoc analysis was used to compare the predicted mesiodistal diameter (MDD) by analysis to the SPCP observed on cast. RESULTS: The mesiodistal width of SPCP of maxilla and mandibular teeth had statistically significant difference (P<0.001) with the predicted width by Ling and Wong method, Bernabe and Flores method and Tanaka and Johnston method for patients of Vidarbha region. CONCLUSIONS: The study concluded that all the three analysis overestimated the mesiodistal width of the sum of permanent canine and premolar in the patients. Tananka and Johnston analysis method was better in predicting the SPCP of the children of Vidarbha region.

Safety of low dose efavirenz regimen in Indian adults with HIV-1 infection: Insights from a phase 4 interventional randomised trial.

BACKGROUND: A randomized interventional phase 4 study in the Indian population confirmed the non-inferiority of the combination tenofovir/lamivudine/efavirenz (TLE)-400 to TLE600. The current manuscript describes in detail the safety profile and patient-reported safety outcomes obtained from the phase 4 study. METHODS: This investigation was part of a phase 4 non-inferiority study with a blinded assessment, conducted across 17 sites in India. The duration of the study was 24 weeks. Safety endpoints assessed included all the adverse events (AEs) related to the study treatment (TLE400 and TLE600). The depression anxiety stress 21-item scale questionnaire and efavirenz-related symptom questionnaire were also used to measure depression, anxiety, stress, and patient experience. RESULTS: A total of 68 patients (52.3%) reported 261 AEs and 87 patients (64.9%) reported 379 AEs related to study treatment in TLE400 group and TLE600 group respectively, P = .037. The reported AEs associated with central nervous system disorders were lower in the TLE400 group with 41 patients (31.5%) to 61 patients (45.5%) in the TLE600 group. The change from mean baseline value for depression anxiety stress 21-item scale at week 28 in TLE400 group and TLE600 group was -5.1 and -6.2 respectively. Similarly, the mean change from baseline score of efavirenz-related symptoms at week 28 in TLE400 group and TLE600 group were -5.1 and -4.1 respectively. CONCLUSION: The low dose efavirenz (400 mg) in combination with tenofovir and lamivudine had a better safety and tolerability profile than the standard dose of efavirenz (600 mg) in combination with tenofovir and lamivudine. Thus, low dose efavirenz should be preferred over the standard dose.

Partial atlantooccipital assimilation causing atlantoaxial instability and early myelopathy in an adult treated with occipitocervical fusion: A case report.

INTRODUCTION & IMPORTANCE: Atlanto-occipital assimilation is a rare congenital abnormality which can cause atlantoaxial instability. Basilar invagination and instability can lead to cord compression and myelopathy in young individuals. CASE REPORT & DISCUSSION: A 37-year-old male presented with gradually worsening axial neck pain for four years duration His deep tendon reflexes are exaggerated in all four limbs but there is no weakness or imbalance. Following radiological evaluation, he was diagnosed to have partial atlantooccipital assimilation causing atlantoaxial instability, basilar invagination and early myelopathy. He was treated with occipital-cervical fusion after the closed reduction of the atlantoaxial joint. CONCLUSION: Atlanto-axial assimilation can lead to atlantoaxial instability and subsequently myelopathy. Dynamic radiographs and computed tomography are helpful in the diagnosis. Reducible atlantoaxial instability can be managed with closed reduction and occipitocervical fusion.

Use of Intralesional Deoxycholic Acid for Antiretroviral Treatment Associated Lipohypertrophy: A Qualitative Open-Label Study of an Innovative Indication.

Background: With the advent of antiretroviral treatment (ART), human immunodeficiency virus/AIDS has become a chronic manageable disease. Though life expectancy has improved, it brings alongside effects of long-term medical treatment. One of the major side effects is body dysmorphism, which leads to esthetic problems. Problems of lipodystrophy (LDS), especially facial lipoatrophy as well as facial and upper back lipohypertrophy are perceived by patients as highly stigmatizing manifestations of their human immunodeficiency virus infection. It has been reported to affect mood and quality of life, as well as reduced adherence to antiretroviral medications. Patients feel discomfort while sleeping, dressing, and during day-to-day activities. Aim: The aim of this study was to test a relatively cost-effective and efficacious treatment modality for long-standing ART-associated lipohypertrophy of the submental fat and dorsocervical fat. Materials and Methods: This was a prospective open-label clinical study, in which 21 patients on regular ART with associated lipohypertrophy were enrolled in this open-label study. Deoxycholic acid (DCA) was given intralesionally once every 4-6 weeks. Patients were assessed for response, any adverse events, and patient satisfaction during every visit. Results: Intralesional DCA seems to be a promising treatment modality for long-standing ART-induced LDS with better cost-benefit in comparison with surgical interventions. Limitations: It was a small-sized sample that was studied. The lag time between starting the treatment and optimum results was long in comparison with liposuction. The result is better appreciated at the end of treatment rather than after every session implying that it has a cumulative effect. Neither pre- and post-ultrasonography nor metric documentation was done. Conclusions: Intralesional DCA seems to be a promising treatment modality for long-standing ART-induced LDS with better cost-benefit in comparison with surgical interventions.

Impact of COVID-19 Pandemic on HIV Testing Uptake Among Key Populations Enrolled in Targeted Intervention Program in Maharashtra, India.

The COVID-19 pandemic posed unprecedented challenges to HIV services globally. We evaluated the impact of the COVID-19 pandemic on the uptake of HIV testing in the Targeted Intervention (TI) program in Maharashtra-a high HIV burden state in India. Annual HIV testing was sustained during the pandemic year (2020-2021), at levels similar to the pre-pandemic year (2019-2020), among Female Sex Workers (FSW), Men having Sex with Men (MSM), Transgender (TG), and Truckers; but not among Migrants and Intravenous Drug Users (IDU). There was an acute decline during the lockdown across all typologies. Sharp recovery was seen among FSW, MSM, and TG during the early months of the un-lockdown. The community-based screening (CBS) approach primarily contributed to this recovery. Among migrants and truckers, recovery was delayed. There was an overall reduction of 58% in annual HIV-positive registrations. The community-based networks, participatory structures, and processes of HIV programs played an essential role in reaching the community during the pandemic.

Can we increase the cervical cancer screening interval with an HPV test for women living with HIV? Results of a cohort study from Maharashtra, India.

We are reporting (a) updated incidence of cervical intraepithelial neoplasia (CIN) among women who did not have colposcopic or histopathological disease at baseline and (b) disease outcomes among women treated for CIN and their follow-up HPV status; in a cohort of women living with HIV (WHIV). The median overall follow-up was 3.5 years (IQR 2.8-4.3). The incidence of any CIN and that of CIN 2 or worse disease was 16.7 and 7.0 per 1000 person-years of observation (PYO), respectively. Compared with women who were HPV negative at baseline, women who cleared HPV infection had 23.95 times increased risk of incident CIN 2 or worse lesions (95% CI 2.40-661.07). Women with persistent HPV infection had 138.18 times increased risk of CIN 2 or worse lesions (95% CI 20.30-3300.22). Complete disease regression was observed in 65.6% of the HPV positive women with high-grade CIN and were treated with thermal ablation but HPV persistence was seen in 44.8% of those with high-grade disease. Among those who did not have any disease at baseline and were also HPV negative, about 87% (95% CI 83.79-89.48) women remained HPV negative during consecutive HPV test/s with the median interval of 3.5 years. Long-term surveillance of WHIV treated for any CIN is necessary for the prevention of cervical cancer among them. Our study provides an early indication that the currently recommended screening interval of 3 to 5 years among WHIV may be extended to at least 5 years among HPV negative women. Increasing the screening interval can be cost saving and improve scalability among WHIV to support WHO's cervical cancer elimination initiative.

Efficacy and safety of 400 mg efavirenz versus standard 600 mg dose when taken with tenofovir and lamivudine combination in Indian adult patients with HIV-1 infection: An open-label, interventional, randomized, non-inferiority trial.

BACKGROUND: To evaluate the non-inferiority of low dose efavirenz (400 mg) to standard dose efavirenz (600 mg), when taken in combination with tenofovir and lamivudine in Indian patients with HIV-1 infection. METHODS: An open-label, interventional phase IV study with blinded assessment was conducted across 17 sites in India. HIV-1-infected antiretroviral therapy-naive adult patients (≥18 years of age) with a plasma HIV-1 viral load of at least 1000 copies per mL were randomized to receive either tenofovir/lamivudine/efavirenz (TLE) 400 or TLE 600. The primary endpoint was the difference in the proportion of patients achieving < 200 copies per mL at the end of 24 weeks. RESULTS: A total of 265 patients were enrolled and were randomized in 1:1 ratio to TLE 400 group (130 patients) and TLE 600 group (135 patients). At week 24, the proportion of patients with a viral load of less than 200 copies per mL was 80.70% for TLE 400 and 78.95% for TLE 600 (difference 1.75%, 90% confidence interval: -7.01, 10.49) which was within the predefined margin of -10% (90% confidence interval). Significantly lower study drug-related adverse events were observed in TLE 400 group compared to TLE 600 group (52.30%, n = 68 vs 64.92%, n = 87; P = .037). The treatment discontinuation percentage was marginally higher by 2.08% in TLE 600 group. CONCLUSION: The fixed-dose combination of TLE 400 is non-inferior to TLE 600 in terms of viral suppression and has an improved safety profile over 24 weeks in adult Indian patients with HIV-1 infection.

Understanding Emergent Dynamism of Covid-19 Pandemic in a City.

Predicting the evolution of a pandemic requires precise understanding of the pathogen and disease progression, the susceptible population group, means of transmission, and possible control mechanisms. It has been a significant challenge as Covid-19 virus (SARS-CoV-2 family) is not well understood yet; the entire human population is susceptible, and the virus transmits easily through airborne particles. Given its size and connectedness, it is not feasible to test the entire population and to isolate the infected individuals. Moreover, rapid and continuous mutation of virus open up the possibility of reinfection. As a result, the evolution of pandemic is not uniform and in-step throughout the world but is significantly influenced by local characteristics pertaining to people, places, dominant virus strain, extent of vaccination, and adherence to pandemic control interventions. Traditional macro-modelling techniques, such as variations of SEIR models, provide only a coarse-grained, 'lumped up' understanding of the pandemic which is not enough for exploring and understanding possible fine-grained factors that are effective for controlling the Covid-19 pandemic. This paper explores the problem space from a system theoretic perspective and presents a fine-grained city digital twin as an in-silico experimentation aid to understand the complex interplay of factors that influence infection spread and also help in controlling the Covid-19 pandemic. Our focus is not to speculate the possibility of the next wave or how the next wave may look like. Instead, we systematically seek answers to questions such as: what are indicators should we consider for a future wave? What are the parameters that may influence those indicators? When and why should they be tweaked (in terms of interventions) to control unacceptable situations? We validate our approach on the second and third waves of Covid-19 pandemic in Pune city.

A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1.

Purpose: WHO recommends dolutegravir (DTG) based regimens as first-line treatment for HIV-1 infection. However, few studies have been conducted in Indian population. Hence, our study evaluated the safety, tolerability, and efficacy of DTG 50 mg with Tenofovir and Lamivudine (300/300mg) fixed dose combination in treatment naïve adult Indian patients. Methods: This was an open label, multicenter, prospective, interventional, phase IV study conducted across 14 sites between February 2019 and July 2020. 24 weeks was the treatment duration for each subject. The primary end point was to assess the incidence of adverse events (AEs) and secondary end points were to assess the proportion of patients achieving plasma HIV-1 RNA levels <50 copies/mL at week 24 and change in CD4+ cell count from the baseline. Safety analysis was conducted using Safety Analysis Set and efficacy analysis was carried out using Full Analysis Set and Per protocol set. Results: A total of 288 patients were screened; 250 were enrolled; and 229 completed the study. 389 AEs were reported from 58% of patients. Of these, 61 were related to study treatment. One event of decreased creatinine clearance led to study discontinuation. One serious event of pyrexia was reported, which was unrelated to the study drug. The most common AEs were headache (18%), pyrexia (14%), vomiting (6.4%) and upper respiratory tract infections (6%). No deaths were reported. At week 24, 86.8% of the patients achieved plasma HIV-1 RNA levels <50 copies/mL and the mean CD4 cell count increased from 350.2 (SD, 239.73) at baseline to 494.6 (SD, 261.40) with an average increase of 143.2 (SD, 226.14) cells. Conclusion: This study demonstrated the safety and efficacy of DTG based regimen in treatment naïve HIV-1 patients in Indian population and support use of DTG as first-line treatment regimen.

Band decomposition of asynchronous electroencephalogram signal for upper limb movement classification.

Decoding asynchronous electroencephalogram (A-EEG) signals is a crucial challenge in the emerging field of EEG based brain-computer interface. In the case of A-EEG signals, the time markers of motor activity are absent. The paper proposes a method to decompose the A-EEG signals using gabor elementary function designed with Gabor frames. The scale-space analysis extracts Gabor dominant frequencies from A-EEG signals. Statistical and temporal moment dependent features are used to create the feature vector for each estimated gabor band. The statistical significance of the features is tested with the Kruskal-Wallis test. The deep neural network is implemented with bi-directional long short-term memory block to classify the upper limb movement. The EEG data of healthy volunteers have been collected using the Enobio-20 electrode system and ArmeoSpring rehabilitation device. The proposed methodology has achieved an average classification accuracy of 96.83%, precision 0.96, recall 0.96, and F1-score of 0.93 on the acquired data set. The designed framework for decoding upper limb movement outperforms the existing state-of-the-art methods. In the future, the proposed framework could increase classification performance by incorporating multiple types of biological inputs for investigating various brain functions.

AI-driven streamlined modeling: experiences and lessons learned from multiple domains.

Model-driven technologies (MD*), considered beneficial through abstraction and automation, have not enjoyed widespread adoption in the industry. In keeping with the recent trends, using AI techniques might help the benefits of MD* outweigh their costs. Although the modeling community has started using AI techniques, it is, in our opinion, quite limited and requires a change in perspective. We provide such a perspective through five industrial case studies where we use AI techniques in different modeling activities. We discuss our experiences and lessons learned, in some cases evolving purely modeling solutions with AI techniques, and in others considering the AI aids from the beginning. We believe that these case studies can help the researchers and practitioners make sense of various artifacts and data available to them and use applicable AI techniques to enhance suitable modeling activities.

Mapping HIV risk trajectories from adolescence to young adulthood: a life-course study among unmarried urban Indian youth.

The study explores trajectories of HIV risks from adolescence to adulthood among unmarried, educated (12+ years of formal education), 20-29 year old youth. Retrospective time event data (n=517) was used to build HIV risk trajectories (age 10 onwards), employing group-based trajectory technique and multinomial logistic regression in SAS v9.4. Among men (n=271), 10% had "Declining risk - high to low", and 15% had "consistent high risk". Among women (n=246), 11% had "late-rising risk", and 15% had "consistent high risk". Among women, childhood experience of sexual abuse, having self-income, father education until 12th standard, frequent alcohol use predicted higher risk trajectories. Among men, it was an early sexual debut, alcohol dependency in parent/s, non-heterosexual orientation, early sexual debut, and frequent alcohol use. The HIV risk behaviors of unmarried Indian youth are diverse. A subsection engages in high-risk behaviors that change over time and have linkages to developmental factors.

Practical Guidelines to Develop and Evaluate a Questionnaire.

Life expectancy is gradually increasing due to continuously improving medical and nonmedical interventions. The increasing life expectancy is desirable but brings in issues such as impairment of quality of life, disease perception, cognitive health, and mental health. Thus, questionnaire building and data collection through the questionnaires have become an active area of research. However, questionnaire development can be challenging and suboptimal in the absence of careful planning and user-friendly literature guide. Keeping in mind the intricacies of constructing a questionnaire, researchers need to carefully plan, document, and follow systematic steps to build a reliable and valid questionnaire. Additionally, questionnaire development is technical, jargon-filled, and is not a part of most of the graduate and postgraduate training. Therefore, this article is an attempt to initiate an understanding of the complexities of the questionnaire fundamentals, technical challenges, and sequential flow of steps to build a reliable and valid questionnaire.

Mobile Screening Unit (MSU) for the Implementation of the 'Screen and Treat' Programme for Cervical Cancer Prevention In Pune, India.

OBJECTIVES: We are reporting the evaluation of an opportunistic point of care cervical cancer screening initiative in Pune, India using a mobile screening unit (MSU). METHODS: We conducted 290 cervical cancer screening outreach clinics in the MSU. Screening was performed by trained nurses/ health care providers using visual inspection with 5% acetic acid (VIA). Screen positive women when eligible were treated by thermal ablation during the same sitting. Women with large lesions not eligible for treatment with thermal ablation were referred for colposcopy and treatment. RESULTS: A total of 10, 925 women were screened between Nov 2016 and June 2019 in 290 outreach clinics in the MSU. The overall screen positivity was 6.6% (95% CI 6.1, 7.0) with a declining trend over time. A total of 304/717 (42.4%, 95% CI 38.7, 46.1) women received treatment with thermal ablation. About 3.6% (11/304) reported minor side effects and 1.6% (5/304) reported lower abdominal pain and all of them subsided after treatment.  Among the 413 women who were advised colposcopy, only 84 (20.33%) women underwent the procedure. Of these 84 women, 64 (76.19%) had normal colposcopy/ histopathology, 7 (8.33%) had CIN1, 2 (2.38%) had CIN 2, 9 (10.71%) had CIN 3 disease and 2 (2.38%) women were diagnosed with invasive cancer. CONCLUSION: MSUs are useful for providing cervical cancer screening services, using the 'screen and treat' strategy.  Thermal ablation is safe in the field clinics. Additional efforts are needed to improve the compliance for referral of those with large lesions requiring additional visits.

An Agent-Based Digital Twin for Exploring Localized Non-pharmaceutical Interventions to Control COVID-19 Pandemic.

The COVID-19 epidemic created, at the time of writing the paper, highly unusual and uncertain socio-economic conditions. The world economy was severely impacted and business-as-usual activities severely disrupted. The situation presented the necessity to make a trade-off between individual health and safety on one hand and socio-economic progress on the other. Based on the current understanding of the epidemiological characteristics of COVID-19, a broad set of control measures has emerged along dimensions such as restricting people's movements, high-volume testing, contract tracing, use of face masks, and enforcement of social-distancing. However, these interventions have their own limitations and varying level of efficacy depending on factors such as the population density and the socio-economic characteristics of the area. To help tailor the intervention, we develop a configurable, fine-grained agent-based simulation model that serves as a virtual representation, i.e., a digital twin of a diverse and heterogeneous area such as a city. In this paper, to illustrate our techniques, we focus our attention on the Indian city of Pune in the western state of Maharashtra. We use the digital twin to simulate various what-if scenarios of interest to (1) predict the spread of the virus; (2) understand the effectiveness of candidate interventions; and (3) predict the consequences of introduction of interventions possibly leading to trade-offs between public health, citizen comfort, and economy. Our model is configured for the specific city of interest and used as an in-silico experimentation aid to predict the trajectory of active infections, mortality rate, load on hospital, and quarantine facility centers for the candidate interventions. The key contributions of this paper are: (1) a novel agent-based model that seamlessly captures people, place, and movement characteristics of the city, COVID-19 virus characteristics, and primitive set of candidate interventions, and (2) a simulation-driven approach to determine the exact intervention that needs to be applied under a given set of circumstances. Although the analysis presented in the paper is highly specific to COVID-19, our tools are generic enough to serve as a template for modeling the impact of future pandemics and formulating bespoke intervention strategies.

Love, sex, and commitment: relationship choices and trajectories among unmarried youth in India.

There is limited research in India to understand young people's decision-making processes about intimate relationships before marriage. This paper, adopting a life course perspective, explains relationship choices and diachronic trajectories of relationships from adolescence to young adulthood. Retrospective data were collected from 1240 never married 20-29-year-old men and women living in Pune using a relationships history calendar. All the relationships from 10 years of age onwards were plotted on the calendar, and information on predictor variables was collected through structured questionnaires. Data were analysed using descriptive statistics. Sequence analysis approach was used to identify different typologies. Overall, 76% of the participants reported having at least one relationship. More women compared to men (84% vs 70%) ever had a relationship. The median age of starting the first relationship was 17 years for women and 18 for men. Different relationship types were reported, such as "serious", casual, "friends with benefit", and "exploring". The level of emotional involvement, commitment, and physical intimacy significantly differed in different relationship types with significant gender differences. Four typologies of relationships were observed, labelled as (1) Commitment-No sex (N = 187); (2) Commitment-Sex-Some exploration (N = 189); (3) No commitment-Exploration (N = 281), and (4) No relationship (N = 583). Compared to men, women were more likely to follow the trajectory of "Commitment-No sex" (RR 2.13, CI 1.5-3.03). Family environment was significantly related to young people's relationship choices. The findings strongly suggest the need to adopt a developmental perspective towards intimate relationships to understand and address the vulnerabilities of young people across the life course.

Importance of early diagnosis for developmental dysplasia of the hip: A 5-year radiological outcome study comparing the effect of early and late diagnosis.

AIM: Australia utilises a selective ultrasound screening programme. The rate of late diagnosis of developmental dysplasia of the hip (DDH) in Australia is increasing. The aim of this study is to quantify the treatment required and compare the 5-year radiological outcomes between early and late diagnosis in children with DDH with frank dislocation. METHODS: We performed a case-matched control study of children with frank DDH dislocations from 2000 to 2010 comparing three groups: children with an early diagnosis successfully treated in a Pavlik harness (SP), children with an early diagnosis who failed Pavlik harness treatment (FP) and children with a late diagnosis (LD). Minimum follow-up was 4 years. RESULTS: A total of 115 hips were included. Patients in the LD group required significantly more open reductions (P < 0.001), acetabular osteotomies (P < 0.001) and femoral osteotomies (P < 0.001). LD was also associated with significantly higher rates of growth disturbance at 46.3%, compared to 20.6% in the FP group and 5% in the SP group (P < 0.001). Overall, there were excellent radiological outcomes in 58.5% of the LD group compared to 79.4% in the FP group and 100% in the SP group. CONCLUSION: In Australia, high rates of LD in DDH persist in the context of selective ultrasound screening. While good radiological outcomes are achievable, a significantly greater level of surgical intervention is required and this is associated with significantly higher rates of growth disturbance. Optimisation of screening in Australia is vital.

Immunogenicity and safety of the AS04-HPV-16/18 and HPV-6/11/16/18 human papillomavirus vaccines in asymptomatic young women living with HIV aged 15-25 years: A phase IV randomized comparative study.

BACKGROUND: Women living with HIV (WLWH) are at higher risk of acquisition and progression of human papillomavirus (HPV) infection. Evidence on effect of HPV vaccination in this population is limited. METHODS: This phase IV randomized controlled observer-blind study assessed immunogenicity and safety of two HPV vaccines (AS04-HPV-16/18 vs. 4vHPV) given in WLWH (stage 1) and HIV- females aged 15-25 years. Co-primary endpoints were to demonstrate, in WLWH subjects, non-inferiority (and if demonstrated, superiority) of AS04-HPV-16/18 vs. 4vHPV for HPV-16 and HPV-18 by pseudovirion-based neutralization assay (PBNA) at month 7 and safety. Non-inferiority criteria was lower limit (LL) of the 95% confidence interval (CI) of the GMT ratio AS04-HPV-16/18/4vHPV above 0.5, in the according to protocol population. NCT01031069. FINDINGS: Among 873 subjects recruited between 26-Oct-2010 and 14-May-2015, 546 were randomized (1:1) and received at least one vaccine dose (total vaccinated cohort, TVC): 257 were WLWH (129 AS04-HPV-16/18; 128 4vHPV) and 289 were subjects without HIV (144 AS04-HPV-16/18; 145 4vHPV). Baseline CD4 cell count in WLWH was at least 350 cells/mm3.At month 7, AS04-HPV-16/18 showed immunological superiority to 4vHPV in WLWH. Neutralizing anti-HPV-16 and HPV-18 antibody GMTs were 2·74 (95% CI: 1·83; 4·11) and 7·44 (95% CI: 4·79; 11·54) fold higher in AS04-HPV-16/18 vs. 4vHPV (LL of the GMT ratio >1 in TVC, p<0·0001), respectively. Similar results were observed by ELISA up to month 24.Solicited local and general symptoms were in line with product labels. The number of reported serious adverse events (SAEs) was balanced throughout the study. INTERPRETATION: Both vaccines showed an acceptable safety profile in all subjects. Despite the absence of an immunological correlate of protection for HPV, differences in immune responses elicited by the vaccines especially for HPV-18 may translate into longer lasting or more robust protection against cervical cancer with the AS04-HPV-16/18 vaccine in WLWH.