Efficacy of nonoxynol 9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes.
OBJECTIVE
To determine the efficacy of the nonoxynol 9 contraceptive sponge in preventing sexual acquisition of the human immunodeficiency virus (HIV).


METHODS
Prospective, randomized placebo-controlled trial.


METHODS
Research clinic for prostitutes in Nairobi, Kenya.


METHODS
One hundred thirty-eight HIV-seronegative women were enrolled, of whom 74 were assigned to nonoxynol 9 sponge use and 64 to placebo use. These two groups did not significantly differ with respect to demographic characteristics, sexual practices, or prevalence of genital infections at enrollment, except for a lower number of sex partners per week and a higher initial prevalence of genital ulcers among women assigned to nonoxynol 9 sponge use. Among the 116 women who returned for follow-up, the mean durations of follow-up were 14 and 17 months for the two groups, respectively.


METHODS
HIV seroconversion.


RESULTS
Nonoxynol 9 sponge use was associated with an increased frequency of genital ulcers (relative risk [RR], 3.3; P less than .0001) and vulvitis (RR, 3.3; P less than .0001) and a reduced risk of gonococcal cervicitis (RR, 0.4; P less than .0001). Twenty-seven (45%) of 60 women in the nonoxynol 9 sponge group and 20 (36%) of 56 women in the placebo group developed HIV antibodies. The hazard ratio for the association between nonoxynol 9 sponge use and HIV seroconversion was 1.7 (95% confidence interval [CI], 0.9 to 3.0). Using multivariate analysis to control for the presence of genital ulcers at enrollment, the adjusted hazard ratio for the association between nonoxynol 9 sponge use and seroconversion was 1.6 (95% CI, 0.8 to 2.8).


CONCLUSIONS
Genital ulcers and vulvitis occurred with increased frequency in nonoxynol 9 sponge users. We were unable to demonstrate that nonoxynol 9 sponge use was effective in reducing the risk of HIV infection among highly exposed women.
Kreiss
J
J
Department of Epidemiology, University of Washington, Seattle.
Ngugi
E
E
Holmes
K
K
Ndinya-Achola
J
J
Waiyaki
P
P
Roberts
P L
PL
Ruminjo
I
I
Sajabi
R
R
Kimata
J
J
Fleming
T R
TR
D000328:Adult; D003274:Contraceptive Devices, Female; D003902:Detergents; D005260:Female; D005500:Follow-Up Studies; D005831:Genital Diseases, Female / Q000139:chemically induced / Q000209:etiology; D015658:HIV Infections / Q000517:prevention & control*; D006679:HIV Seropositivity / Q000453:epidemiology; D006801:Humans; D007630:Kenya; D017137:Nonoxynol; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D015995:Prevalence; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012307:Risk Factors; D011477:Sex Work; D012725:Sexual Behavior; D013089:Spermatocidal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D014456:Ulcer / Q000139:chemically induced / Q000209:etiology; D014622:Vaginal Creams, Foams, and Jellies; D014847:Vulvitis / Q000139:chemically induced / Q000209:etiology
D003902:Detergents; D013089:Spermatocidal Agents; D014622:Vaginal Creams, Foams, and Jellies; D017137:Nonoxynol; D011092:Polyethylene Glycols