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      Beyond syndromic management: Opportunities for diagnosis-based treatment of sexually transmitted infections in low- and middle-income countries

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          Abstract

          Introduction

          In light of the limited impact the syndromic management approach has had on the global sexually transmitted infection (STI) epidemic, we assessed a care model comprising point-of-care (POC) STI testing, immediate treatment, and expedited partner therapy (EPT) among a cohort of young women at high HIV risk in South Africa.

          Methods and findings

          HIV negative women presenting for STI care underwent POC testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV), and swabs were sent for NG culture and susceptibility testing. Results were available within 2 hours and women with STIs were immediately treated and offered EPT packs, including medication, condoms, and information for sexual partners. An EPT questionnaire was administered after one week, and women retested for STIs after 6 and 12 weeks. 267 women, median age 23 (IQR 21–26), were recruited and 88.4% (236/267) reported genital symptoms. STI prevalence was CT 18.4% (95%CI 13.7–23.0), NG 5.2% (95%CI 2.6–7.9) and TV 3.0% (95%CI 1.0–5.0). After 12 weeks, all but one NG and two CT infections were cleared. No cephalosporin-resistant NG was detected. Of 63/267 women (23.6%) diagnosed with STIs, 98.4% (62/63) were offered and 87.1% (54/62) accepted EPT. At one week 88.9% (48/54) stated that their partner had taken the medication. No allergic reactions or social harms were reported. Of 51 women completing 6-week follow up, detection rates were lower amongst women receiving EPT (2.2%, 1/46) compared to those who did not (40.0%, 2/5), p = 0.023. During focus group discussions women supported the care model, because they received a rapid, specific diagnosis, and could facilitate their partners’ treatment.

          Conclusions

          POC STI testing and EPT were acceptable to young South African women and their partners, and could play an important role in reducing STI reinfection rates and HIV risk. Larger studies should evaluate the feasibility and cost-effectiveness of implementing this strategy at population level.

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          Most cited references28

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          Epidemiological synergy. Interrelationships between human immunodeficiency virus infection and other sexually transmitted diseases.

          Understanding the role of other sexually transmitted diseases (STDs) in the transmission of human immunodeficiency virus (HIV), the role of STDs in progression of HIV disease, and the role of HIV infection in alterations of natural history, diagnosis, or response to therapy of STDs is critical to the development of optimal strategies for HIV control. One hundred sixty-three studies on the interrelationships between HIV infection and other STDs were examined. Of 75 studies on the role of STDs in HIV transmission, the 15 analyses of examination or laboratory evidence of STDs adjusted for sexual behavior showed that both ulcerative and nonulcerative STDs increase the risk of HIV transmission approximately 3- to 5-fold. Due to limited data, the role of STDs in progression of disease remains unclear. Preliminary data from 83 reports on the impact of HIV infection on STDs suggest that, at a community level, HIV infection may increase the prevalence of some STDs (e.g., genital ulcers). If coinfection with HIV prolongs or augments the infectiousness of individuals with STDs, and if the same STDs facilitate transmission of HIV, these infections may greatly amplify one another. This "epidemiological synergy" may be responsible for the explosive growth of the HIV pandemic in some populations. Effective STD control programs will be essential to HIV prevention in these communities.
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            Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae.

            Tests for Chlamydia trachomatis and Neisseria gonorrhoeae, which can provide results rapidly to guide therapeutic decision-making, offer patient care advantages over laboratory-based tests that require several days to provide results. We compared results from the Cepheid GeneXpert CT/NG (Xpert) assay to results from two currently approved nucleic acid amplification assays in 1,722 female and 1,387 male volunteers. Results for chlamydia in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 97.4%, 98.7%, and 97.6%, respectively, and for urine samples from males, a sensitivity of 97.5%, with all specificity estimates being ≥ 99.4%. Results for gonorrhea in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 100.0%, 100.0%, and 95.6%, respectively, and for urine samples from males, a sensitivity of 98.0%, with all estimates of specificity being ≥ 99.8%. These results indicate that this short-turnaround-time test can be used to accurately test patients and to possibly do so at the site of care, thus potentially improving chlamydia and gonorrhea control efforts.
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              Cofactors in male-female sexual transmission of human immunodeficiency virus type 1.

              In a study of human immunodeficiency virus type 1 (HIV-1)-uninfected African prostitutes, 83 (67%) of 124 seroconverted to HIV-1. Oral contraceptive use (odds ratio [OR], 3.1; 95% confidence interval [CI], 1.1-8.6; P less than .03), genital ulcers (mean annual episodes, 1.32 +/- 0.55 in seroconverting women vs. 0.48 +/- 0.21 in seronegative women; P less than .02) and Chlamydia trachomatis infections (OR, 3.6; CI, 1.3-11.0; P less than .02) were associated with increased risk of HIV-1 infection. Condom use reduced the risk of HIV-1 infection (OR, 0.11; CI, 0.05-0.27; P less than .0001). Stepwise logistic regression analysis confirmed independent associations between HIV-1 infection and oral contraceptive use, condom use, genital ulcers, and C. trachomatis. The presence of other sexually transmitted diseases may in part explain the heterosexual HIV-1 epidemic in Africa and may represent important targets for intervention to control HIV-1 infection.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: ValidationRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Project administrationRole: Writing – review & editing
                Role: Formal analysisRole: InvestigationRole: Project administrationRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: MethodologyRole: Writing – review & editing
                Role: InvestigationRole: Project administrationRole: Writing – review & editing
                Role: ConceptualizationRole: Project administrationRole: ResourcesRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: Project administrationRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: InvestigationRole: ResourcesRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: ResourcesRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: ResourcesRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                24 April 2018
                2018
                : 13
                : 4
                : e0196209
                Affiliations
                [1 ] Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa
                [2 ] School of Nursing and Public Health, Discipline of Public Health Medicine, University of KwaZulu-Natal, Durban, South Africa
                [3 ] South African Medical Research Council, Durban, South Africa
                [4 ] Department of Epidemiology, Columbia University, New York City, United States of America
                [5 ] Prince Cyril Zulu Communicable Disease Centre, eThekwini Municipality, Durban, South Africa
                [6 ] Department of Microbiology, University of KwaZulu-Natal, Durban, South Africa
                [7 ] National Health Laboratory Service, Durban, South Africa
                [8 ] Johns Hopkins University, Baltimore, United States of America
                University of Ottawa, CANADA
                Author notes

                Competing Interests: The authors of this manuscript have the following competing interests: Cepheid Inc loaned two 4-module GeneXpert machines to the study team free-of-charge, but had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

                Author information
                http://orcid.org/0000-0002-4530-234X
                http://orcid.org/0000-0003-1935-4637
                http://orcid.org/0000-0003-2812-5377
                http://orcid.org/0000-0002-4986-2133
                http://orcid.org/0000-0002-8436-3268
                http://orcid.org/0000-0001-6398-9061
                http://orcid.org/0000-0002-8780-9982
                Article
                PONE-D-17-31053
                10.1371/journal.pone.0196209
                5918163
                29689080
                2dfd6d5a-58c7-4b90-a5bb-2f4412cdb29a
                © 2018 Garrett et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 23 August 2017
                : 9 April 2018
                Page count
                Figures: 1, Tables: 4, Pages: 13
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100000002, National Institutes of Health;
                Award ID: AI116759
                Award Recipient :
                This study was funded by a United States – South African Program for Collaborative Biomedical Research grant through the South African Medical Research Council and the National Institute of Health (AI116759). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Medicine and health sciences
                Epidemiology
                HIV epidemiology
                Medicine and Health Sciences
                Urology
                Genitourinary Infections
                Bacterial Vaginosis
                Medicine and Health Sciences
                Infectious Diseases
                Sexually Transmitted Diseases
                Bacterial Vaginosis
                Biology and Life Sciences
                Microbiology
                Medical Microbiology
                Microbial Pathogens
                Viral Pathogens
                Immunodeficiency Viruses
                HIV
                Medicine and Health Sciences
                Pathology and Laboratory Medicine
                Pathogens
                Microbial Pathogens
                Viral Pathogens
                Immunodeficiency Viruses
                HIV
                Biology and Life Sciences
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                Viruses
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                HIV
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                Organisms
                Viruses
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                Pathogens
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                Lentivirus
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                Medicine and Health Sciences
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                Biology and Life Sciences
                Organisms
                Eukaryota
                Protists
                Trichomonas
                Trichomonas Vaginalis
                Medicine and health sciences
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                People and places
                Geographical locations
                Africa
                South Africa
                Biology and Life Sciences
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                Chlamydia Trachomatis
                Medicine and Health Sciences
                Pathology and Laboratory Medicine
                Pathogens
                Microbial Pathogens
                Bacterial Pathogens
                Chlamydia Trachomatis
                Biology and Life Sciences
                Organisms
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                Chlamydia
                Chlamydia Trachomatis
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                All relevant data are within the paper and its Supporting Information files.

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