Advancing prevention of sexually transmitted infections through point-of-care testing : target product profiles and landscape analysis

Objectives: Advancing the field of point-of-care testing (POCT) for STIs can rapidly and substantially improve STI control and prevention by providing targeted, essential STI services (case detection and screening). POCT enables definitive diagnosis and appropriate treatment in a single visit and home and community-based testing. Methods: Since 2014, the WHO Department of Reproductive Health and Research, in collaboration with technical partners, has completed four landscape analyses of promising diagnostics for use at or near the point of patient care to detect syphilis, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and the human papillomavirus. The analyses comprised a literature review and interviews. Two International Technical Consultations on STI POCTs (2014 and 2015) resulted in the development of target product profiles (TPP). Experts in STI microbiology, laboratory diagnostics, clinical management, public health and epidemiology participated in the consultations with representation from all WHO regions. Results: The landscape analysis identified diagnostic tests that are either available on the market, to be released in the near future or in the pipeline. The TPPs specify 28 analytical and operational characteristics of POCTs for use in different populations for surveillance, screening and case management. None of the tests that were identified in the landscape analysis met all of the targets of the TPPs. Conclusion: More efforts of the global health community are needed to accelerate access to affordable quality-assured STI POCTs, particularly in low-and middle-income countries, by supporting the development of new diagnostic platforms as well as strengthening the validation and implementation of existing diagnostics according to internationally endorsed standards and the best available evidence

Evidence and knowledge gaps on the disease burden in sexual and gender minorities : a review of systematic reviews

Sexual and gender minorities (SGM) include individuals with a wide range of sexual orientations, physical characteristics, and gender identities and expressions. Data suggest that people in this group face a significant and poorly understood set of additional health risks and bear a higher burden of some diseases compared to the general population. A large amount of data is available on HIV/AIDS, but far less on other health problems. In this review we aimed to synthesize the knowledge on the burden of communicable and non-communicable diseases, mental health conditions and violence experienced by SGM, based on available systematic reviews. We conducted a global review of systematic reviews, including searching the Cochrane and the Campbell Collaboration libraries, as well as PubMed, using a range of search terms describing the populations of interest, without time or language restrictions. Google Scholar was also scanned for unpublished literature, and references of all selected reviews were checked to identify further relevant articles. We found 30 systematic reviews, all originally written in English. Nine reviews provided data on HIV, 12 on other sexually transmitted infections (STIs), 4 on cancer, 4 on violence and 3 on mental health and substance use. A quantitative meta-analysis was not possible. The findings are presented in a narrative format. Our review primarily showed that there is a high burden of disease for certain subpopulations of SGM in HIV, STIs, STI-related cancers and mental health conditions, and that they also face high rates of violence. Secondly, our review revealed many knowledge gaps. Those gaps partly stem from a lack of original research, but there is an equally urgent need to conduct systematic and literature reviews to assess what we already know on the disease burden in SGM. Additional reviews are needed on the non-biological factors that could contribute to the higher disease burden. In addition, to provide universal access to health-care for all, more information is needed on the barriers that SGM face in accessing health services, including the attitudes of health-care providers. Understanding these barriers and the additional health risks they impose is crucial to improving the health status of SGM

Advancing point of care diagnostics for the control and prevention of STIs: the way forward.

WHO recognises the global impact of sexually transmitted infections (STIs) on global public health and individual sexual and reproductive health and well-being. As a component of the WHO Global Health Sector Strategy for the control and prevention of STIs, there has been a growing recognition of the importance of integrating point-of-care tests (POCTs) into overall strategic planning. The process of integrating STI POCTs, in addition to providing a definitive diagnosis and appropriate treatment in a single visit, also includes innovative delivery options, such as on-site delivery, community-based testing (including screening), as well as self-testing at home after purchase of a test online or over-the-counter. WHO organised two technical consultations in May 2014 and July 2015. This article summarises the discussions of the meeting participants on advancing the use of POCTs to control and prevent STIs. The following priorities were identified: the need for pathogens' target discovery; encouragement of multiplexing, miniaturisation, simplification and connectivity; promotion of standardisation of evaluation of new diagnostic platforms across all stages of the evaluation pipeline; the need for an investment case, modelling and scenarios to ensure buy-in among key stakeholders, including developers and the private sector; the need for norms and standards, including guidelines, to support introduction of STI POCTs in programmes; anticipating potential tensions between different parties at the implementation level; and leveraging on the global initiative, Sustainable Development Goals (SDGs)/global health sector STI strategy, to sustain investment in STI POCT programmes. There is a rich pipeline of diagnostic products, but some have stalled in development. An approach to accelerate the evaluation of new diagnostics is to set up a competent network of evaluation sites ahead of time, harmonise regulatory approval processes with development of models to estimate cost-effectiveness, informed by better STI data. This should result in accelerating policy development. Although it may be some time before good POCTs can be widely implemented in low resource settings, it is important to be a catalyst for continued development and use of these essential tools as an integral part of both the WHO Global Health Sector Strategy and the agenda for 2030

Advancing prevention of sexually transmitted infections through point-of-care testing: target product profiles and landscape analysis.

OBJECTIVES: Advancing the field of point-of-care testing (POCT) for STIs can rapidly and substantially improve STI control and prevention by providing targeted, essential STI services (case detection and screening). POCT enables definitive diagnosis and appropriate treatment in a single visit and home and community-based testing. METHODS: Since 2014, the WHO Department of Reproductive Health and Research, in collaboration with technical partners, has completed four landscape analyses of promising diagnostics for use at or near the point of patient care to detect syphilis, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and the human papillomavirus. The analyses comprised a literature review and interviews. Two International Technical Consultations on STI POCTs (2014 and 2015) resulted in the development of target product profiles (TPP). Experts in STI microbiology, laboratory diagnostics, clinical management, public health and epidemiology participated in the consultations with representation from all WHO regions. RESULTS: The landscape analysis identified diagnostic tests that are either available on the market, to be released in the near future or in the pipeline. The TPPs specify 28 analytical and operational characteristics of POCTs for use in different populations for surveillance, screening and case management. None of the tests that were identified in the landscape analysis met all of the targets of the TPPs. CONCLUSION: More efforts of the global health community are needed to accelerate access to affordable quality-assured STI POCTs, particularly in low- and middle-income countries, by supporting the development of new diagnostic platforms as well as strengthening the validation and implementation of existing diagnostics according to internationally endorsed standards and the best available evidence

Evidence and knowledge gaps on the disease burden in sexual and gender minorities: a review of systematic reviews

Sexual and gender minorities (SGM) include individuals with a wide range of sexual orientations, physical characteristics, and gender identities and expressions. Data suggest that people in this group face a significant and poorly understood set of additional health risks and bear a higher burden of some diseases compared to the general population. A large amount of data is available on HIV/AIDS, but far less on other health problems. In this review we aimed to synthesize the knowledge on the burden of communicable and non-communicable diseases, mental health conditions and violence experienced by SGM, based on available systematic reviews. We conducted a global review of systematic reviews, including searching the Cochrane and the Campbell Collaboration libraries, as well as PubMed, using a range of search terms describing the populations of interest, without time or language restrictions. Google Scholar was also scanned for unpublished literature, and references of all selected reviews were checked to identify further relevant articles. We found 30 systematic reviews, all originally written in English. Nine reviews provided data on HIV, 12 on other sexually transmitted infections (STIs), 4 on cancer, 4 on violence and 3 on mental health and substance use. A quantitative meta-analysis was not possible. The findings are presented in a narrative format. Our review primarily showed that there is a high burden of disease for certain subpopulations of SGM in HIV, STIs, STI-related cancers and mental health conditions, and that they also face high rates of violence. Secondly, our review revealed many knowledge gaps. Those gaps partly stem from a lack of original research, but there is an equally urgent need to conduct systematic and literature reviews to assess what we already know on the disease burden in SGM. Additional reviews are needed on the non-biological factors that could contribute to the higher disease burden. In addition, to provide universal access to health-care for all, more information is needed on the barriers that SGM face in accessing health services, including the attitudes of health-care providers. Understanding these barriers and the additional health risks they impose is crucial to improving the health status of SGM

Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy

Objectives: The incidence of HIV and syphilis among men who have sex with men (MSM) in Europe has recently increased. Rapid point-of-care tests (POCTs) for syphilis can improve access to screening. The purpose of this study was to evaluate the performance of two syphilis POCTs compared with laboratory tests among MSM. Methods: The study was undertaken in Verona, Italy. Asymptomatic MSM, potentially exposed to syphilis, were enrolled prospectively. The POCTs evaluated were SD Bioline Syphilis 3.0 and Chembio DPP Syphilis Screen & Confirm Assay on both serum and fingerprick blood. The results of the POCTs were read by the naked eye by two independent readers and their concordance assessed. Results: A total of 289 MSM were enrolled in the study. Based on laboratory tests, 35 MSM (12.1%) were TPPA-positive alone and 16 (5.5%) were both Treponema pallidum particle agglutination test (TPPA) and rapid plasma reagin (RPR)-positive. The specificities of both POCTs were above 99% on both serum and fingerstick blood specimens, while sensitivities varied considerably. The sensitivity of the SD Bioline test was lower on fingerprick blood (51.4% and 54.3%, readers 1 and 2, respectively) compared with that on serum (80.0% and 82.9%). In contrast, the Chembio test exhibited similar sensitivity values for serum and fingerprick samples (57.7% and 64.0% on serum vs 65.4% and 69.2% on fingerprick for the treponemal component; 63.6% on both samples by both readers for the non-treponemal component). The positive predictive value ranged between 100% and 93.9% for the treponemal component of both syphilis POCTs, but was lower (76.3%-100%)%) for the non-treponemal component of the Chembio POCT. The negative predictive value surpassed 90% for both tests on both samples. The agreement between readers was very high (>99%). Conclusion: The diagnostic performance of the syphilis POCTs was lower than expected; however, considering the prevalence of syphilis among MSM, POCTs should be recommended to improve syphilis detection among MSM

Behaviour change techniques in brief interventions to prevent HIV, STI and unintended pregnancies : a systematic review

Background : Behaviour-change interventions have been consistently considered an essential part of comprehensive HIV, STI and unintended pregnancy prevention. In 2015, the World Health Organization reviewed and assessed existing evidence on brief behavioural interventions, leading to the publication of Brief sexuality-related communication: recommendations for a public health approach. This guideline recommends the use of brief behaviour intervention and communication programmes to promote sexual health and to prevent HIV, STIs, and unintended pregnancies in primary health services, particularly sexual and reproductive health services. Objective : With the purpose of informing the development of a brief behaviour intervention in sexual and reproductive health, we conducted a systematic review of brief intervention to prevent HIV, STI and unintended pregnancies, to identify behaviour change techniques (BCTs) used in health care settings. Methods : Participants from all ages and genders were included. Brief interventions delivered in <= 60 minutes were included. Data was extracted, and interventions were coded following the Behaviour Change Techniques Taxonomy (BCTTv1) guidelines. Results : Of the 6.687 articles identified, 355 were reviewed and 37 studies were included. In effective interventions, we identified 48 behaviour change techniques (BCTs). A core set of 8 frequently used behaviour change techniques was identified: "Problem solving", "Feedback on behaviour", "Social support (unspecified)", "Instructions on how to perform the behaviour", "Information about health consequences", "Information about social and environmental consequences", "Demonstration of the behaviour" and "Credible source". Conclusions : The technical content of brief behaviour interventions was identified in a reliable and standardized way providing preliminary indications on potentially effective techniques to achieve behaviour change

Brief intervention to prevent sexually transmitted infections and unintended pregnancies : protocol of a mixed methods feasibility study

Background: Sexual well-being is fundamental to physical and emotional health, and the ability to achieve it depends on access to comprehensive sexuality information and high-quality sexual health care from evidence-informed, nonjudgmental providers. Adequate and timely delivery of these components to individuals who are at high risk for sexually transmitted infections (STIs), including HIV, and unintended pregnancies promotes sexual health and mitigates consequences arising from risky sexual behavior. Brief interventions that allow health care providers to improve the information available to clients and motivate and help them to develop risk-reduction skills are seen as efficient ways to improve knowledge, change client behavior, and reduce provider stigma regarding sexual health. Objective: The aim of the study is to evaluate five aspects of feasibility (acceptability, willingness, safety, satisfaction, and process) of a brief sexuality-related communication (BSC) intervention based on motivational interviewing and behavior change techniques in primary health care settings in low- and middle-income countries (LMICs). Methods: This protocol outlines a multisite, multiphase study of feasibility of a BSC intervention in primary health care settings in LMICs that will be examined across four phases of the study. Phases I through III involve the collection of formative, qualitative data to examine provider and client perceptions of the feasibility of the intervention, adaptation of the intervention guide, and training providers on how to implement the final version of the BSC intervention. During phase IV, the feasibility of the intervention will be tested in a nonrandomized pre-post test trial where providers and clients will be followed for 6 months and participate in multiphase data collection. Results: Phase I is currently underway in Moldova, and phases I and II were completed in Peru in late 2019. Results are expected for the feasibility study in 2021. Conclusions: This feasibility study will determine whether the implementation of brief intervention programs aimed at improving sexual health outcomes is possible in the constraints of LMIC health systems and will add to our understanding of factors shaping clinical practice among primary care providers

The relevance of target product profiles for manufacturers, experiences from the World Health Organization initiative for point-of-care testing for sexually transmitted infections

BACKGROUND: Sexually transmitted infections (STIs) are a significant global public health issue that cause a high burden of disease, especially in low- and middle-income countries. Screening of key populations and early and accurate diagnosis of infection are critical. Testing for syphilis, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, curable STIs, as well as the human papillomavirus (HPV), is frequently unavailable in low-resource settings. Tests for these STIs that can be used at the point of patient care (POCTs) are needed. In recent years, there has been increased attention for STI POCTs, but technical guidance, financial resources and advocacy for additional platforms/tests are required in order to foster the development of STI POCTs. The WHO Department of Sexual and Reproductive Health and Research (SRH) has developed target product profiles (TPPs), a form of technical guidance, for these STI diagnostics. METHODS: SRH conducted a survey of selected companies that are developing POCTs for one or more of the STIs mentioned above to better understand how these TPPs influence the diagnostic development process - to assess their impact. RESULTS: Survey respondents indicated that the STI POCT TPPs provided good guidance with respect to performance expectations and operational characteristics for the tests/platforms. In particular, optimal metrics for sensitivity, specificity, sample types, and time to result were considered to be very useful. Respondents also suggested ways to improve the relevance of the STI POCT TPPs. For example, since it is often not possible for developers to achieve every desired standard, it would be useful to prioritize each performance/operational characteristic of the test and to provide a rationale as to why certain characteristics are considered important. Respondents also emphasized the need to encourage industry participation in the TPP development process and to find creative ways, including via targeted emails, a WHO webpage directed at industry, or a coordinated communications plan to increase awareness of the TPPs. CONCLUSIONS: Companies value the STI POCT TPPs and want them to continue. In order to maximize impact, WHO should consider the proposals from the manufacturers in the interest of increasing and accelerating access to STI diagnostics and treatment in low-resource settings

Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy.

OBJECTIVES: The incidence of HIV and syphilis among men who have sex with men (MSM) in Europe has recently increased. Rapid point-of-care tests (POCTs) for syphilis can improve access to screening. The purpose of this study was to evaluate the performance of two syphilis POCTs compared with laboratory tests among MSM. METHODS: The study was undertaken in Verona, Italy. Asymptomatic MSM, potentially exposed to syphilis, were enrolled prospectively. The POCTs evaluated were SD Bioline Syphilis 3.0 and Chembio DPP Syphilis Screen & Confirm Assay on both serum and fingerprick blood. The results of the POCTs were read by the naked eye by two independent readers and their concordance assessed. RESULTS: A total of 289 MSM were enrolled in the study. Based on laboratory tests, 35 MSM (12.1%) were TPPA-positive alone and 16 (5.5%) were both Treponema pallidum particle agglutination test (TPPA) and rapid plasma reagin (RPR)-positive. The specificities of both POCTs were above 99% on both serum and fingerstick blood specimens, while sensitivities varied considerably. The sensitivity of the SD Bioline test was lower on fingerprick blood (51.4% and 54.3%, readers 1 and 2, respectively) compared with that on serum (80.0% and 82.9%). In contrast, the Chembio test exhibited similar sensitivity values for serum and fingerprick samples (57.7% and 64.0% on serum vs 65.4% and 69.2% on fingerprick for the treponemal component; 63.6% on both samples by both readers for the non-treponemal component). The positive predictive value ranged between 100% and 93.9% for the treponemal component of both syphilis POCTs, but was lower (76.3%-100%)%) for the non-treponemal component of the Chembio POCT. The negative predictive value surpassed 90% for both tests on both samples. The agreement between readers was very high (>99%). CONCLUSION: The diagnostic performance of the syphilis POCTs was lower than expected; however, considering the prevalence of syphilis among MSM, POCTs should be recommended to improve syphilis detection among MSM