Dataset Information

Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea).

ABSTRACT: Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods: The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI 'syndromic' management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery <37 completed weeks of gestation as determined by ultrasound) and/or low birth weight (<2500 g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care. Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032.

SUBMITTER: Vallely AJ

PROVIDER: S-EPMC6979472 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea).

Vallely Andrew J AJ Pomat William S WS Homer Caroline C Guy Rebecca R Luchters Stanley S Mola Glen D L GDL Mola Glen D L GDL Kariwiga Grace G Vallely Lisa M LM Wiseman Virginia V Morgan Chris C Wand Handan H Rogerson Stephen J SJ Tabrizi Sepehr N SN Whiley David M DM Low Nicola N Peeling Rosanna R Siba Peter P Riddell Michaela M Laman Moses M Bolnga John J Robinson Leanne J LJ Morewaya Jacob J Badman Steven G SG Batura Neha N Kelly-Hanku Angela A Toliman Pamela J PJ Peter Wilfred W Babona Delly D Peach Elizabeth E Garland Suzanne M SM Kaldor John M JM

Wellcome open research 20190322

Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field ...[more]

PMID: 32030356

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Project description:IntroductionLeft untreated, sexually transmitted and genital infections (henceforth STIs) in pregnancy can lead to serious adverse outcomes for mother and child. Papua New Guinea (PNG) has among the highest prevalence of curable STIs including syphilis, chlamydia, gonorrhoea, trichomoniasis and bacterial vaginosis, and high neonatal mortality rates. Diagnosis and treatment of these STIs in PNG rely on syndromic management. Advances in STI diagnostics through point-of-care (PoC) testing using GeneXpert technology hold promise for resource-constrained countries such as PNG. This paper describes the planned economic evaluation of a cluster-randomised cross-over trial comparing antenatal PoC testing and immediate treatment of curable STIs with standard antenatal care in two provinces in PNG.Methods and analysisCost-effectiveness of the PoC intervention compared with standard antenatal care will be assessed prospectively over the trial period (2017-2021) from societal and provider perspectives. Incremental cost-effectiveness ratios will be calculated for the primary health outcome, a composite measure of the proportion of either preterm birth and/or low birth weight; for life years saved; for disability-adjusted life years averted; and for non-health benefits (financial risk protection and improved health equity). Scenario analyses will be conducted to identify scale-up options, and budget impact analysis will be undertaken to understand short-term financial impacts of intervention adoption on the national budget. Deterministic and probabilistic sensitivity analysis will be conducted to account for uncertainty in key model inputs.Ethics and disseminationThis study has ethical approval from the Institutional Review Board of the PNG Institute of Medical Research; the Medical Research Advisory Committee of the PNG National Department of Health; the Human Research Ethics Committee of the University of New South Wales; and the Research Ethics Committee of the London School of Hygiene and Tropical Medicine. Findings will be disseminated through national stakeholder meetings, conferences, peer-reviewed publications and policy briefs.Trial registration numberISRCTN37134032.

Project description:Background and aimsSexually transmitted infections (STIs) pose a considerable concern for global healthcare systems. We examined the prevalence and correlates of self-reported STIs (SR-STIs) among men and women in Papua New Guinea.MethodsA total of 7,195 women and 4,069 men from Papua New Guinea who participated in the 2016-2018 Demographic and Health Survey were included in this study. Percentages were used to summarize the prevalence of SR-STIs among men and women. A multivariable multilevel binary logistic regression was used to examine the correlates of SR-STIs in men and women.ResultsAn overall 5.9% and 4.6% prevalence of SR-STIs were recorded among women and men, respectively, in Papua New Guinea. The odds of SR-STIs were higher among women who ever tested for HIV (aOR = 2.47, CI: 1.80-3.39), those who had first sex below 20 years (aOR = 1.76, CI: 1.10-2.80), those who watched television less than once a week (aOR = 1.83, CI: 1.13-2.95) and those from the Highlands and Momase regions (aOR = 5.55, CI: 3.30-9.33) compared to their counterparts who never tested for HIV, who had their first sexual intercourse when they were 20 years and above, who did not watch television at all, and those from the Southern Region. For men, the odds of SR-STIs were high among those who ever tested for HIV (aOR = 1.65, CI: 1.11-2.45), those with one (aOR= 2.08, CI: 1.05-4.14) and two or more (aOR = 3.77, CI: 1.49, 9.52) sexual partners excluding spouse in the 12 months preceding the survey, those living in the Highlands region (aOR = 2.52, CI: 1.48-4.29), and those living in communities with medium literacy level (aOR = 2.33, CI: 1.38-3.94) compared to their counterparts who had never tested for HIV, those with zero sexual partners excluding their spouse in the 12 months preceding the survey, those living in the Southern region, and those living in communities with low literacy levels.ConclusionWe recommend that the National AIDS Council of Papua New Guinea through the National HIV and STI 2018-2022 Strategy program should be realigned to address these correlates and ensure that more sexual and reproductive health resources are provided to men and women in the Highlands and Momase regions.

Project description:BackgroundPapua New Guinea (PNG) has a high burden of sexually transmitted infections (STIs) and the highest adult HIV prevalence in the Pacific region. Despite this burden of disease, heterosexual anal intercourse (HAI) has rarely been considered. Given the increasing number of, and interest in, behavioural surveys in PNG and the changing nature of PNG's HIV epidemic, it is timely to conduct a systematic review of HAI in PNG order to improve sexual health.MethodsWe performed a systematic review of HAI in PNG as reported in peer-reviewed and non-peer-reviewed publications for the period 1950-May 2012. The search strategy identified 475 publications. After screening by geographical location, topic and methodology, we identified 23 publications for full text review, following which 13 publications were included in the final review. Using data from the review, we performed a risk equation analysis to demonstrate the potential impact of HAI on HIV acquisition and incidence in PNG.ResultsThere is a paucity of well-informed behavioural research on HAI in PNG. Inconsistency in key questions on HAI made it impossible to conduct a meta-analysis. The data available on HAI shows that it is practiced in all geographical areas and among all populations. Of those who reported HAI, rates varied from as low as 8% to as high as 77% depending on the recall period and partner type. Condom use during HAI was consistently low. Our risk equation analysis indicates that even if only 20% of females engage in HAI, and only 10% of sex acts involve HAI, the total number of new HIV infections among females would be 40% greater than if vaginal intercourse only occurred.ConclusionsOur findings of indicate that HAI may be an important driver of the HIV epidemic in PNG. In order to improve the sexual health of Papua New Guineans, efforts are required to improve behavioural surveillance of HAI as well as develop national HIV/STI programing and policy to better address the risks associated with unprotected HAI.

Project description:BackgroundProviding reproductive and sexual health services is an important and challenging aspect of caring for displaced populations, and preventive and curative sexual health services may play a role in reducing HIV transmission in complex emergencies. From 1995, the non-governmental "Reproductive Health Group" (RHG) worked amongst refugees displaced by conflicts in Sierra Leone and Liberia (1989-2004). RHG recruited refugee nurses and midwives to provide reproductive and sexual health services for refugees in the Forest Region of Guinea, and trained refugee women as lay health workers. A cross-sectional survey was conducted in 1999 to assess sexual health needs, knowledge and practices among refugees, and the potential impact of RHG's work.MethodsTrained interviewers administered a questionnaire on self-reported STI symptoms, and sexual health knowledge, attitudes and practices to 445 men and 444 women selected through multistage stratified cluster sampling. Chi-squared tests were used where appropriate. Multivariable logistic regression with robust standard errors (to adjust for the cluster sampling design) was used to assess if factors such as source of information about sexually transmitted infections (STIs) was associated with better knowledge.Results30% of women and 24% of men reported at least one episode of genital discharge and/or genital ulceration within the past 12 months. Only 25% correctly named all key symptoms of STIs in both sexes. Inappropriate beliefs (e.g. that swallowing tablets before sex, avoiding public toilets, and/or washing their genitals after sex protected against STIs) were prevalent. Respondents citing RHG facilitators as their information source were more likely to respond correctly about STIs; RHG facilitators were more frequently cited than non-healthcare information sources in men who correctly named the key STI symptoms (odds ratio (OR) = 5.2, 95% confidence interval (CI) 1.9-13.9), and in men and women who correctly identified effective STI protection methods (OR = 2.9, 95% CI 1.5-5.8 and OR = 4.6, 95% CI 1.6-13.2 respectively).ConclusionOur study revealed a high prevalence of STI symptoms, and gaps in sexual health knowledge in this displaced population. Learning about STIs from RHG health facilitators was associated with better knowledge. RHG's model could be considered in other complex emergency settings.

Project description:Background Sexually transmitted infections (STIs) in low- and middle-income countries (LMICs) are predominantly managed by syndromic management. However, most STIs are asymptomatic. These untreated STIs cause individual morbidity, and lead to high STI prevalences. There is increasing interest in the use of point-of-care tests (POCTs) for STIs in LMICs, which could facilitate same day testing and treatment. To best utilise these tests, we must understand the facilitators and barriers to their implementation. The aim of this review is to explore how point-of-care testing for STIs has been implemented into healthcare systems in LMIC and the facilitators and barriers to doing so. Methods A scoping review was conducted by searching MEDLINE, Embase, Emcare, CINAHL, Scopus, LILACS, the Cochrane Library, and ProQuest Dissertations and Theses for studies published between 1st January 1998 and 5th June 2020. Abstracts and full articles were screened independently by two reviewers. Studies were considered for inclusion if they assessed the acceptability, feasibility, facilitators, or barriers to implementation of point-of-care testing for chlamydia, gonorrhoea, trichomoniasis or syphilis in LMICs. Thematic analysis was used to analyse and present the facilitators and barriers to point-of-care STI testing. Results The literature search revealed 82 articles suitable for inclusion; 44 (53.7%) from sub-Saharan Africa; 21 (25.6%) from Latin American and the Caribbean; 10 (12.2%) from East Asia and the Pacific; 6 (7.3%) from South Asia; and one (1.2%) multi-regional study. Thematic analysis revealed seven overarching themes related to the implementation of POCTs in LMICs, namely (i) Ideal test characteristics, (ii) Client factors, (iii) Healthcare provision factors, (iv) Policy, infrastructure and health system factors, (v) Training, audit, and feedback, (vi) Reaching new testing environments, and (vii) Dual testing. Conclusion Implementation of POCTs in LMICs is complex, with many of the barriers due to wider health system weakness. In addition to pressing for broader structural change to facilitate basic healthcare delivery, these themes may also be used as a basis on which to develop future interventions. The literature was heavily skewed towards syphilis testing, and so more research needs to be conducted assessing chlamydia, gonorrhoea, and trichomoniasis testing, as well as home or self-testing. Supplementary Information The online version contains supplementary material available at 10.1186/s12879-022-07534-9.

Project description:IntroductionSexually transmitted infections (STIs) remain prevalent and are increasing in several populations. Appropriate STI diagnosis is crucial to prevent the transmission and sequelae of untreated infection. We reviewed the diagnostic accuracy of syndromic case management and existing point-of-care tests (POCTs), including those in the pipeline, to diagnose STIs in resource-constrained settings.MethodsWe prioritized updating the systematic review and meta-analysis of the diagnostic accuracy of vaginal discharge from 2001 to 2015 to include studies until 2018. We calculated the absolute effects of different vaginal flowcharts and the diagnostic performance of POCTs on important outcomes. We searched the peer-reviewed literature for previously conducted systematic reviews and articles from 1990 to 2018 on the diagnostic accuracy of syndromic management of vaginal and urethral discharge, genital ulcer and anorectal infections. We conducted literature reviews from 2000 to 2018 on the existing POCTs and those in the pipeline.Results and discussionsThe diagnostic accuracy of urethral discharge and genital ulcer disease syndromes is relatively adequate. Asymptomatic Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections limit the use of vaginal discharge and anorectal syndromes. The pooled diagnostic accuracy of vaginal syndromic case management for CT/NG is low, resulting in high numbers of overtreatment and missed treatment. The absolute effect of POCTs was reduced overtreatment and missed treatment. Findings of the reviews on syndromic case management underscored the need for low-cost and accurate POCTs for the identification, first, of CT/NG, and, second, of Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) and NG and MG resistance/susceptibility testing. Near-patient POCT molecular assays for CT/NG/TV are commercially available. The prices of these POCTs remain the barrier for uptake in resource-constrained settings. This is driving the development of lower cost solutions.ConclusionsThe WHO syndromic case management guidelines should be updated to raise the quality of STI management through the integration of laboratory tests. STI screening strategies are needed to address asymptomatic STIs. POCTs that are accurate, rapid, simple and affordable are urgently needed in resource-constrained settings to support the uptake of aetiological diagnosis and treatment.

Dataset Information

Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea).

Publications

Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea).

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