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HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial

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      Abstract

      Background

      HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia.

      Methods and findings

      Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator–FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99–1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86–1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04–1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98–1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92–1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94–1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05–1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 ( N = 144) and 4 months ( N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing.

      Conclusions

      In this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high.

      Trial registration

      ClinicalTrials.gov NCT02827240

      Abstract

      In a cluster-randomized trial done in Zambia, Catherine Oldenburg and colleagues study HIV self-testing for female sex workers.

      Author summary

      Why was this study done?
      • HIV self-testing can be done in the absence of a health provider and may close gaps in the HIV treatment and prevention cascades.

      • Female sex workers are at increased risk of HIV acquisition and may particularly benefit from HIV self-testing because it could address some of their specific barriers to HIV testing, e.g., health provider stigma and discrimination, health facility hours, and distance to the health facility.

      • How HIV self-tests are delivered to female sex workers may impact the effectiveness of this HIV testing intervention.

      What did the researchers do and find?
      • We measured the effectiveness of 2 HIV self-testing distribution mechanisms by randomizing 965 female sex workers in 3 Zambian transit towns to (1) direct delivery of an HIV self-test (delivery arm), (2) a coupon for collection of an HIV self-test from a health clinic/pharmacy (coupon arm), and (3) referral to standard-of-care HIV testing and counseling (standard-of-care arm) (all provided by peer educators).

      • At the 1-month and 4-month follow-up, overall HIV testing in the previous month was high (1-month: 94.9% delivery arm, 84.4% coupon arm, 88.5% standard-of-care arm), and there were few statistically significant differences across study arms.

      • Among participants reporting an HIV-positive test result, linkage to HIV-related care and ART initiation were non-significantly lower among those in the HIV self-testing arms compared to the standard-of-care arm at both time points, although there was limited power to detect differences.

      • Three adverse events related to HIV self-testing were reported over the duration of the study, all of which were intimate partner violence.

      What do these findings mean?
      • HIV self-testing appears safe, acceptable, and accessible among female sex workers in Zambian transit towns.

      • HIV self-testing, regardless of the delivery model, may not sustainably increase HIV cascade progression in contexts where overall HIV testing is high.

      Related collections

      Most cited references 28

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      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.
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        Effectiveness of peer education interventions for HIV prevention in developing countries: a systematic review and meta-analysis.

        Peer education for HIV prevention has been widely implemented in developing countries, yet the effectiveness of this intervention has not been systematically evaluated. We conducted a systematic review and meta-analysis of peer education interventions in developing countries published between January 1990 and November 2006. Standardized methods of searching and data abstraction were utilized. Merged effect sizes were calculated using random effects models. Thirty studies were identified. In meta-analysis, peer education interventions were significantly associated with increased HIV knowledge (odds ratio [OR]: 2.28; 95%, confidence interval [CI]:1.88, 2.75), reduced equipment sharing among injection drug users (OR: 0.37; 95% CI: 0.20, 0.67), and increased condom use (OR: 1.92; 95% CI: 1.59, 2.33). Peer education programs had a nonsignificant effect on sexually transmitted infections (OR: 1.22; 95% CI:0.88, 1.71). Meta-analysis indicates that peer education programs in developing countries are moderately effective at improving behavioral outcomes but show no significant impact on biological outcomes. Further research is needed to determine factors that maximize the likelihood of program success.
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          Effectiveness of interventions for the prevention of HIV and other sexually transmitted infections in female sex workers in resource poor setting: a systematic review.

          To systematically review the evidence for effectiveness of HIV and sexually transmitted infection (STI) prevention interventions in female sex workers in resource poor settings. Published and unpublished studies were identified through electronic databases (Cochrane database, Medline, Embase, and Web of Science), hand searching and contacting experts. Randomized-controlled-trials and quasi-experimental studies were included if they were conducted in female sex workers from low and middle income settings; if the exposure was described; if the outcome was externally measurable, it was after the discovery of HIV, and if follow-up was longer than 6 months. A priori criteria were used to extract data. Meta-analysis was not performed due to the heterogeneity of studies. Twenty-eight interventions were included. Despite methodological limitations, the evidence suggested that combining sexual risk reduction, condom promotion and improved access to STI treatment reduces HIV and STI acquisition in sex workers receiving the intervention. Strong evidence that regular STI screening or periodic treatment of STIs confers additional protection against HIV was lacking. It appears that structural interventions, policy change or empowerment of sex workers, reduce the prevalence of STIs and HIV. Rigorous evaluation of HIV/STI prevention interventions in sex workers is challenging. There is some evidence for the efficacy of multi-component interventions, and/or structural interventions. The effect of these interventions on the wider population has rarely been evaluated.
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            Author and article information

            Affiliations
            [1 ] John Snow, Inc., Lusaka, Zambia
            [2 ] Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America
            [3 ] John Snow, Inc., Boston, Massachusetts, United States of America
            [4 ] Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America
            [5 ] Research Department of Infection and Population Health, Institute for Global Health, University College London, London, United Kingdom
            [6 ] Heidelberg Institute of Public Health, University of Heidelberg, Heidelberg, Germany
            [7 ] Africa Health Research Institute, KwaZulu-Natal, South Africa
            [8 ] Francis I. Proctor Foundation for Research in Ophthalmology, University of California, San Francisco, California, United States of America
            [9 ] Department of Ophthalmology, University of California, San Francisco, California, United States of America
            [10 ] Department of Epidemiology and Biostatistics, University of California, San Francisco, California, United States of America
            Desmond Tutu HIV Centre, SOUTH AFRICA
            Author notes

            The authors have declared that no competing interests exist.

            Contributors
            Role: Conceptualization, Role: Data curation, Role: Funding acquisition, Role: Investigation, Role: Methodology, Role: Project administration, Role: Resources, Role: Supervision, Role: Writing – review & editing
            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: Supervision, Role: Writing – review & editing
            Role: Data curation, Role: Investigation, Role: Project administration, Role: Resources, Role: Supervision, Role: Writing – review & editing
            Role: Investigation, Role: Project administration, Role: Resources, Role: Supervision, Role: Writing – review & editing
            Role: Investigation, Role: Project administration, Role: Supervision, Role: Writing – review & editing
            Role: Investigation, Role: Project administration, Role: Resources, Role: Supervision, Role: Writing – review & editing
            Role: Conceptualization, Role: Funding acquisition, Role: Investigation, Role: Methodology, Role: Project administration, Role: Resources, Role: Supervision, Role: Writing – review & editing
            Role: Funding acquisition, Role: Investigation, Role: Project administration, Role: Resources, Role: Supervision, Role: Writing – review & editing
            Role: Investigation, Role: Methodology, Role: Project administration, Role: Supervision, Role: Writing – review & editing
            ORCID: http://orcid.org/0000-0001-6604-491X, Role: Conceptualization, Role: Formal analysis, Role: Funding acquisition, Role: Investigation, Role: Methodology, Role: Project administration, Role: Supervision, Role: Validation, Role: Writing – review & editing
            Role: Conceptualization, Role: Formal analysis, Role: Funding acquisition, Role: Investigation, Role: Methodology, Role: Project administration, Role: Resources, 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: Resources, Role: Supervision, Role: Visualization, 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
            21 November 2017
            November 2017
            : 14
            : 11
            29161260 5697803 10.1371/journal.pmed.1002442 PMEDICINE-D-17-01847
            © 2017 Chanda 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: 2, Tables: 3, Pages: 19
            Product
            Funding
            Funded by: International Initiative for Impact Evaluation
            Award Recipient :
            Funded by: funder-id http://dx.doi.org/10.13039/100000026, National Institute on Drug Abuse;
            Award ID: T32DA013911
            Award Recipient : ORCID: http://orcid.org/0000-0002-0763-399X
            Funded by: National Institute of Mental Health (US)
            Award ID: R25MH083620
            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: T32AI007535
            Award Recipient : ORCID: http://orcid.org/0000-0002-5675-8836
            Funded by: funder-id http://dx.doi.org/10.13039/100000071, National Institute of Child Health and Human Development;
            Award ID: R01HD084233
            Award Recipient :
            Funded by: funder-id http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;
            Award ID: R01AI124389
            Award Recipient :
            Funded by: funder-id http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;
            Award ID: R01AI112339
            Award Recipient :
            The Zambian Peer Educators for HIV Self-Testing (ZEST) study was funded by the International Initiative for Impact Evaluation (3ie). CEO was supported in part by the National Institute on Drug Abuse T32-DA013911 (PI Flanigan) and the National Institute of Mental Health R25-MH083620 (PI Nunn). KFO was supported in part by the National Institute of Allergy and Infectious Disease T32-AI007535 (PI Seage). TB was supported in part by the National Institute of Child Health and Human Development R01-HD084233 and the National Institute of Allergy and Infectious Diseases R01-AI124389 and R01-AI112339. OraQuick HIV self-tests were obtained from the manufacturer 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
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            RNA viruses
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            Biology and Life Sciences
            Microbiology
            Medical Microbiology
            Microbial Pathogens
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            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
            Public and Occupational Health
            Traumatic Injury Risk Factors
            Violent Crime
            Intimate Partner Violence
            Social Sciences
            Sociology
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            Crime
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            Intimate Partner Violence
            Medicine and health sciences
            Public and occupational health
            Preventive medicine
            HIV prevention
            Social Sciences
            Sociology
            Education
            Educational Attainment
            People and Places
            Population Groupings
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            People and Places
            Geographical Locations
            Africa
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            Research and Analysis Methods
            Research Design
            Clinical Research Design
            Adverse Events
            Medicine and Health Sciences
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            Custom metadata
            De-identified data from this study are available from the Harvard Dataverse: http://dx.doi.org/10.7910/DVN/7DJTBN.

            Medicine

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