Sexually Transmitted Infections Clinical Trial
Official title:
Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label
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