Blog
About

  • Record: found
  • Abstract: found
  • Article: found
Is Open Access

Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial

Read this article at

Bookmark
      There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

      Abstract

      BackgroundHIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs), who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities.Methods and findingsWe conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of 2 HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (1 peer educator and 8 participants) were randomized to either (1) direct provision of HIV self-tests, (2) provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3) standard of care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18, 2016, to November 16, 2016. Participants’ median age was 28 years (IQR 24–32). Our prespecified primary outcomes were self-report of any HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care and ART initiation. In addition, we analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing—to understand the intervention effects on frequent testing—and self-reported facility-based testing—to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (risk ratio [RR] 1.33, 95% CI 1.17–1.51, p < 0.001) and at 4 months (RR 1.14, 95% CI 1.07–1.22, p < 0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, 95% CI 1.07–1.31, p = 0.001) and at 4 months (RR 1.03, 95% CI 1.01–1.05, p = 0.02). At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm, but these differences were not significant and were reduced in magnitude at 4 months. There were no statistically significant differences in ART initiation across study arms. At 4 months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard of care arm (RR 1.51, 95% CI 1.29–1.77, p < 0.001) and those in the facility collection arm (RR 1.22, 95% CI 1.08–1.37, p = 0.001). Participants in the HIV self-testing arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIV self-testing were reported: interpersonal violence and mental distress. Study limitations included self-reported outcomes and limited generalizability beyond FSWs in similar settings.ConclusionsIn this study, HIV self-testing appeared to be safe and increased recent and repeat HIV testing among FSWs. We found that direct provision of HIV self-tests was significantly more effective in increasing HIV testing among FSWs than passively offering HIV self-tests for collection in healthcare facilities. HIV self-testing could play an important role in supporting HIV interventions that require frequent HIV testing, such as HIV treatment as prevention, behavior change for transmission reduction, and pre-exposure prophylaxis.Trial registrationClinicalTrials.gov NCT02846402

      Abstract

      In a cluster-randomized trial, Katrina Ortblad and colleagues study the provision of HIV self-tests for female sex workers in Uganda.

      Author summary

      Why was this study done?HIV self-testing can increase the convenience and privacy of HIV testing because it allows individuals to test for HIV at any time and place they choose and without the presence of another person.Many sub-Saharan governments are considering HIV self-testing for FSWs, but little evidence exists on the delivery, uptake, and effects of HIV self-testing among members of this population.What did the researchers do and find?We randomized 960 FSWs in 120 peer educator groups 1:1:1 to (1) direct provision of HIV self-tests, (2) provision of a coupon for free collection of HIV self-tests in a healthcare facility, and (3) standard of care facility-based HIV testing services. Participants received 1 HIV self-test (in the direct provision arm) or 1 coupon (in the facility collection arm) shortly after randomization and again 3 months later.Any recent HIV testing (at 1 month and at 4 months) and repeat HIV testing (at 4 months) was significantly greater in the direct provision arm compared to the facility collection arm and the standard of care arm.FSWs in the intervention arms almost completely substituted HIV self-testing for facility-based HIV testing.Fewer FSWs in the interventions arms sought HIV-related medical care than those in the standard of care arm at 1 month; however, this difference disappeared by 4 months.What do these findings mean?HIV self-testing appears to be safe and increases recent and repeat HIV testing among FSW in Uganda.The active approach to directly provide HIV self-tests to FSWs is more effective in increasing HIV testing than the passive approach to offer free access to HIV self-tests via coupons that can be used to collect self-tests in healthcare facilities.Almost all FSWs who had access to HIV self-testing used this new testing technology instead of facility-based HIV testing.It is possible that self-testing in homes and other private locations (rather than in healthcare facilities) may reduce linkage to care in the short term.Sub-Saharan African governments should consider HIV self-testing for FSWs but ensure it is delivered with linkage-enhancing interventions. Where possible, governments should introduce active HIV self-testing models (delivering HIV self-tests directly to FSWs) rather than passive models (requiring FSWs to collect self-tests in healthcare facilities).

      Related collections

      Most cited references 56

      • Record: found
      • Abstract: found
      • Article: not found

      Prevention of HIV-1 infection with early antiretroviral therapy.

      Antiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. In nine countries, we enrolled 1763 couples in which one partner was HIV-1-positive and the other was HIV-1-negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1-infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive antiretroviral therapy either immediately (early therapy) or after a decline in the CD4 count or the onset of HIV-1-related symptoms (delayed therapy). The primary prevention end point was linked HIV-1 transmission in HIV-1-negative partners. The primary clinical end point was the earliest occurrence of pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death. As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P=0.01). The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 052 ClinicalTrials.gov number, NCT00074581.).
        Bookmark
        • Record: found
        • Abstract: found
        • Article: not found

        A modified poisson regression approach to prospective studies with binary data.

         Guangyong Zou (2004)
        Relative risk is usually the parameter of interest in epidemiologic and medical studies. In this paper, the author proposes a modified Poisson regression approach (i.e., Poisson regression with a robust error variance) to estimate this effect measure directly. A simple 2-by-2 table is used to justify the validity of this approach. Results from a limited simulation study indicate that this approach is very reliable even with total sample sizes as small as 100. The method is illustrated with two data sets.
          Bookmark
          • Record: found
          • Abstract: found
          • Article: not found

          Burden of HIV among female sex workers in low-income and middle-income countries: a systematic review and meta-analysis.

          Female sex workers are a population who are at heightened risk of HIV infection secondary to biological, behavioural, and structural risk factors. However, three decades into the HIV pandemic, understanding of the burden of HIV among these women remains limited. We aimed to assess the burden of HIV in this population compared with that of other women of reproductive age. We searched PubMed, Embase, Global Health, SCOPUS, PsycINFO, Sociological Abstracts, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Web of Science, and POPLine for studies of female sex workers in low-income and middle-income countries published between Jan 1, 2007, and June 25, 2011. Studies of any design that measured the prevalence or incidence of HIV among female sex workers, even if sex workers were not the main focus of the study, were included. Meta-analyses were done with the Mantel-Haenszel method with a random-effects model characterising an odds ratio for the prevalence of HIV among female sex workers compared with that for all women of reproductive age. Of 434 selected articles and surveillance reports, 102 were included in the analyses, representing 99,878 female sex workers in 50 countries. The overall HIV prevalence was 11·8% (95% CI 11·6-12·0) with a pooled odds ratio for HIV infection of 13·5 (95% CI 10·0-18·1) with wide intraregional ranges in the pooled HIV prevalence and odds ratios for HIV infection. In 26 countries with medium and high background HIV prevalence, 30·7% (95% CI 30·2-31·3; 8627 of 28,075) of sex workers were HIV-positive and the odds ratio for infection was 11·6 (95% CI 9·1-14·8). Although data characterising HIV risk among female sex workers is scarce, the burden of disease is disproportionately high. These data suggest an urgent need to scale up access to quality HIV prevention programmes. Considerations of the legal and policy environments in which sex workers operate and actions to address the important role of stigma, discrimination, and violence targeting female sex workers is needed. The World Bank, UN Population Fund. Copyright © 2012 Elsevier Ltd. All rights reserved.
            Bookmark

            Author and article information

            Affiliations
            [1 ] Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America
            [2 ] International Research Consortium, Kampala, Uganda
            [3 ] Uganda Health Marketing Group, Kampala, Uganda
            [4 ] Ugandan Ministry of Health, Kampala, Uganda
            [5 ] Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America
            [6 ] Department of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, United States of America
            [7 ] Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America
            [8 ] Department of Ophthalmology, University of California, San Francisco, San Francisco, California, United States of America
            [9 ] Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California, United States of America
            [10 ] Africa Health Research Institute, KwaZulu-Natal, South Africa
            [11 ] Heidelberg Institute of Public Health, University of Heidelberg, Heidelberg, Germany
            University of California, San Francisco, UNITED STATES
            Author notes

            I have read the journal's policy and the authors of this manuscript have the following competing interests: JEH has been a paid consultant for the NIH, WHO, and Merck. JEH also owns stock in Natera.

            Contributors
            ORCID: http://orcid.org/0000-0002-5675-8836, Role: Conceptualization, Role: Data curation, Role: Formal analysis, Role: Funding acquisition, Role: Investigation, Role: Methodology, Role: Project administration, Role: Software, Role: Validation, Role: Visualization, Role: Writing – original draft, Role: Writing – review & editing
            Role: Conceptualization, Role: Data curation, Role: Funding acquisition, Role: Investigation, Role: Methodology, Role: Project administration, Role: Supervision, Role: Writing – review & editing
            Role: Conceptualization, Role: Data curation, Role: Funding acquisition, Role: Project administration, Role: Writing – review & editing
            Role: Data curation, Role: Investigation, Role: Project administration, Role: Supervision, Role: Writing – review & editing
            Role: Conceptualization, Role: Funding acquisition, Role: Project administration, Role: Writing – review & editing
            Role: Data curation, Role: Project administration, Role: Writing – review & editing
            Role: Conceptualization, Role: Funding acquisition, Role: Project administration, Role: Supervision, Role: Writing – review & editing
            Role: Data curation, Role: Project administration, Role: Writing – review & editing
            ORCID: http://orcid.org/0000-0001-5845-3190, Role: Methodology, Role: Supervision, Role: Writing – review & editing
            Role: Methodology, Role: Supervision, Role: Writing – review & editing
            ORCID: http://orcid.org/0000-0002-0763-399X, Role: Conceptualization, Role: Data curation, Role: Formal analysis, Role: Funding acquisition, Role: Investigation, Role: Methodology, Role: Project administration, Role: Supervision, Role: Validation, Role: Writing – original draft, Role: Writing – review & editing
            Role: Conceptualization, Role: Funding acquisition, Role: Investigation, Role: Methodology, Role: Supervision, Role: Writing – original draft, Role: Writing – review & editing
            Role: Academic Editor
            Journal
            PLoS Med
            PLoS Med
            plos
            plosmed
            PLoS Medicine
            Public Library of Science (San Francisco, CA USA )
            1549-1277
            1549-1676
            28 November 2017
            November 2017
            : 14
            : 11
            29182634
            5705079
            10.1371/journal.pmed.1002458
            PMEDICINE-D-17-02975
            (Academic Editor)
            © 2017 Ortblad 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.

            Counts
            Figures: 4, Tables: 3, Pages: 24
            Product
            Funding
            Funded by: International Initiative for Impact Evaluation
            Award Recipient :
            Funded by: funder-id http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;
            Award ID: T32-AI007535
            Award Recipient : ORCID: http://orcid.org/0000-0002-5675-8836
            Funded by: funder-id http://dx.doi.org/10.13039/100000026, National Institute on Drug Abuse;
            Award ID: T32-DA013911
            Award Recipient : ORCID: http://orcid.org/0000-0002-0763-399X
            Funded by: funder-id http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;
            Award ID: R25-MH083620
            Award Recipient : ORCID: http://orcid.org/0000-0002-0763-399X
            Funded by: Alexander von Humboldt-Stiftung (DE)
            Award ID: Alexander von Humboldt Professorship
            Award Recipient :
            Funded by: German Federal Ministry of Education and Research
            Award Recipient :
            Funded by: Clinton Health Access Initiative
            Award Recipient :
            Funded by: funder-id http://dx.doi.org/10.13039/100000002, National Institutes of Health;
            Award ID: R01-HD084233
            Award Recipient :
            Funded by: funder-id http://dx.doi.org/10.13039/100000002, National Institutes of Health;
            Award ID: R01-AI124389
            Award Recipient :
            Funded by: National Institutes of Health (US)
            Award ID: R01-AI112339
            Award Recipient :
            Funded by: National Institutes of Health (US)
            Award ID: D43-TW009775
            Award Recipient :
            Funded by: funder-id http://dx.doi.org/10.13039/100004440, Wellcome Trust;
            Award Recipient :
            Funded by: funder-id http://dx.doi.org/10.13039/501100000780, European Commission;
            Award Recipient :
            This study was funded by the International Initiative for Impact Evaluation (3ie) ( http://www.3ieimpact.org/). KO was additionally supported by the NIH: National Institute of Allergy and Infectious Disease ( https://www.niaid.nih.gov/) [T32-AI007535, PI: Seage]. CEO was supported in part by the NIH: National Institute on Drug Abuse ( https://www.drugabuse.gov/) [T32-DA013911, PI: Flanigan] and the NIH: National Institute of Allergy and Mental Health [R25-MH083620, PI: Nunn]. TB was funded by the Alexander von Humboldt Foundation ( https://www.humboldt-foundation.de) through the Alexander von Humboldt Professorship endowed by the German Federal Ministry of Education and Research ( https://www.bmbf.de). TB was also supported by the Wellcome Trust ( https://wellcome.ac.uk/), the European Commission ( https://ec.europa.eu), the Clinton Health Access Initiative ( https://clintonhealthaccess.org/), NIH: National Institute of Child Health and Human Development ( https://www.nichd.nih.gov) [R01-HD084233], NIH: National Institute of Allergy and Infectious Diseases ( https://www.niaid.nih.gov/) [R01-AI124389 and R01-AI112339], and NIH: Fogarty International Center ( https://www.fic.nih.gov) [D43-TW009775]. Oral HIV self-tests were obtained from OraSure Technologies at cost. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
            Categories
            Research Article
            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
            Organisms
            Viruses
            Viral Pathogens
            Immunodeficiency Viruses
            HIV
            Biology and Life Sciences
            Organisms
            Viruses
            Immunodeficiency Viruses
            HIV
            Biology and life sciences
            Organisms
            Viruses
            RNA viruses
            Retroviruses
            Lentivirus
            HIV
            Biology and Life Sciences
            Microbiology
            Medical Microbiology
            Microbial Pathogens
            Viral Pathogens
            Retroviruses
            Lentivirus
            HIV
            Medicine and Health Sciences
            Pathology and Laboratory Medicine
            Pathogens
            Microbial Pathogens
            Viral Pathogens
            Retroviruses
            Lentivirus
            HIV
            Biology and Life Sciences
            Organisms
            Viruses
            Viral Pathogens
            Retroviruses
            Lentivirus
            HIV
            Medicine and Health Sciences
            Health Care
            Health Care Facilities
            Medicine and health sciences
            Public and occupational health
            Preventive medicine
            HIV prevention
            Medicine and Health Sciences
            Health Care
            Health Education and Awareness
            Research and Analysis Methods
            Research Design
            Clinical Research Design
            Adverse Events
            Medicine and Health Sciences
            Health Care
            Health Services Research
            People and Places
            Geographical Locations
            Africa
            Uganda
            People and Places
            Geographical Locations
            Africa
            Custom metadata
            All data is publicly available at the online data repository run by the International Initiative for Impact Evaluation (3ie): https://dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/OVEAC9

            Medicine

            Comments

            Comment on this article