Clinical trial NCT02780986: STI Prevention Program for Entertainment Establishments in Singapore
Official title: Efficacy of a Health Promotion and STI Prevention Program for Entertainment Establishments in Singapore
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexually Transmitted Infections
Keywords: female entertainment worker
heterosexual men
entertainment establishment
condom use
sexually transmitted infection
Singapore
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
name: National Skin Centre, Singapore
First posted: 2016-05-24
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: BACKGROUND:

Globalisation has led to an influx of women from surrounding Asian countries with high prevalence of sexually transmitted infections (STIs) to work in entertainment establishments (EEs) in Singapore. Men frequenting EEs reported high levels of unprotected sex with commercial and casual partners.

OBJECTIVES:

The aim is to assess the efficacy of a multi-component intervention on STI prevention and condom use in female entertainment workers and men frequenting EEs in Singapore, using a quasi-experimental design. The hypothesis is that a comprehensive sexual health promotion program which incorporates behavioural (STI/HIV education, condom use and condom negotiation skills), biomedical (STI screening and treatment services) and structural components (free access to condoms) to female entertainment workers as well as behavioural (sexual well-being and safe sex edutainment) and structural (free access to condoms) interventions to men patronising EEs in Singapore will achieve an increase in condom use (for both target groups) and a reduction in incident STIs (only for female EE workers).

METHODS:

Female EE workers:

Joo Chiat and Golden Mile Complex will be selected purposively as control cluster sites with 220 entertainment workers being recruited and followed up at 6 weeks. The same sites will be used as intervention sites with recruitment of a separate sample of 220 participants after a 3-months' 'wash out' period to ensure comparability. 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. The short follow-up period is because almost all of these women come to Singapore to work illegally on 1 to 2 months social visit passes.

Heterosexual men:

The investigators are unable to recruit heterosexual men from the same study sites of the female EE workers due to feasibility and safety considerations. Instead, Clark Quay will be selected purposively as the intervention site for the heterosexual men. 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.

MAIN OUTCOMES:

The primary outcomes for female EE workers are consistent condom use for vaginal sex with paid and casual partner respectively in the past 1 month and the secondary outcome is STI incidence. The primary outcomes for heterosexual men are condom use at last vaginal and oral sex respectively with casual partner in the past 6 months.

POSSIBLE APPLICATIONS:

The study will provide pertinent data for planning STI/HIV prevention programs for female entertainment workers and men patronising EEs in Singapore and the region.

Eligibility criteria: Inclusion Criteria:

For female EE workers:

Female entertainment worker who is either a Vietnamese or Thai between the ages of 18 to 69 years old satisfying the 2 criteria:

(i) Planning to work for at least 6 weeks after the baseline survey in Singapore (ii) Have engaged in vagina, oral or anal sex with either a casual or paid male partner in the past month

The casual or paid male partner need not come from the EE that the female EE worker works in.

For heterosexual men:

Male resident who is either a Singapore Citizen or a Permanent Resident between the ages of 21 to 69 years satisfying the 2 criteria:

(i) Patronise the EEs in the site at least once in the past 6 months (ii) Have engaged in vagina, oral or anal sex with either a casual or paid female partner in the past 6 months

The casual or paid female partner need not come from the EEs in the site that the heterosexual man has patronised.

Exclusion Criteria:

For female EE workers in the intervention group only:

Female EE workers who have participated in the control group would be excluded from participating in the intervention group

For heterosexual men during the post-intervention survey of the control group only:

Heterosexual men from the control site who have patronised EEs in the intervention site or who have been exposed to the interventions in the past 6 months would be excluded from the post-intervention survey for the control group.

For heterosexual men during the post-intervention survey of the intervention group only:

Heterosexual men from the intervention site who have not been exposed to at least 1 of the 3 main activities of the intervention in the past 6 months would be excluded from the post-intervention survey for the intervention group.

Primary outcomes:
measure: Consistent condom use for vaginal sex with paid partners (for female entertainment workers)
timeFrame: 1 month
measure: Consistent condom use for vaginal sex with casual partners (for female entertainment workers)
timeFrame: 1 month
measure: Condom use at last vaginal sex with casual partners (for heterosexual men)
timeFrame: 6 months
measure: Condom use at last oral sex with casual partners (for heterosexual men)
timeFrame: 6 months
Secondary outcomes:
measure: STI incidence (for female entertainment workers)
timeFrame: 6 weeks
measure: Consistent condom use for oral sex with paid partners (for female entertainment workers)
timeFrame: 1 month
measure: Consistent condom use for oral sex with casual partners (for female entertainment workers)
timeFrame: 1 month
measure: Consistent condom use for vaginal sex with casual partners (for heterosexual men)
timeFrame: 6 months
measure: HIV knowledge (for both target groups)
timeFrame: 1 month for female entertainment workers and 6 months for heterosexual men
measure: Success in condom negotiation (for female entertainment workers)
timeFrame: 1 month
measure: Number of sexual partners (for both target groups)
timeFrame: 1 month for female entertainment workers and 6 months for heterosexual men
measure: HIV/STI testing uptake (for heterosexual men)
timeFrame: 6 months
measure: Consistent and last condom use with regular partners (for both target groups)
timeFrame: 1 month for female entertainment workers and 6 months for heterosexual men
measure: Consistent condom use for oral sex with casual partners (for heterosexual men)
timeFrame: 6 months
measure: Consistent and last condom use with female entertainment workers (for heterosexual men)
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Saw Swee Hock School of Public Health, National University of Singapore
Study officials:
affiliation: Saw Swee Hock School of Public Health, National University of Singapore
name: Mee Lian Wong, MBBS, MPH, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1006/pmed.1998.0398.
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. doi: 10.1097/00002030-200405210-00013.
citation: 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. doi: 10.1258/0956462971920280.
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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 Singap. 2006 Apr;35(4):229-35.
citation: Lim RBT, Tham DKT, Cheung ON, Adaikan PG, Wong ML. A Public Health Communication Intervention Using Edutainment and Communication Technology to Promote Safer Sex among Heterosexual Men Patronizing Entertainment Establishments. J Health Commun. 2019;24(1):47-64. doi: 10.1080/10810730.2019.1572839. Epub 2019 Jan 30.
citation: Lim RBT, Cheung ONY, Tham DKT, La HH, Win TT, Chan R, Wong ML. Using qualitative and community-based engagement approaches to gain access and to develop a culturally appropriate STI prevention intervention for foreign female entertainment workers in Singapore. Global Health. 2018 Apr 16;14(1):36. doi: 10.1186/s12992-018-0358-5.
citation: Lim RB, Wong ML, Cheung ON, Tham DK, Tai BC, Chan R. Factors associated with consistent condom use and STIs among foreign female entertainment workers: results from a cross-sectional survey in Singapore. Sex Transm Infect. 2017 Mar;93(2):118-124. doi: 10.1136/sextrans-2015-052530. Epub 2016 Jul 7.