title: Acceptability of a carrageenan-based candidate vaginal microbicide and matching placebo: findings from a phase II safety trial among women in Chiang Rai, Thailand.
abstract: OBJECTIVE
  To evaluate extended acceptability of vaginal use of a carrageenan-based candidate microbicide and placebo in northern Thai women.
  
  
  METHODS
  As part of a randomized, placebo-controlled, triple-blinded clinical trial, women were asked to insert gel with each vaginal sex act and at least three times per week for 1 year. Used applicators were collected monthly; acceptability questions were asked quarterly.
  
  
  RESULTS
  One hundred sixty-five women were enrolled (83 microbicide, 82 placebo); 148 (90%) remained in the study for 12 months. Gel use was high, with > or =87% returning at least three used applicators per week at each visit. Although acceptability was generally high, some decline in positive reporting was noted in terms of ease of application, timing of gel insertion, and gel volume over time. Approximately one quarter reported gel use increased her sexual pleasure. Over one quarter reported that gel volume of 5 mL was too much. All women with a steady partner at 12 months reported talking to their partner about using the gel. Only 2 women spontaneously mentioned being able to use a product covertly as one of the most appealing attributes of a potential microbicide.
  
  
  CONCLUSIONS
  Although women in this study generally reported high acceptability and use, some found 5 mL of gel to be too much. Focusing on enhanced sexual pleasure and lubrication may be beneficial for marketing proven microbicides. Development of products will need to balance lubrication and efficacy with perceptions of too much volume. The ability to use a product covertly was not a high priority in this population.
authors: Population Council, New York, New York, USA. hej2103@columbia.edu
authors: Heidi E
authors: HE
authors: Jones
authors: Supaporn
authors: S
authors: Chaikummao
authors: Janneke H H M
authors: JH
authors: van de Wijgert
authors: Barbara A
authors: BA
authors: Friedland
authors: Chomnad
authors: C
authors: Manopaiboon
authors: Paisit
authors: P
authors: Witwatwongwana
authors: Mayuree
authors: M
authors: Wankrairot
authors: Nartlada
authors: N
authors: Chantharojwong
authors: Peter H
authors: PH
authors: Kilmarx
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000009:adverse effects; D002351:Carrageenan / Q000008:administration & dosage* / Q000009:adverse effects; D003075:Coitus / Q000523:psychology; D003257:Consumer Product Safety; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008153:Lubrication; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D010919:Placebos; D012749:Sexually Transmitted Diseases / Q000188:drug therapy*; D015229:Sexually Transmitted Diseases, Viral / Q000517:prevention & control*; D013089:Spermatocidal Agents / Q000494:pharmacology; D013785:Thailand; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D010919:Placebos; D013089:Spermatocidal Agents; D014622:Vaginal Creams, Foams, and Jellies; D002351:Carrageenan