STI Prevention Program for Entertainment Establishments in Singapore

NCT02780986 | Unknown DMC

• 1 other identifier: CDPHRG12NOV020
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexually Transmitted Infections

Keywords

female entertainment worker; heterosexual men; entertainment establishment; condom use; sexually transmitted infection; Singapore

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (11)

• STI incidence (for female entertainment workers)

  6 weeks

• Consistent condom use for oral sex with paid partners (for female entertainment workers)

  1 month

• Consistent condom use for oral sex with casual partners (for female entertainment workers)

  1 month

• Consistent condom use for vaginal sex with casual partners (for heterosexual men)

  6 months

• HIV knowledge (for both target groups)

  1 month for female entertainment workers and 6 months for heterosexual men

Study Arms (4)

Female entertainment worker intervention group

ACTIVE COMPARATOR

The intervention program for the female EE workers aims to increase STI/HIV prevention knowledge and develop their condom negotiation and application skills so as to increase condom use with both casual and paid partners. It consists of a total of 4 sessions: 2 on-site and 2 online sessions. For each on-site session, groups of 4 to 5 female EE workers will be gathered. The 2 on-site sessions would be delivered by peer educators. The 2 online sessions would be conducted via phone and other modes of network communication (e.g. SMS message or WhatsApp message) depending on the preference of each participant. In addition, all the intervention materials and video demonstrations will also be uploaded onto the web portal for the participant to access during their free time.

Behavioral: Female entertainment worker intervention group

Female entertainment worker control group

NO INTERVENTION

The female EE workers in the control group will receive the same number of 2 onsite and 2 online sessions but covering healthy eating and physical activity. The following gives a summarised breakdown and content of each session: Session 1 (on-site immediately after baseline survey, 10 minutes): The peer educator will share information on healthy eating and physical activity using the educational pamphlets from the Health Promotion Board (HPB) with the participants. Session 2 (online 1-2 weeks after baseline survey, 5 minutes): The peer educator will share an app on healthy eating with the participants. Session 3 (online 3-4 weeks after baseline survey, 5 minutes): The peer educator will share an app on physical activity with the participants. Session 4 (onsite during follow-up survey, 10 minutes): The peer educator will reinforce information on healthy eating and physical activity based on the educational pamphlets from HPB with the participants.

Heterosexual men intervention group

ACTIVE COMPARATOR

The intervention program for heterosexual men patronising EEs will be a holistic non disease-centric, non-stigmatising and non-judgemental program addressing sexual well-being, avoidance of casual and paid sex if possible and safe sex such as condom use.

Behavioral: Heterosexual men intervention group

Heterosexual men control group

NO INTERVENTION

There will be a simultaneous programme on healthy eating and physical activity at the control site at Tanjong Pagar. Health promoters will go around Tanjong Pagar and distribute pamphlets and brochures developed by the HPB on healthy eating and physical activity to the heterosexual men who step into or out of the EEs there. These health promoters have been trained to give simple health advice on healthy eating and physical activity if the heterosexual men wish to find out more information.

Interventions

Female entertainment worker intervention group BEHAVIORAL

The following summarises the content of each session: Session 1 (on-site): The peer educator will play 2 videos, demonstrating 5 sexy ways of putting on a condom in a pleasurable manner, and another one focusing on condom negotiation skills. Session 2 (online): The peer educator will share an app game on condom usage and relevant online resources with the participants. Session 3 (onsite): There will be discussion of common problems encountered in condom usage and condom negotiation by the participants. The peer educators will then conduct role plays with the participants to demonstrate the counter-strategies. In addition, the peer educators will get the participants who have been successful in condom negotiation to share their success stories. Session 4 (online): The peer educator will share information about safe consumption of alcohol and tips to avoid getting drunk through the online platforms.

Female entertainment worker intervention group

Heterosexual men intervention group BEHAVIORAL

This will be delivered via 3 main activities: 1. Edutainment in the form of talk-shows based on 6 themes of sexual well-being and safe sex, held in the EE setting hosted by a famous female local comedian. 2. Web portal named THINK: This contains educational materials based on 6 themes of sexual health and safe sex, HIV risk profiling tool to calculate the risk of contracting HIV, videos on true life experiences of heterosexual men engaging in high risk sexual behaviour and another video on exit strategies to avoid casual or paid sex, online support for STI testing services and consultation with a clinical sexologist. 3. Public education event/photo booth: i. Distribution of pamphlets and brochures on sexual well-being and safe sex ii. Interactions with health promoters iii. Photo taking on safe sex messages iv. Free access to condoms and lubricants

Heterosexual men intervention group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Singapore: lead
• Ministry of Health, Singapore: collaborator
• National Skin Centre, Singapore: collaborator

Study Sites (1)

Saw Swee Hock School of Public Health, National University of Singapore

Singapore, Singapore, 117549, Singapore

RECRUITING

Related Publications (9)

• 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.

  PMID: 22707309 BACKGROUND

• 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.

  PMID: 9922072 BACKGROUND

• 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.

  PMID: 15166535 BACKGROUND

• 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.

  PMID: 9179647 BACKGROUND

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

  PMID: 1295409 BACKGROUND

• 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.

  PMID: 16710492 BACKGROUND

• 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.

  PMID: 30698082 DERIVED

• 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.

  PMID: 29661249 DERIVED

• 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.

  PMID: 27388458 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mee Lian Wong, MBBS, MPH, MD

  Saw Swee Hock School of Public Health, National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mee Lian Wong, MBBS, MPH, MD

CONTACT

(65) 6516 4965; mee_lian_wong@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 24, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

SG (1)