Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001250325
Ethics application status
Approved
Date submitted
22/08/2017
Date registered
28/08/2017
Date last updated
4/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of sexually transmitted infection (STI) testing on STI prevalence and safe sex behaviours of brothel sex workers in Bangladesh
Scientific title
The effects of sexually transmitted infection (STI) testing on STI prevalence and safe sex behaviours of brothel sex workers in Bangladesh: a randomised controlled trial
Secondary ID [1] 292569 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevalence of sexually transmitted infections 304238 0
Commercial safe sex behaviours 304239 0
Condition category
Condition code
Infection 303590 303590 0 0
Sexually transmitted infections
Public Health 303591 303591 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Brief name: Urine testing for sexually transmitted infections (STIs)

2. Why: No studies have looked at the associated sexual behaviours of female sex workers (FSWs) in Bangladesh after they are informed of their STI results. Past studies have shown that FSWs, especially those in developing countries, are less likely to seek treatment for STIs due to factors such as lack of money, lack of knowledge, and stigmatisation from health care professionals. They may even continue to engage in unprotected sex despite knowing their STI-positive status. This intervention examines whether providing STI testing to brothel sex workers (BSWs) in Bangladesh, informing them their test results, and providing information about where to seek treatment among those tested positive may influence their subsequent sexual behaviours.

3. What (materials): Each BSW in the intervention group received a urine bottle to collect their urine specimens.

4. What (procedures): Each BSW in the intervention group received a urine bottle the night before the urine collection from the designated urine collectors in our study. BSWs in the intervention group were instructed by the urine collectors to use the bottles to store their first morning urine the following day. The urine collectors returned to the brothels the following morning to collect the urine specimens from the BSWs. The urine specimens were then deposited into coolers and transported to the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) to test for chlamydia, gonorrhoea, herpes type I, herpes type II and syphilis. After the STI testing results were released by ICDDR,B, a certified doctor visited the brothels to inform the BSWs of their test results. The doctor also advised STI-positive BSWs on where to seek for STI treatment by providing them the names and addresses of the closest clinics.

5. Who provided: Two urine collectors trained by ICDDR,B with regard to the collection and storage of urine specimens. A certified doctor informed the BSWs of their urine test results and where to seek treatment if they were tested STI-positive. The doctor is currently a practising doctor at a government hospital in Bangladesh.

6. How: The urine collectors handed out the urine bottles and provided instructions to each BSW individually in person. The doctor informed BSWs of their urine test results individually in person.

7. Where: The urine test trial was conducted in two brothels, Mymensingh and Tangail, in Bangladesh. The urine test bottles were handed out to BSWs individually in each of their rooms at the brothels. The doctor informed BSWs of their urine test results individually in each of their rooms at the brothels.

8. When and how much: The urine test bottles were handed out to BSWs in the intervention group the night before their urine specimens were collected by our urine collectors the following morning.

9. Tailoring: After the urine specimens were analysed, a certified doctor in our study visited the BSWs individually to inform them of their urine test results.

10. Modifications: Nil.

11. How well (planned): The urine collectors in our study were trained by ICDDR,B on the collection and storage of urine specimens. The doctor in our study was instructed to deliver the urine test results to BSWs and to advise STI-positive BSWs on where to seek treatment by providing BSWs with the names and addresses of the closest clinics.

12. How well (actual): Urine specimens of all BSWs (235) in the intervention group were successfully analysed for STIs.
Intervention code [1] 298775 0
Diagnosis / Prognosis
Intervention code [2] 298950 0
Behaviour
Comparator / control treatment
Brothel sex workers in the control group did not undergo urine testing for sexually transmitted infections.
Control group
Active

Outcomes
Primary outcome [1] 303079 0
Change in prevalence of sexually transmitted infections (STIs) among brothel sex workers (BSWs) in the intervention group as assessed by a urine test conducted at follow-up.

The STI prevalence of BSWs in the intervention group is not compared to BSWs in the control group.
Timepoint [1] 303079 0
2 months after BSWs were informed of their first urine test results.
Secondary outcome [1] 337524 0
Commercial safe sex behaviours of brothel sex workers (BSWs) as assessed by a survey designed to elicit transactional information from BSWs.

The survey was designed specifically for this study.
Timepoint [1] 337524 0
2 months after BSWs were informed of their first urine test results.

Eligibility
Key inclusion criteria
-Brothel sex worker (BSW) had received clients in the past three days when the baseline survey was conducted.
- BSW had intended to continue to work as a sex worker in the brothel in the next six months when the baseline survey was conducted.
Minimum age
17 Years
Maximum age
36 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- BSW was pregnant at the time the baseline survey was conducted.
- BSW had only worked in the sex work industry for less than a month at the time the baseline survey was conducted.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the random number generator created by the statistical software, Stata (version 14). Simple randomisation is conducted on the recruited sample.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
- Sample size calculation: Past literature has detected a 51% decrease in prevalence of sexually transmitted diseases (STIs) when STI treatment was provided to female sex workers in Bangladesh. As our study provides brothel sex workers with information about treatment, our power calculations are carried out to detect a more conservative 25% reduction in STI prevalence among BSWs at follow-up. We use the Optimal Design software to calculate the minimum number of sex workers required to detect a 25% reduction in STI prevalence with an alpha of 0.10 and 80% power.

-Logistic regression models and linear regression models will be used to estimate the effects of STI testing on STI prevalence and commercial safe sex behaviours of brothel sex workers using the statistical software Stata (version 14). The p-values obtained from the regression models will be reported to determine if the effects are statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/02/2016
Date of last participant enrolment
Anticipated
Actual
5/03/2016
Date of last data collection
Anticipated
Actual
18/11/2016
Sample size
Target
480
Accrual to date
Final
467
Recruitment outside Australia
Country [1] 9120 0
Bangladesh
State/province [1] 9120 0
Mymensingh
Country [2] 9121 0
Bangladesh
State/province [2] 9121 0
Tangail

Funding & Sponsors
Funding source category [1] 297149 0
University
Name [1] 297149 0
Monash University
Country [1] 297149 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road, Clayton, VIC 3800
Country
Australia
Secondary sponsor category [1] 296178 0
Charities/Societies/Foundations
Name [1] 296178 0
Global Development & Research Initiative
Address [1] 296178 0
Shahid Sangbadik Selina Parveen Sarak
Apt-7/C (7th Floor), Hall Marks
66 Outer Circular Road, Boro Mogbazar
Dhaka-1217, Bangladesh.
Country [1] 296178 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298317 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 298317 0
Ethics committee country [1] 298317 0
Australia
Date submitted for ethics approval [1] 298317 0
Approval date [1] 298317 0
13/05/2014
Ethics approval number [1] 298317 0
CF13/3517 - 2013001769

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1934 1934 0 0
/AnzctrAttachments/373409-2013001769-approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 76694 0
A/Prof Asadul Islam
Address 76694 0
Caulfield Campus
Building H, Room 4.37, 26 Sir John Monash Drive
Monash University, VIC 3145
Country 76694 0
Australia
Phone 76694 0
+61 3 99032783
Fax 76694 0
Email 76694 0
[email protected]
Contact person for public queries
Name 76695 0
Asadul Islam
Address 76695 0
Caulfield Campus
Building H, Room 4.37, 26 Sir John Monash Drive
Monash University, VIC 3145
Country 76695 0
Australia
Phone 76695 0
+61 3 99032783
Fax 76695 0
Email 76695 0
[email protected]
Contact person for scientific queries
Name 76696 0
Asadul Islam
Address 76696 0
Caulfield Campus
Building H, Room 4.37, 26 Sir John Monash Drive
Monash University, VIC 3145
Country 76696 0
Australia
Phone 76696 0
+61 3 99032783
Fax 76696 0
Email 76696 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of testing on sexually transmitted infections among female brothel sex workers in bangladesh: A randomized controlled trial.2021https://dx.doi.org/10.4269/ajtmh.20-0942
N.B. These documents automatically identified may not have been verified by the study sponsor.