A formal decision analysis identifies an optimal treatment strategy in a resource-poor setting.

OBJECTIVE: Decision analytic techniques use formal specifications of utility for the four fundamental decision events: true positives, false positives, true negatives, and false negatives. An optimal policy is the one with the lowest expected net cost. In this paper, decision analytic techniques for treatment selection based on patient characteristics are applied to a resource-poor setting. STUDY DESIGN AND SETTING: A cohort of 986 female sex workers in Antananarivo and Tamatave, Madagascar were tested for cervical infection at baseline and again 2 months later after presumptive treatment for gonorrhea and chlamydia. RESULTS: Three equivalent approaches to identify the optimal policy based on patient characteristic subgroups are demonstrated. Two of them require exhaustive searches of all possible alternatives. The third identifies the optimal policy as an analytic expression that compares a decision function with a threshold and leads to a closed-form solution. With this approach, the optimal policy can be expressed in four equivalent forms using basic epidemiological measures: likelihood ratio, predicted probability of disease, logistic regression parameters, and total risk score. CONCLUSION: These methods illustrate the application of a decision analysis to clinical epidemiology. Management of cervical infection for sex workers in Madagascar occurs under severe resource constraints, and therefore requires an algorithm for identifying optimal treatment regimens.

Evidence-based planning of a randomized controlled trial on diaphragm use for prevention of sexually transmitted infections.

OBJECTIVES: We conducted formative research to evaluate the acceptability and feasibility of continuous diaphragm use among low-income women highly exposed to sexually transmitted infections (STIs) in Madagascar. GOAL: To identify potential obstacles to researching the effectiveness of diaphragm use for STI prevention in a randomized controlled trial. STUDY DESIGN: Mixed methods to collect complex information. In a quantitative pilot study, women were asked to use diaphragms continuously (removing once daily for cleaning) for 8 weeks and promote consistent male condom use; they were interviewed and examined clinically during follow-up. Focus group discussions (FGDs) were conducted pre-/postpilot study. Audiotaped FGDs were transcribed, translated, coded, and analyzed. RESULTS: Ninety-three women participated in prepilot FGDs, 91 in the pilot study, and 82 in postpilot FGDs. Diaphragm use was acceptable and feasible, but participants reported lower condom use in FGDs than during interviews. Most participants reported in interviews that they used their diaphragms continuously, but FGDs revealed that extensive intravaginal hygiene practices may impede effective continuous diaphragm use. Despite counseling by study staff, FGDs revealed that participants believed the diaphragm provided effective protection against STIs and pregnancy. CONCLUSIONS: Mixed methods formative research generated information that the prospective pilot study alone could not provide and revealed contradictory findings. Results have methodological and ethical implications that affect trial design including provision of free hormonal contraceptives, and additional instructions for vaginal hygiene to avoid displacing the diaphragm. Mixed methods formative research should be encouraged to promote evidence-based study design and implementation.

Socio-demographic and behavioural factors associated with high incidence of sexually transmitted infections in female sex workers in Madagascar following presumptive therapy.

BACKGROUND: Too little is known about the many women who generate income in Madagascar by trading sex. METHODS: Clinical and laboratory exams were offered to 493 non-care seeking female sex workers (SWs) in Antananarivo and 493 in Tamatave. SWs were recruited by peers in their community; they were interviewed, counselled and treated for sexually transmitted infections (STIs) at recruitment and re-evaluated 2 months later. RESULTS: One hundred and eighty six (38%) of the SWs in Antananarivo and 113 (23%) in Tamatave did not complete primary school (P < 0.0001). The incidence rates per person per month in Antananarivo and Tamatave, respectively, were 0.09 and 0.08 for gonorrhoea; 0.05 and 0.03 for chlamydia; 0.24 and 0.15 for trichomoniasis; 0.07 and 0.05 for syphilis. At follow-up, consistent condom use with clients was reported by 56 (12%) SWs in Antananarivo and 137 (29%) in Tamatave (P < 0.0001); 320 (70%) SWs in Antananarivo and 11 (2%) in Tamatave reported sex with a non-paying partner in the past month (P < 0.0001). In Antananarivo, 422 (92%) of the SWs thought they were at no or low risk of having an STI compared to 100 (21%) in Tamatave (P = 0.02). At follow-up, 277 (61%) SWs reported no birth control for their last sex act in Antananarivo, compared to 26 (5%) in Tamatave (P < 0.0001). Socio-demographic and behavioural risk factors for incident gonorrhoea, chlamydia and trichomoniasis varied by city. CONCLUSIONS: Strategies to address the needs of women who trade sex should include educational and economic opportunities; should tackle male partners of SWs; promote dual protection against unintended pregnancy and STIs, while taking into account local socio-demographic and behavioural characteristics.

Genetic typing of the porin protein of Neisseria gonorrhoeae from clinical noncultured samples for strain characterization and identification of mixed gonococcal infections.

Molecular methods that characterize the Neisseria gonorrhoeae porin protein Por are needed to study gonococcal pathogenesis in the natural host and to classify strains from direct clinical samples used with nucleic acid amplification-based tests. We have defined the capabilities of por variable region (VR) typing and determined suitable conditions to apply the method to direct clinical specimens. Nested PCR from spiked urine samples detected 1 to 10 copies of template DNA; freezing spiked whole urine greatly reduced the ability to amplify porB. In a laboratory model of mixed gonococcal infections, the por type of one strain could be determined in the presence of a 100-fold excess of another. por VR typing was used to examine clinical samples from women enrolled in studies conducted in Baltimore, Md., and Madagascar. por type was determined from 100% of paired cervical swab and wick samples from 20 culture-positive women from Baltimore; results for eight individuals (40%) suggested infection with more than one strain. In frozen urine samples from Madagascar, porB was amplified and typed from 60 of 126 samples from ligase chain reaction (LCR)-positive women and 3 samples from LCR-negative women. The por VR types of 13 samples (21%) suggested the presence of more than one gonococcal strain. Five por types, identified in >45% of women with typed samples, were common to both geographic areas. Molecular typing is an important adjunct to nucleic acid amplification-based diagnostics. Methods that utilize direct clinical samples and can identify mixed infections may contribute significantly to studies of host immunity, gonococcal epidemiology, and pathogenesis.

Participatory mapping of sex trade and enumeration of sex workers using capture-recapture methodology in Diego-Suarez, Madagascar.

BACKGROUND: Capture-recapture methodology has been employed to estimate the size of hidden or difficult-to-reach human populations such as sex workers, homeless persons, and intravenous drug users. This study took place in the context of efforts to improve the quality of curative and preventive services for sexually transmitted infections offered to sex workers in Diego-Suarez, Madagascar in partnership with sex workers. GOAL: The goal of this study was to better understand sex-trading practices, map out sex work sites, and estimate the size of a mobile sex-worker population in Diego-Suarez, Madagascar using methods that can be reproduced in other resource-poor settings. STUDY DESIGN: Forty sex workers were trained to function as field researchers. Key informants in designated neighborhoods were identified and interviewed. Basic maps of sex-trade sites were designed by hand. The number of sex workers in Diego-Suarez was estimated using capture-recapture methodology. An educational brochure was used to "capture" sex workers during a first phase, and "recapture" 2 weeks later. RESULTS: Most sex trade was street based and mobile. Capture-recapture methods estimated a total of 2684 sex workers (95% CI: 2588-2780) in Diego-Suarez, or approximately 12% of the 15- to 49-year-old female population in the city. CONCLUSION: Geographic mapping and capture-recapture proved to be low-cost and relatively easy to use techniques for counting a hard-to-reach population, such as female street-based sex workers. Sex workers can be capable fieldworkers, and their active participation in research concerning sex work should be considered whenever possible. A high proportion of women of reproductive age were found to engage in sex work, indicating that there is an urgent need to scale up sexually transmitted infection and HIV prevention activities targeting sex workers, their sexual partners, and the general population.

Evidence-based treatment guidelines for sexually transmitted infections developed with and for female sex workers.

BACKGROUND: Sex work is frequently one of the few options women in low-income countries have to generate income for themselves and their families. Treating and preventing sexually transmitted infections (STIs) among sex workers (SWs) is critical to protect the health of the women and their communities; it is also a cost-effective way to slow the spread of HIV. Outside occasional research settings however, SWs in low-income countries rarely have access to effective STI diagnosis. OBJECTIVES: To develop adequate, affordable, and acceptable STI control strategies for SWs. METHODS: In collaboration with SWs we evaluated STIs and associated demographic, behavioural, and clinical characteristics in SWs living in two cities in Madagascar. Two months post-treatment and counselling, incident STIs and associated factors were determined. Evidence-based STI management guidelines were developed with SW representatives. RESULTS: At baseline, two of 986 SWs were HIV+; 77.5% of the SWs in Antananarivo and 73.5% in Tamatave had at least one curable STI. Two months post-treatment, 64.9% of 458 SWs in Antananarivo and 57.4% of 481 women in Tamatave had at least one STI. The selected guidelines include speculum exams; syphilis treatment based on serologic screening; presumptive treatment for gonorrhoea, chlamydia, and trichomoniasis during initial visits, and individual risk-based treatment during 3-monthly follow-up visits. SWs were enthusiastic, productive partners. CONCLUSIONS: A major HIV epidemic can still be averted in Madagascar but effective STI control is needed nationwide. SWs and health professionals valued the participatory research and decision-making process. Similar approaches should be pursued in other resource-poor settings where sex work and STIs are common and appropriate STI diagnostics lacking.

Genital ulcers: etiology, clinical diagnosis, and associated human immunodeficiency virus infection in Kingston, Jamaica

Individuals presenting consecutively with genital ulcers in Kingston, Jamaica, underwent serological testing for human immunodeficiency virus (HIV) infection , chlamydial infection, and syphilis. Ulcer material was analyzed by the multiplex polymerase chain reaction (M-PCR) analysis DNA from herpes simplex virus (HSV), Haemophilus ducreyi, and Treponema pallidum was detected in 158 (52.0 percent), 72 (23.7 percent), and 31 (10.2 percent) of 304 ulcer specimens. Of the 304 subjects, 67 (22 percent) were HIV-seropositive and 64 (21 percent) were T. pallidum-seroactive. Granuloma inguinale was clinically diagnosed in nine (13.4 percent) of 67 ulcers negative by M-PCR analysis and in 12 (5.1 percent) of 237 ulcers positive by M-PCR analysis (P = .03). Lymphogranuloma venereum was clinically diagnosed in eight patients. Compared with M-PCR analysis, the sensitivity and specificity of a clinical diagnosis of syphilis, herpes, and chancroid were 67.7 percent, 53.8 percent, and 75 percent and 91.2 percent, 83.6 percent, and 75.4 percent, respectively. Reactive syphilis serology was 74 percent sensitive and 85 percent specific compared with M-PCR analysis. Reported contact with a prostitute in the preceding 3 months was associated with chancroid (P = .009), reactive syphilis serology (P = .011), and HIV infection (P = .007). The relatively poor pleads for syndromic management of genital ulcers in Jamaica. Prevention efforts should be intensified.(Au)

Sexually transmitted diseases are common in women attending Jamaican family planning clinics and appropriate detection tools are lacking

OBJECTIVES: To assess sexually transmitted diseases (STD) among women attending Jamaican family planning clinics and to evaluate decision models as alternatives to STD laboratory diagnosis. METHODS: Women attending two family planning clinics in Kingston were interviewed and tested for syphilis seroreactivity using toluidine red unheated serum test and Treponema pallidum haemagglutination, for gonorrhoea using culture, for chalamydial infection using enzyme linked immunoassay, and for trichomoniasis using culture. Urine was tested with leucocyte esterase dipstick (LED). The women were treated based upon a clinical algorithm. Computer simulations explored the use of risk inclusive decision models for detection of cervical infection and/or trichomoniasis. RESULTS: Among 767 women, 206 (26.9 percent) had at least one STD. The prevalence of gonorrhoea was 2.7 percent: chlamydial infection 12.2 percent, gonococcal and/or chlamydial cervical infection 14.1 percent; trichomoniasis 11.5 percent; syphilis seroreactivity 5.9 percent. The clinical algorithm was 3.7 percent sensitive and 96.7 percent specific in detecting cervical infection. Detection of cervical infection and/or trichomoniasis was 63.5 percent sensitive and 60.6 percent specific using LE and 57.7 percent sensitive and 46.2 percent specific using the risk inclusive algorithm employed in Jamaica STD clinics. Either cervical friability or LED (+) or family planning clinic attender less than 25 years old with more than one sexual partner in the past year was 72.5 percent sensitive and 53.3 percent specific. The positive predictive values of the STD clinic algorithm, LED, and two developed decision models ranged from 25.0 percent to 33.4 percent to detect cervical infection and/or trichomoniasis in these women. CONCLUSION: STDs were quite prevalent in these mainly asymptomatic family planning clinic attenders. None of the evaluated decision models can be considered a good alternative to case detection using laboratory diagnosis. Appropriate detection tools are needed. In the meantime, available STD control strategies should be maximised, such as promotion of condom use; adequate treatment of symptomatic STD patients and partners; and education of women and men (AU)

Aetiology of genital ulcer disease in patients attending an STD clinic in Kingston, Jamaica

The purpose of this study was to determine the aetiology of genital ulcers (GUD) in STD clinic attenders, using state-of-the-art diagnostic tests, and to compare this with clinical diagnosis. Patients attending an STD clinic in Kingston, Jamaica for a new STD complaints were screened for GUD and clinically diagnosed. Swabs of ulcers were taken and tested for T. pallidum (TP), herpes simplex virus (HSV), and H. ducreyi (HD), using polymerase chain reaction (PCR). Sera were tested for syphilis and HIV infection. Of 4873 patients screened, 304 (6.2 percent) had GUD. In patients with ulcers, 158 (52 percent) were HSV (+), 73 (24 percent) were HD (+), and 31 (10 percent) were TP (+). Dual infections were identified in 20 (7 percent) ulcers. Clinically, herpes was diagnosed in 85/158 (54 percent) of HSV (+) ulcers, chancroid in 54/72 (75 percent) of HD (+) ulcers, and syphilis in 21/31 (68 percent) of TP (+) ulcers. Over three-quarters of GUD in Kingston had defined aetiology for herpes, chancroid or syphilis using PCR, with herpes being the commonest. Uniformly, clinical diagnosis performed poorly and Jamaican algorithms for the management of GUD will need to take into account the findings of this study, and should include counselling for herpes.(AU)

Improving sexually transmitted disease management in the private sector: the Jamaica experience

OBJECTIVES: To improve the quality of sexually transmitted disease (STD) case management in Jamaica by providing comprehensive continuing medical education to private practitioners who manage 60 percent of all STDs on the island. METHODS: Six half-day STD seminars were presented at 3-4 month intervals and repeated in three separate geographic locations. All Jamaican practitioners received invitations. The subjects were as follows: urethritis, genital ulcer disease, HIV infection, vaginal discharge syndrome, STDs in children and adolescents, and a review seminar. The program effectiveness was evaluted with a written, self-reported pre-test and a telephone post-test that measured changes in clinical management. RESULTS: Six hundred and twenty eight practitioners attended at least one seminar. Comparing pre-versus post-test scores, there were practitioner improvement trends in all four of the general STD management categories: counseling/education (69.8-73.3 percent; P > 0.05); diagnostics/screening (57.2-71.0 percent; P = 0.042); treatment (68.3-74.5 percent; P > 0.05)l and knowledge (66.4-83.2 percent; P = 0.002). Obtaining syphilis serologies during pregnancy rose from 38.3 to 83.8 percent (P = 0.001), and providing effective treatment for gonorrhea rose form 57.8 to 81.1 percent (P = 0.002), but correct responses on treatment for mucopurulent cervicitis at the post-test was a low 32.4 percent. CONCLUSION: The introduction of contiuing medical education for improved STD care targetting private physicians in Jamaica was successful based on high attendance rates and self-reported STD management practices. However, efforts should continue to address the weaknesses found in STD management and counseling and to reach the providers who did not participate. In the global effort to reduce HIV transmission by improving STD care services. continuing education programs that target the private sector can be successful and should be included as standard activity to improve care and providee a public/private link to STD/HIV control.(Au)

The decentralization of syphilis screening for improved care in Jamaican public clinics: Collaborative Working Group on Decentralization Syphilis Screening

OBJECTIVES: This study examined the decentralization of syphilis screening for improved care in Jamaican public clinics. METHODS: One of every five serum samples tested at the six peripheral sites was frozen and retested at the central laboratory in Kingston. Patient files and laboratory logbooks were compared over a 3-month period. RESULTS: Between May 1993 and December 1994, 15.5 percent of 32913 patients with sexually transmitted disease and 8.3 percent of 8914 women seeking prenatal care were found syphilis seroreactive. Of 2001 samples evaluated, 1933 (96.6 percent) had been correctly reported at the peripheral sites. Of 129 syphilis seroreactors detected at the peripheral sites, 88 (68 percent) were treated the same day and 21 (16 percent) more within 3 days after testing. CONCLUSIONS: Syphilis seroreactors were accurately detected and quickly treated at the peripheral sites. If these efforts can be sustained, Jamaican syphilis rates should decrease.(AU)

Genital ulcer audit, Jamaica: patient profile - abstract

Between March and August 1996, 4873 patients (2,181 men and 2,682 women) attending the Comprehensive Health Centre, Kingston, for a new STD complaint were screened for genital ulcer disease (GUD). Prevalence of GUD was 7.3 percent (356/4,873; men 13.4 percent women 2.4 percent). This represented a two-fold decrease in six years. 304 (men 252, women 52) ulcer patients were questioned for demographic and behavioural factors related to STD, clinically assessed for GUD, and tested for HIV infection, syphilis and other GUDs. The employment rate among GUD patients was 77 percent (M 83 percent, F50 percent), 79 percent were single or had a steady visiting partner and 55 percent had completed secondary education. Condoms were reportedly used more than half of the time by 34 percent. Of 280 patients, 17 percent reported no contacts, 53 percent one, and 47 percent two or more in the past month. Of 274 subjects who admitted having sex in the previous three months, 55 percent were with steady partners, 43 percent with casual partners, 27 percent with new partners and 13 percent with prostitutes. A history of bruising was obtained from 50 percent of patients. It was significantly associated with the presence of more than 1 ulcer ( p=0.005), but not with clinical assessment of herpes. 24 percent of patients continued to have sex despite their ulcers and despite the fact that 58 percent of the ulcers were painful. One-third of patients had one ulcer, the rest, two or more. Prevalence of HIV-1 infection was 22 percent (M23 percent, F 19 percent), three times the rate in the general STD population. HIV infection was significantly higher (p<0.002) in patients clinically assessed as having granuloma inguinale, and in those with reactive tests for syphilis (p<0.002). Prevalence of syphilis serology [TRUST + MHA - TP(+)] was 24 percent (M 22 percent, F 33 percent). GUDs continue to be important in the transmission of HIV infection. Creative clinical and community approaches are required for its effective control. (AU)

Facility based assessment study, 1996 - abstract

The 1991 Facility Based Study Assessing STD case management identified the need to improve provider performance in the areas of history taking, treatment of syphilis, provision of education and counselling as well as distribution of condoms. The repeat Facility Based Study in 1996 showed much improvement. Adequate history taking increased from 34.2 percent to 86 percent at the Comprehensive Clinic (which has the greatest STD case load) and from 26.9 percent to 63.6 percent at the level 3 clinics with Contact Investigators (CIs). Treatment of syphilis was appropriate in 100 percent of cases in 1996 as compared with 74 percent in 1991. In level 3 clinics without CIs, providers discussed condom use with clients 25 percent of times in 1991 compared with 63 percent in 1996. Distribution of condoms at the clinics increased from 8 percent to 34 percent. The Facility Based Assessment is a useful method to guide improvements in STD case management and should be used every two or three years. (AU)

Vaginal discharge.

Preview A variety of genital pathogens, many of which are sexually transmitted, cause infections of the vagina and cervix. Discharge is often a prominent and telling symptom. Which infectious agents should be suspected when the discharge is accompanied by itching? Vulvar pain? Odor? Which laboratory tests are most helpful in making a diagnosis? The authors answer these and other questions in this overview of genital infections in women.