Clinical Trial: Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections
Brief Summary: 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 Summary:
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.
Sponsor: University of Aarhus
Current Primary Outcome: Measurement of urogenital schistosomiasis and STI prevalence [ Time Frame: 2 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Urogenital and STI associated morbidity [ Time Frame: 2 months ]
Original Secondary Outcome: Same as current
Information By: University of Aarhus
Dates:
Date Received: July 8, 2008
Date Started: August 2001
Date Completion:
Last Updated: July 11, 2008
Last Verified: July 2008
