Serologic testing algorithm for recent HIV seroconversion in estimating incidence of HIV-1 among adults visiting a VCT centre at a Kenyan tertiary health institution.

OBJECTIVE: To determine HIV high risk groups among adults visiting Kenyatta National Hospital Voluntary Counselling and Testing Centre by use of Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS). DESIGN: A cross-sectional study of adults. SETTING: Kenyatta National Hospital Voluntary and Counselling Centre. RESULTS: Of the 6,415 adults screened for antibodies to HIV at Kenyatta National Hospital VCT Centre between July 2002 and February 2003, 728 tested positive in the two HIV screening tests used at the center, indicating a prevalence of 11%. Of these seropositive cases, 355 consented to participate in the study. Using STARHS, 34 (9.6%) of the plasma samples were classified as being from individuals with recent infection (within 170 days), giving an annual estimated HIV-1 incidence in this population of 1.3 infections per 100 person-years with a 95% CI of 0.872-1.728%. Young adults had a higher rate of new infection than older adults. Young females were infected much earlier in life, with a peak age of new infections of 26 years, versus 31 years for young males. CONCLUSION: This study confirms our hypothesis that STARHS or Detuned assay can be used to determine HIV incidence in this population. The HIV high risk groups as identified by this study are young women between ages 16 to 26 years old and men between ages 45 to 55 years of age.

Acceptability of human immunodeficiency virus testing in patients with invasive cervical cancer in Kenya.

Invasive cervical cancer (ICC) is common in areas where human immunodeficiency virus (HIV) is also prevalent. Currently, HIV seroprevalence as well as acceptability of HIV testing in ICC patients in Kenya is unknown. The objective of this study was to determine the acceptability of HIV testing among patients with ICC. Women with histologically verified ICC at Kenyatta National Hospital participated in the study. A structured questionnaire was administered to patients who gave informed consent. HIV pre- and posttesting counseling was done. Blood was tested for HIV using enzyme-linked immunosorbent assay. Overall, 11% of ICC patients were HIV seropositive. The acceptance rate of HIV testing was 99%; yet, 5% of the patients did not want to know their HIV results. Patients less than 35 years old were two times more likely to refuse the result of the HIV test (odds ratio [OR] 2.2). Patients who did not want to know their HIV results were three times more likely to be HIV seropositive (OR 3.1). Eighty four percent of the patients were unaware of their HIV seropositive status. The HIV-1 seroprevalence in ICC patients was comparable to the overall seroprevalence in Kenya. ICC patients were interested in HIV testing following pretest counseling. Offering routine HIV testing is recommended in ICC patients.

Comparison of pap smear, visual inspection with acetic acid, human papillomavirus DNA-PCR testing and cervicography.

OBJECTIVE: To assess the test qualities of four screening methods to detect cervical intra-epithelial neoplasia in an urban African setting. METHOD: Six hundred fifty-three women, attending a family planning clinic in Nairobi (Kenya), underwent four concurrent screening methods: pap smear, visual inspection with acetic acid (VIA), PCR for high risk human papillomavirus (HR HPV) and cervicography. The presence of cervical intra-epithelial neoplasia (CIN) was verified by colposcopy or biopsy. RESULT: Sensitivity (for CIN2 or higher) and specificity (to exclude any CIN or cancer) were 83.3% (95% CI [73.6, 93.0]) and 94.6% (95% CI [92.6, 96.5]), respectively, for pap smear; 73.3% (95% CI [61.8, 84.9]) and 80.0% (95% CI [76.6, 83.4]) for VIA; 94.4% (95% CI [84.6, 98.8]) and 73.9% (95% CI [69.7, 78.2]) for HR HPV; and 72.3% (95% CI [59.1, 85.6]) and 93.2% (95% CI [90.8, 95.7]) for cervicography. CONCLUSION: The pap smear had the highest specificity (94.6%) and HPV testing the highest sensitivity (94.4%). The visual methods, VIA and cervicography, were similar and showed an accuracy in between the former two tests.

Congenital syphilis in a Nairobi maternity hospital.

OBJECTIVE: To assess adverse pregnancy outcome associated with maternal syphilis and congenital syphilis rate based on FTA-ABS-19s-IgM. DESIGN: Descriptive cross-sectional study. SETTING: Pumwani Maternity Hospital (PMH), the largest maternity unit in Nairobi, Kenya. SUBJECTS: Rapid Plasma Reagin reactive women and their live born infants. MAIN OUTCOME MEASURES: Syphilis serology in pregnant women, FTA-ABS-19s-IgM in cord blood and pregnancy outcome. RESULTS: Three hundred and seventy seven out of 12,414 women (3%) were RPR+. 4.0% of RPR+ and 1.4% of RPR- women delivered a stillbirth (OR 3.0, p<0.001). 19% of RPR+ and 10% of RPR- had low birth weight deliveries (OR 2.1, p<0.001). Mothers untreated for syphilis during pregnancy had significantly more preterm births (18.5% vs 9.2%, OR 2.3, p=0.026), and more stillbirths (5.4% vs 1.0%, OR 6.3, p=0.044). Of the 200 randomly selected cord bloods of RPR+ women, 142 (72%) were TPHA+. Nine (6.3%) of the 142 TPHA+ cords were FTA-ABS-19s-IgM+. CONCLUSIONS: Stillbirth and low birth weight rates were high in RPR+ untreated pregnant women and treatment significantly improved pregnancy outcome. Based on very stringent laboratory criteria (FTA-ABS-19s-IgM), 6.3% of live born infants with TPHA+ cord blood were considered syphilis infected.

Knowledge and practice about cervical cancer and Pap smear testing among patients at Kenyatta National Hospital, Nairobi, Kenya.

Invasive cervical cancer (ICC) is the leading cause of cancer-related death among women in developing countries. Population-based cytologic screening and early treatment does reduce morbidity and mortality associated with cervical cancer. Some of the factors related to the success of such a program include awareness about cervical cancer and its screening. The objective of this study was to assess knowledge and practice about cervical cancer and Pap smear testing among cervical cancer and noncancer patients using a structured questionnaire to obtain information. Fifty-one percent of the respondents were aware of cervical cancer while 32% knew about Pap smear testing. There were no significant differences in knowledge between cervical cancer and noncancer patients. Health care providers were the principal source of information about Pap testing (82%). Only 22% of all patients had had a Pap smear test in the past. Patients aware of cervical cancer were more likely to have had a Pap smear test in the past. The level of knowledge is low among ICC and noncancer patients. There is need to increase the level of knowledge and awareness about ICC and screening among Kenyan women to increase uptake of the currently available hospital screening facilities.

Traditional healers and the management of sexually transmitted diseases in Nairobi, Kenya.

To describe the role of traditional healers in STD case management, in-depth interviews were held with 16 healers (seven witchdoctors, five herbalists and four spiritual healers) in four slum areas in Nairobi, Kenya. All healers believed that STDs are sexually transmitted and recognized the main symptoms. The STD-caseload varied largely, with a median of one patient per week. Witchdoctors and herbalists dispensed herbal medication for an average of seven days, whereas spiritual healers prayed. Thirteen healers gave advice on sexual abstinence during treatment, 11 on contact treatment, four on faithfulness and three on condom use. All healers asked patients to return for review and 13 reported referring patients whose conditions persist to public or private health care facilities. Thus, traditional healers in Nairobi play a modest but significant role in STD management. Their contribution to STD health education could be strengthened, especially regarding the promotion of condoms and faithfulness.

Partner notification in the management of sexually transmitted infections in Nairobi, Kenya.

OBJECTIVE: To assess utilization of partner notification as a tool in prevention and control of Sexually transmitted infections in Nairobi City Council clinics. DESIGN: A cross-sectional study carried out between April and September 2000. SETTING: Nairobi City Council health clinics were stratified into eight administrative divisions and a total of 16 out of 54 primary health clinics with at least four STIs patients per day were selected. A standard questionnaire was administered to every fourth patient with clinical diagnosis of STIs who gave consent on exist. Sexual partners referred by index cases during the five day period from each clinic were also enrolled into the study. An additional questionnaire was administered to HCP who were managing STIs patients and their sex partners. RESULTS: Of 407 STIs patients recruited between April and September 2000, 20.6% were primary and 2% were secondary referrals giving an average referral rate of 23%. Respondents with multiple sex partners were less likely to refer their partners compared to those who had one partner (17.9% vs 82.1%, p < 0.005). Counseling of STI patients on the importance of partner referral was more effective than issuing referral cards alone (72.8% vs 56.8% % p = < 0.006). Barriers to partner notification included partners being out of town (44.6%) fear of quarrels and violence from partners (32.5%) and casual partners (15.1%) whose sex partners were unknown. CONCLUSION: Counseling and understanding of STIs patients on the need to treat all sexual partners is pivotal to the success of partner referral.

HLA-A and HLA-B in Kenya, Africa: allele frequencies and identification of HLA-B*1567 and HLA-B*4426.

HLA-A and HLA-B alleles of a population from Kenya, Africa were examined by sequencing exon 2 and exon 3 DNA and typing using a Taxonomy-based Sequence-analysis (TBSA) method. Extensive diversities were observed at both HLA-A and HLA-B loci in this population. Forty-one HLA-A alleles were identified from 159 unrelated individuals. The most frequently observed alleles were A*6802 (11.64%), A*02011/09 (9.75%), A*7401/02 (9.43%), A*3001 (7.86%), A*3002 (7.23%) and A*3601 (6.6%). Forty-nine HLA-B alleles were identified in 161 unrelated individuals, including two novel alleles, B*1567 and B*4426. The most frequently observed HLA-B alleles were B*5301 (9.01%), B*5801 (8.38%), B*4201 (7.76%), B*1503 (7.14%), B*1801 (6.21%), and B*5802 (5.90%). The most frequently observed HLA-A-B haplotypes were A*3601-B*5301 (3.55%) and A*3001-B*4201 (3.19%), followed by A*7401/02-B*5801 (2.84%), A*7401/02-B*5802 (2.84%) and A*02011/09-B*1503 (2.13%). Linkage disequilibrium and chi2 analysis showed the association of these HLA-A-B haplotypes at the antigen level to be significant. The frequencies of HLA-A and HLA-B alleles from the Kenyan population were compared with that of a population from Cameroon. The difference in allele and haplotype frequency distributions partly reflected the different ethnic composition of these two African populations.

HIV and cervical cancer in Kenya.

OBJECTIVES: To determine the effect of the HIV epidemic on invasive cervical cancer in Kenya. METHODS: Of the 3902 women who were diagnosed with reproductive tract malignancies at Kenyatta National Hospital (KNH) from 1989 to 1998, 85% had invasive cervical cancer. Age at presentation and severity of cervical cancer were studied for a 9-year period when national HIV prevalence went from 5% to 5-10%, to 10-15%. RESULTS: There was no significant change in either age at presentation or severity of cervical cancer. Of the 118 (5%) women who were tested for HIV, 36 (31%) were seropositive. These women were 5 years younger at presentation than HIV-negative women. CONCLUSIONS: A two- to three-fold increase in HIV prevalence in Kenya did not seem to have a proportional effect on the incidence of cervical cancer. Yet, HIV-positive women who presented with cervical cancer were significantly younger than HIV-negative women.

Prevalence of Helicobacter pylori and endoscopic findings in HIV seropositive patients with upper gastrointestinal tract symptoms at Kenyatta National Hospital, Nairobi.

BACKGROUND: Human immunodeficiency virus (HIV) seropositive patients frequently experience upper gastrointestinal tract (GIT) symptoms that cause considerable morbidity and are due to multiple aetiologies. The role of Helicobacter pylori gastric mucosal infection in HIV related upper GIT morbidity is unclear. No data exist on the prevalence of H. pylori gastric mucosal infection and upper gastrointestinal endoscopic findings in HIV seropositive patients at the Kenyatta National Hospital. OBJECTIVES: The aim of the study was to determine the prevalence of H. pylori gastric mucosal infection and the pattern of upper gastrointestinal endoscopic findings in HIV seropositive patients. DESIGN: A hospital-based prospective case-control study. SETTING: Kenyatta National Hospital, Endoscopy Unit. SUBJECTS: Fifty two HIV seropositive patients with upper GIT symptoms were recruited (as well as 52 HIV seronegative age and gender matched controls). INTERVENTION: Both cases and control subjects underwent upper GIT endoscopy and biopsies were taken according to a standard protocol. H. pylori detection was done by the rapid urease test and histology, and H. pylori gastric mucosal infection was considered to be present in the presence of a positive detection by both tests; biopsies were also taken for tissue diagnosis and CD4+ peripheral lymphocyte counts were determined using flow cytometry. RESULTS: H. pylori prevalence was 73.1% [95% CI 59.9-83.8] in HIV positive subjects and 84.6% [95% CI 72.9-92.6] in HIV negative controls (p=0.230). Prevalence of H. pylori decreased with decreasing peripheral CD4+ lymphocyte counts. Median CD4+ lymphocyte count was 67 cells per cubic millimetre in HIV positive patients. On endoscopy, the most common lesion in HIV positive patients was oesophageal candidiasis (occurring in 51.9%), which was often associated with presence of oral candidiasis and, together with erosions, ulcers and nodules in the oesophagus, occurred exclusively in these patients. A few cases of cytomegalovirus and herpes simplex oesophagitis were seen, as were cases of upper GIT Kaposi's sarcoma, and one gastric lymphoma. CONCLUSIONS: H. pylori prevalence was not significantly different between HIV positive and HIV negative subjects, and decreased in HIV positive subjects with decreasing CD4+ cell counts. Oesophageal candidiasis was the most important endoscopic finding in HIV positive patients and was often associated with oral thrush.

Childcare practices of commercial sex workers.

OBJECTIVE: To determine the childcare practices of commercial sex workers (CSWs). DESIGN: A descriptive cross-sectional survey was conducted between July and December 2000 during which a structured questionnaire was administered. SETTING: Kibera slum, Nairobi, Kenya. SUBJECTS: Three hundred eighty five CSWs and four focus group discussions (FGDs) held. Health cards from 126 under five years old children belonging to the respondents were reviewed for immunization status and regularity of growth monitoring. RESULTS: The mean age of the 385 CSWs surveyed was 32 +/- 7 years and mean duration of sex work was 6 +/- 4 years. The mean number of living children was 3.4 +/- 2 and 81.2% of the mothers lived with their children. Three quarters of the CSWs practised prostitution at home. The most common daily childcare activities by the mothers were food preparation (96.2%) and washing children's clothes (91.3%). Overall 96.8% of their under-five years old children were fully immunized and 80% of their under one year old children had their growth monitored monthly. About three quarters of the mothers with adolescent children educated them on HIV/STDs. Health seeking behaviour for the children was hampered by health care cost (71.4%) and consumption of alcohol by the mothers. Like other mothers, the CSWs encouraged their adolescent children to take up some adult roles such as maintaining a clean house (93.3%). However only 2.0% took time to converse or counsel the children. Focus group discussions (FGDs) with the CSWs showed that children were left unattended at night while the mothers went out in search of clients. Efforts to provide better education for the children were undermined by lack of funds (52.2%) and truancy (46.6%). One third of the study population had invested for the future maintenance of their children. CONCLUSION: There was more emphasis on physical, rather than psychological aspect of childcare. The practice of living with the children ensured that earnings from the sex trade were used for the immediate needs of the children such as food. However this practice had a negative influence on the children as the majority of the respondents conducted their sexual business at home with little or no privacy. Health seeking behaviour for the children was hampered by lack of funds and to some extent alcohol consumption by the mothers. Efforts to invest in the education of their children were undermined by lack of funds and truancy.

Morbidity and mortality in breastfed and formula-fed infants of HIV-1-infected women: A randomized clinical trial.

CONTEXT: Breastfeeding among women infected with human immunodeficiency virus type 1 (HIV-1) is associated with substantial risk of HIV-1 transmission, but little is known about the morbidity risks associated with formula feeding in infants of HIV-1-infected women in resource-poor settings. OBJECTIVE: To compare morbidity, nutritional status, mortality adjusted for HIV-1 status, and cause of death among formula-fed and breastfed infants of HIV-1-infected women. DESIGN: Randomized clinical trial conducted between 1992 and 1998. SETTING: Four antenatal clinics in Nairobi, Kenya. PARTICIPANTS: Of 401 live-born, singleton, or first-born twin infants of randomized HIV-1-seropositive mothers, 371 were included in the analysis of morbidity and mortality. INTERVENTIONS: Mothers were randomly assigned either to use formula (n = 186) or to breastfeed (n = 185) their infants. MAIN OUTCOME MEASURES: Mortality rates, adjusted for HIV-1 infection status; morbidity; and nutritional status during the first 2 years of life. RESULTS: Two-year estimated mortality rates among infants were similar in the formula-feeding and breastfeeding arms (20.0% vs 24.4%; hazard ratio [HR], 0.8; 95% confidence interval [CI], 0.5-1.3), even after adjusting for HIV-1 infection status (HR, 1.1; 95% CI, 0.7-1.7). Infection with HIV-1 was associated with a 9.0-fold increased mortality risk (95% CI, 5.3-15.3). The incidence of diarrhea during the 2 years of follow-up was similar in formula and breastfeeding arms (155 vs 149 per 100 person-years, respectively). The incidence of pneumonia was identical in the 2 groups (62 per 100 person-years), and there were no significant differences in incidence of other recorded illnesses. Infants in the breastfeeding arm tended to have better nutritional status, significantly so during the first 6 months of life. CONCLUSIONS: In this randomized clinical trial, infants assigned to be formula fed or breastfed had similar mortality rates and incidence of diarrhea and pneumonia during the first 2 years of life. However, HIV-1-free survival at 2 years was significantly higher in the formula arm. With appropriate education and access to clean water, formula feeding can be a safe alternative to breastfeeding for infants of HIV-1-infected mothers in a resource-poor setting.

How important is the 'quality' of the cytotoxic T lymphocyte (CTL) response in protection against HIV infection?

Cytotoxic T lymphocyte (CTL) responses have been associated with protection from HIV-1 infection in people with a high degree of exposure to HIV and who show no serological evidence of HIV infection (HEPS, highly exposed persistently seronegative). However, it remains unclear how protective CTL responses could apparently develop in a minority of people, whilst the great majority of HIV-infected people make strong CTL responses yet progress to AIDS and death. In this paper we review the data which supports the hypothesis that the quality of the T-cell response, rather than its magnitude, may be an important factor that merits further investigation.

New insights into HIV-1 specific cytotoxic T-lymphocyte responses in exposed, persistently seronegative Kenyan sex workers.

A clearer understanding of HIV-1 specific immune responses in highly-exposed, persistently seronegative (HEPS) subjects is important in developing models of HIV-1 protective immunity. HIV-1 specific cytotoxic T-lymphocytes (CTL) have been described in a cohort of HEPS Kenyan sex workers, and recent work has further elucidated these responses. CTL specific for HIV-1 Env were found in the blood of over half the sex workers meeting criteria for HIV resistance, and in some women recognized unmapped epitopes. The proportion of women with Env-specific CTL increased with the duration of uninfected HIV exposure, suggesting that these responses were acquired over time. CD8+ lymphocyte responses directed against predefined HIV-1 CTL epitopes from various HIV-1 genes were found in the blood and genital tract of >50% resistant sex workers, at a ten-fold lower frequency than in infected subjects. The epitope specificity of CD8+ responses differs between HEPS and HIV infected women, and in HEPS the maintenance of responses appears to be dependent on persistent HIV exposure. Several HIV-1 'resistant' sex workers have become HIV infected over the past 6 years, possibly related to waning of pre-existing HIV-specific CTL, and infection has often been associated with a switch in the epitope specificity of CD8+ responses. These findings suggest that vaccine-induced protective HIV immunity is a realistic goal, but that vaccine strategies of boosting or persistent antigen may be necessary for long-lived protection.

Functional HIV-1 specific IgA antibodies in HIV-1 exposed, persistently IgG seronegative female sex workers.

Although HIV-specific cellular immune responses are found in a number of HIV highly-exposed, persistently seronegative (HEPS) cohorts, late seroconversion can occur despite pre-existing cytotoxic T lymphocytes (CTL), suggesting that a protective HIV vaccine may need to induce a broader range of HIV-specific immune responses. Low levels of HIV-specific IgA have been found in the genital tract and plasma of the majority of Nairobi HEPS sex workers and appeared to be independent of HIV-specific cellular responses. IgA purified from genital tract, saliva and plasma of most HEPS sex workers were able to neutralize infection of PBMC by a primary (NSI) clade B HIV isolate, as well as viral isolates from clades A and D, which predominate in Kenya. In addition, these IgA were able to inhibit transcytosis of infective HIV virions across a transwell model of the human mucosal epithelium in an HIV-specific manner. Preliminary work in other HEPS cohorts has suggested the recognition of different gp41 epitopes in HEPS and HIV-infected subjects. Although present at low levels, these IgA demonstrated cross-clade neutralizing activity and were able to inhibit HIV mucosal transcytosis, suggesting an important functional role in protection against HIV infection.

Human leucocyte antigen supertypes and immune susceptibility to HIV-1, implications for vaccine design.

T cell responses against HIV-1 have been identified in a number of exposed uninfected populations. We hypothesized that the ability to mount an effective T cell response is partly determined by the human leucocyte antigens (HLA) phenotype of the individual. We examined whether certain HLA supertypes were associated with differential HIV-1 susceptibility in sexually exposed adults and in the setting of mother to child HIV-1 transmission. By multivariate analysis, decreased HIV-1 infection risk was strongly associated with possession of a cluster of closely related class I HLA alleles (A2/6802 supertype) in sexually exposed adults (Hazard ratio=0.42, 95% confidence intervals (CI): 0.22-0.81, P=0.009) and perinatally exposed infants (Odds ratio=0.12, 95% CI: 0.03-0.54, P=0.006). The alleles in this HLA supertype are known in some cases, to present the same peptide epitopes (termed 'supertopes'), for T cell recognition. The identification of HIV-1 supertopes, which are associated with protection from HIV-1 infection, has important implications for the application of epitope-based HIV-l vaccines in a variety of racial groups.

Quality of sexually transmitted disease case management in Nairobi, Kenya: a comparison among different types of healthcare facilities.

BACKGROUND: In Nairobi, the prevalence for sexually transmitted diseases (STDs) among attenders at antenatal and family planning clinics is substantial, but knowledge about the quality of STD case management is scarce. GOAL: To assess quality of STD case management in Nairobi healthcare facilities. STUDY DESIGN: All the facilities in five sublocations were enumerated. In 142 facilities, 165 providers were interviewed, observed during 441 interactions with patients who had STDs, and visited by a simulated patient. RESULTS: For observations of patients with STDs, correct history-taking ranged from 60% to 92% among the various types of facilities, correct examination from 31% to 66%, and correct treatment from 30% to 75%. The percentage of correctness for all three aspects (World Health Organization prevention indicator 6) varied between 14% and 48%. Public clinics equipped for STD care performed best in all aspects, whereas treatment was poorest in pharmacies and private clinics. The providers trained in STD management performed better than those without training. CONCLUSIONS: Quality of STD case management was unsatisfactory except in public STD-equipped clinics. This indicates the need for improvement by interventions such as further training in syndromic management, improved supervision, and the introduction of prepackaged syndromic management kits.

Hormonal contraception and risk of sexually transmitted disease acquisition: results from a prospective study.

OBJECTIVES: To examine the relationship between use of oral contraceptive pills or depot medroxyprogesterone acetate and sexually transmitted disease acquisition. STUDY DESIGN: Prospective cohort included 948 Kenyan prostitutes. Multivariate Andersen-Gill proportional hazards models were constructed, adjusting for sexual behavioral and demographic variables. RESULTS: When compared with women who were using no contraception, users of oral contraceptive pills were at increased risk for acquisition of chlamydia (hazard ratio, 1.8; 95% confidence interval, 1.1-2.9) and vaginal candidiasis (hazard ratio, 1.5; 95% confidence interval, 1.2-1.9) and at decreased risk for bacterial vaginosis (hazard ratio, 0.8; 95% confidence interval, 0.7-1.0). Women using depot medroxyprogesterone acetate had significantly increased risk of chlamydia infection (hazard ratio, 1.6; 95% confidence interval, 1.1-2.4) and significantly decreased risk of bacterial vaginosis (hazard ratio, 0.7; 95% confidence interval, 0.5-0.8), trichomoniasis (hazard ratio, 0.6; 95% confidence interval, 0.4-1.0), and pelvic inflammatory disease (hazard ratio, 0.4; 95% confidence interval, 0.2-0.7). Consistent condom use was associated with significantly decreased risk of gonorrhea, chlamydia, genital ulcer disease, bacterial vaginosis, and pelvic inflammatory disease. CONCLUSIONS: The use of oral or injectable hormonal contraception altered susceptibility to sexually transmitted diseases, which may in turn influence transmission of human immunodeficiency virus type 1. Consistent condom use was protective with regards to sexually transmitted disease and should be encouraged for the prevention of sexually transmitted disease and human immunodeficiency virus type 1 among women who use hormonal contraception.

Evaluation of a low-dose nonoxynol-9 gel for the prevention of sexually transmitted diseases: a randomized clinical trial.

BACKGROUND: Low-dose nonoxynol-9 products have a potential advantage of reduced toxicity. However, little is known about their efficacy in reducing the incidence of sexually transmitted diseases (STDs). GOAL: To determine the effect that an intravaginal gel containing 52.5 mg of nonoxynol-9 has on the acquisition of STDs in a cohort of HIV-1-seronegative female sex workers in Mombasa, Kenya. STUDY DESIGN: A randomized double-blind placebo controlled trial was performed. RESULTS: In this study, 139 women were randomized to the nonoxynol-9 group and 139 to the placebo group. No significant differences were found between the two study groups in terms of safety outcomes and reported symptoms, except for a lower incidence of vaginal erythema in the nonoxynol-9 group. There was a significantly higher incidence of gonorrhea in the nonoxynol-9 group than in the placebo group. No significant differences were observed between the groups for acquisition of Candida, trichomonas, bacterial vaginosis, C trachomatis, syphilis, or HIV-1, although the statistical power to detect differences for some of these STDs was limited. CONCLUSIONS: In this randomized placebo-controlled trial of a low-dose nonoxynol-9 gel, a significantly higher incidence of gonorrhea was found in the nonoxynol-9 group, but no significant differences between the groups were found for Candida, trichomonas, bacterial vaginosis, C trachomatis, syphilis, or HIV-1.