Globally, in 2016 there was estimated to be a total of 376.4 million new curable sexually transmitted infections (STIs; namely chlamydia, gonorrhea, trichomoniasis, and syphilis) acquired among people aged 15 to 49 years.1 Low-income countries, according to the World Bank classification, were found to have the highest prevalence of gonorrhea, trichomoniasis, and syphilis.1 Both chlamydia and gonorrhea can cause pelvic inflammatory disease in women, leading to tubal factor infertility, risk of ectopic pregnancy, or chronic pelvic pain. They can also be transmitted during delivery and can cause ophthalmia neonatorum, a potentially blinding neonatal conjunctivitis. Babies born to women with trichomoniasis are more likely to have a low birth weight or be delivered pre-term. Additionally, in 2012, an estimated 930,000 maternal syphilis infections globally caused around 350,000 adverse pregnancy outcomes.2 Furthermore, STIs increase both susceptibility to and the infectiousness of HIV.3 In areas with a high prevalence of STIs, management of STIs may form an important component of HIV control.4
In low- and middle-income countries (LMIC), syndromic management of STIs has traditionally been the recommended strategy due to the time and resource constraints in implementing etiological diagnosis.5 Syndromic management is the provision of treatment to cover the majority of organisms that could cause a set of signs and symptoms. By definition, it will therefore miss asymptomatic infections, which applies to the majority of STIs.6 Syndromic management of genital ulcer disease and male urethral discharge is cost-effective; however, the algorithms for vaginal discharge have low sensitivity and specificity for the detection of cervical infections, leading to both overtreatment and undertreatment.7 Undertreatment has the potential to lead to complications as a result of untreated STIs and also allows for ongoing transmission. Overtreatment leads to unnecessary drug costs and may expose patients to the risk of adverse reactions and facilitate antimicrobial resistance (which is becoming increasingly widespread in Neisseria gonorrhoeae and Mycoplasma genitalium).8 There are also consequences for relationships and social status associated with being diagnosed with an STI.
As a result of the shortcomings of syndromic management, there have been increasing calls for the implementation of point-of-care tests (POCTs) into management of STIs in LMIC.9,10 One trial, the women's improvement of sexual and reproductive health (WISH) study based in Kigali, Rwanda, compared a risk-based algorithm with both syndromic management and gold standard testing.11 The study found that the WISH algorithm had higher sensitivity and specificity for detecting chlamydia, gonorrhea, and trichomonas infections compared to World Health Organization (WHO) syndromic management.
In 2006, the WHO developed the ASSURED criteria,12 recommending POCTs for STIs aim to be affordable, sensitive, specific, user-friendly, rapid, robust, equipment-free, and deliverable in low resource settings. Historically, POCTs in STI management have included gram staining and wet mount microscopy; however, there are limitations to their sensitivity, especially in women.13 They also require trained staff and specialist equipment.
The need for rapid results in low-resource settings is due to the infrastructural, time, and cost barriers that patients often face in reaching the clinic.14 If not treated during the visit, patients may not have the means to return. Although ASSURED POCTs are currently available for trichomoniasis and syphilis, at present there are no POCTs for chlamydia or gonorrhea that meet all ASSURED criteria.15 However, the WHO Global Sector Strategy for STIs notes that innovations in POCTs are anticipated, and that investing in POCTs now will generate future savings by reducing the burden of STIs through improved case management and detection of asymptomatic infections.16 Rapid HIV tests are an example where POCTs meeting ASSURED criteria have been widely and effectively introduced into low-resource settings.
As the availability and suitability for implementation of POCTs for STIs into LMIC increases, it is important to understand the feasibility and acceptability of their use in LMIC. Additionally, it is important to identify the critical facilitators and barriers to implementation to understand how best to implement them in real-world settings. Their success will ultimately be determined by how effectively they can be integrated into existing health care systems.17 It is critical to examine the current literature to determine in what ways POCTs have been incorporated into different models of care in LMIC previously. This constitutes factors such as the populations involved, the health care settings (such as hospital or community-based), as well as to which individuals POCTs are offered. For example, in the WISH study algorithm, all participants received point-of-care testing for trichomoniasis, however, only those with positive risk factors received POCTs for chlamydia, gonorrhea, and syphilis.11
A preliminary search of PROSPERO, MEDLINE, the Cochrane Database of Systematic Reviews and the JBI Database of Systematic Reviews and Implementation Reports was conducted. No current or in-progress scoping reviews or systematic reviews on the topic were identified that assessed strategies for testing using POCTs in LMIC for multiple curable STIs. A Cochrane review specifically assessed the use of POCTs for syphilis in pregnant women, and concluded that POCTs for syphilis showed promising results in antenatal care but that more trials were needed.18 In addition to including testing for other curable STIs, this review will also look at populations other than pregnant women.
The aim of this scoping review is to assess how point-of-care STI testing has been implemented into health care systems in LMIC and the facilitators and barriers to doing so.
- i) How have point-of-care STI tests been incorporated into different models of care in LMIC?
- ii) Which point-of-care STI tests have been trialed in LMIC?
- iii) What is the feasibility and acceptability of using point-of-care STI tests in LMIC?
- iv) What are the facilitators and barriers to using point-of-care STI tests in LMIC?
- v) What gaps are present in the research knowledge base regarding the use point-of-care STI tests in LMIC?
This scoping review will consider studies that include participants either receiving point-of-care STI testing or health care professionals providing point-of-care STI testing. Study participants can be of any age or risk group. Health care and systems assessments not directly involving patients will also be considered for inclusion.
This review will consider studies that explore the use of point-of-care STI tests in terms of how they are implemented into models of care and the feasibility, acceptability, facilitators, and barriers to doing so. Facilitators are factors that promote implementation or adoption of POCTs, whereas barriers impede implementation or adoption of POCTs in these settings. For example, a potential facilitator could be improved job satisfaction through providing a diagnosis, whereas a likely barrier will be material costs. How feasibility and acceptability are defined will vary between studies. Feasibility will generally refer to the ease and success with which POCTs are implemented logistically, whereas acceptability will be based on levels of uptake of POCTs by individuals. Studies featuring testing for chlamydia, gonorrhea, trichomoniasis, or syphilis infection will be considered. This review will not cover HIV testing and studies focusing only HIV on testing will be excluded. There is already a substantial literature base regarding point-of-care testing for HIV, and WHO guidelines regarding implementation of HIV POCTs are available.19
Only studies that are based in LMIC will be considered for inclusion. The review will include countries defined as low, lower-middle, and upper-middle income economies as defined by the World Bank.20
Types of sources
This scoping review will consider quantitative, qualitative, and mixed methods study designs for inclusion. Quantitative study designs to be considered for inclusion include randomized controlled trials, non-randomized controlled trials, before and after studies, interrupted time-series studies, retrospective and prospective cohort, case-control, analytical and descriptive cross-sectional studies, case series, and individual case reports. Qualitative studies with methodologies including but not limited to grounded theory, phenomenology, and ethnography will be considered. In addition, systematic reviews will be considered for inclusion in the proposed scoping review. Articles published in English from 1998 onwards will be included as the earliest treponemal rapid diagnostic tests for syphilis were developed at this time.21,22
The proposed scoping review will be conducted in accordance with JBI methodology for scoping reviews.23
The search strategy will aim to locate both published and unpublished primary studies and reviews. An experienced clinical librarian and author (TR) assisted in the development of the search strategy. An initial limited search of MEDLINE and Embase was undertaken to identify articles on the topic. The text words contained in the titles and abstracts of relevant articles, and the index terms used to describe the articles were used to develop a full search strategy for MEDLINE (Appendix I). The filter for LMIC is a Cochrane filter based on the 2009 classification of countries by The World Bank,24 which is to prevent exclusion of studies from countries that were low or middle income at the time of publication but have since become high-income countries. The search strategy, including all identified keywords and index terms will be adapted for each included information source. The reference lists of articles included in the review will be screened for additional papers.
The databases to be searched include MEDLINE, Embase and Emcare (Ovid SP), CINAHL (EBSCO), Scopus, LILACS and African Index Medicus, and the Cochrane Library, including the Cochrane Central Register of Controlled Trials (Wiley). These databases have been chosen to allow for a broad range of studies, including those focused on biomedicine, nursing, and social sciences. Study authors may also be contacted for further information if necessary.
Sources of unpublished studies and gray literature to be searched include Google Scholar, ProQuest Dissertations and Theses, and the WHO website.
Following the search, all identified records will be collated and uploaded into EndNote X9 (Clarivate Analytics, PA, USA) and duplicates removed. Titles and abstracts will then be screened by two independent reviewers for assessment against the inclusion criteria for the review. Potentially relevant papers will be retrieved in full and their citation details imported into the JBI System for the Unified Management, Assessment and Review of Information (JBI SUMARI; JBI, Adelaide, Australia). The full text of selected citations will be assessed in detail against the inclusion criteria by two independent reviewers. Reasons for exclusion of full text papers that do not meet the inclusion criteria will be recorded and reported in the scoping review. Any disagreements that arise between the reviewers at each stage of the selection process will be resolved through discussion, or with a third reviewer. The results of the search will be reported in full in the final scoping review and presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) flow diagram.25
Data will be extracted from papers included in the scoping review by two independent reviewers using a data extraction tool developed by the reviewers (Appendix II). The data extracted will include specific details about the study country, setting, population, methods, the POCTs used, feasibility, acceptability, and facilitators and barriers to POCT use. The draft data extraction tool will be modified and revised as necessary during the process of extracting data from each included paper. Modifications will be detailed in the full scoping review. Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer. Authors of papers will be contacted to request missing or additional data, where required.
Characteristics of research studies, including population, setting, POCT used, and how they were incorporated into a model of care will be presented in tabular form. A narrative summary will accompany the tabulated results and will describe the feasibility, acceptability, facilitators, and barriers noted during implementation of the POCTs. Apparent gaps in the literature will also be identified. Given the differences in antenatal care compared to the general population, results for pregnant women will be presented separately.
Appendix I: Search strategy
MEDLINE (Ovid) search conducted in April 2020.
Appendix II: Data extraction instrument
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