Clinical trial NCT00713999: Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar
Official title: Study of Reproductive Health in Rural Madagascar With Emphasis on Urogenital Schistosomiasis and Sexually Transmitted Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections
Schistosoma Haematobium
Keywords: Sexually transmitted infections
Urogenital schistosomiasis
Schistosoma haematobium
Reproductive health
Pelvic examination
Ultrasonography
Questionnaire
Madagascar
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
First posted: 2008-07-14
Enrollment: 680
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* adults
* positive Schistosoma haematobium egg excretion in urine
* signed written consensus

Exclusion Criteria:

* children
* negative Schistosoma haematobium egg excretion in urine

Primary outcomes:
measure: Measurement of urogenital schistosomiasis and STI prevalence
timeFrame: 2 months
Secondary outcomes:
measure: Urogenital and STI associated morbidity
timeFrame: 2 months
Other outcomes:
Locations:
city: Antananarivo
country: Madagascar
facility: Institut Pasteur
Study officials:
affiliation: Danish Bilharziasis Laboratory
name: Peter DC Leutscher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: