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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02780986
Other study ID # CDPHRG12NOV020
Secondary ID
Status Recruiting
Phase N/A
First received May 19, 2016
Last updated May 23, 2016
Start date March 2015

Study information

Verified date May 2016
Source National University, Singapore
Contact Mee Lian Wong, MBBS, MPH, MD
Phone (65) 6516 4965
Email mee_lian_wong@nuhs.edu.sg
Is FDA regulated No
Health authority Singapore: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators aim to assess the efficacy of a multi-component intervention on condom use and sexually transmitted infection (STIs) in female entertainment workers and men frequenting entertainment establishments (EEs), using a quasi-experimental design. Joo Chiat and Golden Mile Complex will be selected purposively as control cluster sites (n=220) with follow-up of entertainment workers at 6 weeks. The same sites will be used as intervention sites after a 3-months 'wash out' period. Self-reported condom use, vaginal swab samples for polymerase chain reaction (PCR) for cervical gonorrhoea and chlamydia infections, and throat swabs for culture for pharyngeal gonorrhoea will be assessed. Clark Quay will be the intervention venue for the heterosexual men while Tanjong Pagar will be the equivalent control site. Using time location sampling, cross-sectional samples of men patronising these establishments will be assessed on self-reported condom use at baseline (n=600) and 6 months after the intervention (n=400) in both intervention and control groups.


Description:

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Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention


Intervention

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Locations

Country Name City State
Singapore Saw Swee Hock School of Public Health, National University of Singapore Singapore

Sponsors (3)

Lead Sponsor Collaborator
National University, Singapore Ministry of Health, Singapore, National Skin Centre, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (6)

Chan R, Goh CL. STD/AIDS knowledge and risk behaviour among masseuses and bar hostesses in Singapore. Int J STD AIDS. 1997 Jun;8(6):373-7. — View Citation

Heng BH, Lee HP, Kok LP, Ong YW, Ho ML. A survey of sexual behaviour of Singaporeans. Ann Acad Med Singapore. 1992 Nov;21(6):723-9. — View Citation

Sen P, Chio MT, Tan HH, Chan RK. Rising trends of STIs and HIV infection in Singapore-- a review of epidemiology over the last 10 years (1994 to 2003). Ann Acad Med Singapore. 2006 Apr;35(4):229-35. — View Citation

Wong ML, Chan KW, Koh D. A sustainable behavioral intervention to increase condom use and reduce gonorrhea among sex workers in Singapore: 2-year follow-up. Prev Med. 1998 Nov-Dec;27(6):891-900. — View Citation

Wong ML, Chan R, Koh D. Long-term effects of condom promotion programmes for vaginal and oral sex on sexually transmitted infections among sex workers in Singapore. AIDS. 2004 May 21;18(8):1195-9. — View Citation

Wong ML, Chan R, Tan HH, Yong E, Lee L, Cutter J, Tay J, Koh D. Sex work and risky sexual behaviors among foreign entertainment workers in urban Singapore: findings from Mystery Client Survey. J Urban Health. 2012 Dec;89(6):1031-44. doi: 10.1007/s11524-012-9723-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Consistent condom use for vaginal sex with paid partners (for female entertainment workers) This is assessed by 2 questions, "Did the participant ever have vaginal sex in the past 1 month?" (Options of no and yes) and "If the participant had vaginal sex, how often did she use condoms with paid partners?" (Options of not applicable, never, sometimes and always). Participants who give the answer as 'Yes' to the first question and 'Always' to the second question are classified as having consistent condom usage for vaginal sex with paid partners. 1 month No
Primary Consistent condom use for vaginal sex with casual partners (for female entertainment workers) This is assessed by 2 questions, "Did the participant ever have vaginal sex in the past 1 month?" (Options of no and yes) and "If the participant had vaginal sex, how often did she use condoms with casual partners?" (Options of not applicable, never, sometimes and always). Participants who give the answer as 'Yes' to the first question and 'Always' to the second question are classified as having consistent condom usage for vaginal sex with causal partners. 1 month No
Primary Condom use at last vaginal sex with casual partners (for heterosexual men) This is determined by 2 questions, "Did the participant ever have vaginal sex in the past 6 months?" (Options of no and yes) and "If the participant had vaginal sex, did he use a condom the last time he had vaginal sex with the casual partner?" (Options of not applicable, no and yes). Participants who give the answer as 'Yes' to the first question and 'Yes' to the second question are classified as having used condom at last vaginal sex with casual partners. 6 months No
Primary Condom use at last oral sex with casual partners (for heterosexual men) This is determined by 2 questions, "Did the participant ever have oral sex in the past 6 months?" (Options of no and yes) and "If the participant had oral sex, did he use a condom the last time he had oral sex with the casual partner?" (Options of not applicable, no and yes). Participants who give the answer as 'Yes' to the first question and 'Yes' to the second question are classified as having used condom at last oral sex with casual partners. 6 months No
Secondary STI incidence (for female entertainment workers) This is defined as having a positive laboratory test result for a new episode of cervical chlamydia, cervical gonorrhoea or pharyngeal gonorrhoea at 6 weeks post-intervention. 6 weeks No
Secondary Consistent condom use for oral sex with paid partners (for female entertainment workers) 1 month No
Secondary Consistent condom use for oral sex with casual partners (for female entertainment workers) 1 month No
Secondary Consistent condom use for vaginal sex with casual partners (for heterosexual men) 6 months No
Secondary HIV knowledge (for both target groups) 1 month for female entertainment workers and 6 months for heterosexual men No
Secondary Success in condom negotiation (for female entertainment workers) 1 month No
Secondary Number of sexual partners (for both target groups) 1 month for female entertainment workers and 6 months for heterosexual men No
Secondary HIV/STI testing uptake (for heterosexual men) 6 months No
Secondary Consistent and last condom use with regular partners (for both target groups) 1 month for female entertainment workers and 6 months for heterosexual men No
Secondary Consistent condom use for oral sex with casual partners (for heterosexual men) 6 months No
Secondary Consistent and last condom use with female entertainment workers (for heterosexual men) 6 months No
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