Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000161729
Ethics application status
Approved
Date submitted
1/12/2021
Date registered
31/01/2022
Date last updated
31/01/2022
Date data sharing statement initially provided
31/01/2022
Date results provided
31/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a safe sex intervention on the sexual behavior of brothel sex workers.
Scientific title
Effects of a safe sex intervention on the commercial sexual behavior of brothel sex workers in Bangladesh.
Secondary ID [1] 306112 0
None
Universal Trial Number (UTN)
U1111-1272-0832
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Sexually transmitted infections 324536 0
Human immune deficiency virus infection 324537 0
Condition category
Condition code
Infection 322004 322004 0 0
Sexually transmitted infections
Infection 322005 322005 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We randomly assigned Female Sex Workers (FSWs) employed in our study to one of two treatment groups or the control group. In treatment 1 (T1), SWs participated in a safe sex information session in which they were provided with information on STIs/HIV and safe sex practices. In treatment 2 (T2), they participated in a safe sex information session, and received a counselling session in which they were taught the skills and techniques to negotiate with their clients to get them to wear condoms.
For counselling, we adapted four approaches of condom negotiation that were used by Wong et al. (1994), and Maher et al. (2013) with FSWs in Singapore and Cambodia, respectively. The four approaches are the positive approach, fear arousal approach, peer pressure approach and assertive approach. The positive approach highlights the benefits of condom use to clients; the fear arousal approach emphasises the consequences of non-condom use to clients (i.e. increased risk of contracting STIs or HIV/AIDS); the peer pressure approach encourages clients to wear condoms by highlighting that other clients are also wearing condoms; and with the assertive approach FSWs are taught how to encourage clients to use condoms by refusing to have any form of sexual penetration with the client unless he agrees to wear a condom.

In addition to the enumerators employed in our study, who were responsible for conducting the baseline survey and T1 intervention, qualified education psychologists were deployed as counsellors to conduct the T2 intervention. The counsellors were trained by a professional counsellor, who had prior counselling experience in HIV/AIDS prevention programmes in Bangladesh, on how to conduct the condom negotiation session with the participants.

Both interventions were conducted between April 2016 and June 2016. The follow-up survey was conducted with all participants between October 2016 and November 2016, which was approximately eight months after the baseline survey was first rolled out, and approximately six months after the intervention first commenced.

2.3.1 T1: Safe sex information intervention

The safe sex information intervention was carried out between each enumerator and participant, one at a time, in the participant’s room. Each enumerator began the intervention by providing participants with information on STIs with the help of a flipchart. The STIs that we focused on were chlamydia, gonorrhoea, syphilis, hepatitis B and HIV/AIDS. The flipchart provides information on the symptoms, consequences, testing, treatment, and prevention of these STIs. The flipchart also provided pictorial examples of the STIs. Once the flipchart was completed, the enumerators proceeded to show participants a seven-minute video on HIV/AIDS, which was specifically prepared for this purpose. The HIV/AIDS video was prepared with assistance from experts in the sex work industry with the objective of educating participants on safe sex behaviour. To ensure that the video was relevant to the participants, we employed actresses to play the role of sex workers working in brothels.

We then instructed the enumerators to conduct a health knowledge test with the participants to ensure that the participants understood and remembered the safe sex information provided to them. The health knowledge test is made up of twenty items and was conducted after the enumerators had completed the flipchart session and participants had watched the video. The enumerators began the test by reading out the first question followed by the available options that the participants could choose as their answers.

After the participant answered the first question, the enumerators then proceeded to the second question. This process continued until participants had answered all twenty questions. At the end of the test, the enumerators tallied the total score. If the participants failed to get full marks on their first attempt at the test, the enumerators went over the incorrectly answered questions and provided participants with the correct answers to these questions. Once this process was completed, the enumerators conducted the test with the participants again. The maximum number of attempts allowed for the test was two.

At the end of the test, participants in T1 were paid 100 Taka (US$1.28) each to compensate them for their time. The whole process for the T1 intervention took between thirty to forty minutes to complete.

2.3.2 T2: Safe sex information plus counselling intervention

Similar to T1, the safe sex information session and counselling session were carried out between one counsellor and one participant at a time in the participant’s room. The safe sex information session in T2 followed the same process in T1 as discussed above. Once the safe sex information session was completed, the counsellors proceeded with the counselling session in the participant’s room.

The counselling session was done in a relatively informal manner. Instead of immediately addressing the four approaches available for condom use negotiation, the counsellors began by asking participants general questions about their occupation and work experience. The purpose of doing this was to create a more comfortable discussion environment, and build trust, so that participants were more willing to share their commercial sexual experiences with the counsellors. This has also helped the counsellors to tailor the way that they presented the four approaches to condom use negotiation based on the responses of participants.

At the end of the counselling session, participants in T2 were paid 150 Taka (US$1.92) each to compensate them for their time. T2 took between sixty to seventy-five minutes to complete.

A follow-up session was also conducted between the counsellors and their assigned participants one week after the T2 intervention for both the T1 and T2 participants. The follow-up session was conducted between one counsellor and one participant at a time in the participant’s room. Each follow-up session was conducted over approximate 30 minutes. The purpose of the follow-up session was to gain a brief understanding of the safe sex behaviour of the participants with their clients after the intervention, and for the counsellors to remind the participants about the four approaches to condom use negotiation. No data was collected during this follow-up session. Monitoring to check the adherence or compliance of the interventions was not conducted because of the pattern of the study population.
Intervention code [1] 322333 0
Behaviour
Comparator / control treatment
The control group did not receive any treatment.
Control group
Active

Outcomes
Primary outcome [1] 330010 0

Proportion of repeat clients (%)

The proportion of repeat clients (%) assessed by a study-specific questionnaire approved by the ethics committee.
Timepoint [1] 330010 0
Six months after the intervention
Primary outcome [2] 330226 0
Proportion of clients inspected for STIs (%)

The proportion of clients inspected for STIs (%) was assessed by a study-specific questionnaire approved by the ethics committee.
Timepoint [2] 330226 0
Six months after intervention
Primary outcome [3] 330228 0
Proportion of clients used condom (%)

The proportion of clients who used condoms (%) was assessed by a study-specific questionnaire approved by the ethics committee.
Timepoint [3] 330228 0
Six months after the intervention
Secondary outcome [1] 405363 0

Proportion of regular clients (%); Primary

The proportion of regular clients (%) was assessed by a study-specific questionnaire approved by the ethics committee.
Timepoint [1] 405363 0
Six months after the intervention
Secondary outcome [2] 405364 0
Proportion of clients suspected of having STIs (%); Primary

The proportion of clients suspected of having STIs (%) was assessed by a study-specific questionnaire approved by the ethics committee.
Timepoint [2] 405364 0
Six months after the intervention
Secondary outcome [3] 405365 0
Price per client

The information related to the price per client was assessed by a study-specific questionnaire approved by the ethics committee.
Timepoint [3] 405365 0
Six months after the intervention
Secondary outcome [4] 405366 0
Monthly earnings

The information related to the monthly earnings was assessed by a study-specific questionnaire approved by the ethics committee.
Timepoint [4] 405366 0
Six months after the intervention
Secondary outcome [5] 405367 0
Health score (on a scale of 0-20)
Timepoint [5] 405367 0
Six months after intervention
Secondary outcome [6] 405368 0
Overall risk attitude (on a scale of 0-10)
Timepoint [6] 405368 0
Six months after intervention
Secondary outcome [7] 405369 0
Financial risk attitude (on a scale of 0-10)
Timepoint [7] 405369 0
Six months after intervention
Secondary outcome [8] 405370 0
Health risk attitude (on a scale of 0-10)
Timepoint [8] 405370 0
Six months after intervention

Eligibility
Key inclusion criteria
Female Sex Workers: (i) aged between 17 and 36 years; (ii) must have engaged in a commercial transaction in the past few days; and (iii) not be pregnant.
Minimum age
17 Years
Maximum age
36 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 17 years and more than 36 years
Not involved in commercial transaction

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomization was done.

For the purpose of randomization, we grouped together rooms that were close to one another. Participants located in rooms in a building (or in blocks in some cases) that are close to one another may share similar characteristics.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participants’ characteristics were summarized using descriptive statistics, mean and standard deviation (SD). Ordinary least square regression models were used to measure the impact of our intervention on the outcomes of interest. The first set of outcomes of interest are market transaction outcomes (e.g., earnings and the commercial sexual transaction price) and behavioural responses (e.g., whether the client was a regular, whether the client was suspected of having STIs; whether the participant inspected the client for STIs, and whether the transaction involved safe sex) based on the last three transactions. In the appendix, we also report results based on the last three days’ transactions which are potentially more susceptible to recall errors or bias. The second set of outcomes was beliefs and knowledge about HIV and other STIs and self-reported risk attitudes (overall risk, financial risk, and health risk). We also estimated the effect of the intervention on self-reported risk attitudes and the anxiety level of FSWs using the Health Anxiety Inventory (HAI-18).18 All outcomes of interest were collected at baseline and follow-up. Finally, we measured whether the interventions indirectly influence non-treated individuals. We conduct our analysis, including the balancing test for randomization, by clustering the standard errors at the building (blocks) level. Within the area in which FSWs reside, we also used a randomized saturation design in which there was exogenous variation in the saturation/intensity of participants assigned to the treated group across the buildings, which ranged between 0 and 100 percent. The ‘intensity’ measure is defined as the number of participants assigned to the treated group in each building (or block) divided by the total number of participants in the building. The variation in the intensity measure allows us to estimate any potential spillover effects. To do that, we again used ordinary least square regression models.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
31/07/2016
Date of last data collection
Anticipated
Actual
30/11/2016
Sample size
Target
1140
Accrual to date
Final
1132
Recruitment outside Australia
Country [1] 24360 0
Bangladesh
State/province [1] 24360 0
Dhaka

Funding & Sponsors
Funding source category [1] 310281 0
University
Name [1] 310281 0
Monash University
Country [1] 310281 0
Australia
Funding source category [2] 310282 0
Government body
Name [2] 310282 0
National Institute of Health
Country [2] 310282 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 311388 0
Government body
Name [1] 311388 0
National Institute of Health
Address [1] 311388 0
10 Center Dr, Bethesda, MD 20814, United States
Country [1] 311388 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309950 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 309950 0
Ethics committee country [1] 309950 0
Australia
Date submitted for ethics approval [1] 309950 0
Approval date [1] 309950 0
13/05/2014
Ethics approval number [1] 309950 0
CF13/3517 - 2013001769

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115958 0
Prof Asad Islam
Address 115958 0
Monash University Caulfield campus
Building H, Room # H4.37, Caulfield Campus
Caulfield East VIC 3145, Australia
Country 115958 0
Australia
Phone 115958 0
+61 3 990 32783
Fax 115958 0
Email 115958 0
[email protected]
Contact person for public queries
Name 115959 0
Asad Islam
Address 115959 0
Monash University Caulfield campus
Building H, Room # H4.37, Caulfield Campus
Caulfield East VIC 3145, Australia
Country 115959 0
Australia
Phone 115959 0
+61 3 990 32783
Fax 115959 0
Email 115959 0
[email protected]
Contact person for scientific queries
Name 115960 0
Asad Islam
Address 115960 0
Monash University Caulfield campus
Building H, Room # H4.37, Caulfield Campus
Caulfield East VIC 3145, Australia
Country 115960 0
Australia
Phone 115960 0
+61 3 990 32783
Fax 115960 0
Email 115960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be available upon reasonable request. Only aggregate data will be available in that case.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14294Ethical approval    383225-(Uploaded-30-11-2021-19-19-14)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.