Safety and Adherence to Intermittent Pre-Exposure Prophylaxis (PrEP) for HIV-1 in African Men Who Have Sex with Men and Female Sex Workers
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{"title"=>"Safety and Adherence to Intermittent Pre-Exposure Prophylaxis (PrEP) for HIV-1 in African Men Who Have Sex with Men and Female Sex Workers", "type"=>"journal", "authors"=>[{"first_name"=>"Gaudensia", "last_name"=>"Mutua"}, {"first_name"=>"Eduard", "last_name"=>"Sanders"}, {"first_name"=>"Peter", "last_name"=>"Mugo"}, {"first_name"=>"Omu", "last_name"=>"Anzala"}, {"first_name"=>"Jessica E.", "last_name"=>"Haberer"}, {"first_name"=>"David", "last_name"=>"Bangsberg"}, {"first_name"=>"Burc", "last_name"=>"Barin"}, {"first_name"=>"James F.", "last_name"=>"Rooney"}, {"first_name"=>"David", "last_name"=>"Mark"}, {"first_name"=>"Paramesh", "last_name"=>"Chetty"}, {"first_name"=>"Patricia", "last_name"=>"Fast"}, {"first_name"=>"Frances H.", "last_name"=>"Priddy"}], "year"=>2012, "source"=>"PLoS ONE", "identifiers"=>{"scopus"=>"2-s2.0-84865779923", "sgr"=>"84865779923", "issn"=>"1932-6203", "isbn"=>"1932-6203 (Electronic)\\n1932-6203 (Linking)", "pmid"=>"22511916", "doi"=>"10.1371/journal.pone.0033103", "pui"=>"366360130", "arxiv"=>"arXiv:1011.1669v3"}, "id"=>"672ccec2-3b66-3b6a-8296-6ee9312805f6", "abstract"=>"BACKGROUND: Little is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM) and female sex workers (FSW).\\n\\nMETHODS/PRINCIPAL FINDINGS: MSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral FTC/TDF or placebo in a 2:1:2:1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS). Sexual activity data were collected via daily text message (SMS) queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63-92] for daily dosing and 55% [IQR:28-78] for fixed intermittent dosing (p = 0.003), while adherence to any post-coital doses was 26% [IQR:14-50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen.\\n\\nCONCLUSIONS/SIGNIFICANCE: Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens.\\n\\nTRIAL REGISTRATION: ClinicalTrials.gov NCT00971230.", "link"=>"http://www.mendeley.com/research/safety-adherence-intermittent-preexposure-prophylaxis-prep-hiv1-african-men-sex-men-female-sex-worke", "reader_count"=>152, "reader_count_by_academic_status"=>{"Unspecified"=>7, "Professor > Associate Professor"=>3, "Researcher"=>30, "Student > Doctoral Student"=>10, "Student > Ph. D. Student"=>17, "Student > Postgraduate"=>7, "Other"=>13, "Student > Master"=>41, "Student > Bachelor"=>22, "Lecturer > Senior Lecturer"=>1, "Professor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>7, "Professor > Associate Professor"=>3, "Researcher"=>30, "Student > Doctoral Student"=>10, "Student > Ph. D. Student"=>17, "Student > Postgraduate"=>7, "Other"=>13, "Student > Master"=>41, "Student > Bachelor"=>22, "Lecturer > Senior Lecturer"=>1, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>12, "Agricultural and Biological Sciences"=>5, "Arts and Humanities"=>2, "Philosophy"=>1, "Business, Management and Accounting"=>2, "Chemistry"=>2, "Computer Science"=>1, "Economics, Econometrics and Finance"=>1, "Nursing and Health Professions"=>11, "Biochemistry, Genetics and Molecular Biology"=>3, "Mathematics"=>1, "Medicine and Dentistry"=>68, "Psychology"=>12, "Social Sciences"=>31}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>68}, "Social Sciences"=>{"Social Sciences"=>31}, "Psychology"=>{"Psychology"=>12}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>12}, "Arts and Humanities"=>{"Arts and Humanities"=>2}, "Chemistry"=>{"Chemistry"=>2}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>5}, "Computer Science"=>{"Computer Science"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>2}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>11}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>3}, "Philosophy"=>{"Philosophy"=>1}}, "reader_count_by_country"=>{"United States"=>5, "United Kingdom"=>1, "Kenya"=>1, "Nigeria"=>1}, "group_count"=>25}

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  • {"files"=>["https://ndownloader.figshare.com/files/654468"], "description"=>"<p>Number (percentage) of volunteers with AEs categorized by maximum severity experienced, and treatment assignment and schedule.</p>", "links"=>[], "tags"=>["volunteers", "aes", "categorized", "severity"], "article_id"=>324948, "categories"=>["Biotechnology", "Medicine", "Infectious Diseases"], "users"=>["Gaudensia Mutua", "Eduard Sanders", "Peter Mugo", "Omu Anzala", "Jessica E. Haberer", "David Bangsberg", "Burc Barin", "James F. Rooney", "David Mark", "Paramesh Chetty", "Patricia Fast", "Frances H. Priddy"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0033103.t002", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Number_percentage_of_volunteers_with_AEs_categorized_by_maximum_severity_experienced_and_treatment_assignment_and_schedule_/324948", "title"=>"Number (percentage) of volunteers with AEs categorized by maximum severity experienced, and treatment assignment and schedule.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-04-12 01:22:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/654425"], "description"=>"*<p>P = 0.022.</p>", "links"=>[], "tags"=>["demographics", "hiv", "28", "days", "assignment-schedule"], "article_id"=>324900, "categories"=>["Biotechnology", "Medicine", "Infectious Diseases"], "users"=>["Gaudensia Mutua", "Eduard Sanders", "Peter Mugo", "Omu Anzala", "Jessica E. Haberer", "David Bangsberg", "Burc Barin", "James F. Rooney", "David Mark", "Paramesh Chetty", "Patricia Fast", "Frances H. Priddy"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0033103.t001", "stats"=>{"downloads"=>1, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_demographics_and_HIV_risk_behavior_for_the_past_28_days_by_treatment_assignment_schedule_and_study_site_/324900", "title"=>"Baseline demographics and HIV risk behavior for the past 28 days by treatment assignment-schedule and study site.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-04-12 01:21:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/654519"], "description"=>"*<p>Adjusted accounts for extra openings and extra pills taken out.</p>**<p>Days on which sexual event reported per SMS.</p>", "links"=>[], "tags"=>["adherence", "rates", "intermittent"], "article_id"=>325000, "categories"=>["Biotechnology", "Medicine", "Infectious Diseases"], "users"=>["Gaudensia Mutua", "Eduard Sanders", "Peter Mugo", "Omu Anzala", "Jessica E. Haberer", "David Bangsberg", "Burc Barin", "James F. Rooney", "David Mark", "Paramesh Chetty", "Patricia Fast", "Frances H. Priddy"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0033103.t003", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_PrEP_adherence_rates_for_daily_and_intermittent_groups_/325000", "title"=>"PrEP adherence rates for daily and intermittent groups.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-04-12 01:23:20"}
  • {"files"=>["https://ndownloader.figshare.com/files/336015", "https://ndownloader.figshare.com/files/336226"], "description"=>"<div><h3>Background</h3><p>Little is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM) and female sex workers (FSW).</p> <h3>Methods/Principal Findings</h3><p>MSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral FTC/TDF or placebo in a 2∶1∶2∶1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS). Sexual activity data were collected via daily text message (SMS) queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63–92] for daily dosing and 55% [IQR:28–78] for fixed intermittent dosing (p = 0.003), while adherence to any post-coital doses was 26% [IQR:14–50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen.</p> <h3>Conclusions/Significance</h3><p>Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens.</p> <h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://www.clinicaltrials.gov/ct2/show/NCT00971230?term=\">NCT00971230</a></p> </div>", "links"=>[], "tags"=>["adherence", "intermittent", "pre-exposure", "prophylaxis", "hiv-1", "african", "men", "workers"], "article_id"=>126383, "categories"=>["Cancer", "Medicine", "Biotechnology"], "users"=>["Gaudensia Mutua", "Eduard Sanders", "Peter Mugo", "Omu Anzala", "Jessica E. Haberer", "David Bangsberg", "Burc Barin", "James F. Rooney", "David Mark", "Paramesh Chetty", "Patricia Fast", "Frances H. Priddy"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0033103.s001", "https://dx.doi.org/10.1371/journal.pone.0033103.s002"], "stats"=>{"downloads"=>8, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Safety_and_Adherence_to_Intermittent_Pre_Exposure_Prophylaxis_PrEP_for_HIV_1_in_African_Men_Who_Have_Sex_with_Men_and_Female_Sex_Workers/126383", "title"=>"Safety and Adherence to Intermittent Pre-Exposure Prophylaxis (PrEP) for HIV-1 in African Men Who Have Sex with Men and Female Sex Workers", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2012-04-12 01:46:23"}

PMC Usage Stats | Further Information

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  • {"unique-ip"=>"9", "full-text"=>"8", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2015", "month"=>"8"}
  • {"unique-ip"=>"14", "full-text"=>"15", "pdf"=>"7", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2015", "month"=>"9"}
  • {"unique-ip"=>"32", "full-text"=>"33", "pdf"=>"11", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"1", "cited-by"=>"0", "year"=>"2015", "month"=>"10"}
  • {"unique-ip"=>"14", "full-text"=>"12", "pdf"=>"7", "abstract"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2014", "month"=>"7"}
  • {"unique-ip"=>"21", "full-text"=>"26", "pdf"=>"10", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2014", "month"=>"8"}
  • {"unique-ip"=>"22", "full-text"=>"16", "pdf"=>"12", "abstract"=>"1", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"0", "year"=>"2014", "month"=>"9"}
  • {"unique-ip"=>"27", "full-text"=>"27", "pdf"=>"13", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"0", "year"=>"2014", "month"=>"10"}
  • {"unique-ip"=>"14", "full-text"=>"15", "pdf"=>"11", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"2"}
  • {"unique-ip"=>"11", "full-text"=>"7", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"1", "cited-by"=>"2", "year"=>"2014", "month"=>"11"}
  • {"unique-ip"=>"17", "full-text"=>"17", "pdf"=>"13", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"1", "cited-by"=>"0", "year"=>"2014", "month"=>"12"}
  • {"unique-ip"=>"13", "full-text"=>"13", "pdf"=>"7", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2015", "month"=>"1"}
  • {"unique-ip"=>"29", "full-text"=>"33", "pdf"=>"14", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"3", "year"=>"2015", "month"=>"11"}
  • {"unique-ip"=>"18", "full-text"=>"16", "pdf"=>"11", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2015", "month"=>"12"}
  • {"unique-ip"=>"14", "full-text"=>"24", "pdf"=>"8", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"2", "supp-data"=>"5", "cited-by"=>"0", "year"=>"2016", "month"=>"1"}
  • {"unique-ip"=>"22", "full-text"=>"18", "pdf"=>"14", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"1", "cited-by"=>"0", "year"=>"2016", "month"=>"3"}
  • {"unique-ip"=>"14", "full-text"=>"15", "pdf"=>"8", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"4"}
  • {"unique-ip"=>"15", "full-text"=>"15", "pdf"=>"7", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"1", "year"=>"2016", "month"=>"5"}
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  • {"unique-ip"=>"11", "full-text"=>"14", "pdf"=>"4", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"8"}
  • {"unique-ip"=>"24", "full-text"=>"25", "pdf"=>"6", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"2", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"9"}
  • {"unique-ip"=>"18", "full-text"=>"19", "pdf"=>"24", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"0", "year"=>"2016", "month"=>"10"}
  • {"unique-ip"=>"16", "full-text"=>"16", "pdf"=>"8", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"11"}
  • {"unique-ip"=>"15", "full-text"=>"17", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"12"}
  • {"unique-ip"=>"11", "full-text"=>"9", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"1", "cited-by"=>"0", "year"=>"2017", "month"=>"1"}
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Relative Metric

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