Modelling the cost per ulcer treated of incorporating episodic treatment for HSV-2 into the syndromic algorithm for genital ulcer disease.

BACKGROUND: The proportion of genital ulcer disease (GUD) due to herpes simplex virus type-2 (HSV-2) has increased in sub-Saharan Africa. The most recent 2003 WHO syndromic GUD algorithm includes antiviral treatment for HSV-2 for anyone with "typical" symptoms/signs, and suggests that all GUD patients receive treatment for HSV-2 in settings where HSV-2 GUD aetiology is greater than 30%. The previous algorithm (1994) only targeted Haemophilus ducreyi (HD) and Treponema pallidum (TP). METHODS: A static deterministic model was used to compare the cost per ulcer treated of using the 1994 and 2003 algorithms amongst individuals presenting with GUD, with sensitivity analyses for different economic and epidemiological scenarios. RESULTS: Except when the proportion of ulcers due to HD/TP (defined as ulcer prevalence) is high (>40%), and HSV-2 ulcer prevalence is low (<30%), the 2003 algorithm should result in more patients receiving the correct treatment (correct drugs for the syndrome) than the 1994 algorithm, and it will cost less per ulcer treated if HSV-2 treatment costs less than US$2. Greatest impact in terms of ulcers treated is achieved with the 2003 algorithm if HSV-2 treatment is given to all GUD patients. The incremental and/or relative cost per ulcer treated of doing this, compared to only treating those with typical symptoms/signs, is reduced if the HSV-2 ulcer prevalence is high and/or the HSV-2 treatment cost or sensitivity of HSV-2 ulcer diagnosis (using symptoms/signs) is low. CONCLUSIONS: In certain scenarios, including HSV-2 treatment can increase the number of ulcers treated and reduce the cost per ulcer treated of GUD syndromic management.

Field evaluation of the performance and testing costs of a rapid point-of-care test for syphilis in a red-light district of Manaus, Brazil.

OBJECTIVES: To assess the performance, usefulness and cost of a rapid treponemal antibody assay (VisiTect Syphilis) to detect syphilis in high risk populations. METHODS: People who attended STI clinics in Manaus, Brazil, were screened for syphilis using the fluorescent treponemal antibody absorption (FTA-Abs) test and a non-treponemal test (Venereal Diseases Research Laboratory (VDRL)), and for HIV. Finger prick blood samples were tested with VisiTect Syphilis. The rapid test was evaluated against the reference FTA-Abs and for its usefulness in detecting active syphilis (FTA-Abs and VDRL positive). Operational performance was assessed through providers' and patients' interviews. An economic evaluation was conducted from the provider's perspective. RESULTS: 510 patients (60% men) were enrolled, of whom 13 (2.5%) were HIV-1 seropositive. Syphilis prevalence (FTA-Abs) was 18% and active syphilis prevalence was 7.5%. 11% (57/506) of samples were positive by VisiTect. The sensitivity, specificity, positive and negative predictive values of VisiTect Syphilis were 57% (95% CI 45.8 to 66.7), 99% (95% CI 97.0 to 99.6), 91% (95% CI 80.0 to 96.7) and 91% (95% CI 88.0 to 93.5), respectively. VisiTect Syphilis identified 79% (30/38) of active syphilis cases. The cost per case of syphilis was $16.8 for VDRL, $33.2 for low cost and $56.3 for high cost VisiTect Syphilis; the cost per case of active syphilis was $21.3, $57.5 and $97.6, respectively. Patients identified finger prick pain and preference for venous blood collection as minor barriers to test use. CONCLUSION: VisiTect Syphilis had low sensitivity in field use and was less cost effective than conventional VDRL. However, rapid and correct identification of a high proportion of active syphilis cases combined with operational characteristics suggest a role in high risk populations.

Management of sexually transmitted diseases in urban pharmacies in The Gambia.

This study aimed to describe the quality and costs of sexually transmitted disease (STD) case management in urban pharmacies in The Gambia, and explore pharmacy workers' (PWs) willingness to improve the STD care they provide. PWs from 24 registered pharmacies were interviewed in order to collect information on their knowledge and practices regarding management of STDs. The same pharmacies were visited by a male 'simulated client' (SC) to ascertain how urethral discharge syndrome (UDS) cases were managed in practice. Fifteen (63%) pharmacies were equipped for treatment of UDS, pelvic inflammatory disease (PID) and genital ulcer syndrome (GUS), according to national guidelines. Appropriate syndromic management for UDS was mentioned by 11% of PWs but actually given to 4.4% of the SC visits. None of the PID or GUS cases would be treated correctly. Forty-two per cent of PWs advised on partner notification, 38% on safe sex and 29% on treatment compliance in the SC visits. The reported costs for treatment of UDS, PID and GUS ranged from $2.5-$15.0. The cost of treatment actually purchased by the SC averaged $3.5 (range $1.5-$9.6) for UDS. Excluding the pharmacy sector from interventions will limit the impact of STD control measures. Regular training in syndromic management and rational drug use, with a concise manual for reference are recommended. Strategies to lower the cost of drugs should be explored.

Operational performance of an STD control programme in Mwanza Region, Tanzania.

OBJECTIVES: To describe important details of the design and operational features of the Mwanza sexually transmitted diseases (STD) control programme. To assess the feasibility of the intervention, the distribution of STD syndromes observed, the clinical effectiveness of syndromic STD case management, the utilisation of STD services by the population, and the quality of syndromic STD services delivered at rural health units. METHODS: The intervention was integrated into rural primary healthcare (PHC) units. It comprised improved STD case management using the syndromic approach, facilitated by a regional programme office which ensured the training of health workers, a reliable supply of effective drugs, and regular support supervision. Five studies were performed to evaluate operational performance: (i) a survey of register books to collect data on patients presenting with STDs and reproductive tract infections (RTIs) to rural health units with improved STD services, (ii) a survey of register books from health units in communities without improved services, (iii) a survey of register books from referral clinics, (iv) a home based cross sectional study of STD patients who did not return to the intervention health units for follow up, (v) a cross sectional survey of reported STD treatment seeking behaviour in a random cohort of 8845 adults served by rural health units. RESULTS: During the 2 years of the Mwanza trial, 12,895 STD syndromes were treated at the 25 intervention health units. The most common syndromes were urethral discharge (67%) and genital ulcers (26%) in men and vaginal discharge (50%), lower abdominal tenderness (33%), and genital ulcers (13%) in women. Clinical treatment effectiveness was high in patients from whom complete follow up data were available, reaching between 81% and 98% after first line treatment and 97%-99% after first, second, and third line treatment. Only 26% of patients referred to higher levels of health care had presented to their referral institutions. During the trial period, data from the cohort showed that 12.8% of men and 8.6% of women in the intervention communities experienced at least one STD syndrome. Based on various approaches, utilisation of the improved health units by symptomatic STD patients in these communities was estimated at between 50% and 75%. During the first 6 months of intervention attendance at intervention units increased by 53%. Thereafter, the average attendance rate was about 25% higher than in comparison communities. Home visits to 367 non-returners revealed that 89% had been free of symptoms after treatment, but 28% became symptomatic again within 3 months of treatment. 100% of these patients reported that they had received treatment, but only 74% had been examined, only 57% had been given health education, and only 30% were offered condoms. Patients did not fully recall which treatment they had been given, but possibly only 63% had been treated exactly according to guidelines. CONCLUSIONS: This study demonstrated that it is feasible to integrate effective STD services into the existing PHC structure of a developing country. Improved services attract more patients, but additional educational efforts are needed to further improve treatment seeking behaviour. Furthermore, clear treatment guidelines, a reliable drug supply system, and regular supervision are critical. All efforts should be made to treat patients on the spot, without delay, as referral to higher levels of care led to a high number of dropouts. The syndromic approach to STD control should be supported by at least one reference clinic and laboratory per country to ensure monitoring of prevalent aetiologies, of the development of bacterial resistance, and of the effectiveness of the syndromic algorithms in use.

Effectiveness, impact and cost of syndromic management of sexually transmitted diseases in Tanzania.

PIP: HIV infection continues to occur at high levels in sub-Saharan Africa, with adult prevalence often exceeding 20% in some urban areas. Prevalence is lower, but steadily increasing in rural areas where most Africans still live. Managing STDs is an increasingly recommended HIV prevention strategy, since the results of many epidemiological studies suggest that the presence of STDs may enhance the sexual transmission of HIV. However, in many parts of Africa, no resources exist with which to properly diagnose STDs. The World Health Organization has therefore been promoting the syndromic management of STDs, an approach which provides immediate diagnosis and treatment without expensive and time-consuming laboratory tests. Findings are reported from a study conducted to assess the impact of improved STD services at the primary care level upon the incidence of HIV infection in Mwanza Region, northern Tanzania. 6 rural communities received improved STD case management, while 6 other communities received only the usual STD services. Communities were matched in pairs based upon pre-intervention STD attendance rates and location. Over the course of 2 years, 11,632 STD syndromes were treated in the intervention health units. Observed cure rates were high. At baseline, HIV-1 prevalence rates in the intervention and control communities were 3.8% and 4.4%, respectively. HIV-1 seroconversion was 1.2% over 2 years in the intervention communities and 1.9% in the control communities, corresponding to a 42% decreased risk of seroconversion in the intervention communities after adjusting for age, sex, history of travel, baseline STD prevalence, and male circumcision.^ieng

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.

STD rapid assessment in Rwandan refugee camps in Tanzania.

OBJECTIVE: To obtain baseline information on sexually transmitted diseases (STDs) in the Rwandan refugees camps in Tanzania, prior to establishment of STD services. SETTING: The largest camps of Rwandan refugees in the Ngara District of Tanzania (estimated population 300,000). The study was carried out in 8 days in August 1994. SUBJECTS AND METHODS: A rapid assessment technique was used to measure STD prevalences among: (i) 100 antenatal clinic attenders (ANC); (ii) 239 men from outpatient clinics (OPD); and (iii) 289 men from the community. Interviews (by questionnaire) and genital examination were performed for all participants; sampling for females included genital swabs for the the diagnosis of Neisseria gonorrhoeae (NG), Candida albicans (CA), Trichomonas vaginalis (TV), bacterial vaginosis (BV) and a blood sample for syphilis serology. Men provided urine samples which were screened for leucocytes using the leucocyte esterase (LE) dipstick; urethral swabs for Gram stain were taken from men with a reactive LE test and from those with symptoms or signs of urethritis. OPD males provided a blood sample for syphilis serology. RESULTS: All groups reported frequent experience with STDs and engaging in risky sexual behaviour prior to the survey. During the establishment of the camps, sexual activity was reportedly low. Over 50% of ANC attenders were infected with agents causing vaginitis (TV/BV/CA) and 3% were infected with NG. The prevalence of active syphilis was 4%. In the male outpatients, the prevalence of urethritis was 2.6% and of serological syphilis was 6.1%. Among males in the community, the prevalence of urethritis was 2.9% (the majority being asymptomatic infections). We noted frequent over-reporting of STD symptoms, unconfirmed clinically or biologically. CONCLUSIONS: STD case detection and management should be improved by training health workers in using the WHO syndromic approach, and through IEC campaigns encouraging attendance at clinics. Rapid epidemiological methods provide quick and useful information at low cost in refugee camps.

Cost-effectiveness of improved treatment services for sexually transmitted diseases in preventing HIV-1 infection in Mwanza Region, Tanzania.

BACKGROUND: A community-randomised trial was undertaken to assess the impact, cost, and cost-effectiveness of averting HIV-1 infection through improved management of sexually transmitted diseases (STDs) by primary-health-care workers in Mwanza Region, Tanzania. METHODS: The impact of improved treatment services for STDs on HIV-1 incidence was assessed by comparison of six intervention communities with six matched communities. We followed up a random cohort of 12,537 adults aged 15-54 years for 2 years to record incidence of HIV-1 infection. The total and incremental costs of the intervention were estimated (ingredients approach) and used to calculate the total cost per case treated, the incremental cost per HIV-1 infection averted, and the incremental cost per disability-adjusted life-year (DALY) saved. FINDINGS: During 2 years of follow-up, 11,632 cases of STDs were treated in the intervention health units. The baseline prevalence of HIV-1 infection was 4%. The incidence of HIV-1 infection during the 2 years was 1.16% in the intervention communities and 1.86% in the comparison communities. An estimated 252 HIV-1 infections were averted each year. The total annual cost of the intervention was US$59,060 (1993 prices), equivalent to $0.39 per head of population served. The cost for STD case treated was $10.15, of which the drug cost was $2.11. The incremental annual cost of the intervention was $54,839, equivalent to $217.62 per HIV-1 infection averted and $10.33 per DALY saved (based on Tanzanian life expectancy) or $9.45 per DALY saved (based on the assumptions of the World Development Report). In a sensitivity analysis of factors influencing cost-effectiveness, cost per DALY saved ranged from $2.51 to $47.86. INTERPRETATION: Improved management of STDs in rural health units reduced the incidence of HIV-1 infection in the general population by about 40%. The estimated cost-effectiveness of this intervention ($10 per DALY) compares favourably with that of, for example, childhood immunisation programmes ($12-17 per DALY). Cost-effectiveness should be further improved when the intervention is applied on a larger scale. Resources should be made available for this highly cost-effective HIV control strategy.

PIP: Improved management of sexually transmitted diseases (STDs) is consistently advocated as an effective strategy for HIV prevention. The impact, cost, and cost-effectiveness of this approach were evaluated in a prospective, comparative study of six communities in Tanzania's Mwanza Region in which primary health care center workers were trained to provide improved STD treatment and six matched non-intervention communities. The baseline prevalence of HIV was 4% in both groups. During the 2-year study period, 11,632 cases of STDs were treated in the intervention health units. The HIV seroconversion rate was 1.16% in the intervention communities and 1.86% in the comparison communities--a difference in HIV incidence of 0.70 (95% confidence interval, 0.37-1.09) and a reduction of about 40%. The total annual cost of the intervention was US$59,060 ($0.39 per person served). The cost of STD treatment was $10.15 per case. An estimated 252 HIV-1 infections were averted each year. The incremental annual cost of the program was $54,839, equivalent to $217.62 per HIV infection averted and $10.33 per disability-adjusted-life-year (DALY) saved. The estimated cost-effectiveness compares favorably with that of childhood immunization programs ($12-17 per DALY saved) and could be further enhanced through implementation of the intervention on a wider scale. The intervention subsequently has been expanded to encompass 65 health units in Mwanza Region, with no increase in investment costs.

Taking early action in emergencies to reduce the spread of STDs and HIV.

PIP: The disintegration of family life, disruption of social norms, poverty, and commercial sexual activity associated with the lives of Rwandan refugees in camps in northwest Tanzania increase their susceptibility to sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV). To prevent such an outcome, the African Medical and Research Foundation proposed that STD/HIV interventions be launched under the auspices of the governing body in the refugee camps. A rapid assessment methodology survey was conducted to acquire baseline data for resource allocation (drugs and personnel), case finding strategies, and staff training. Each refugee community was visited by a team of specially trained health behavior promoters who presented a four-part IEC package: sensitization of camp leaders, general STD/HIV awareness, STD treatment-seeking behaviors, and sexual behavior modification through peer education. Condoms and health education materials were distributed by peer educators. STD services have been introduced to outpatient, family planning, and prenatal clinics in the camps. Although HIV testing was not undertaken for political reasons, pregnant women at three camps received screening for syphilis. Such STD control interventions should become a standard component of refugee assistance.^ieng

Risk assessment and other screening options for gonorrhoea and chlamydial infections in women attending rural Tanzanian antenatal clinics.

Sexually transmitted diseases (STDs) are a major cause of morbidity and mortality in developing countries and may play a key role in enhancing the heterosexual transmission of human immunodeficiency virus (HIV). Treatment of STDs is one of the most cost-effective of all health interventions in developing countries; however, STDs among women in rural populations have received little attention. In this study, we report that prevalences of STDs among 964 women attending antenatal clinics in a rural area of the United Republic of Tanzania. A total of 378 (39%) of these women were infected with at least one STD pathogen, 97 (10%) had syphilis, and 81 (8%) has Neisseria gonorrhoeae (NG) and/or Chlamydia trachomatis (CT) infection. The recommended syndromic approach to screening for NG/CT infection, based on reported genital symptoms, had a low sensitivity (43%) and failed to discriminate between infected and uninfected women. A risk score approach that we developed, based on sociodemographic and other factors associated with NG/CT infection, had a higher sensitivity and lower cost per true case treated than other approaches, although its positive predictive value was only about 20%.

PIP: During 1992-1993 in 12 rural health centers in Mwanza region, Tanzania, a baseline survey was conducted of 964 women attending a prenatal clinic to determine the prevalence of sexually transmitted diseases (STDs) and to evaluate various screening methods to identify those infected with Neisseria gonorrhoeae and Chlamydia trachomatis. Only 2.7% had ever used condoms. 66% had symptoms (vaginal discharge, genital itching, lower abdominal pain, painful or difficult urination, difficult or painful intercourse) associated with genital tract infection. 37% had abnormal vaginal discharge. 39% had a laboratory-confirmed STD. 49% had a reproductive tract infection. 10.1% had syphilis. 8.4% had gonorrhea and/or chlamydia. Sociodemographic factors associated with gonorrhea/chlamydia included age less than 25 (odds ratio [OR] = 2.2), unmarried status (OR = 3.2;), polygamous marriage (OR = 2.3), last child born more than 5 years earlier (OR = 3.2), and more than 1 sexual partner during the last year (OR = 1.7). When the researchers adjusted for these factors, the only signs or symptoms associated with gonorrhea/chlamydia were painful intercourse (OR = 2.1; p 0.02) and cervical discharge (OR = 3.2; p 0.06). The syndromic approach (based on vaginal discharge and/or genital itching and other symptoms related to the genital tract but not necessarily indicative of gonorrhea/chlamydia in pregnancy) had a higher sensitivity than the recommended syndromic approach based only on vaginal discharge and/or genital itching (72% vs. 43%). The risk score approach based on sociodemographic and other factors associated with gonorrhea/chlamydia infection had a higher sensitivity and lower cost/true case treated than other approaches. Yet, its positive predictive value was no greater than about 20%. A combination of case management using the World Health Organization syndromic approach for women with self-recognized genital infections together with screening for gonorrhea/chlamydia using a score-driven approach may be the most cost-effective approach to diagnosing and treating STDs.