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      Factors associated with retention on pre-exposure prophylaxis among female sex workers in Kigali, Rwanda

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          Abstract

          Pre-Exposure Prophylaxis (PrEP) is recommended as an additional HIV prevention measure for persons at substantial risk of HIV acquisition. Although uptake of PrEP among female sex workers (FSW) has increased, retention remains low, resulting in suboptimal benefits. This study aimed at determining PrEP retention rates and associated factors among FSW in Kigali, Rwanda. We retrospectively studied records of 309 FSW abstracted from five (5) health centers for the period between April-June 2020 and April-June 2021. PrEP retention was defined as presenting for a scheduled follow-up visit. We used Kaplan-Meier survival analysis to estimate survival probabilities at months 1,3,6,9, and 12 post-PrEP initiation and Cox regression to determine factors associated with 12-month PrEP retention. Data was analyzed using STATA (version 14.0). Out of 309 FSW whose records were reviewed, data for 268 (87%) were complete. One half (50%, n = 133) of the respondents were aged 25–34 years; slightly more than half (52%, n = 136) were single; nearly three-quarters (73%, n = 196) had completed primary school; majority (88%, n = 236) lived alone; while 69% (n = 184) had no formal employment besides sex work. PrEP dropout rates were 228, 65, 29, 49, and 36 per 100-persons years at months 1, 3, 6, 9 and 12 respectively, with 81%, 72%, 67%, 59% and 53% of FSW that started PrEP retained at these time periods. Multivariable Cox regression revealed that compared to FSW opposed to additional children, the desire to have two or more children (adjusted Hazard Ratio [aHR] = 1.654; 95% Confidential Interval [95%CI]: 1.008, 2.713); and using hormonal (aHR = 2.091, 95%CI: 1.181, 3.702) or no method of contraception other than condoms (aHR = 2.036, 95%CI: 1.006, 4.119) were factors positively associated with PrEP retention. Conversely, compared to consistent condom-use, not using (aHR = 0.329; 95%CI: 0.149, 0.726) or inconsistently using condoms (aHR = 0.413; 95%CI: 0.228, 0.749), and accessing PrEP from ultra-urban clinics (aHR = 0.290; 95%CI: 0.183, 0.458) compared to clinics in the outskirts of the city, were factors negatively associated with PrEP retention. The study found a continuous decline in PrEP retention among FSW with slightly more than half retained at 12 months. To improve outcomes, PrEP retention monitoring should target FSW enrolled in ultra-urban clinics and those not or inconsistently using condoms.

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          Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

          Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).
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            Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

            New England Journal of Medicine, 367(5), 399-410
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              Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

              Summary Background Randomised placebo-controlled trials have shown that daily oral pre-exposure prophylaxis (PrEP) with tenofovir–emtricitabine reduces the risk of HIV infection. However, this benefit could be counteracted by risk compensation in users of PrEP. We did the PROUD study to assess this effect. Methods PROUD is an open-label randomised trial done at 13 sexual health clinics in England. We enrolled HIV-negative gay and other men who have sex with men who had had anal intercourse without a condom in the previous 90 days. Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. Randomisation was done via web-based access to a central computer-generated list with variable block sizes (stratified by clinical site). Follow-up was quarterly. The primary outcomes for the pilot phase were time to accrue 500 participants and retention; secondary outcomes included incident HIV infection during the deferral period, safety, adherence, and risk compensation. The trial is registered with ISRCTN (number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986). Findings We enrolled 544 participants (275 in the immediate group, 269 in the deferred group) between Nov 29, 2012, and April 30, 2014. Based on early evidence of effectiveness, the trial steering committee recommended on Oct 13, 2014, that all deferred participants be offered PrEP. Follow-up for HIV incidence was complete for 243 (94%) of 259 patient-years in the immediate group versus 222 (90%) of 245 patient-years in the deferred group. Three HIV infections occurred in the immediate group (1·2/100 person-years) versus 20 in the deferred group (9·0/100 person-years) despite 174 prescriptions of post-exposure prophylaxis in the deferred group (relative reduction 86%, 90% CI 64–96, p=0·0001; absolute difference 7·8/100 person-years, 90% CI 4·3–11·3). 13 men (90% CI 9–23) in a similar population would need access to 1 year of PrEP to avert one HIV infection. We recorded no serious adverse drug reactions; 28 adverse events, most commonly nausea, headache, and arthralgia, resulted in interruption of PrEp. We detected no difference in the occurrence of sexually transmitted infections, including rectal gonorrhoea and chlamydia, between groups, despite a suggestion of risk compensation among some PrEP recipients. Interpretation In this high incidence population, daily tenofovir–emtricitabine conferred even higher protection against HIV than in placebo-controlled trials, refuting concerns that effectiveness would be less in a real-world setting. There was no evidence of an increase in other sexually transmitted infections. Our findings strongly support the addition of PrEP to the standard of prevention for men who have sex with men at risk of HIV infection. Funding MRC Clinical Trials Unit at UCL, Public Health England, and Gilead Sciences.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – review & editing
                Role: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: Writing – review & editing
                Role: Data curationRole: MethodologyRole: Project administrationRole: SoftwareRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Funding acquisitionRole: Project administrationRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: SoftwareRole: ValidationRole: VisualizationRole: Writing – review & editing
                Role: ConceptualizationRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – review & editing
                Role: Editor
                Journal
                PLOS Glob Public Health
                PLOS Glob Public Health
                plos
                PLOS Global Public Health
                Public Library of Science (San Francisco, CA USA )
                2767-3375
                6 November 2023
                2023
                : 3
                : 11
                : e0002524
                Affiliations
                [1 ] Health Program Unit, Society for Family Health, Kigali, Rwanda
                [2 ] Makerere University School of Public Health, Kampala, Uganda
                [3 ] Rwanda Biomedical Center, Ministry of Health, Kigali, Rwanda
                [4 ] Health Research and Evaluation Consultant, Kampala, Uganda
                [5 ] Department of Community and Public Health, Faculty of Health Sciences, Busitema University, Mbale, Uganda
                PLOS: Public Library of Science, UNITED STATES
                Author notes

                The authors have declared that no competing interests exist.

                Author information
                https://orcid.org/0009-0006-6014-0154
                Article
                PGPH-D-23-00956
                10.1371/journal.pgph.0002524
                10627470
                1c5467ca-42bc-4029-96bb-e9745ccf195f
                © 2023 Mubezi 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
                : 19 June 2023
                : 18 September 2023
                Page count
                Figures: 2, Tables: 2, Pages: 14
                Funding
                The authors received no specific funding for this work.
                Categories
                Research Article
                Medicine and Health Sciences
                Public and Occupational Health
                Preventive Medicine
                Prophylaxis
                Pre-Exposure Prophylaxis
                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
                Epidemiology
                Medical Risk Factors
                Medicine and health sciences
                Public and occupational health
                Preventive medicine
                HIV prevention
                People and Places
                Geographical Locations
                Africa
                Rwanda
                Medicine and health sciences
                Epidemiology
                HIV epidemiology
                Medicine and Health Sciences
                Women's Health
                Obstetrics and Gynecology
                Contraception
                Social Sciences
                Sociology
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                Custom metadata
                Data related to this manuscript is client-level data and is fully owned by Rwanda Ministry of Health and Rwanda Biomedical Center (RBC) from whom Society for Family Health (SFH) Rwanda obtained rights to access. The data cannot be shared publicly to protect client privacy and confidentiality considering that FSW are a sensitive key population. However, researchers that meet set criteria can access the data upon approval by RBC. Please contact RBC at: info@ 123456rbc.gov.rw and SFH Rwanda at: info@ 123456sfhrwanda.org .

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