Acceptability of Carraguard vaginal microbicide gel among HIV-infected women in Chiang Rai, Thailand

• Published in: PloS one Vol. 6; no. 9; p. e14831
• Main Authors: Whitehead, Sara J, McLean, Catherine, Chaikummao, Supaporn, Braunstein, Sarah, Utaivoravit, Wat, van de Wijgert, Janneke H, Mock, Philip A, Siraprapasiri, Taweesap, Friedland, Barbara A, Kilmarx, Peter H, Markowitz, Lauri E
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 07-09-2011; Public Library of Science (PLoS)
• Subjects: Acceptability; Acquired immune deficiency syndrome; Administration, Intravaginal; AIDS; Anti-Infective Agents - administration & dosage; Anti-Infective Agents - therapeutic use; Antiretroviral drugs; Clinical trials; Collaboration; Councils; Disease control; Disease prevention; Double-Blind Method; Female; Gels; Hepatitis; HIV; HIV infections; HIV Infections - prevention & control; HIV patients; Human immunodeficiency virus; Humans; Infectious Diseases/Epidemiology and Control of Infectious Diseases; Infectious Diseases/HIV Infection and AIDS; Infectious Diseases/Sexually Transmitted Diseases; Medical research; Methyl cellulose; Methylcellulose; Population; Public health; Randomization; Rheology; Safety; Sexual behavior; Studies; Thailand; Tuberculosis; Vagina; Vaginal Creams, Foams, and Jellies - administration & dosage; Vaginal Creams, Foams, and Jellies - therapeutic use; Womens health; Working groups; Thailand; Atlanta Georgia; New York; Georgia; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0014831

Few studies of microbicide acceptability among HIV-infected women have been done. We assessed Carraguard® vaginal gel acceptability among participants in a randomized, controlled, crossover safety trial in HIV-infected women in Thailand.
Participants used each of 3 treatments (Carraguard gel, methylcellulose placebo gel, and no product) for 7 days, were randomized to one of six treatment sequences, and were blinded to the type of gel they received in the two gel-use periods. After both gel-use periods, acceptability was assessed by face-to-face interview. Responses were compared to those of women participating in two previous Carraguard safety studies at the same study site. Sixty women enrolled with a median age of 34 years; 25% were sexually active. Self-reported adherence (98%) and overall satisfaction rating of the gels (87% liked "somewhat" or "very much") were high, and most (77%) considered the volume of gel "just right." For most characteristics, crossover trial participants evaluated the gels more favorably than women in the other two trials, but there were few differences in the desired characteristics of a hypothetical microbicide. Almost half (48%) of crossover trial participants noticed a difference between Carraguard and placebo gels; 33% preferred Carraguard while 12% preferred placebo (p = 0.01).
Daily Carraguard vaginal gel use was highly acceptable in this population of HIV-infected women, who assessed the gels more positively than women in two other trials at the site. This may be attributable to higher perceived need for protection among HIV-infected women, as well as to study design differences. This trial was registered in the U.S. National Institutes of Health clinical trials registry under registration number NCT00213044.