Vaginal microbicides can interfere with nucleic acid amplification tests used for the diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae infection.

We confirmed findings from previous studies that cellulose sulfate gel can interfere with nucleic acid amplification tests used for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. We therefore recommend that the effects of microbicide gels on diagnostic assays of sexually transmitted infections be established before starting up clinical studies.

Penile application of dextrin sulphate gel (Emmelle).

Dextrin sulphate (DS) gel (Emmelle) is under development as a vaginal microbicide. Males who do not use condoms will be exposed to DS gel through sexual intercourse. A randomized, double-blind, placebo-controlled trial was conducted among 16 HIV-positive and 12 HIV-negative men to establish whether 4% DS gel has an acceptable safety profile. Men were asked to apply the gel to the penis once per day for 14 consecutive days and to leave it on for a minimum of 6 h. Results from laboratory evaluations, genital examinations, and adverse events reports showed that 4% DS gel administered topically to the penis was well tolerated when compared with placebo.

The impact of incident and prevalent herpes simplex virus-2 infection on the incidence of HIV-1 infection among commercial sex workers in South Africa.

This study investigated the impact of prevalent and incident HSV-2 infection on the incidence of HIV-1 infection in a cohort of female commercial sex workers in KwaZulu-Natal, South Africa. Prior to a vaginal microbicide trial, 416 women were screened for antibodies to HIV-1 and herpes simplex virus-2 (HSV-2) infections and a questionnaire was used to establish behavioral, social, and demographic characteristics. A total of 187 HIV-1-seronegative women were followed up at monthly intervals when blood was drawn and used to detect HIV-1 and HSV-2 antibodies. The median duration of follow-up was 2.2 years. At screening 50% of the women were HIV-1 seropositive and 84% were HSV-2 seropositive. The hazards of HIV-1 among women who were HSV-2 seropositive or seronegative throughout, or among those who seroconverted during the study, were not significantly different. When HSV-2 seroconversion was analyzed as a time-dependent covariate, the hazard ratio for HIV-1 seroconversion was 6.0 (95% CI: 2.6-14.0) times greater among women with incident than among women with prevalent HSV-2 infections. Drawing on other recent studies these data suggest that incident HSV-2 infection increases the risk of HIV-1 infection; the effect wanes with time since infection; and the effect is significantly greater for men than it is for women.

Assessment of the validity of and adherence to sexually transmitted infection algorithms at a female sex worker clinic in Abidjan, Côte d'Ivoire.

BACKGROUND: Algorithms for sexually transmitted infection (STI) case management were designed in a female sex worker (FSW) clinic in Abidjan, Côte d'Ivoire, in 1993. GOAL: The goal was to evaluate the long-term validity of the algorithms for returning clients of the clinic and to assess the adherence of the health workers to their application. STUDY DESIGN: A cross-sectional study was conducted from 1999 to 2000 among FSWs attending as returning clients. RESULTS: The prevalences of genital infections were as follows: Neisseria gonorrhoeae and/or Chlamydia trachomatis, 8.2%; Trichomonas vaginalis, 16.7%; bacterial vaginosis, 62.3%; and Candida albicans, 6.2%. The sensitivity of the algorithms was 20% and the positive predictive value was 14% for cervical infection. The proportion of cases for which all steps of the algorithm were correctly applied was 30%. CONCLUSION: Algorithms for the treatment of STIs in FSWs should be periodically reevaluated and adapted to the changing population. To maintain healthcare workers' adherence to the algorithms, supervision should be ongoing and reinforced.

Performance of commercially available enzyme immunoassays for detection of antibodies against herpes simplex virus type 2 in African populations.

Data are accumulating on the performance of enzyme immunoassays (EIAs) for the detection of herpes simplex virus type 2 (HSV-2) infection in North America and Europe, but little is known about their performance in other populations. Nine test kits were evaluated with 330 serum samples from sub-Saharan Africa. The tests were first compared to the monoclonal antibody (MAb) EIA (Central Public Health Laboratory, London, United Kingdom). Samples that gave discordant results in the MAb EIA and in the three tests that performed best compared to the MAb EIA were tested by Western blotting (University of Washington, Seattle). A random sample of concordant samples was also tested, and the sensitivities and specificities of the different tests were calculated, taking into account this sampling strategy. The sensitivities of the tests ranged from 86 to 100%; the specificities ranged from 47 to 99%. The tests that performed best were the Gull Premier EIA (sensitivity, 86.3%; specificity, 97.6%) and the Kalon Biological (sensitivity, 92.3%; specificity, 97.7%) and Biokit (sensitivity, 86.7%; specificity, 92.6%) tests. It cannot be assumed that enzyme immunoassays for the detection of HSV-2 infection that perform well in industrialized countries will perform equally well in other populations.

Syndromic versus laboratory-based diagnosis of cervical infections among female sex workers in Benin: implications of nonattendance for return visits.

BACKGROUND: The syndromic diagnostic approach is the most realistic and cost-effective strategy for controlling sexually transmitted infections (STIs) in the developing world. Its potential advantages should be evaluated. GOAL: The goal of the current study was to examine whether the syndromic approach might diagnose more cases of cervicitis due to Neisseria gonorrhoeae or Chlamydia trachomatis than laboratory tests. STUDY DESIGN: The participants were 481 female sex workers in Benin, screened for STIs and treated on the basis of the clinical findings. They were asked to return to the clinic within 10 days for laboratory test results and appropriate treatment when necessary. RESULTS: The prevalence of cervical infections was 24.5%. In comparison to the gold standard, the sensitivity of the syndromic diagnosis approach for the detection of N gonorrhoeae/C trachomatis infections was 48.3%; that of the locally performed laboratory tests was 74.6%. However, the sensitivity of the laboratory tests dropped to 28.8% when it was taken into consideration that 57.6% of the infected women did not return to the clinic within 10 days. CONCLUSIONS: The syndromic diagnosis approach should continue to be used for female sex workers in Benin because returning for treatment is problematic. Presumptive treatment at their initial visit could be a complement to this approach, given the high prevalence of cervicitis in this population.