Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar

Study Overview
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Brief Summary
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A cross-sectional study of urogenital schistosomiasis and sexually transmitted infections (STI) prevalence and associated morbidity in a rural community in Madagascar. Clearance of infections and resolution of morbidity were subsequently studied in two phases following systematic anti-STI and anti-schistosoma treatment, respectively.

Detailed Description
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The study was conducted in the Schistosoma haematobium high-endemic SIRAMA sugarcane plantation near the Ambilobe town in the northern province of Diego Suarez in Madagascar. A neighboring low-endemic village, Mataipako, was selected a control village. Participants aged 15 to 49 years old from SIRAMA were included in the study if positive for S.haematobium egg in urine. A questionnaire addressing previous medical history and current urogenital symptoms was applied. A physical examination, including ultrasonophical (US) examination of urinary tract by transabdominal route, was undertaken. A pelvic examination, including transvaginal US was performed in women. In men, the prostate and the seminal vesicles were examined by transrectal US. The following sexually transmitted infections (STI) were systematically assessed: Neisseria gonorrheae Chlamydia trachomatis Mycoplasma genitalium Trichomonas Treponema pallidum Herpes simplex 1 and 2 After baseline assessment, all participants (and partners) were systematically treated with an anti-STI regimen according to the existing guidelines by the Ministry of Health in Madagascar. Re-assessment by questionnaire, physical examination and sampling for STIs was undertaken 4 weeks later followed by systematic praziquantel treatment to general community, including study participants. A final follow-up study following the baseline protocol was conducted 5 months later.

Official Title
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Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections

Conditions
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Sexually Transmitted Infections, Schistosoma Haematobium

Intervention / Treatment
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* Drug: Treatment with anti-STI and anti-schistosoma regimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults positive Schistosoma haematobium egg excretion in urine signed written consensus Exclusion Criteria: children negative Schistosoma haematobium egg excretion in urine

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STI/PZQ 1<br>Baseline and post-treatment follow-up (anti-STI and praziquantel Rx) | Drug: Treatment with anti-STI and anti-schistosoma regimens<br>* Anti-STI regimen: ciprofloxacin 500mg orally, doxycycline 100mg BID orally 7 days and metronidazole 2g orally (cefuroxime im and/or azithromycin alternatively for pregnant and breastfeeding women) Anti-schistosoma regimen: Praziquantel 40mg/kg<br>* Other names: Biltricide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of urogenital schistosomiasis and STI prevalence |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urogenital and STI associated morbidity |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexually transmitted infections, Urogenital schistosomiasis, Schistosoma haematobium, Reproductive health, Pelvic examination, Ultrasonography, Questionnaire, Madagascar