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      Acceptability of HIV self-testing to support pre-exposure prophylaxis among female sex workers in Uganda and Zambia: results from two randomized controlled trials

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          Abstract

          Background

          HIV pre-exposure prophylaxis (PrEP) is highly effective for prevention of HIV acquisition, but requires HIV testing at regular intervals. Female sex workers (FSWs) are a priority population for HIV prevention interventions in many settings, but face barriers to accessing healthcare. Here, we assessed the acceptability of HIV self-testing for regular HIV testing during PrEP implementation among FSWs participating in a randomized controlled trial of HIV self-testing delivery models.

          Methods

          We used data from two HIV self-testing randomized controlled trials with identical protocols in Zambia and in Uganda. From September–October 2016, participants were randomized in groups to: (1) direct delivery of an HIV self-test, (2) delivery of a coupon, exchangeable for an HIV self-test at nearby health clinics, or (3) standard HIV testing services. Participants completed assessments at baseline and 4 weeks. Participants reporting their last HIV test was negative were asked about their interest in various PrEP modalities and their HIV testing preferences. We used mixed effects logistic regression models to measure differences in outcomes across randomization arms at four weeks.

          Results

          At 4 weeks, 633 participants in Zambia and 749 participants in Uganda reported testing negative at their last HIV test. The majority of participants in both studies were “very interested” in daily oral PrEP (91% Zambia; 66% Uganda) and preferred HIV self-testing to standard testing services while on PrEP (87% Zambia; 82% Uganda). Participants in the HIV self-testing intervention arms more often reported preference for HIV self-testing compared to standard testing services to support PrEP in both Zambia ( P = 0.002) and Uganda ( P < 0.001).

          Conclusion

          PrEP implementation programs for FSW could consider inclusion of HIV self-testing to reduce the clinic-based HIV testing burden.

          Trial registration

          ClinicalTrials.gov NCT02827240 and NCT02846402.

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          Most cited references19

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          Attitudes and Acceptability on HIV Self-testing Among Key Populations: A Literature Review

          HIV self-testing (HIVST) is a potential strategy to overcome disparities in access to and uptake of HIV testing, particularly among key populations (KP). A literature review was conducted on the acceptability, values and preferences among KP. Data was analyzed by country income World Bank classification, type of specimen collection, level of support offered and other qualitative aspects. Most studies identified were from high-income countries and among men who have sex with men (MSM) who found HIVST to be acceptable. In general, MSM were interested in HIVST because of its convenient and private nature. However, they had concerns about the lack of counseling, possible user error and accuracy. Data on the values and preferences of other KP groups regarding HIVST is limited. This should be a research priority, as HIVST is likely to become more widely available, including in resource-limited settings. Electronic supplementary material The online version of this article (doi:10.1007/s10461-015-1097-8) contains supplementary material, which is available to authorized users.
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            HIV pre-exposure prophylaxis and early antiretroviral treatment among female sex workers in South Africa: Results from a prospective observational demonstration project

            Background Operational research is required to design delivery of pre-exposure prophylaxis (PrEP) and early antiretroviral treatment (ART). This paper presents the primary analysis of programmatic data, as well as demographic, behavioural, and clinical data, from the TAPS Demonstration Project, which offered both interventions to female sex workers (FSWs) at 2 urban clinic sites in South Africa. Methods and findings The TAPS study was conducted between 30 March 2015 and 30 June 2017, with the enrolment period ending on 31 July 2016. TAPS was a prospective observational cohort study with 2 groups receiving interventions delivered in existing service settings: (1) PrEP as part of combination prevention for HIV-negative FSWs and (2) early ART for HIV-positive FSWs. The main outcome was programme retention at 12 months of follow-up. Of the 947 FSWs initially seen in clinic, 692 were HIV tested. HIV prevalence was 49%. Among those returning to clinic after HIV testing and clinical screening, 93% of the women who were HIV-negative were confirmed as clinically eligible for PrEP (n = 224/241), and 41% (n = 110/270) of the women who were HIV-positive had CD4 counts within National Department of Health ART initiation guidelines at assessment. Of the remaining women who were HIV-positive, 93% were eligible for early ART (n = 148/160). From those eligible, 98% (n = 219/224) and 94% (n = 139/148) took up PrEP and early ART, respectively. At baseline, a substantial fraction of women had a steady partner, worked in brothels, and were born in Zimbabwe. Of those enrolled, 22% on PrEP (n = 49/219) and 60% on early ART (n = 83/139) were seen at 12 months; we observed high rates of loss to follow-up: 71% (n = 156/219) and 30% (n = 42/139) in the PrEP and early ART groups, respectively. Little change over time was reported in consistent condom use or the number of sexual partners in the last 7 days, with high levels of consistent condom use with clients and low use with steady partners in both study groups. There were no seroconversions on PrEP and 7 virological failures on early ART among women remaining in the study. Reported adherence to PrEP varied over time between 70% and 85%, whereas over 90% of participants reported taking pills daily while on early ART. Data on provider-side costs were also collected and analysed. The total cost of service delivery was approximately US$126 for PrEP and US$406 for early ART per person-year. The main limitations of this study include the lack of a control group, which was not included due to ethical considerations; clinical study requirements imposed when PrEP was not approved through the regulatory system, which could have affected uptake; and the timing of the implementation of a national sex worker HIV programme, which could have also affected uptake and retention. Conclusions PrEP and early ART services can be implemented within FSW routine services in high prevalence, urban settings. We observed good uptake for both PrEP and early ART; however, retention rates for PrEP were low. Retention rates for early ART were similar to retention rates for the current standard of care. While the cost of the interventions was higher than previously published, there is potential for cost reduction at scale. The TAPS Demonstration Project results provided the basis for the first government PrEP and early ART guidelines and the rollout of the national sex worker HIV programme in South Africa.
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              An action agenda for HIV and sex workers.

              The women, men, and transgender people who sell sex globally have disproportionate risks and burdens of HIV in countries of low, middle, and high income, and in concentrated and generalised epidemic contexts. The greatest HIV burdens continue to be in African female sex workers. Worldwide, sex workers still face reduced access to needed HIV prevention, treatment, and care services. Legal environments, policies, police practices, absence of funding for research and HIV programmes, human rights violations, and stigma and discrimination continue to challenge sex workers' abilities to protect themselves, their families, and their sexual partners from HIV. These realities must change to realise the benefits of advances in HIV prevention and treatment and to achieve global control of the HIV pandemic. Effective combination prevention and treatment approaches are feasible, can be tailored for cultural competence, can be cost-saving, and can help to address the unmet needs of sex workers and their communities in ways that uphold their human rights. To address HIV in sex workers will need sustained community engagement and empowerment, continued research, political will, structural and policy reform, and innovative programmes. But such actions can and must be achieved for sex worker communities everywhere.
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                Author and article information

                Contributors
                katort@uw.edu
                michael_chanda@zm.jsi.com
                kibuukamd@sfg-group.comthoms
                tngabirano@gmail.com
                magdalenemwale7@gmail.com
                aidahnakitende@yahoo.com
                chongostp@yahoo.com
                nyambekamu@gmail.com
                cathykanchele@gmail.com
                till.baernighausen@uni-heidelberg.de
                415-502-8843 , catherine.oldenburg@ucsf.edu
                Journal
                BMC Infect Dis
                BMC Infect. Dis
                BMC Infectious Diseases
                BioMed Central (London )
                1471-2334
                4 October 2018
                4 October 2018
                2018
                : 18
                : 503
                Affiliations
                [1 ]ISNI 0000000122986657, GRID grid.34477.33, International Clinical Research Center, , University of Washington, ; Seattle, USA
                [2 ]John Snow, Inc, Lusaka, Zambia
                [3 ]International Research Consortium, Kampala, Uganda
                [4 ]Uganda Health Marketing Group, Kampala, Uganda
                [5 ]ISNI 000000041936754X, GRID grid.38142.3c, Department of Global Health and Population, , Harvard T.H. Chan School of Public Health, ; Boston, USA
                [6 ]GRID grid.488675.0, Africa Health Research Institute, ; KwaZulu-Natal, South Africa
                [7 ]ISNI 0000 0001 2190 4373, GRID grid.7700.0, Heidelberg Institute of Public Health, , University of Heidelberg, ; Heidelberg, Germany
                [8 ]ISNI 0000 0001 2297 6811, GRID grid.266102.1, Francis I. Proctor Foundation, , University of California San Francisco, ; 513 Parnassus Ave, Room S334J, San Francisco, CA USA
                [9 ]ISNI 0000 0001 2297 6811, GRID grid.266102.1, Department of Ophthalmology, , University of California, San Francisco, ; San Francisco, USA
                [10 ]ISNI 0000 0001 2297 6811, GRID grid.266102.1, Department of Epidemiology & Biostatistics, , University of California, ; San Francisco, USA
                Author information
                http://orcid.org/0000-0002-0763-399X
                Article
                3415
                10.1186/s12879-018-3415-z
                6172754
                30286737
                1c0d756f-8de5-44ba-b913-0365a8120d14
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 3 July 2018
                : 26 September 2018
                Funding
                Funded by: International Initiative for Impact Evaluation
                Funded by: National Institute of Allergy and Infectious Disease
                Award ID: T32-AI007535
                Funded by: National Institute of Mental Health
                Award ID: R01-MH110296
                Award ID: R01-MH113572
                Funded by: Alexander von Humboldt Foundation
                Funded by: Wellcome Trust
                Funded by: European Commission
                Funded by: Clinton Health Access Initiative
                Funded by: NICHD
                Award ID: R01-HD084233
                Award Recipient :
                Funded by: NIAID
                Award ID: R01-AI124389
                Award ID: R01-AI112339
                Award Recipient :
                Funded by: Forgarty International Center
                Award ID: D43-TW009775
                Award Recipient :
                Funded by: National Institute on Drug Abuse
                Award ID: T32-DA013911
                Funded by: NIMH
                Award ID: R25-MH083620
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2018

                Infectious disease & Microbiology
                pre-exposure prophylaxis,female sex workers,hiv self-testing,zambia,uganda

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