title: Long-term consistent use of a vaginal microbicide gel among HIV-1 sero-discordant couples in a phase III clinical trial (MDP 301) in rural south-west Uganda.
abstract: BACKGROUND
  A safe and effective vaginal microbicide could substantially reduce HIV acquisition for women. Consistent gel use is, however, of great importance to ensure continued protection against HIV infection, even with a safe and effective microbicide. We assessed the long-term correlates of consistent gel use in the MDP 301 clinical trial among HIV-negative women in sero-discordant couples in south-west Uganda.
  
  
  METHODS
  HIV-negative women living with an HIV-infected partner were enrolled between 2005 and 2008, in a three-arm phase III microbicide trial and randomized to 2% PRO2000, 0.5% PRO2000 or placebo gel arms. Follow-up visits continued up to September 2009. The 2% arm was stopped early due to futility and the 229 women enrolled in this arm were excluded from this analysis. Data were analyzed on 544 women on the 0.5% and placebo arms who completed at least 52 weeks of follow-up, sero-converted or became pregnant before 52 weeks. Consistent gel use was defined as satisfying all of the following three conditions: (i) reported gel use at the last sex act for at least 92% of the 26 scheduled visits or at least 92% of the visits attended if fewer than 26; (ii) at least one used applicator returned for each visit for which gel use was reported at the last sex act; (iii) attended at least 13 visits (unless the woman sero-converted or became pregnant during follow-up). Logistic regression models were fitted to investigate factors associated with consistent gel use.
  
  
  RESULTS
  Of the 544 women, 473 (86.9%) were followed for at least 52 weeks, 29 (5.3%) sero-converted and 42 (7.7%) became pregnant before their week 52 visit. Consistent gel use was reported by 67.8%. Women aged 25 to 34 years and those aged 35 years or older were both more than twice as likely to have reported consistently using gel compared to women aged 17 to 24 years. Living in a household with three or more rooms used for sleeping compared to one room was associated with a twofold increase in consistent gel use.
  
  
  CONCLUSIONS
  In rural Uganda younger women and women in houses with less space are likely to require additional support to achieve consistent microbicide gel use.
  
  
  BACKGROUND
  Protocol Number ISRCTN64716212.
authors: MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda. Andrew.Abaasa@mrcuganda.org
authors: Andrew
authors: A
authors: Abaasa
authors: Angela
authors: A
authors: Crook
authors: Mitzy
authors: M
authors: Gafos
authors: Zacchaeus
authors: Z
authors: Anywaine
authors: Jonathan
authors: J
authors: Levin
authors: Symon
authors: S
authors: Wandiembe
authors: Ananta
authors: A
authors: Nanoo
authors: Andrew
authors: A
authors: Nunn
authors: Sheena
authors: S
authors: McCormack
authors: Richard
authors: R
authors: Hayes
authors: Anatoli
authors: A
authors: Kamali
mesh_terms: D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D018023:HIV Seronegativity; D006679:HIV Seropositivity; D015497:HIV-1 / Q000276:immunology*; D006798:Housing; D006801:Humans; D016013:Likelihood Functions; D016015:Logistic Models; D008297:Male; D055118:Medication Adherence; D015999:Multivariate Analysis; D009282:Naphthalenesulfonates / Q000008:administration & dosage*; D016017:Odds Ratio; D011108:Polymers / Q000008:administration & dosage*; D011247:Pregnancy; D012307:Risk Factors; D012423:Rural Health; D012747:Sexual Partners; D012959:Socioeconomic Factors; D013997:Time Factors; D016896:Treatment Outcome; D014454:Uganda; D014622:Vaginal Creams, Foams, and Jellies; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D009282:Naphthalenesulfonates; C120231:PRO 2000; D011108:Polymers; D014622:Vaginal Creams, Foams, and Jellies
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