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临床试验/NCT02780986
NCT02780986Unknown不适用

Efficacy of a Health Promotion and STI Prevention Program for Entertainment Establishments in Singapore

National University of Singapore2 个研究点 分布在 1 个国家目标入组 1,440 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,440
试验地点
2
主要终点
Consistent condom use for vaginal sex with paid partners (for female entertainment workers)

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 1 month

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.

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

时间窗: 1 month

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.

Condom use at last vaginal sex with casual partners (for heterosexual men)

时间窗: 6 months

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.

Condom use at last oral sex with casual partners (for heterosexual men)

时间窗: 6 months

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.

次要结局

  • Number of sexual partners (for both target groups)(1 month for female entertainment workers and 6 months for heterosexual men)
  • HIV/STI testing uptake (for heterosexual men)(6 months)
  • Consistent and last condom use with regular partners (for both target groups)(1 month for female entertainment workers and 6 months for heterosexual men)
  • Consistent condom use for oral sex with casual partners (for heterosexual men)(6 months)
  • Consistent and last condom use with female entertainment workers (for heterosexual men)(6 months)
  • 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)
  • Success in condom negotiation (for female entertainment workers)(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wong Mee Lian

Associate Professor

National University of Singapore

研究点 (2)

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