title: High HIV, HPV, and STI prevalence among young Western Cape, South African women: EVRI HIV prevention preparedness trial.
abstract: BACKGROUND
  This study sought to assess the feasibility of conducting a phase III HIV prevention trial using a multivalent human papillomavirus (HPV) vaccine (Gardasil; Merck, Whitehouse Station, NJ).
  
  
  METHODS
  A total of 479 sexually active women aged 16-24 years in the Western Cape, South Africa, were enrolled in the Efficacy of HPV Vaccine to Reduce HIV Infection (EVRI) Trial. Of these, 402 were HIV negative, nonpregnant, and randomized 1:1 to receive Gardasil or a saline placebo vaccine. Vaccine doses were administered at enrollment, month 2, and month 6, and participants were followed for 1 month after the third dose. Enrollment HIV, HPV, other sexually transmitted infections (STIs), and cervical cytology were evaluated. Rates of accrual, vaccine compliance, and adherence to protocol were monitored.
  
  
  RESULTS
  High rates of accrual of eligible females to study (93%) and completion of the 3-dose vaccine series (91%) were noted, with few protocol violations. Ineligibility due to reported HIV positivity was 19%, and another 12% of those enrolled tested HIV positive. STI prevalence was high, with 6.2%, 10.9%, and 32.8% testing positive for syphilis, gonorrhea, and chlamydia, respectively. Cervical prevalence of ≥1 of 37 HPV types was 71%. STI and HPV prevalence was highest among the youngest women (<19 years).
  
  
  CONCLUSIONS
  Feasibility (successful accrual, retention, and vaccination) of conducting randomized placebo-controlled trials of HPV vaccines among HIV high-risk women in South Africa was demonstrated. This work demonstrates that phase III HIV prevention trials need to intervene at young ages and screen and treat multiple STIs concurrently to have a measurable impact on HIV acquisition.
authors.affiliation: *Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL; †Department of Obstetrics and Gynaecology and Unit for Gynaecological Oncology, Tygerberg Hospital, Stellenbosch University, Cape Town, South Africa; ‡Department of Medicine and Centre for Infectious Diseases, Stellenbosch University, Cape Town, South Africa; §Division of Medical Virology, Stellenbosch University and NHLS Tygerberg, Cape Town, South Africa; ‖Department of Research, Cluster Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, the Netherlands; ¶Department of Internal Medicine, Center for Infection and Immunity Amsterdam (CINIMA), Academic Medical Center, Amsterdam, the Netherlands; and #FHI 360, Durham, NC.
authors.forename: Anna R
authors.initials: AR
authors.lastname: Giuliano
authors.forename: Matthys H
authors.initials: MH
authors.lastname: Botha
authors.forename: Michele
authors.initials: M
authors.lastname: Zeier
authors.forename: Martha E
authors.initials: ME
authors.lastname: Abrahamsen
authors.forename: Richard H
authors.initials: RH
authors.lastname: Glashoff
authors.forename: Louvina E
authors.initials: LE
authors.lastname: van der Laan
authors.forename: Mary
authors.initials: M
authors.lastname: Papenfuss
authors.forename: Susan
authors.initials: S
authors.lastname: Engelbrecht
authors.forename: Maarten F
authors.initials: MF
authors.lastname: Schim van der Loeff
authors.forename: Staci L
authors.initials: SL
authors.lastname: Sudenga
authors.forename: Benji N
authors.initials: BN
authors.lastname: Torres
authors.forename: Siegfried
authors.initials: S
authors.lastname: Kipping
authors.forename: Douglas
authors.initials: D
authors.lastname: Taylor
mesh_terms: D000293:Adolescent; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D053918:Papillomavirus Vaccines / Q000008:administration & dosage*; D010919:Placebos / Q000008:administration & dosage; D015995:Prevalence; D012749:Sexually Transmitted Diseases / Q000453:epidemiology* / Q000517:prevention & control*; D013019:South Africa / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; D010919:Placebos