"This is really something: same place, same day result, same day treatment" women's experiences of testing positive for HPV and receiving same-day treatment in Papua New Guinea: an interpretative phenomenological analysis.

INTRODUCTION: Human papillomavirus (HPV) testing is transforming cervical screening globally. The World Health Organization (WHO) now recommends same-day HPV screen-and-treat for primary cervical screening in low- and middle-income countries (LMIC) but there is a lack of evidence on women's lived experience of testing positive for oncogenic HPV and receiving same-day treatment. This study aimed to address this knowledge gap among women participating in a same-day HPV screen-and-treat (HPV S&T) program in Papua New Guinea. METHODS: As part of a larger qualitative study, this paper explores the lived experiences of 26 women who tested positive for oncogenic HPV and were treated the same day. We analysed the data using the interpretative phenomenological analysis method. All data were managed using Nvivo 12.5. RESULTS: The interpretative phenomenological analysis led to three superordinate themes: 1) facing and alleviating initial worries, (2) transforming the disclosure process, and (3) connecting to their faith. Women's experiences of the same day HPV screen-and-treat were framed by initial emotional reactions to their positive HPV test result, and having access to treatment on the same day, which helped address their worries and fears, and transformed their experience of disclosing their test result and subsequent treatment to family and friends. CONCLUSION: This study shows that, while women experience similar initial emotional reactions, undergoing same day treatment quickly resolved the women's worries, making this program highly acceptable. Overall, women's engagement in the program confirmed its high acceptability and cultural congruence, leaving women feeling empowered and hopeful about their future, and the future of all Papua New Guinea women.

Flexible and Innovative Connectivity Solution to Support National Decentralized Infectious Diseases Point-of-Care Testing Programs in Primary Health Services: Descriptive Evaluation Study.

BACKGROUND: Molecular point-of-care (POC) testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) has been available in regional and remote primary health services in Australia as part of a decentralized POC testing program since 2016 and for SARS-CoV-2 from 2020. As there was no suitable existing connectivity infrastructure to capture and deliver POC test results to a range of end users, a new system needed to be established. OBJECTIVE: The aim of the study is to design, implement, and optimize a connectivity system to meet clinical management, analytical quality management, and public health surveillance needs. METHODS: We used commercially available e-messaging technology coupled with adapted proprietary software to integrate a decentralized molecular POC testing platform (GeneXpert) in primary health services and interface with end-user databases. This connectivity infrastructure was designed to overcome key barriers to the implementation, integration, and monitoring of these large multijurisdictional infectious disease POC testing networks. Test result messages were tailored to meet end-user needs. Using centrally captured deidentified data, we evaluated the time to receipt of test results and completeness of accompanying demographic data. RESULTS: From January 2016 to April 2020, we operationalized the system at 31 health services across 4 jurisdictions and integrated with 5 different patient management systems to support the real-time delivery of 29,356 CT/NG and TV test results to designated recipients (patient management system and local clinical and central program databases). In 2019, 12,105 CT/NG and TV results were delivered, and the median time to receipt of results was 3.2 (IQR 2.2-4.6) hours, inclusive of test runtime. From May 2020 to August 2022, we optimized the system to support rapid scale-up of SARS-CoV-2 testing (105 services; 6 jurisdictions; 71,823 tests) and additional sexually transmissible infection testing (16,232 tests), including the electronic disease-specific notifications to jurisdictional health departments and alerts for connectivity disruption and positive results. In 2022, 19,355 results were delivered with an overall median transmission time of 2.3 (IQR 1.4-3.1) hours, 2.2 (IQR 1.2-2.3) hours for SARS-CoV-2 (n=16,066), 3.0 (IQR 2.0-4.0) hours for CT/NG (n=1843), and 2.6 (IQR 1.5-3.8) hours for TV (n=1446). Demographic data (age, sex, and ethnicity) were completed for 99.5% of test results in 2022. CONCLUSIONS: This innovative connectivity system designed to meet end-user needs has proven to be sustainable, flexible, and scalable. It represents the first such system in Australia established independent of traditional pathology providers to support POC testing in geographically dispersed remote primary health services. The system has been optimized to deliver real-time test results and has proven critical for clinical, public health, and quality management. The system has significantly supported equitable access to rapid diagnostics for infectious diseases across Australia, and its design is suitable for onboarding other POC tests and testing platforms in the future.

Women's acceptability of a self-collect HPV same-day screen-and-treat program in a high burden setting in the Pacific.

BACKGROUND: A field trial to evaluate a self-collect point-of-care HPV screen-and-treat (HPV S&T) program was implemented in two Well Women Clinics in Papua New Guinea (Papua New Guinea). Assessing the acceptability of a health intervention is a core element of evaluation. In this study, we examined women's acceptability of both self-collection and HPV S&T intervention in Papua New Guinea.  METHODS: Sixty-two semi-structured interviews were conducted with women who had undergone cervical screening in the same-day self-collected HPV screen-and-treat program in Madang and Western Highlands Provinces, Papua New Guinea. Data were thematically analysed using the Theoretical Framework of Acceptability (TFA) and managed using NVivo 12.5. RESULTS: Most women agreed that self-collection was transformative: it helped circumvent the culturally embarrassing pelvic examination and increased their self-efficacy, especially due to the provision of health education, instructions, and pictorial aids. The availability of same-day results, and treatment if indicated, was particularly valued by the women because it reduced the financial and temporal burden to return to the clinic for results. It also meant they did not need to wait anxiously for long periods of time for their results. Women also appreciated the support from, and expertise of, health care workers throughout the process and spoke of trust in the HPV-DNA testing technology. Most women were willing to pay for the service to ensure its sustainability and timely scale-up throughout Papua New Guinea to support access for women in harder to reach areas. CONCLUSION: This study reported very high levels of acceptability from a field trial of self-collection and HPV same-day screen-and-treat. The program was deemed culturally congruent and time efficient. This innovative cervical screening modality could be the 'solution' needed to see wider and more immediate impact and improved outcomes for women in Papua New Guinea and other high-burden, low-resource settings.

Mycoplasma genitalium and Other Reproductive Tract Infections in Pregnant Women, Papua New Guinea, 2015-2017.

Much about the range of pathogens, frequency of coinfection, and clinical effects of reproductive tract infections (RTIs) among pregnant women remains unknown. We report on RTIs (Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum subspecies pallidum, bacterial vaginosis, and vulvovaginal candidiasis) and other reproductive health indicators in 699 pregnant women in Papua New Guinea during 2015-2017. We found M. genitalium, an emerging pathogen in Papua New Guinea, in 12.5% of participants. These infections showed no evidence of macrolide resistance. In total, 74.1% of pregnant women had >1 RTI; most of these infections were treatable. We detected sexually transmitted infections (excluding syphilis) in 37.7% of women. Our findings showed that syndromic management of infections is greatly inadequate. In total, 98.4% of women had never used barrier contraception. These findings will inform efforts to improve reproductive healthcare in Papua New Guinea.

High Prevalence of Chlamydia and Gonorrhea and the Need for Sexually Transmitted Infection Testing Among Men Who Have Sex With Men and Transgender Women in Papua New Guinea.

BACKGROUND: Papua New Guinea has among the highest prevalence of sexually transmitted infections in the world but no estimates of Chlamydia trachomatis, Neisseria gonorrhoeae, or hepatitis B virus (HBV) are available among men who have sex with men (MSM) or transgender women (TGW). METHODS: We conducted respondent-driven sampling surveys among MSM and TGW in Port Moresby, Lae, and Mt Hagen (2016-2017) to characterize the prevalence of these infections. Eligibility criteria were as follows: aged ≥12 years, born male, could speak English or Tok Pisin, and had oral or anal sex with another person born male in the past 6 months. Participants were surveyed face-to-face and offered testing for anorectal and genital chlamydia and gonorrhea, syphilis, HIV, and HBV. All results are respondent-driven sampling weighted. RESULTS: We enrolled 400 participants in Port Moresby, 352 in Lae, and 111 in Mt Hagen. Chlamydia prevalence rates in the 3 cities regardless of anatomical site were 19.9%, 19.2%, and 24.3%, respectively. Gonorrhea prevalence rates regardless of anatomical site were 10.3%, 9.4%, and 9.6%, respectively. Hepatitis B virus prevalence rates were 11.7%, 13.8%, and 13.6%, respectively. In multivariable analysis, syphilis was associated with having either chlamydia or gonorrhea in Port Moresby (adjusted odds ratio, 4.0; 95% confidence interval, 2.0-7.9) and Lae (adjusted odds ratio, 2.4; 95% confidence interval, 1.2-5.0). CONCLUSIONS: There is a large unmet need among MSM and TGW in Papua New Guinea for chlamydia and gonorrhea detection and treatment. The high prevalence of HBV reinforces the importance of ensuring introduction and scale-up of HBV treatment and immunization. Urgent efforts are needed to introduce laboratory-based diagnosis for chlamydia and gonorrhea to ensure these populations have access to much needed treatment services.

Gaps in HIV Testing and Treatment Among Female Sex Workers in Lae and Mt. Hagen, Papua New Guinea.

We conducted biobehavioral surveys among female sex workers (FSW) in Lae and Mt. Hagen, Papua New Guinea (January-December 2017). Respondent-driven sampling was used to recruit FSW aged ≥ 12 years, who were assigned female sex at birth, who spoke English or Tok Pisin, and who sold or exchanged sex for money, goods, or services in the last 6 months. When adjusted for viral suppression, 48.9% of FSW Lae and 61.9% in Mt. Hagen were aware of their HIV positive status. Of these women, 95.3% in Lae and 98.9% in Mt. Hagen were on antiretroviral therapy, and of these, 83.5% in Lae and 87.0% in Mt. Hagen had suppressed viral load. Renewed efforts are needed to increase HIV testing among FSW and provide support to FSW on treatment in both cities to attain viral suppression.

A socio-ecological analysis of factors influencing HIV treatment initiation and adherence among key populations in Papua New Guinea.

BACKGROUND: In Papua New Guinea (PNG) members of key populations, including female sex workers (FSW), men who have sex with men (MSM) and transgender women (TGW), have higher rates of HIV compared to the general adult population and low engagement in HIV care. This paper examines the socio-ecological factors that encourage or hinder HIV treatment initiation and adherence among HIV positive members of key populations in PNG. METHODS: As part of a larger biobehavioural survey of key populations in PNG, 111 semi-structured interviews were conducted with FSW, MSM and TGW, of whom 28 identified as living with HIV. Interviews from 28 HIV positive participants are used in this analysis of the influences that enabled or inhibited HIV treatment initiation and treatment adherence. RESULTS: Enablers included awareness of the biomedical benefits of treatment; experiences of the social, familial and health benefits of early treatment initiation and adherence; support provided by family and friends; and non-judgmental and supportive HIV service provision. Factors that inhibited treatment initiation and adherence included perception of good health and denial of HIV diagnosis; poor family support following positive diagnosis; and anonymity and stigma concerns in HIV care services. CONCLUSION: Exploring health promotion messages that highlight the positive health impacts of early treatment initiation and adherence; providing client-friendly services and community-based treatment initiation and supply; and rolling out HIV viral load testing across the country could improve health outcomes for these key populations.

Operational experiences associated with the implementation of near point-of-care early infant diagnosis of HIV in Myanmar: a qualitative study.

BACKGROUND: Timely diagnosis and early initiation of life-saving antiretroviral therapy are critical factors in preventing mortality among HIV-infected infants. However, resource-limited settings experience numerous challenges associated with centralised laboratory-based testing, including low rates of testing, complex sample referral pathways and unacceptably long turnaround times for results. Point-of-care (POC) HIV testing for HIV-exposed infants can enable same-day communication of results and early treatment initiation for HIV-infected infants. However, complex operational issues and service integration can limit utility and must be well understood prior to implementation. We explored and documented the challenges and enabling factors in implementing the POC Xpert® HIV-1 Qual test (Cepheid, Sunnyvale, CA, USA) for early infant diagnosis (EID) as part of routine services in four public hospitals in Myanmar. METHODS: This sub-study was part of a randomised controlled stepped-wedge trial (Australian and New Zealand Clinical Trials Registry, number 12616000734460) designed to investigate the impact of POC testing for EID in Myanmar and Papua New Guinea. Infants recruited during the intervention phase underwent POC testing at the participating hospitals as part of routine care. Semi-structured interviews with 23 caregivers, 12 healthcare providers and 10 key informants were used to explore experiences of POC-EID testing. The research team and hospital staff documented and discussed implementation challenges throughout the study. RESULTS: Overall, caregivers and healthcare workers were satisfied with the short turnaround time of the POC test. Occasional delays in POC testing were mostly attributable to late receipt of samples by laboratory technicians and communication constraints among healthcare staff. Hospital staff valued technical assistance from the research group and the National Health Laboratory. Despite staff shortages and infrastructure challenges such as unreliable electricity supply and cramped space, healthcare workers and caregivers found the implementation of the POC test to be feasible at pilot sites. CONCLUSIONS: As plans for national scale-up evolve, there needs to be a continual focus on staff training, communication pathways and infrastructure. Other models of care, such as allowing non-laboratory-trained personnel to perform POC testing, and cost effectiveness should also be evaluated.

Considerable distance to reach 90-90-90 targets among female sex workers, men who have sex with men and transgender women in Port Moresby, Papua New Guinea: findings from a cross-sectional respondent-driven sampling survey.

OBJECTIVE: To characterise the Joint United Nations Programme on HIV/AIDS 90-90-90 cascade among female sex workers (FSW) and men who have sex with men (MSM)/transgender women (TGW) in Port Moresby, Papua New Guinea (PNG). METHODS: We conducted respondent-driven sampling surveys among FSW and MSM/TGW in Port Moresby, PNG from June to October 2016. All participants spoke English or Tok Pisin and were aged >12 years. FSW had to be born female and sell/exchange sex with a male in the past 6 months. MSM/TGW had to be born male and have oral/anal sex with another male-born person in the past 6 months. Participants were interviewed and offered rapid HIV diagnostic and viral load testing. HIV viral suppression (VS) was defined as <1000 copies/mL. RESULTS: We recruited 674 FSW and 400 MSM/TGW; HIV prevalence was 15.2% (95% CI 11.7 to 18.8) and 8.5% (95% CI 5.0 to 11.9), respectively. Among FSW living with HIV, 39.0% (95% CI 26.6 to 51.4) self-reported having been diagnosed; of them 79.6% (95% CI 62.7 to 96.5) self-reported being on antiretroviral therapy (ART), and 54.1% (95% CI 31.8 to 76.4) achieved VS. Among MSM/TGW living with HIV, 24.4% (95% CI 4.7 to 44.1) self-reported having been diagnosed; of them 43.9% (95% CI 33.6 to 54.8) self-reported being on ART, and 86.1% (95% CI 71.1 to 93.9) achieved VS. CONCLUSIONS: ART use among those aware of their HIV status is encouraging. However, the generally low awareness of infection status among FSW and MSM/TGW with HIV and the low VS among FSW on ART indicate an urgent need for innovative strategies to increase testing uptake and ART adherence among these populations. Monitoring drug resistance may be warranted.

Peer-delivered point-of-care testing for Chlamydia trachomatis and Neisseria gonorrhoeae within an urban community setting: a cross-sectional analysis.

Background The advent of fully automated nucleic acid amplification test (NAAT) technology brings new public health opportunities to provide Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) point-of-care testing (POCT) in non-traditional settings. METHODS: This pilot study evaluated the integration of the CT/NG Xpert diagnostic assay into an urban peer-led community setting providing HIV and syphilis POCT. A comprehensive protocol of testing, result notification, referral and follow up, managed by peer test facilitators, was undertaken. RESULTS: Over 67 weeks, there were 4523 occasions of CT/NG testing using urine, oropharyngeal and anorectal samples with 25.7% (803) of the 3123 unique participants returning for repeat testing. The prevalence of CT and NG was 9.5% and 5.4% respectively. Where CT and or NG infection was detected, 98.4% (604/614) of participants were successfully notified of detected infection and referred for treatment. Evaluation Survey responses (11.4%, 516/4523) indicated a substantial proportion of respondents (27.1%, 140/516) 'would not have tested anywhere else'. Of note, 17.8% (92/516) of participants reported no previous CT/NG test and an additional 17.8% (92/516) reported testing more than 12 months ago. A total of 95.9% (495/516) of participants 'Strongly agreed' or 'Agreed' to being satisfied with the service. CONCLUSION: The project successfully demonstrated an acceptable and feasible model for a peer-delivered community-led service to provide targeted molecular CT/NG POCT. This model offers capacity to move beyond the traditional pathology and STI testing services and establish community-led models that build trust and increase testing rates for key populations of epidemiological significance.

Reduced sensitivity from pooled urine, pharyngeal and rectal specimens when using a molecular assay for the detection of chlamydia and gonorrhoea near the point of care.

Background The aim of this study was to compare the performance of pooled self-collected urogenital, pharyngeal and anorectal specimens to that of individual specimen results for the molecular detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) near the point of care (POC) for diagnostic sensitivity. METHODS: Clients (mostly men who have sex with men) attending an urban community testing service and three sex-on-premises venues in Brisbane, Australia, were offered CT and NG testing by trained lay providers. Participants provided three self-collected specimens (urine, pharyngeal and rectal) for testing by GeneXpert (Cepheid, Sunnyvale, CA, USA). If any of the individual specimens from a participant were positive, all three specimens were pooled and retested. RESULTS: Of the 388 participants who provided three individual anatomical specimens, 76 (19.6%) were found to be positive for CT and/or NG at one or more sites. The pooling approach failed to detect five CT rectal and four NG pharyngeal infections. The overall performance (sensitivity) of the pooling approach compared with individual specimen testing and Cohen's κ were 90.0% and 0.86 respectively for CT and 89.7% and 0.89 respectively for NG. CONCLUSIONS: Reduced sensitivity was observed when using pooled specimens for the detection of CT and NG using GeneXpert near the POC, similar to results reported in laboratory-based CT and NG pooling studies. These data suggest specimen pooling is feasible near to the POC, potentially saving time and costs when screening at-risk populations for CT and NG. Our data also suggest a reduction in pooled urine could improve overall test sensitivity.

Factors associated with HIV and syphilis infection among female sex workers in three cities in Papua New Guinea: findings from Kauntim mi tu, a biobehavioral survey.

Background In this paper, factors associated with HIV and syphilis infection in three cities in Papua New Guinea are explored. METHODS: Respondent-driven sampling surveys among FSW in Port Moresby, Lae, and Mt. Hagen (2016-17) were conducted. FSW who were aged ≥12 years, who were born female, who spoke English or Tok Pisin and who had sold or exchanged vaginal sex in the past 6 months were eligible to participate. Participants were interviewed face-to-face and offered rapid HIV and syphilis testing. Survey logistic procedures were used to identify factors associated with HIV and syphilis infection, including modern contraception use, physical violence and having a casual male partner. Weighted data analysis was conducted. RESULTS: Overall, 2901 FSW (Port Moresby, 673; Lae, 709; and Mt. Hagen, 709) were enrolled in the study. HIV prevalence was 15.2% in Port Moresby, 11.9% in Lae and 19.6% in Mt. Hagen. Factors associated with HIV varied by city; for example, use of modern contraception in Port Moresby, experiences of physical violence in Lae and ever having tested for HIV in Mt. Hagen. No one variable was associated with HIV in all cities. Prevalence of syphilis infection was 7.1%, 7.0%, and 3.0% in Port Moresby, Lae, and Mt. Hagen, respectively. Factors associated with syphilis infection also varied by city and were only significant in Lae. CONCLUSION: The different factors associated with HIV and syphilis infection in each city highlight the complex HIV and syphilis epidemics among FSW and the importance of conducting surveys in multiple locations and developing local interventions.

Developing a culturally appropriate illustrated tool for the self-collection of anorectal specimens for the testing of sexually transmitted infections: lessons from Papua New Guinea.

BACKGROUND: Papua New Guinea (PNG) has a high prevalence of sexually transmitted infections (STIs). There is increasing evidence that anorectal STIs are important in terms of the dual epidemics of HIV and STIs in this setting. At the time of this study, anorectal STI testing was not possible, and there was no mechanism for self-collection of anorectal specimen among at risk 'key populations'. This paper documents the development of a culturally appropriate tool that has been used to facilitate self-collection of anorectal specimens with key populations in PNG. METHODS: This qualitative study involved four focus groups conducted with a purposive sample of 35 participants, including female sex workers, men who have sex with men and transgender women in Port Moresby and Goroka in 2015. During focus groups, participants reviewed and provided critical feedback for the adaption of a previously piloted and published pictorial anorectal specimen collection tool for use with key populations in PNG. RESULTS: The final instruction tools are presented in English language and Tok Pisin. To develop these, participants feedback resulted in six key areas of the existing instruction document being modified to ensure it was appropriate for use in PNG. These included translating complex words for sexual health issues (i.e. 'STIs', 'anorectal STIs', 'anus', 'anal sex'), biomedical instruments (i.e. 'specimen bottle', 'specimen packet' and 'swab'), and aspects of the clinical procedure (i.e. inserting the swab 3-4 cm into the anus to collect a specimen). The visual identity of the graphics was redesigned to localise the images for use in PNG. CONCLUSIONS: This paper describes the development of a culturally and linguistically appropriate tool for a biomedical and clinical intervention with key populations in PNG based around self-collection of anorectal specimens for molecular STI testing. The final tools have been used to facilitate the self-collection of anorectal specimens following a clear clinical protocol during a large bio-behavioural survey in PNG.

One size does not fit all: HIV prevalence and correlates of risk for men who have sex with men, transgender women in multiple cities in Papua New Guinea.

BACKGROUND: Biobehavioral data about men who have sex with men (MSM) and transgender women (TGW) in Papua New Guinea (PNG) are limited to those who sell sex. Information about those MSM and TGW who do not sell sex is necessary to guide HIV prevention and treatment efforts. METHODS: We conducted respondent-driven sampling (RDS) surveys among MSM and TGW in Port Moresby, Lae, and Mt. Hagen, PNG from in 2016 and 2017. Eligibility criteria was: aged > 12 years, born male, could speak English or Tok Pisin and had oral or anal sex with another person born male in the past 6 months. Participants were interviewed face-to-face and offered rapid HIV testing. Weighted data analysis was conducted using RDS-Analyst (v. 0.62). RESULTS: We enrolled 400 participants in Port Moresby, 352 in Lae, and 111 in Mt. Hagen. In the last six months, 73.2% of MSM/TGW in Port Moresby, 77.9% in Lae, and 75.9% in Mt. Hagen, had a concurrent sexual partnership. Upwards of 70% of MSM/TGW in all three cities had sex with a woman in the same period. Less than half of MSM/TGW had ever tested for HIV. HIV prevalence among MSM/TGW was 8.5% in Port Moresby and 6.9% in Lae. Among participants in Mt. Hagen it was 1.3%. HIV was associated with not having sex with a woman in the last six months and sexually transmitted disease symptoms in the last 12 months in Port Moresby and Lae. In Port Moresby, it was also associated with an uncut foreskin, and in Lae with earning income in the formal sector and being unable to rely on other MSM or TGW to accompany them to healthcare services. CONCLUSIONS: The large proportion of MSM and TGW with concurrent sexual partnerships, combined with the low testing coverage, indicates strong potential for the spread of HIV. The different correlates of HIV in Port Moresby and Lae highlight the importance of conducting surveys in multiple locations and using data to develop locally appropriate interventions even within a country.

Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation.

OBJECTIVES: A new molecular test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) (GeneXpert CT/NG) has been demonstrated to be as accurate as conventional nucleic acid amplification tests (NAAT), but performance has not been evaluated in routine primary care, performed at the point of care by clinicians. We aimed to examine its diagnostic performance when used by clinicians in remote community health services in Australia with high prevalences of CT and NG infection. The trial was registered with the Australian and New Zealand Clinical Trials Registry (#12613000808741) METHODS: At 12 health services, training was provided to 99 clinicians in the use of the GeneXpert CT/NG assay who tested specimens from all patients undergoing STI screening. Specimens were also sent in parallel for conventional laboratory-based NAATs and the concordance of results was evaluated. RESULTS: Clinicians conducted 2486 tests: CT concordance was 99.4% (95% CI 99.1 to 99.7) with a positive concordance of 98.6% (95% CI 95.9 to 99.7) and negative concordance of 99.5% (95% CI 99.1 to 99.8); NG concordance was 99.9% (95% CI 99.7 to 100.0) with a positive concordance of 100.0% (95% CI 97.5 to 100.0) and negative concordance of 99.9% (95% CI 99.7 to 100.0). CONCLUSIONS: In this first study reporting routine point-of-care use of GeneXpert CT/NG by primary care clinicians, we found excellent concordance with conventional NAATs. The use of the GeneXpert CT/NG at the point of care could potentially transform management and control of these infections in many endemic settings, including low/middle-income countries.

A novel point-of-care testing strategy for sexually transmitted infections among pregnant women in high-burden settings: results of a feasibility study in Papua New Guinea.

BACKGROUND: Sexually transmitted and genital infections in pregnancy are associated with an increased risk of adverse maternal and neonatal health outcomes. High prevalences of sexually transmitted infections have been identified among antenatal attenders in Papua New Guinea. Papua New Guinea has amongst the highest neonatal mortality rates worldwide, with preterm birth and low birth weight major contributors to neonatal mortality. The overall aim of our study was to determine if a novel point-of-care testing and treatment strategy for the sexually transmitted and genital infections Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Bacterial vaginosis (BV) in pregnancy is feasible in the high-burden, low-income setting of Papua New Guinea. METHODS: Women attending their first antenatal clinic visit were invited to participate. CT/NG and TV were tested using the GeneXpert platform (Cepheid, USA), and BV tested using BVBlue (Gryphus Diagnostics, USA). Participants received same-day test results and antibiotic treatment as indicated. Routine antenatal care including HIV and syphilis screening were provided. RESULTS: Point-of-care testing was provided to 125/222 (56 %) of women attending routine antenatal care during the three-month study period. Among the 125 women enrolled, the prevalence of CT was 20.0 %; NG, 11.2 %; TV, 37.6 %; and BV, 17.6 %. Over half (67/125, 53.6 %) of women had one or more of these infections. Most women were asymptomatic (71.6 %; 47/67). Women aged 24 years and under were more likely to have one or more STI compared with older women (odds ratio 2.38; 95 % CI: 1.09, 5.21). Most women with an STI received treatment on the same day (83.6 %; 56/67). HIV prevalence was 1.6 % and active syphilis 4.0 %. CONCLUSION: Point-of-care STI testing and treatment using a combination of novel, newly-available assays was feasible during routine antenatal care in this setting. This strategy has not previously been evaluated in any setting and offers the potential to transform STI management in pregnancy and to prevent their associated adverse health outcomes.

Clinical effectiveness and analytical quality of a national point-of-care testing network for sexually transmitted infections integrated into rural and remote primary care clinics in Australia, 2016-2022: an observational program evaluation.

Background: To address inequitable diagnostic access and improve time-to-treatment for First Nations peoples, molecular point-of-care (POC) testing for chlamydia, gonorrhoea and trichomonas was integrated into 49 primary care clinics across Australia. We conducted an observational evaluation to determine clinical effectiveness and analytical quality of POC testing delivered through this national program. Methods: We evaluated (i) implementation by measuring trends in mean monthly POC testing; ii) clinical effectiveness by comparing proportions of positive patients treated by historical control/intervention period and by test type, and calculated infectious days averted; (iii) analytical quality by calculating result concordance by test type, and proportion of unsuccessful POC tests. Findings: Between 2016 and 2022, 46,153 POC tests were performed; an increasing mean monthly testing trend was observed in the first four years (p < 0.0001). A greater proportion of chlamydia/gonorrhoea positives were treated in intervention compared with historical control periods (≤2 days: 37% vs 22% [RR 1.68; 95% CI 1.12, 2.53]; ≤7 days: 48% vs 30% [RR 1.6; 95% CI 1.10, 2.33]; ≤120 days: 79% vs 54% [RR 1.46; 95% CI 1.10, 1.95]); similarly for trichomonas positives and by test type. POC testing for chlamydia, gonorrhoea and trichomonas averted 4930, 5620 and 7075 infectious days, respectively. Results concordance was high [99.0% (chlamydia), 99.3% (gonorrhoea) and 98.9% (trichomonas)]; unsuccessful POC test proportion was 1.8% for chlamydia/gonorrhoea and 2.1% for trichomonas. Interpretation: Molecular POC testing was successfully integrated into primary care settings as part of a routinely implemented program achieving significant clinical benefits with high analytical quality. In addition to the individual health benefits of earlier treatment, fewer infective days could contribute to reduced transmissions in First Nations communities. Funding: This work was supported by an Australian National Health and Medical Research Council Partnership Grant (APP1092503), the Australian Government Department of Health, Western Australia and Queensland Departments of Health.

Performance of CADM1, MAL and miR124-2 methylation as triage markers for early detection of cervical cancer in self-collected and clinician-collected samples: an exploratory observational study in Papua New Guinea.

OBJECTIVE: WHO recommends human papillomavirus (HPV) testing for cervical screening, with triage of high-risk HPV (hrHPV) positive women. However, there are limitations to effective triage for low-resource, high-burden settings, such as Papua New Guinea. In this exploratory study, we assessed the performance of host methylation as triage tools for predicting high-grade squamous intraepithelial lesions (HSIL) in self-collected and clinician-collected samples. DESIGN: Exploratory observational study. SETTING: Provincial hospital, same-day cervical screen-and-treat trial, Papua New Guinea. PARTICIPANTS: 44 hrHPV+women, with paired self/clinician-collected samples (4 squamous cell carcinomas (SCC), 19 HSIL, 4 low-grade squamous intraepithelial lesions, 17 normal). PRIMARY AND SECONDARY OUTCOME MEASURES: Methylation levels of CADM1, MAL and miR124-2 analysed by methylation-specific PCRs against the clinical endpoint of HSIL or SCC (HSIL+) measured using liquid-based-cytology/p16-Ki67 stain. RESULTS: In clinician-collected samples, MAL and miR124-2 methylation levels were significantly higher with increasing grade of disease (p=0.0046 and p<0.0015, respectively). miR124-2 was the best predictor of HSIL (area under the curve, AUC 0.819) while MAL of SCC (AUC 0.856). In self-collected samples, MAL best predicted HSIL (AUC 0.595) while miR124-2 SCC (AUC 0.812). Combined miR124-2/MAL methylation yielded sensitivity and specificity for HSIL+ of 90.5% (95% CI 69.6% to 98.8%) and 70% (95% CI 45.7% to 88.1%), respectively, in clinician-collected samples, and 81.8% (95% CI 59.7% to 94.8%) and 47.6% (95% CI 25.7% to 70.2%), respectively, in self-collected samples. miR124-2/MAL plus HPV16/HPV18 improved sensitivity for HSIL+ (95.2%, 95% CI 76.2% to 99.9%) but decreased specificity (55.0%, 95% CI 31.5% to 76.9%). CONCLUSION: miR124-2/MAL methylation is a potential triage strategy for the detection of HSIL/SCC in low-income and middle-income country.

Mycoplasma genitalium in pregnancy, including specific co-infections, is associated with lower birthweight: A prospective cohort study.

BACKGROUND: Mycoplasma genitalium infection in pregnancy is increasingly reported at similar frequencies to other sexually transmitted infections (STIs). Knowledge on its contribution to adverse pregnancy outcomes is very limited, especially relative to other STIs or bacterial vaginosis (BV). Whether M. genitalium influences birthweight remains unanswered. METHODS: Associations between birthweight and M. genitalium and other STIs (Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis) and BV in pregnancy were examined in 416 maternal-newborn pairs from a prospective cohort study in Papua New Guinea. FINDINGS: Compared to uninfected women, M. genitalium (-166.9 g, 95% confidence interval [CI]: -324.2 to -9.7 g, p = 0.038) and N. gonorrhoeae (-274.7 g, 95% CI: -561.9 to 12.5 g, p = 0.061) infections were associated with lower birthweight in an adjusted analysis. The association for C. trachomatis was less clear, and T. vaginalis and BV were not associated with lower birthweight. STI prevalence was high for M. genitalium (13.9%), N. gonorrhoeae (5.0%), and C. trachomatis (20.0%); co-infections were frequent. Larger effect sizes on birthweight occurred with co-infections of M. genitalium, N. gonorrhoeae, and/or C. trachomatis. CONCLUSION: M. genitalium is a potential contributor to lower birthweight, and co-infections appear to have a greater negative impact on birthweight. Trials examining the impact of early diagnosis and treatment of M. genitalium and other STIs in pregnancy and preconception are urgently needed. FUNDING: Funding was received from philanthropic grants, the National Health and Medical Research Council, and the Burnet Institute. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Point-of-care testing and treatment of sexually transmitted and genital infections to improve birth outcomes in high-burden, low-resource settings (WANTAIM): a pragmatic cluster randomised crossover trial in Papua New Guinea.

BACKGROUND: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and bacterial vaginosis have been associated with adverse maternal and perinatal outcomes, but there is conflicting evidence on the benefits of antenatal screening and treatment for these conditions. We aimed to determine the effect of antenatal point-of-care testing and immediate treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis on preterm birth, low birthweight, and other adverse maternal and perinatal outcomes compared with current standard of care, which included symptom-based treatment without laboratory confirmation. METHODS: In this pragmatic cluster randomised crossover trial, we enrolled women (aged ≥16 years) attending an antenatal clinic at 26 weeks' gestation or earlier (confirmed by obstetric ultrasound), living within approximately 1 h drive of a study clinic, and able to provide reliable contact details at ten primary health facilities and their catchment communities (clusters) in Papua New Guinea. Clusters were randomly allocated 1:1 to receive either the intervention or control (standard care) in the first phase of the trial. Following an interval (washout period) of 2-3 months at the end of the first phase, each cluster crossed over to the other group. Randomisation was stratified by province. Individual participants were informed about trial group allocation only after completing informed consent procedures. The primary outcome was a composite of preterm birth (livebirth before 37 weeks' gestation), low birthweight (<2500 g), or both, analysed according to the intention-to-treat population. This study is registered with ISRCTN Registry, ISRCTN37134032, and is completed. FINDINGS: Between July 26, 2017, and Aug 30, 2021, 4526 women were enrolled (2210 [63·3%] of 3492 women in the intervention group and 2316 [62·8%] of 3687 in the control group). Primary outcome data were available for 4297 (94·9%) newborn babies of 4526 women. The proportion of preterm birth, low birthweight, or both, in the intervention group, expressed as the mean of crude proportions across clusters, was 18·8% (SD 4·7%) compared with 17·8% in the control group (risk ratio [RR] 1·06, 95% CI 0·78-1·42; p=0·67). There were 1052 serious adverse events reported (566 in the intervention group and 486 in the control group) among 929 trial participants, and no differences by trial group. INTERPRETATION: Point-of-care testing and treatment of C trachomatis, N gonorrhoeae, T vaginalis, and bacterial vaginosis did not reduce preterm birth or low birthweight compared with standard care. Within the subgroup of women with N gonorrhoeae, there was a substantial reduction in the primary outcome. FUNDING: UK Department of Health and Social Care; UK Foreign, Commonwealth and Development Office; UK Medical Research Council; the Wellcome Trust; the Australian National Health and Medical Research Council; and Swiss National Science Foundation.