Efficacy of nonoxynol 9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes.

Abstract

OBJECTIVE:

To determine the efficacy of the nonoxynol 9 contraceptive sponge in preventing sexual acquisition of the human immunodeficiency virus (HIV).

DESIGN:

Prospective, randomized placebo-controlled trial.

SETTING:

Research clinic for prostitutes in Nairobi, Kenya.

PATIENTS AND INTERVENTIONS:

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.

MAIN OUTCOME MEASURE:

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.

• Authors: J Kreiss, E Ngugi, K Holmes, J Ndinya-Achola, P Waiyaki, P L Roberts, I Ruminjo, R Sajabi, J Kimata, T R Fleming
• Journal: JAMA (JAMA) 1992 Jul 22-29 Vol. 268 Issue 4 Pg. 477-82 ISSN: 0098-7484 [Print] United States
• PMID: 1320133 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Detergents
• Spermatocidal Agents
• Vaginal Creams, Foams, and Jellies
• Nonoxynol
• Polyethylene Glycols

Topics

• Adult
• Contraceptive Devices, Female
• Detergents
• Female
• Follow-Up Studies
• Genital Diseases, Female (chemically induced, etiology)
• HIV Infections (prevention & control)
• HIV Seropositivity (epidemiology)
• Humans
• Kenya
• Nonoxynol
• Polyethylene Glycols (administration & dosage, adverse effects)
• Prevalence
• Proportional Hazards Models
• Prospective Studies
• Risk Factors
• Sex Work
• Sexual Behavior
• Spermatocidal Agents (administration & dosage, adverse effects)
• Ulcer (chemically induced, etiology)
• Vaginal Creams, Foams, and Jellies
• Vulvitis (chemically induced, etiology)