title: Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study.
abstract: BACKGROUND
  The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort.
  
  
  METHODS
  HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed.
  
  
  RESULTS
  Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (<5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log(10) copies/mL for CD4 350-499 and >500 relative to <350, respectively, p<0.001).
  
  
  CONCLUSIONS
  The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00194519.
authors.affiliation: Department of Global Health, University of Washington, Seattle, Washington, United States of America.
authors.forename: Jairam R
authors.initials: JR
authors.lastname: Lingappa
authors.forename: Erin
authors.initials: E
authors.lastname: Kahle
authors.forename: Nelly
authors.initials: N
authors.lastname: Mugo
authors.forename: Andrew
authors.initials: A
authors.lastname: Mujugira
authors.forename: Amalia
authors.initials: A
authors.lastname: Magaret
authors.forename: Jared
authors.initials: J
authors.lastname: Baeten
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Bukusi
authors.forename: Craig R
authors.initials: CR
authors.lastname: Cohen
authors.forename: Elly
authors.initials: E
authors.lastname: Katabira
authors.forename: Allan
authors.initials: A
authors.lastname: Ronald
authors.forename: James
authors.initials: J
authors.lastname: Kiarie
authors.forename: Carey
authors.initials: C
authors.lastname: Farquhar
authors.forename: Grace John
authors.initials: GJ
authors.lastname: Stewart
authors.forename: Joseph
authors.initials: J
authors.lastname: Makhema
authors.forename: M
authors.initials: M
authors.lastname: Essex
authors.forename: Edwin
authors.initials: E
authors.lastname: Were
authors.forename: Kenneth
authors.initials: K
authors.lastname: Fife
authors.forename: Guy
authors.initials: G
authors.lastname: Debruyn
authors.forename: Glenda
authors.initials: G
authors.lastname: Gray
authors.forename: James
authors.initials: J
authors.lastname: McIntyre
authors.forename: Rachel
authors.initials: R
authors.lastname: Manongi
authors.forename: Saidi
authors.initials: S
authors.lastname: Kapiga
authors.forename: David
authors.initials: D
authors.lastname: Coetzee
authors.forename: Susan
authors.initials: S
authors.lastname: Allen
authors.forename: Mubiana
authors.initials: M
authors.lastname: Inambao
authors.forename: Kayitesi
authors.initials: K
authors.lastname: Kayitenkore
authors.forename: Etienne
authors.initials: E
authors.lastname: Karita
authors.forename: William
authors.initials: W
authors.lastname: Kanweka
authors.forename: Sinead
authors.initials: S
authors.lastname: Delany
authors.forename: Helen
authors.initials: H
authors.lastname: Rees
authors.forename: Bellington
authors.initials: B
authors.lastname: Vwalika
authors.forename: Robert W
authors.initials: RW
authors.lastname: Coombs
authors.forename: Rhoda
authors.initials: R
authors.lastname: Morrow
authors.forename: William
authors.initials: W
authors.lastname: Whittington
authors.forename: Lawrence
authors.initials: L
authors.lastname: Corey
authors.forename: Anna
authors.initials: A
authors.lastname: Wald
authors.forename: Connie
authors.initials: C
authors.lastname: Celum
mesh_terms: D000212:Acyclovir / Q000008:administration & dosage; D000328:Adult; D000349:Africa; D000998:Antiviral Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission*; D015497:HIV-1 / Q000235:genetics; D006558:Herpes Genitalis / Q000188:drug therapy*; D018258:Herpesvirus 2, Human; D020010:Heterosexuality; D006801:Humans; D008297:Male; D012367:RNA, Viral / Q000097:blood; D012747:Sexual Partners; D012749:Sexually Transmitted Diseases
chemical_list: D000998:Antiviral Agents; D012367:RNA, Viral; D000212:Acyclovir