Acceptability of a carrageenan-based candidate vaginal microbicide and matching placebo: findings from a phase II safety trial among women in Chiang Rai, Thailand.
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.
Jones
Heidi E
HE
Population Council, New York, New York, USA. hej2103@columbia.edu
Chaikummao
Supaporn
S
van de Wijgert
Janneke H H M
JH
Friedland
Barbara A
BA
Manopaiboon
Chomnad
C
Witwatwongwana
Paisit
P
Wankrairot
Mayuree
M
Chantharojwong
Nartlada
N
Kilmarx
Peter H
PH
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
D000891:Anti-Infective Agents, Local; D010919:Placebos; D013089:Spermatocidal Agents; D014622:Vaginal Creams, Foams, and Jellies; D002351:Carrageenan