A clinical utility evaluation of dual HIV/Syphilis point-of-care tests in non-clinical settings for screening for HIV and syphilis in men who have sex with men.

BACKGROUND: Dual point-of-care tests (POCTs) for the simultaneous detection of antibodies to HIV and syphilis have been developed. Since community-based organisations (CBO) are effective providers of HIV and syphilis testing among men who have sex with men (MSM), evaluation of the utility of these dual tests at CBO testing services is a high priority. The aim of this study is to determine the feasibility of performing dual HIV-syphilis POCT testing among both users and providers at these non-clinical sites. METHODS: This evaluation assessed the utility of two lateral flow immunochromatographic antibody technologies for dual screening for HIV/syphilis among MSM seeking testing in four CBO testing services in Spain, Slovenia, Latvia, and Ukraine. The study's conceptual framework divides the concept of feasibility into two inter-related domains, acceptability, and usability and further breaks it down into six subdomains: learnability, willingness, suitability, satisfaction, efficacy, and effectiveness. The feasibility analysis was performed by calculating the median score in 3 stages (for individual questions, subdomains, and domains), using a summated scores method. RESULTS: The final sample included 844 participants, 60 of which were found to be HIV test positive (7.1%) and 61 (7.2%) positive on testing for syphilis. There was a small difference (1.1%) when comparing the results of the two dual POCTs under evaluation to the tests routinely used at each site. The inter-rater agreement showed a high concordance between two independent readings. The analysis of the feasibility for the users of the services indicated good satisfaction, suitability, and willingness. In addition, among 18 providers the total mean score showed good acceptability and usability, good willingness, easy learnability, high suitability, and good efficacy, but lower satisfaction and effectiveness. The operational characteristics of both dual study POCTs were well evaluated by providers. CONCLUSIONS: The introduction of dual HIV and syphilis  POCTs in CBO testing services for screening of MSM is feasible, with a high acceptability and usability both for users and providers. Implementation of dual POCTs for HIV and syphilis in CBO testing services is an opportunity for scaling up integrated HIV/syphilis testing for MSM.

Clinic-based evaluation of the dual Xpert CT/NG assay on the GeneXpert System for screening for extragenital chlamydial and gonococcal infections amongst men who have sex with men.

BACKGROUND: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections have increased globally. Asymptomatic infections represent a significant risk of long-term complications. Men who have sex with men (MSM) are disproportionally affected, underscoring the need to offer screening programmes to this population. CT/NG Point of Care Testing (POCT) constitutes a strategic tool to improve the continuum of STI care, however extensive real-life evaluations amongst at risk populations are lacking. The aim of this study is to estimate the GeneXpert CT/NG assay performance and usability for CT and NG at genital and extragenital sites for screening amongst MSM. METHODS: This study was a multi-site sexual health clinic-based evaluation (Italy, Malta and Peru) with consecutive enrolment. A first void urine sample (divided in two aliquots), two oropharyngeal and two anorectal swabs were collected for each study participant. One specimen set (one for each anatomical site) was tested with the dual index test (Cepheid) at the clinics by the healthcare staff, the other set with FDA/CE approved Nucleic Acid Amplification Tests (NAATs) at the laboratory. Clinical sites and reference laboratories participated in an internal and external quality control programme. Sensitivity, specificity, positive and negative likelihood ratios, positive and negative predictive values for each anatomical site were estimated using a meta-analytic approach. RESULTS: One thousand seven hundred two MSM were recruited across all clinical sites for a total of 5049 biological specimens. NG and CT were respectively detected in 274 and 287 of samples. Overall, the NG POCT sensitivity and specificity was 91.43% and 99.75% in urine (LR + 372.80, LR- 0.09), 89.68% and 99.55% in rectal specimens (LR + 197.30, LR- 0.10) and 75.87% and 98.77% at the pharynx respectively (LR + 61.94, LR- 0.24). The CT component of the POCT sensitivity was 84.82% and specificity 99.63% in urine (LR + 228.68, LR- 0.15), 78.07% and 99.19% respectively on rectal site (LR + 96.23, LR-0.22), 67.79% and 99.88% respectively at pharyngeal site (LR + 554.89, LR- 0.32). 95.95% of MSM reported to be willing to wait for POCT results and no provider reported difficulties in terms of performance or interpretation of the results of the Xpert CT/NG. CONCLUSION: Rapid turnaround time, ease of use and high acceptability make the Xpert CT/NG testing system a strategic tool for increasing testing frequency, reaching those not yet tested and offering the possibility of immediate treatment if needed. The assay showed good negative likelihood ratios and confirms its use to rule out CT/NG infections. Sensitivity varied across sites and pathogens. Periodic staff training at the testing sites should be mandatory.

Independent clinic-based evaluation of dual POCTs for screening for HIV and syphilis in men who have sex with men in Italy, Malta, Peru, and the United Kingdom.

INTRODUCTION: Globally, the incidence of HIV and syphilis can be reduced by the use of validated point of care tests (POCTs). As part of the WHO PRoSPeRo Network, we aimed to evaluate the performance, acceptability, and operational characteristics of two dual HIV/syphilis POCTs (Bioline HIV/Syphilis Duo (Abbott) and DPP® HIV-Syphilis assay (Chembio) for the screening of HIV and syphilis amongst men who have sex with men (MSM). METHOD AND ANALYSES: A cross sectional study of 2,577 MSM in Italy, Malta, Peru, and the United Kingdom (UK) presenting to seven clinic sites, were enrolled. Finger prick blood was collected to perform POCTs and results compared with standard laboratory investigations on venepuncture blood. Acceptability and operational characteristics were assessed using questionnaires. Diagnostic meta-analysis was used to combine data from the evaluation sites. RESULTS: Based on laboratory tests, 23.46% (n = 598/2549) of participants were confirmed HIV positive, and 35.88% of participants (n = 901/2511) were positive on treponemal reference testing. Of all participants showing evidence of antibodies to Treponema pallidum, 50.56% (n = 455/900) were Rapid Plasma Reagin (RPR) test reactive. Of HIV positive individuals, 60.62% (n = 354/584) had evidence of antibodies to T. pallidum, and of these 60.45% (n = 214/354) exhibited reactive RPR tests indicating probable (co)infection. For Bioline POCT, pooled sensitivities and specificities for HIV were 98.95% and 99.89% respectively, and for syphilis were 73.79% and 99.57%. For Chembio pooled sensitivities and specificities for HIV were 98.66% and 99.55%, and for syphilis were 78.60% and 99.48%. Both tests can detect greater than 90% of probable active syphilis cases, as defined by reactive RPR and treponemal test results. These dual POCTs were preferred by 74.77% (n = 1,926) of participants, due to their convenience, and the operational characteristics made them acceptable to health care providers (HCPs). CONCLUSIONS: Both the Bioline and the Chembio dual POCT for syphilis and HIV had acceptable performance, acceptability and operational characteristics amongst MSM in the PRoSPeRo network. These dual POCTs could serve as a strategic, more cost effective, patient and healthcare provider (HCP) friendly alternative to conventional testing; in clinical and other field settings, especially those in resource-limited settings.

Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa.

BACKGROUND: In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening 'women at risk' for chlamydia (CT), gonorrhoea (NG) and trichomonas (TV) in four countries - Australia, Guatemala, Morocco and South Africa. METHODS: Study participants completed a pre-test questionnaire which included demographics, clinical information and general questions on POC testing (POCT). Two vaginal swab samples (either self-collected or clinician collected) from each patient were tested on the GeneXpert at the POC and at a reference laboratory using quality-assured nucleic acid amplification tests (NAATs). RESULTS: One thousand three hundred and eighty-three women were enrolled: 58.6% from South Africa, 29.2% from Morocco, 6.2% from Guatemala, and 6.0% from Australia. 1296 samples for CT/NG and 1380 samples for TV were tested by the GeneXpert and the reference NAAT. The rate of unsuccessful tests on the GeneXpert was 1.9% for CT, 1.5% for NG and 0.96% for TV. The prevalence of CT, NG and TV was 31%, 13% and 23%, respectively. 1.5% of samples were positive for all three infections; 7.8% were positive for CT and NG; 2.4% were positive for NG and TV; and 7.3% were positive for CT and TV. Compared to reference NAATs, pooled estimates of sensitivity for the GeneXpert tests were 83.7% (95% confidence intervals 69.2-92.1) for CT, 90.5% (85.1-94.1) for NG and 64.7% (58.1-70.7) for TV (although estimates varied considerably between countries). Estimates for specificity were ≥96% for all three tests both within- and between-countries. Pooled positive and negative likelihood ratios were: 32.7 ([CI] 21.2-50.5) and 0.17 (0.08-0.33) for CT; 95.3 (36.9-245.7) and 0.10 (0.06-0.15) for NG; and 56.5 (31.6-101.1) and 0.35 (0.27-0.47) for TV. CONCLUSION: This multi-country evaluation is the first of its kind world-wide. Positive likelihood ratios, as well as specificity estimates, indicate the GeneXpert POC test results for CT, NG and TV were clinically acceptable for ruling in the presence of disease. However, negative likelihood ratios and variable sensitivity estimates from this study were poorer than expected for ruling out these infections, particularly for TV. TRIAL REGISTRATION: Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee, as well as local ethics committees from all participating countries.

Upregulation of PTPRC and Interferon Response Pathways in HIV-1 Seroconverters Prior to Infection.

Human immunodeficiency virus 1 (HIV-1) exposed seronegative (HESN) individuals may have unique characteristics that alter susceptibility to HIV-1 infection. However, identifying truly exposed HESN is challenging. We utilized stored data and biospecimens from HIV-1 serodifferent couple cohorts, in which couples' HIV-1 exposures were quantified based on unprotected sex frequency and viral load of the partner with HIV-1. We compared peripheral blood gene expression between 15 HESN and 18 seroconverters prior to infection. We found PTPRC (encoding CD45 antigen) and interferon-response pathways had significantly higher expression among individuals who went on to become seropositive and thus may be a signature for increased acquisition risk.

The impact of community and provider-driven social accountability interventions on contraceptive use: findings from a cohort study of new users in Ghana and Tanzania.

BACKGROUND: Although contraceptive use has increased over 15 years, discontinuation rates remain high. Contraceptive use is becoming more important when addressing unmet need for family planning. Social accountability, defined here as collective processes for holding duty bearers to account for their actions, is a rights-based participatory process that supports service provision and person-centred care, as well as, informed decision-making among community members regarding their health. A study implemented in Ghana and Tanzania was designed to understand and evaluate how social accountability and participatory processes influences quality of care and client satisfaction and whether this results in increased contraceptive uptake and use. We report here on the relationship between social accountability and the use of modern contraceptives, i.e., contraceptive method discontinuation, contraceptive method switching, and contraceptive discontinuation. METHODS: As part of Community and Provider driven Social Accountability Intervention (CaPSAI) Project, a cohort of women aged 15 to 49 years who were new users of contraception and accessing family planning and contraceptives services at the study facilities across both intervention and control groups were followed-up over a 12-month period to measure changes contraceptive use. RESULTS: In this cohort study over a one-year duration, we did not find a statistically significant difference in Ghana and Tanzania in overall method discontinuation, switching, and contraceptive discontinuation after exposure to a social accountability intervention. In Ghana but not in Tanzania, when stratified by the type of facility (district level vs. health centre), there were significantly less method and contraceptive discontinuation in the district level facility and significantly more method and contraceptive discontinuation in the health centres in the intervention group. In Ghana, the most important reasons reported for stopping a method were fear of side-effects, health concerns and wanting to become pregnant in the control group and fear of side-effects wanting a more effective method and infrequent sex in the intervention group. In Tanzania, the most important reasons reported for stopping a method were fear of side-effects, wanting a more effective method, and method not available in the control group compared to wanting a more effective method, fear of side-effects and health concerns in the intervention group. CONCLUSIONS: We did not demonstrate a statistically significant impact of a six-month CaPSAI intervention on contraceptives use among new users in Tanzania and Ghana. However, since social accountability have important impacts beyond contraceptive use it is important consider results of the intermediate outcomes, cases of change, and process evaluation to fully understand the impact of this intervention. TRIAL REGISTRATION: The CaPSAI Project has been registered at Australian New Zealand Clinical Trials Registry (ACTRN12619000378123, 11/03/2019).

Implementation strategies, facilitators, and barriers to scaling up and sustaining demand generation in family planning, a mixed-methods systematic review.

BACKGROUND: Demand generation aims to increase clients' desire to use family planning. The aim of this work was to systematically summarize strategies, facilitators, and barriers to scaling up and sustaining demand generation in family planning. METHODS: We searched electronic bibliographic databases from inception to October 2022. We included quantitative, qualitative, and mixed methods reports on demand generation strategies in family planning, regardless of country, language, publication status, or methodological limitations. We assessed abstracts, titles and full-text papers according to the inclusion criteria, extracted data, and assessed methodological quality of included reports. We used the convergent integrated approach and a deductive thematic synthesis to summarize demand generation themes and subthemes. We used the health system building blocks to synthesize the factors affecting implementation (barriers and facilitators). We used GRADE-CERQual to assess our confidence in the findings. RESULTS: Forty-six studies (published 1990-2022) were included: forty-one quantitative, one qualitative, and four mixed methods). Three were from one high-income country, and forty three from LMIC settings. Half of reports were judged to be of unclear risk of bias. There were unique yet interrelated strategies of scaling-up demand generation for family planning. Interpersonal communication strategies increase adoption and coverage of modern contraceptive methods, but the effect on sustainability is uncertain. Mass media exposure increases knowledge and positive attitudes and may increase the intention to use modern contraceptive methods. Demand-side financing approaches probably increase awareness of contraceptives and the use of modern contraceptive methods among poor clients. Multifaceted Demand generation approaches probably improve adoption, coverage and sustainability of modern methods use. Factors that influence the success of implementing these strategies include users knowledge about family planning methods, the availability of modern methods, and the accessibility to services. CONCLUSIONS: Demand generation strategies may function independently or supplement each other. The myriad of techniques of the different demand generation strategies, the complexities of family planning services, and human interactions defy simplistic conclusions on how a specific strategy or a bundle of strategies may succeed in increasing and sustaining family planning utilization. TRIAL REGISTRATION: Systematic review registration: Center for Open Science, osf.io/286j5.

Family planning could prevent one third of maternal deaths by allowing women to delay motherhood, avoid unintended pregnancies and subsequent abortions. Demand generation is one of the critical factors for increasing coverage and sustainability of family planning programs. Demand generation activities aim to increase clients' desire to use family planning by changing their attitudes or perceptions about FP or increasing their awareness or knowledge about FP methods and also by improving access to contraceptive services. Many demand generation activities also aim to shift social and cultural norms to affect individual behavior change. Scaling up demand generation and ensuring that demand for family planning is satisfied is essential for achieving universal access to reproductive health-care services. We systematically searched for and summarized reports of strategies to scale up demand generation for family planning. Available evidence shows that interpersonal communication strategies increase adoption and coverage of modern contraceptive methods, but the effect on sustainability is uncertain. Mass media exposure increases knowledge and positive attitudes and may increase the intention to use modern contraceptive methods. The effect of new media is uncertain. Demand-side financing approach probably increase awareness of contraceptives and the use of modern contraceptive methods among poor women. The most apparent factors influencing the success of implementing these strategies include knowledge about family planning methods, especially regarding side effects and health concerns, the availability of modern contraceptive methods, and the accessibility to family planning services.

Implementation strategies, facilitators, and barriers to scaling up and sustaining post pregnancy family planning, a mixed-methods systematic review.

BACKGROUND: Post pregnancy family planning includes both postpartum and post-abortion periods. Post pregnancy women remain one of the most vulnerable groups with high unmet need for family planning. This review aimed to describe and assess the quality of the evidence on implementation strategies, facilitators, and barriers to scaling up and sustaining post pregnancy family planning. METHODS: Electronic bibliographic databases (MEDLINE, PubMed, Scopus, the Cochrane Library, and Global Index Medicus) were searched from inception to October 2022 for primary quantitative, qualitative, and mixed method reports on scaling up post pregnancy family planning. Abstracts, titles, and full-text papers were assessed according to the inclusion criteria to select studies regardless of country, language, publication status, or methodological limitations. Data were extracted and methodological quality assessed using the Mixed Methods Appraisal Tool. The convergent integrated approach and a deductive thematic synthesis were used to identify themes and sub-themes of strategies to scale up post pregnancy family planning. The health system building blocks were used to summarize barriers and facilitators. GRADE-CERQual was used to assess our confidence in the findings. RESULTS: Twenty-nine reports (published 2005-2022) were included: 19 quantitative, 7 qualitative, and 3 mixed methods. Seven were from high-income countries, and twenty-two from LMIC settings. Sixty percent of studies had an unclear risk of bias. The included reports used either separate or bundled strategies for scaling-up post pregnancy family planning. These included strategies for healthcare infrastructure, policy and regulation, financing, human resource, and people at the point of care. Strategies that target the point of care (women and / or their partners) contributed to 89.66% (26/29) of the reports either independently or as part of a bundle. Point of care strategies increase adoption and coverage of post pregnancy contraceptive methods. CONCLUSION: Post pregnancy family planning scaling up strategies, representing a range of styles and settings, were associated with improved post pregnancy contraceptive use. Factors that influence the success of implementing these strategies include issues related to counselling, integration in postnatal or post-abortion care, and religious and social norms. TRIAL REGISTRATION: Center for Open Science, OSF.IO/EDAKM.

Family planning could prevent one third of maternal deaths by allowing women to delay motherhood, avoid unintended pregnancies and subsequent abortions. Post pregnancy family planning includes both postpartum and post-abortion periods. Post pregnancy women remain one of the most vulnerable groups with high unmet need for family planning. Scaling up post pregnancy family planning is essential for achieving universal access to reproductive health-care services. Reports of strategies to scale up post pregnancy family planning were systematically reviewed and summarized. These included strategies for healthcare infrastructure, policy and regulation, financing, human resource, and people at the point of care. Strategies that target the point of care (women and/or their partners) contributed to 89.66% (26/29) of the reports either independently or as part of a bundle. Point of care strategies increase adoption and coverage of post pregnancy contraceptive methods. Certain factors influence the success of implementing these strategies, including issues related to counselling, integration in postnatal or post-abortion care, and religious and social norms.

The role of social accountability in changing service users' values, attitudes, and interactions with the health services: a pre-post study.

This study evaluated the effects of community engagement through social accountability on service users' values, attitudes and interactions. We conducted a pre-post study of the community and provider driven social accountability intervention (CaPSAI) over a 12-month period among 1,500 service users in 8 health facilites in Ghana and in Tanzania (n = 3,000).In both countries, there were significant improvements in women's participation in household decision-making and in how service users' perceive their treatment by health workers. In both settings, however, there was a decline in women's knowledge of rights, perception of service quality, awareness of accountability mechanisms and collective efficacy in the community. Though CaPSAI intervention set out to change the values, attitudes, and interactions between community members and those providing contraceptive services, there were changes in different directions that require closer examination.

Impact of community and provider-driven social accountability interventions on contraceptive uptake in Ghana and Tanzania.

BACKGROUND: Social accountability, which is defined as a collective process for holding duty bearers and service providers to account for their actions, has shown positive outcomes in addressing the interrelated barriers to quality sexual and reproductive health services. The Community and Provider driven Social Accountability Intervention (CaPSAI) Project contributes to the evidence on the effects of social accountability processes in the context of a family planning and contraceptive programme. METHODS: A quasi-experimental study utilizing an interrupted time series design with a control group (ITS-CG) was conducted to determine the actual number of new users of contraception amongst women 15-49 years old in eight intervention and eight control facilities per country in Ghana and Tanzania. A standardized facility audit questionnaire was used to collect facility data and completed every year in both intervention and control groups in each country from 2018-2020. RESULTS: In Ghana, the two-segmented Poisson Generalized Estimating Equation (GEE) model demonstrated no statistically significant difference at post-intervention, between the intervention and control facilities, in the level of uptake of contraceptives (excess level) (p-value = 0.07) or in the rate of change (excess rate) in uptake (p-value = 0.07) after adjusting for baseline differences. Similarly, in Tanzania, there was no statistical difference between intervention and control facilities, in the level of uptake of contraceptives (excess level) (p-value = 0.20), with the rate of change in uptake (p-value = 0.05) after adjusting for the baseline differences. There was no statistical difference in the level of or rate of change in uptake in the two groups in a sensitivity analysis excluding new users recruited in outreach activities in Tanzania. CONCLUSIONS: The CAPSAI project intervention did not result in a statistically significant increase in uptake of contraceptives as measured by the number of or increase in new users. In evaluating the impact of the intervention on the intermediate outcomes such as self-efficacy among service users, trust and countervailing power among social groups/networks, and responsiveness of service providers, cases of change and process evaluation should be considered. TRIAL REGISTRATION: The CaPSAI Project has been registered at the Australian New Zealand Clinical Trials Registry (ACTRN12619000378123, 11/03/2019).

The Use of Time to Pregnancy for Estimating and Monitoring Human Fecundity From Demographic and Health Surveys.

BACKGROUND: Available studies on the prevalence of infertility have proved to have certain limitations, with a scarcity of population-based studies and inconsistent reporting from surveys in countries at all income levels. We wanted to test the applicability of the current duration approach to data from the important Demographic and Health Surveys (DHS) program, funded by USAID since its inception in 1985, https://dhsprogram.com/. METHODS: The current duration approach assumes that there is a well-defined time of initiation of attempts to get pregnant and defines the current duration of a still ongoing pregnancy attempt as the time interval from initiation to interview. The DHS interviews do not have an explicit question about initiation. We focused on nullipari and substituted date of "establishment of relationship with current partner" for initiation. Our study used the current duration approach on 15 datasets from DHS during 2002-2016 in eight different countries from sub-Saharan Africa, Asia, and Latin America. RESULTS: Well-established statistical techniques for current duration data yielded results that for some countries postulated surprisingly long median times to pregnancy and surprisingly high estimates of infertility prevalence. Further study of the data structures revealed serious deviations from expected patterns, in contrast to our earlier experience from surveys in France and the United States where participants were asked explicitly about time of initiation of attempts to become pregnant. CONCLUSIONS: Using cohabitation as a proxy for the initiation of attempts to get pregnant is too crude. Using the current duration approach with DHS data will require more explicit questions during the DHS interviews about initiation of pregnancy attempt.

Global epidemiology of Neisseria gonorrhoeae in infertile populations: systematic review, meta-analysis and metaregression.

OBJECTIVE: To provide an in-depth systematic assessment of the global epidemiology of gonorrhoea infection in infertile populations. METHODS: A systematic literature review was conducted up to 29 April 2019 on international databases and WHO regional databases, and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All prevalence measures of gonorrhoea infection among infertile populations, based on primary data, qualified for inclusion. Infertile populations were broadly defined to encompass women/men undergoing infertility evaluation or treatment (infertility clinic attendees and partners). Pooled mean prevalence by relevant strata was estimated using random-effects meta-analysis. Associations with prevalence and sources of heterogeneity were explored using metaregression. Risk of bias was assessed using four quality domains. FINDINGS: A total of 147 gonorrhoea prevalence studies were identified from 56 countries. The pooled mean prevalence of current gonorrhoea infection was estimated globally at 2.2% (95% CI 1.3% to 3.2%), with the highest prevalence in Africa at 5.0% (95% CI 1.9% to 9.3%). The mean prevalence was higher for populations with tubal factor infertility (3.6%, 95% CI 0.9%-7.7%) and mixed cause and unexplained infertility (3.6%, 95% CI 0.0% to 11.6%) compared with other diagnoses, such as ovarian and non-tubal infertility (0.1%, 95% CI 0.0% to 0.8%), and for secondary (2.5%, 95% CI 0.2% to 6.5%) compared with primary (0.5%, 95% CI 0.0% to 1.7%) infertility. Metaregression identified evidence of variations in prevalence by region and by infertility diagnosis, higher prevalence in women than men and a small-study effect. There was a trend of declining prevalence by about 3% per year over the last four decades (OR=0.97, 95% CI 0.95 to 0.99). CONCLUSIONS: Gonorrhoea prevalence in infertile populations is several folds higher than that in the general population, with even higher prevalence in women with tubal factor infertility and in individuals with secondary infertility. These findings support the potential role of gonorrhoea in infertility and suggest that some infertility is possibly preventable by controlling gonorrhoea transmission. PROSPERO REGISTRATION NUMBER: CRD42018102934.

Postpartum contraceptive practices among urban and peri-urban women in North India: a mixed-methods cohort study protocol.

BACKGROUND: Postpartum family planning (PPFP) helps women space childbirths, increase exclusive breastfeeding and prevent unintended pregnancies, leading to reduction in maternal, infant and child morbidities and mortality. Unmet need of family planning is highest among women in the postpartum period due to lack of knowledge, cultural and religious barriers, access barriers and low antenatal care service utilization. However, in spite of low prevalence of postpartum family planning practices, birth-to-birth interval is reportedly high in Delhi, India. This study explores the postpartum contraception practices and the relationship between use of postpartum contraception and subsequent child linear growth. METHODS: This is a mixed method cohort study on PPFP and is nested within an ongoing "Women and Infants Integrated Interventions for Growth Study" (WINGS). Married women aged 18-30 years who have delivered a live baby are recruited for quantitative interviews at 6 weeks, 6, 12, and 24 months postpartum. In-depth interviews are conducted with a randomly selected sub-sample of women at each of the four time points, 35 husbands and 20 local service providers to understand their perspectives on PPFP practices. DISCUSSION: The findings from the study will provide useful insights into couples' contraception preferences and choice of contraception, modern and traditional, initiation time and the effect of birth spacing and contraception use on subsequent linear growth of the child. This knowledge will be of significant public health relevance and will help in designing appropriate interventions for appropriate postpartum contraception use and delivery strategies. The study aims to work address the Sexual and Reproductive Health and Rights goal of promoting reproductive health, voluntary and safe sexual and reproductive choices for women. TRIAL REGISTRATION: Trial registration number: CTRI/2020/03/023954 .

A High-throughput Bead-based Affinity Assay Enables Analysis of Genital Protein Signatures in Women At Risk of HIV Infection.

Women at high risk of HIV infection, including sex workers and those with active genital inflammation, have molecular signatures of immune activation and epithelial barrier remodeling in samples of their genital mucosa. These alterations in the local immunological milieu are likely to impact HIV susceptibility. We here analyze host genital protein signatures in HIV uninfected women, with high frequency of condom use, living in HIV-serodiscordant relationships. Cervicovaginal secretions from women living in HIV-serodiscordant relationships (n = 62) were collected at three time points over 12 months. Women living in HIV-negative seroconcordant relationships (controls, n = 25) were sampled at one time point. All study subjects were examined for demographic parameters associated with susceptibility to HIV infection. The cervicovaginal samples were analyzed using a high-throughput bead-based affinity assay. Proteins involved in epithelial barrier function and inflammation were increased in HIV-serodiscordant women. By combining several methods of analysis, a total of five proteins (CAPG, KLK10, SPRR3, elafin/PI3, CSTB) were consistently associated with this study group. Proteins analyzed using the affinity set-up were further validated by label-free tandem mass spectrometry in a partially overlapping cohort with concordant results. Women living in HIV-serodiscordant relationships thus had elevated levels of proteins involved in epithelial barrier function and inflammation despite low prevalence of sexually transmitted infections and a high frequency of safe sex practices. The identified proteins are important markers to follow during assessment of mucosal HIV susceptibility factors and a high-throughput bead-based affinity set-up could be a suitable method for such evaluation.

Provider attitudes towards a brief behavioral intervention for sexual health in Moldova.

BACKGROUND: Brief behavioral interventions are seen as an efficient way to improve knowledge, change behavior, and reduce provider stigma regarding sexual health. When grounded in evidence-based behavioral change techniques and delivered using Brief Sexuality-related Communication (BSC) tools, brief behavioral interventions can address client-driven sexual health goals in a single session with their provider. Evidence for the efficacy of brief interventions for creating gains in sexual health comes largely from resource rich settings, and there is a lack of knowledge of how brief interventions can be implemented in the more resource constrained environments of low- and middle-income countries. As a first step in developing a brief intervention to address sexual health issues in Moldova, this paper reports on qualitative data collected from Moldovan providers to understand their attitudes, willingness and perceived barriers to the brief intervention and its implementation. METHODS: Thirty-nine in-depth interviews (IDI) were conducted between February and March 2020, with health providers recruited from three primary health care institutions, two Youth Friendly Health Centers and counselors from three NGOs who work with key populations in Moldova, including health centers selected from two cites - the capital city, Chisinau and from the Comrat Region. The IDI addressed four domains of provider attitudes: 1) attitudes towards the intervention; 2) willingness and motivation to implement the intervention; 3) logistics of providing the intervention and 4) ability to implement the intervention. A coding analysis approach was applied to all interview transcripts. RESULTS: Providers largely reported being willing to be trained in and implement the brief intervention. Willingness to implement the intervention stemmed from two perceptions: that it would improve the ability of providers to talk with their clients about sex, and that vulnerable groups would benefit from these conversations. However, while there were generally positive attitudes towards the intervention, providers consistently reported structural barriers to their perceived ability to implement the intervention. CONCLUSIONS: While providers reported high levels of initial acceptance of a brief behavioral intervention, care is needed to ensure that brief interventions, and the training of providers on brief interventions, incorporate cultural attitudes and norms around sex, particularly in highly patriarchal settings, and provide opportunities for providers to practice the intervention in ways that address their assumptions and implicit biases.

Call to action for health systems integration of point-of-care testing to mitigate the transmission and burden of sexually transmitted infections.

OBJECTIVES: In 2016, WHO estimated 376 million new cases of the four main curable STIs: gonorrhoea, chlamydia, trichomoniasis and syphilis. Further, an estimated 290 million women are infected with human papillomavirus. STIs may lead to severe reproductive health sequelae. Low-income and middle-income countries carry the highest global burden of STIs. A large proportion of urogenital and the vast majority of extragenital non-viral STI cases are asymptomatic. Screening key populations and early and accurate diagnosis are important to provide correct treatment and to control the spread of STIs. This article paints a picture of the state of technology of STI point-of-care testing (POCT) and its implications for health system integration. METHODS: The material for the STI POCT landscape was gathered from publicly available information, published and unpublished reports and prospectuses, and interviews with developers and manufacturers. RESULTS: The development of STI POCT is moving rapidly, and there are much more tests in the pipeline than in 2014, when the first STI POCT landscape analysis was published on the website of WHO. Several of the available tests need to be evaluated independently both in the laboratory and, of particular importance, in different points of care. CONCLUSION: This article reiterates the importance of accurate, rapid and affordable POCT to reach universal health coverage. While highlighting the rapid technical advances in this area, we argue that insufficient attention is being paid to health systems capacity and conditions to ensure the swift and rapid integration of current and future STI POCT. Unless the complexity of health systems, including context, institutions, adoption systems and problem perception, are recognised and mapped, simplistic approaches to policy design and programme implementation will result in poor realisation of intended outcomes and impact.

Human papillomavirus and abnormal cervical lesions among HIV-infected women in HIV-discordant couples from Kenya.

OBJECTIVE: HIV infection increases the risk of high-grade cervical neoplasia and invasive cervical carcinoma. The study addresses the limited data describing human papillomavirus (HPV) infection and cervical neoplasia among HIV-infected women in HIV-discordant relationships in sub-Saharan Africa, which is needed to inform screening strategies. METHODS: A cross-sectional study of HIV-infected women with HIV-uninfected partners was conducted to determine the distribution of type-specific HPV infection and cervical cytology. This study was nested in a prospective cohort recruited between September 2007 and December 2009 in Nairobi, Kenya. Cervical cells for HPV DNA testing and conventional cervical cytology were collected. HPV types were detected and genotyped by Roche Linear Array PCR assay. RESULTS: Among 283 women, the overall HPV prevalence was 62%, and 132 (47%) had ≥1 high-risk (HR)-HPV genotype. Of 268 women with cervical cytology results, 18 (7%) had high-grade cervical lesions or more severe by cytology, of whom 16 (89%) were HR-HPV-positive compared with 82 (41%) of 199 women with normal cytology (p<0.001). The most common HR-HPV types in women with a high-grade lesion or more severe by cytology were HPV-52 (44%), HPV-31 (22%), HPV-35 (22%), HPV-51 (22%) and HPV-58 (22%). HR-HPV genotypes HPV-16 or HPV-18 were found in 17% of women with high-grade lesions or more severe. HR-HPV screening applied in this population would detect 89% of those with a high-grade lesion or more severe, while 44% of women with normal or low-grade cytology would screen positive. CONCLUSION: HR-HPV prevalence was high in this population of HIV-infected women with an uninfected partner. Choice of screening for all HR genotypes versus a subset of HR genotypes in these HIV-infected women will strongly affect the performance of an HPV screening strategy relative to cytological screening. Regional and subpopulation differences in HR-HPV genotype distributions could affect screening test performance.

Association between vaginal washing and detection of Lactobacillus by culture and quantitative PCR in HIV-seronegative Kenyan women: a cross-sectional analysis.

OBJECTIVES: Vaginal washing has been associated with reductions in cultivable Lactobacillus and an increased risk of both bacterial vaginosis (BV) and HIV infection. The effect of vaginal washing on the quantity of individual Lactobacillus species is not well characterised. This analysis tested the hypothesis that vaginal washing would be associated with a lower likelihood of Lactobacillus spp. detected by both culture and quantitative PCR (qPCR). METHODS: We conducted a cross-sectional study of 272 HIV-seronegative women enrolled in an open-cohort study in Mombasa, Kenya. Vaginal washing and sexual risk behaviours were assessed using face-to-face interviews. Vaginal Lactobacillus spp. were detected using cultivation and PCR methods, with L. crispatus, L. jensenii and L. iners concentrations measured using qPCR assays targeting the 16S rRNA gene. Poisson regression with robust SEs was used to assess associations between vaginal washing and Lactobacillus detection by culture and qPCR. RESULTS: Eighty percent (n=217) of participants reported vaginal washing in the prior week. One-fifth (n=58) of participants had BV by Nugent score. In unadjusted analysis, vaginal washing was associated with a 45% decreased likelihood of Lactobacillus spp. detection by culture (prevalence ratio (PR): 0.55, 95% CI 0.37 to 0.82). Adjusting for age and condomless sex in the prior week did not change the magnitude of the association (adjusted PR (aPR): 0.56, 95% CI (0.37 to 0.85). Vaginal washing was associated with approximately a 40% reduction in L. crispatus detection (aPR: 0.57, 95% CI 0.36 to 0.92), but was not significantly associated with L. jensenii (aPR: 0.68, 95% CI 0.42 to 1.09) or L. iners detection (aPR: 1.03, 95% CI 0.92 to 1.15). CONCLUSIONS: Vaginal washing in the prior week was associated with a significantly reduced likelihood of detecting cultivable Lactobacillus and L. crispatus by qPCR. Given associations between Lactobacillus detection and improved reproductive health outcomes, these results provide motivation for additional study of vaginal washing cessation interventions to improve vaginal health.

Task sharing for family planning services, Burkina Faso.

PROBLEM: In Burkina Faso, the coverage of services for family planning is low due to shortage of qualified health staff and limited access to services. APPROACH: Following the launch of the Ouagadougou Partnership, an alliance to catalyse the expansion of family planning services, the health ministry created a consortium of family planning stakeholders in 2011. The consortium adopted a collaborative framework to implement a pilot project for task sharing in family planning at community and primary health-care centre levels in two rural districts. Stakeholders were responsible for their areas of expertise. These areas included advocacy; monitoring and evaluation; and capacity development of community health workers (CHWs) to offer oral and injectable contraceptives to new users and of auxiliary nurses and auxiliary midwives to provide implants and intrauterine devices. The health ministry implemented supportive supervision cascades involving relevant planning and service levels. LOCAL SETTING: In Burkina Faso, only 15% (2563/17 087) of married women used modern contraceptives in 2010. RELEVANT CHANGES: Adoption of new policies and clinical care standards expanded task sharing roles in family planning. The consortium trained a total of 79 CHWs and 124 auxiliary nurses and midwives. Between January 2017 and December 2018, CHWs provided injectables to 3698 new users, and auxiliary nurses or midwives provided 726 intrauterine devices and 2574 implants to new users. No safety issues were reported. LESSONS LEARNT: The pilot project was feasible and safe, however, financial constraints are hindering scale-up efforts. Supportive supervision cascades were critical in ensuring success.