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Biomedical subjects

M Laga

Publications and source records attributed to M Laga.

At least 37 records · Page 2Linked to original sources
PubMed2001

Effect of adverse storage conditions of antigen reagent on performance of the rapid plasma reagin test.

The aim of this study was to evaluate the performance of rapid plasma reagin (RPR) testing using expired and adversely stored antigen reagent. The sensitivity of RPR using antigen stored at 36 degrees C was compared at 3-monthly intervals with RPR using fresh antigen on 116 sera reactive by RPR and by Treponema pallidum particle agglutination (TPPA). After multiple phases of freezing and thawing, 8.3% of initial RPR reactive sera seroreverted. After storage at 36 degrees C for one year and 24 weeks after expiration the overall sensitivity of the adversely stored antigen was 93.8% compared with fresh antigen; the sensitivity was 100% for sera with RPR titres > or = 1:4 and 85.4% for sera with RPR titres of 1:1 and 1:2. The high stability of the reagent may increase the feasibility of the RPR test for use in poorly-equipped healthcare centres in developing countries.

Antibodies, Bacterial↗
PubMed2001

Development of a heminested polymerase chain reaction assay for the detection of Haemophilus ducreyi in clinical specimens.

Detection of Haemophilus ducreyi in genital ulcer specimens by culture lacks sensitivity. To enhance detection, a heminested polymerase chain reaction (PCR) assay was developed targeting the nucleotide sequence of a gene, designated p27, which encodes for a 27 kDa H. ducreyi-specific protein. The p27 PCR assay detected all (37/37) H. ducreyi strains tested and gave no amplified product from DNA extracts of any of 31 other microorganisms, from 30 non-genital ulcer specimens, or from 29 urethral and vaginal swab specimens collected from non-chancroid STD patients. In genital ulcer disease specimens, compared to combined positive results obtained by culture and a previously described PCR assay, the p27 PCR assay showed a sensitivity of 91% (48/53). The p27 PCR assay provides a specific and a sensitive detection of H. ducreyi in clinical specimens.

Bacterial Proteins↗
PubMed2000

Cervicovaginal anti-HIV antibodies in HIV-seronegative female sex workers in Abidjan, Côte d'Ivoire.

OBJECTIVE: To detect anti-HIV antibodies in cervicovaginal secretions of HIV-seronegative female sex workers and to evaluate whether the presence of these antibodies is associated with increased sexual exposure. METHODS: A cross-sectional study was carried out at a confidential clinic for female sex workers in Abidjan, Côte d'Ivoire. The participants were 342 HIV-seronegative female sex workers in whom a cervicovaginal lavage was collected. The main outcome measures were the detection of antibodies to HIV-1 in cervicovaginal lavages using an in-house and a commercial (Seradyn Sentinel; Calypte Biomedical Corporation, Berkeley, California, USA) enzyme immunoassay; the detection of semen in cervicovaginal lavages; and the assessment of epidemiological and biological markers of sexual exposure to HIV. RESULTS: Cervicovaginal anti-HIV antibodies were detected in 7.3 and 29.8% of women using in-house enzyme-linked immunosorbent assay (ELISA) and Seradyn Sentinel respectively. All cervicovaginal secretions found to be positive by in-house ELISA were also positive by Seradyn Sentinel. In a minority of women, ranging from 2.9% by in-house ELISA to 12.3% by Seradyn Sentinel, the anti-HIV antibodies were present in vaginal fluids that did not contain semen. Sexual exposure to HIV was similar in women with anti-HIV antibodies in their semen-free cervicovaginal secretions compared with women without anti-HIV antibodies in their cervicovaginal secretions. CONCLUSIONS: Cervicovaginal HIV-specific antibodies were detected in a minority of sexually exposed HIV-seronegative female sex workers in Abidjan. The lack of association between increased sexual exposure to HIV and presence of cervicovaginal HIV-specific antibodies suggests that the production of genital HIV-specific antibodies in exposed seronegative women depends on the ability of individual women to mount specific mucosal immunity to HIV antigens, the determinants of which are currently unknown.

Adult↗
PubMed2000

Dual infection with human immunodeficiency virus type 1 and type 2: impact on HIV type 1 viral load and immune activation markers in HIV-seropositive female sex workers in Abidjan, Ivory Coast.

To determine the impact of dual infection with HIV-1 and HIV-2 on HIV-1 viral load and markers of immune activation among HIV-seropositive FSWs in Abidjan, we analyzed blood samples obtained from consenting HIV-seropositive FSWs attending a confidential clinic between September 1996 and June 1997 in Abidjan. Among HIV-1 and HIV-2 dually seropositive FSWs, polymerase chain reaction (PCR) testing with HIV-1 and HIV-2 primers was used to differentiate between FSWs who were PCR positive only for HIV-1 and those positive for both HIV-1 and HIV-2 (dually infected). Of the 203 FSWs, 151 (74%) were HIV-1 seropositive only (median age, 26 years), 4 (2%) were HIV-2 seropositive, and 48 (24%) were dually seropositive (median age, 30 years). Of the 48 dually seropositive FSWs, 33 (69%) were dually infected and 15 (31%) were dually seropositive. Median CD4+ T cell counts per microliter were not significantly different among the three groups (525 for HIV-1 positive only, 502 for dually infected, and 416 for dually seropositive) (p = 0.14). Median viral load (log10 copies/ml) was not significantly different among the HIV-1-only FSWs (4.8 log10 copies/ml) compared with the 32 dually infected FSWs (4.6 log10 copies/ml) and 14 dually seropositive FSWs (4.7 log10 copies/ml; p = 0.95). Median levels of HLA-DR immune activation were increased in both CD4+ and CD8+ T cells for the dually infected (n = 27) FSWs compared with those infected with HIV-1 only (n = 123) (p = 0.019 and p = 0.01, respectively). Dual infection does not appear to influence levels of HIV-1 viral load in vivo. However, levels of HLA-DR are higher among FSWs dually infected with HIV-1 and HIV-2 than among those infected with HIV-1 only.

Adult↗
PubMed2000

Safety of multiple daily applications of COL-1492, a nonoxynol-9 vaginal gel, among female sex workers. COL-1492 Phase II Study Group.

RATIONALE: COL-1492 is a nonoxynol-9 (N-9)-containing vaginal gel and may be a potential microbicide. As part of an effectiveness trial, an initial toxicity study was conducted. OBJECTIVES: The main objective of the reported study was the assessment of the toxicity of a 52.5 mg N-9 gel, COL-1492, when used a number of times each day by female sex workers. METHODS: This was a randomized, placebo-controlled triple-blinded trial among female sex workers. The participants were asked to use the product for each vaginal sexual act. At each monthly visit a gynaecological examination with sexually transmitted disease sampling and colposcopy was performed. Venous blood was drawn for syphilis and HIV serology. All women received intensive counselling on condom use. Male condoms and sexually transmitted disease treatment were given free of charge. RESULTS: Only blinded results on the colposcopic examinations are reported. The incidence of lesions with or without an epithelial disruption was low: 0.06 and 0.29, respectively, per 100 woman-days in group A; 0.09 and 0.26 respectively per 100 woman-days in group B. There was no significant difference between the two arms. CONCLUSION: The multiple daily use of COL-1492 by female sex workers did not show an increase of local toxicity over that of a placebo. Colposcopy was discontinued in the autumn of 1997 in accordance with a Data Safety Monitoring Board decision. In the currently ongoing effectiveness trial the assessment of the product's toxicity continues to be monitored by simple visual examination.

Administration, Intravaginal↗
PubMed2000

Cost-effectiveness of management strategies for acute urethritis in the developing world.

OBJECTIVE: To recommend a cost-effective approach for the management of acute male urethritis in the developing world, based on the findings of a theoretical study. METHODS: A model was developed to assess the cost-effectiveness of three urethritis management strategies in a theoretical cohort of 1000 men with urethral syndrome. (1) All patients were treated with cefixime and doxycycline for gonococcal urethritis (GU) and nongonococcal urethritis (NGU), respectively, as recommended by WHO. (2) All patients were treated with doxycycline for NGU; treatment with cefixime was based on the result of direct microscopy of a urethral smear. (3) All patients were treated with cotrimoxazole or kanamycin for GU and doxycycline for NGU. Cefixime was kept for patients not responding to the first GU treatment. Strategy costs included consultations, laboratory diagnosis (where applicable) and drugs. The outcome was the rate of patients cured of urethritis. Cost-effectiveness was measured in terms of cost per cured urethritis. RESULTS: Strategy costs in our model depended largely on drug costs. The first strategy was confirmed as the most effective but also the most expensive approach. Cefixime should cost no more than US$ 1.5 for the strategy to be the most cost-effective. The second strategy saved money and drugs but proved a valuable alternative only when laboratory performance was optimal. The third strategy with cotrimoxazole was the least expensive but a low follow-up visit rate, poor treatment compliance or lower drug efficacy limited effectiveness. Maximizing compliance by replacing cotrimoxazole with single-dose kanamycin had the single greatest impact on the effectiveness of the third strategy. CONCLUSION: Our model suggested that a cost-effective approach would be to treat gonorrhoea with a single-dose antibiotic selected from locally available products that cost no more than US$ 1.5.

Acute Disease↗
PubMed2000

A phase I study of a novel potential intravaginal microbicide, PRO 2000, in healthy sexually inactive women.

BACKGROUND: Although the male condom provides a reliable means of preventing HIV transmission, a broader choice of methods is required particularly in circumstances where the negotiation of condom use is difficult. Development of new products that may be effective as topical vaginal microbicides is the focus of a great deal of research activity currently. The novel agent PRO 2000, a naphthalene sulphonate derivative with in vitro activity against HIV and other sexually transmissible pathogens, is one such compound. We have studied the local and systemic safety and tolerance of a vaginal gel formulation of this agent at two concentrations (0.5% and 4%) over a 2 week period of daily exposure in two cohorts of healthy sexually abstinent women (one in London, UK, and the other in Antwerp, Belgium). METHODS: This was a randomised, placebo controlled, double blind, three arm clinical trial conducted on two sites. Macroscopic evidence of genital epithelial changes was sought using colposcopy and evidence of microscopic inflammation was acquired using high vaginal biopsy from predetermined sites (UK cohort only). Blood levels of PRO 2000 were measured and laboratory safety tests, including coagulation screens, were performed. The impact on vaginal ecology was also assessed. RESULTS: 73 women were enrolled across both sites (36 UK, 37 Belgium); 24, 24, 25 in the 4%, 0.5%, and placebo groups respectively. Of these, 70 completed 2 weeks' exposure to the study gel. Three (all in the 4% group) withdrew owing to adverse events which were possibly or probably gel related. Cervicovaginal abrasion was seen colposcopically in three subjects after 14 days of gel use (two in the 4% group and one in the placebo group). Genital ulceration was not seen during gel use in any of the subjects who completed the study. Histological evaluation of vaginal biopsy samples (36 women only) showed evidence of increased inflammatory signs in one participant of the 4.0% group. One volunteer in the placebo group had moderate inflammation at screening and at follow up. Severe inflammation was not seen among any of the subjects tested. Plasma levels of PRO 2000 and laboratory safety tests showed no evidence of systemic absorption. No impact was seen on normal vaginal ecology in the UK cohort where samples were taken 12 hours after the last gel application. CONCLUSION: In this phase I study PRO 2000 gel was found to be generally well tolerated with promising local and systemic safety profiles. The 0.5% gel was better tolerated than the 4% gel as fewer genital epithelial adverse events were seen in the former. Phase II studies are about to begin in sexually active women.

Administration, Intravaginal↗
PubMed2000

High prevalence of trichomoniasis in rural men in Mwanza, Tanzania: results from a population based study.

OBJECTIVES: To measure the prevalence of urethral infections including trichomoniasis in rural Tanzanian men, to assess the prevalence of symptoms and signs among men with Trichomonas vaginalis, and to analyse the risk factors for trichomoniasis. DESIGN: A cross sectional study of 1004 men aged 15-54 years in a rural community in north west Tanzania. METHODS: Participants were interviewed about sexual behaviour and symptoms of sexually transmitted diseases. First fraction urine samples and urethral swabs were collected and used to test for T vaginalis by wet preparation and culture, Neisseria gonorrhoeae by culture, Chlamydia trachomatis by ligase chain reaction and non-specific urethritis by Gram stain. Urine was also tested for the presence of leucocytes using a leucocyte esterase dipstick. Men were re-interviewed 2 weeks later to document new symptoms and signs of urethritis. RESULTS: Complete laboratory results were available on 980 men. One in four men had laboratory evidence of urethritis. T vaginalis was found in 109 individuals (11%), gonorrhoea in eight (0.8%), and chlamydial infection in 15 (1.5%). Over 50% of men with urethritis were asymptomatic. The prevalence of signs and symptoms was similar among men with T vaginalis alone compared with men with other urethral infections. The sensitivity and specificity of the leucocyte esterase dipstick (LED) test for detecting T vaginalis were 80% and 48% respectively in symptomatic men and 60% and 68% in asymptomatic men. Factors associated with trichomoniasis included religion, type of employment, and marital status. CONCLUSIONS: A high prevalence of urethritis was found in men in this community based study. More than half of the urethral infections detected were asymptomatic. The most prevalent pathogen was T vaginalis. Studies are needed on the prevalence of trichomoniasis in men presenting to health services with complaints suggestive of urethritis since treatment for T vaginalis is not included in the syndromic management of urethritis in most countries. The performance of the LED test as a screening test for trichomoniasis was unsatisfactory in both symptomatic and asymptomatic men. Improved screening tests are urgently needed to identify urethral infections that are asymptomatic and which are not covered by current syndromic management algorithms.

Adolescent↗
PubMed1999

Phase 1 trial of nonoxynol-9 film among sex workers in South Africa.

OBJECTIVES: To assess the acceptability and safety of a vaginal nonoxynol-9 film in a group of sex workers at a truck stop in South Africa. DESIGN: A randomized double-blinded crossover trial was conducted between April 1995 and July 1995. INTERVENTION: Seventy-two mg nonoxynol-9 film and an identical glycerine placebo film. METHODS: Following informed consent, each study participant was randomly assigned the designated pre-coded film for 1 month. The second month was a film-free washout period and the participants used the alternate film in the third month. Besides measuring behavioural and clinical outcomes, colposcopy examination for genital lesions, serology and microbiology investigations for sexually transmitted diseases and semi-quantitative PCR for vaginal HIV load estimates were performed. RESULTS: Twenty women participated in the study. The women reported, on average, 19 sexual encounters per week. Vaginal intercourse was protected 25% of the time by condoms. On average, 11 vaginal films, either nonoxynol-9 or placebos were inserted per week. There were no statistically significant differences between the two treatment groups for genital lesions (P = 0.29), reported side effects (P = 0.73), and viral load (P = 0.9). However, the proportions of clinically detected genital lesions (six out of eight versus two out of eight) and self-reported side-effects (five out of eight versus three out of eight) were higher in the nonoxynol-9 group when compared with the placebo group. Incident sexually transmitted diseases occurred more frequently in the placebo group. An increased viral load was associated with the development of a genital lesion (relative risk, 6.0; 95% confidence interval, 0.81-44.4). CONCLUSIONS: The 72 mg film formulation of nonoxynol-9 was an acceptable product for use in this population of sex workers. Although no statistically significant differences in adverse outcomes were detected, clinically there appeared to be an increase in minor lesions and self-reported side-effects with nonoxynol-9 and less protection against sexually transmitted diseases with the placebo. Furthermore, HIV shedding was correlated with the presence of incident vaginal or cervical lesions. This brings into question the potential narrow margin of safety for this product; additional Phase 2 studies are therefore required.

Administration, Intravaginal↗
PubMed1999

Chlamydia trachomatis prevalence and sexual behaviour among female adolescents in Belgium.

OBJECTIVES: To determine prevalence and risk factors of Chlamydia trachomatis among female secondary school students and to develop potential selective screening strategies. METHODS: A cross sectional survey was conducted in the 17 school medical centres in Antwerp municipality, Belgium. All female students of forms 5 or 6, who were due for their medical check up during the school year 1996-7, were invited to participate. A self administered questionnaire on general and sexual behaviour, and a first void urine sample were collected. The urine specimen was tested for C trachomatis with ligase chain reaction assay, and positive tests were confirmed with polymerase chain reaction assays. RESULTS: 2784 female students participated in the study. Their median age was 17, and 52% of them reported having sexual intercourse at least once. The prevalence of C trachomatis among sexually active women was 1.4%. Factors significantly associated with infection in multivariate analysis were number of lifetime partners, genital complaints of partner, type of secondary school, and a history of pregnancy. Selective screening of those women who are at highest risk for infection would have detected 90% of all infections, and require testing of 14% to 18% of the population. CONCLUSIONS: The prevalence of C trachomatis was relatively low among female secondary school students in Antwerp, but unsafe sex practices were evident because of the high number of unplanned pregnancies. Selective screening strategies with a high sensitivity can be proposed, but should be assessed for acceptability, feasibility, and cost.

Adolescent↗
PubMed1998

Preclinical studies on thiocarboxanilide UC-781 as a virucidal agent.

BACKGROUND: Thiocarboxanilide UC-781 is a highly potent and selective non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1, which also has virucidal properties. Recent studies have shown that UC-781 would seem an ideal candidate for application as a vaginal virucide. OBJECTIVE: To investigate the antiviral potency and stability of UC-781 in a lipophilic gel formulation. METHODS: UC-781 was formulated in replens gel at different concentrations and administered intravaginally to rabbits at 5% in replens gel for 10 days. UC-781 was also exposed to temperatures of 4, 37 and 50 degrees C, and to low pH (6.0, 4.3, 2.0 and 1.2). A number of microorganisms were exposed in culture to serial dilutions of UC-781. RESULTS: The drug was stable under low pH conditions and did not lose its antiviral potency upon 4 h exposure to pH 3.5 (the estimated vaginal pH). UC-781 can be easily formulated into a lipophilic gel (replens; up to 5%) and proved fully stable at 50 degrees C for 30 days. There was no effect on the growth of microorganisms (i.e., Candida and Lactobacillus strains) that are present in the vaginal flora. Neither systemic side-effects, nor local inflammation or damage of the vaginal mucosa or epithelium were observed in rabbits to which 5% UC-781 in replens gel had been administered. UC-781, formulated as 0.5, 0.2 and 0.05% replens gel, and UC-38, alpha-APA and zidovudine, formulated as 0.5 or 0.2% replens gel, were effective in protecting CEM cells in the very beginning against productive HIV-1 replication. This points to an efficient diffusion of the drugs from the lipophilic gel to the hydrophilic culture medium. However, subsequent subcultivations at a dilution rate of 1:10 every 3-4 days resulted in a rapid breakthrough of virus with all drugs except UC-781 in its 0.5 and 0.2% gel formulation. These cultures were fully protected against HIV-1 and remained completely cleared from virus for at least 10 subcultivations. CONCLUSIONS: The virus that emerged under 0.05% UC-781 remained highly sensitive to the NNRTI, including UC-781, in cell culture, suggesting a lack of resistance development under our experimental conditions.

Acquired Immunodeficiency Syndrome↗
PubMed1998

Safety evaluation of nonoxynol-9 gel in women at low risk of HIV infection.

OBJECTIVE: To determine the safety of a vaginal microbicide, COL-1492, containing 52.5 mg nonoxynol-9, applied once daily for 14 days among healthy volunteers. METHODS: A randomized, double-blind controlled trial with three arms, COL-1492 gel versus placebo gel versus no-treatment controls, was conducted. Outcomes of interest were reported genital symptoms, incidence of gynaecological signs, and incidence of genital lesions revealed by colposcopy. Participants were enrolled in four centres (Belgium, The Netherlands, and two in Thailand). RESULTS: A total of 534 women participated in the study: 179 used COL-1492, 178 used placebo, and 177 were no-treatment controls. Study visits were scheduled 1 week prior to enrollment (day -7), day 0 (enrollment), day 8 and day 14. The most frequently reported genital symptom was vaginal discharge in both the COL-1492 and placebo groups. This appeared to be related to leakage of the product out of the vagina. The incidence of lesions associated with epithelial disruption (ulcers and abrasions) was very low (< 2%) and there was no statistically significant difference between the three groups. Of the lesions observed by colposcopy that did not involve epithelial disruption, petechial haemorrhage was the most frequently detected, with an incidence of 20.1, 9.0 and 7.3% in the COL-1492, placebo and control groups, respectively. COL-1492 users had a higher incidence of erythema (8.4 versus 2% in the other groups). CONCLUSION: COL-1492 showed minimal toxicity when applied once daily. A Phase III trial to assess the product's effectiveness in HIV prevention is currently ongoing.

Adult↗
PubMed1998

The rrs (16S)-rrl (23S) ribosomal intergenic spacer region as a target for the detection of Haemophilus ducreyi by a heminested-PCR assay.

The intergenic spacer region between the rrs and rrl ribosomal RNA genes of Haemophilus ducreyi was analysed and the DNA sequence was used for the selection of specific PCR primers. A highly sensitive and specific heminested-PCR assay for the identification of H. ducreyi was developed. The assay showed a sensitivity of 96% on genital ulcer specimens from patients with clinically diagnosed chancroid, compared with a sensitivity of 56% for culture methods. These results indicate that this PCR assay has the potential to become an accurate and easy reference method for the detection of H. ducreyi.

Base Sequence↗
PubMed1998

Prepackaged therapy for urethritis: the "MSTOP" experience in Cameroon.

RATIONALE: The social marketing of STD treatment may be a strategy to increase the availability of effective therapy for urethritis in male patients. OBJECTIVE: To evaluate a pilot project of social marketing of urethritis treatment packages. The project, initially designed for over the counter sale in private pharmacies, was finally restricted by national health authorities to primary healthcare settings in Yaoundé and Douala, Cameroon. METHODS: Monthly sales of packages containing antibiotics, condoms, partner referral cards, and written information on STDs were monitored by the social marketing agency. Structured interviews were conducted with a sample of traceable patients who had consulted for urethritis. Structured interviews completed by focus group discussions were conducted among healthcare providers. Interview findings were further validated by a "mystery patient" survey, using surrogate patients. Lastly, 15 key informants among the decision markers involved in the project were interviewed in depth. Local independent consultants carried out the whole evaluation. RESULTS: A total of 1392 treatment packages were sold in 10 months. Patients who had purchased the package reported high compliance with the treatment, with 99% taking the single dose of cefuroxime-axetil and 83% completing the course of doxycycline. 76% notified all or some partners, and 84% of those who had sex during treatment used condoms. In contrast, only 27% of trained healthcare providers prescribed "MSTOP". They questioned the omission of laboratory diagnosis, the selection of antibiotics, and the duration of therapy. Public health authorities were also sceptical about the choice of antibiotics and viewed the initial project as an overt encouragement of self medication. CONCLUSIONS: Although the MSTOP project was not implemented in the way it had initially been designed, it highlighted the patients' interest in the product. Public health authorities in Cameroon should have been made aware of the limitations of the formal sector's response to STD care among men before over the counter sale of prepackaged therapy could have been considered as an alternative approach to inadequate self medication.

Anti-Bacterial Agents↗
PubMed1998

Evaluation of an HIV saliva test for the detection of HIV-1 and HIV-2 antibodies in high-risk populations in Abidjan, Côte d'Ivoire.

To evaluate saliva testing in a West African field situation where both HIV-1 and HIV-2 are present, a cross-sectional study was conducted among female sex workers (FSWs) and their stable male partners (SMPs) at a STD/HIV clinic in Abidjan, Côte d'Ivoire. Saliva samples were collected with the Omni-SAL device and tested for antibodies to HIV-1 or HIV-2 by GACELISA. The HIV seroprevalence was 71% among 468 FSWs and 61% among 31 SMPs. Salivary HIV antibodies were detected in all 227 HIV-1-seropositive, in all 6 HIV-2-seropositive and in 115 of 117 dually seroreactive participants, while no salivary HIV antibodies were detected in 148 of 149 seronegative participants. The sensitivity and specificity of the saliva test were 99.4% and 99.3% respectively, and the positive and negative predictive values were 99.7% and 98.7% respectively. In this West African field situation saliva testing has a high validity compared to serum testing. The Omni-SAL and GACELISA combination is an alternative strategy to serological testing because of its high sensitivity and specificity, the ease and safety of sample collection and its relatively low cost.

Cote d'Ivoire↗
PubMed1998

Validation of a WHO algorithm with risk assessment for the clinical management of vaginal discharge in Mwanza, Tanzania.

OBJECTIVES: (i) To determine the microbial aetiologies of vaginal discharge in STD clinic and antenatal clinic (ANC) attenders; (ii) to evaluate the performance and costs of a new WHO algorithm for the detection of gonococcal and chlamydial infections in women complaining of vaginal discharge and/or genital itching, using a risk assessment. METHODS: Two groups were enrolled: (i) 395 consecutive female patients attending a hospital outpatient clinic complaining of genital discharge or itching; and (ii) 628 consecutive pregnant women reporting at an urban ANC these symptoms. Patients were interviewed by a nurse, who applied the WHO risk score. They were then referred to the study room for interview concerning the same and other risk factors, examined, and sampled for Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), and Candida albicans (CA). Sensitivity, specificity, positive predictive value, overtreatment and correct treatment rates, and cost of drugs per true case treated were estimated. RESULTS: The prevalence of NG and/or CT infections was 11.4% and 8% at the STD clinic and the ANC respectively. The most prevalent pathogens were CA (38% at both clinics) and TV (25% at the STD clinic and 34% at the ANC). The sensitivity of the WHO algorithm for NG and/or CT was 62% at the STD clinic and 46% at the ANC, and the specificities were 64% and 84% respectively. The operational feasibility of the method was good. The cost of drugs per true case treated in applying the risk assessment approach was $3.5 among nonpregnant women and $5.0 among pregnant women. This compared favourably with respective costs of $8.8 and $25.0 in applying the syndromic management alone. CONCLUSIONS: The WHO risk assessment algorithm for the diagnosis of NG and/or CT infections among women complaining of genital discharge can considerably reduce overtreatment of NG and/or CT in both pregnant and non-pregnant women, but in this study it failed to identify 38% of non-pregnant and 54% of pregnant women with these infections. The elements of the risk score may need adjustment in different settings.

Adult↗