- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02780986
STI Prevention Program for Entertainment Establishments in Singapore
Efficacy of a Health Promotion and STI Prevention Program for Entertainment Establishments in Singapore
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mee Lian Wong, MBBS, MPH, MD
- Número de teléfono: (65) 6516 4965
- Correo electrónico: mee_lian_wong@nuhs.edu.sg
Ubicaciones de estudio
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Singapore, Singapur, 117549
- Reclutamiento
- Saw Swee Hock School of Public Health, National University of Singapore
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Contacto:
- Mee Lian Wong, MBBS, MPH, MD
- Número de teléfono: (65) 6516 4965
- Correo electrónico: mee_lian_wong@nuhs.edu.sg
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Investigador principal:
- Mee Lian Wong, MBBS, MPH, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Female entertainment worker intervention group
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.
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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. |
Sin intervención: Female entertainment worker control group
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. |
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Comparador activo: Heterosexual men intervention group
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.
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This will be delivered via 3 main activities:
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Sin intervención: Heterosexual men control group
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Consistent condom use for vaginal sex with paid partners (for female entertainment workers)
Periodo de tiempo: 1 month
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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.
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1 month
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Consistent condom use for vaginal sex with casual partners (for female entertainment workers)
Periodo de tiempo: 1 month
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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.
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1 month
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Condom use at last vaginal sex with casual partners (for heterosexual men)
Periodo de tiempo: 6 months
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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.
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6 months
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Condom use at last oral sex with casual partners (for heterosexual men)
Periodo de tiempo: 6 months
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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.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
STI incidence (for female entertainment workers)
Periodo de tiempo: 6 weeks
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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.
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6 weeks
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Consistent condom use for oral sex with paid partners (for female entertainment workers)
Periodo de tiempo: 1 month
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1 month
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Consistent condom use for oral sex with casual partners (for female entertainment workers)
Periodo de tiempo: 1 month
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1 month
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Consistent condom use for vaginal sex with casual partners (for heterosexual men)
Periodo de tiempo: 6 months
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6 months
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HIV knowledge (for both target groups)
Periodo de tiempo: 1 month for female entertainment workers and 6 months for heterosexual men
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1 month for female entertainment workers and 6 months for heterosexual men
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Success in condom negotiation (for female entertainment workers)
Periodo de tiempo: 1 month
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1 month
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Number of sexual partners (for both target groups)
Periodo de tiempo: 1 month for female entertainment workers and 6 months for heterosexual men
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1 month for female entertainment workers and 6 months for heterosexual men
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HIV/STI testing uptake (for heterosexual men)
Periodo de tiempo: 6 months
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6 months
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Consistent and last condom use with regular partners (for both target groups)
Periodo de tiempo: 1 month for female entertainment workers and 6 months for heterosexual men
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1 month for female entertainment workers and 6 months for heterosexual men
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Consistent condom use for oral sex with casual partners (for heterosexual men)
Periodo de tiempo: 6 months
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6 months
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Consistent and last condom use with female entertainment workers (for heterosexual men)
Periodo de tiempo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mee Lian Wong, MBBS, MPH, MD, Saw Swee Hock School of Public Health, National University of Singapore
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDPHRG12NOV020
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