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临床试验/NCT03186183
NCT03186183已完成不适用

GPS: Adaptation Trial of an HIV Prevention Counselling Program for HIV-positive and HIV-negative Gay and Bisexual Men

Toronto Metropolitan University6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
6
主要终点
Change in the number of serodiscordant condomless anal sex acts

研究概览

简要总结

GPS is a sexual health promotion and HIV prevention peer-delivered counselling program. The GPS program has 4 parts: information provision about HIV and sexually transmitted infections, motivational interviewing counselling, sexual health behavioural skills building, and linkage to care. The adaptation grant has three goals: 1) to establish a multi-region and multi-sectoral team that can deliver the revised program across a variety of settings, 2) to learn how best to deliver this program as individual counselling program and also how to adapt this program for HIV-negative MSM, and 3) to pilot the individual program in 5 settings across Ontario and British Columbia. The research team will evaluate the pilot adaptation through mixed methods, employing a quantitative questionnaire and one-on-one semi-structured interviews.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •aged 18 years or older
  • •self-identify as a man
  • •self-identify as gay, bisexual, queer, same-gender-loving, or a man who has sex with men
  • •report having engaged in condomless anal sex in the last 3 months
  • •able to speak, read, and aurally comprehend English
  • •depending on the study site, report HIV-negative or HIV-positive status

排除标准

  • 未提供

研究组 & 干预措施

GPS program

Experimental

The individual GPS motivational interviewing counseling program has 4-6 sessions.

Week 1: information on sexually transmitted infections and HIV disclosure laws is reviewed. Participants are introduced to the sex diary, stress exercise, and stages of change model.

Week 2: a decisional balance exercise about the participant's current sexual behavior is completed and a behavioral goal is chosen.

Week 3: participants explore their greatest fears and hopes about the goal, and the importance of and their confidence in achieving it.

Week 4: the facilitator and participant identify triggers, automatic thoughts, counters, strategies, supports, and rewards pertaining to the pursuit of the goal and role play the new goal.

1-2 supplemental sessions may be added as needed.

干预措施: GPS program (Behavioral)

结局指标

主要结局

Change in the number of serodiscordant condomless anal sex acts

时间窗: Past 2 months (measured at baseline, post-treatment, and 3-month follow-up)

Participants will be asked to report the number of times they engaged in anal sex in the without a condom with a partner of opposite or unknown HIV status in the past two months as part of a self-report questionnaire. This self-report questionnaire is administered at baseline, post-treatment (which is approximately 6 weeks after baseline), and at 3-month follow-up in order to measure changes over time.

次要结局

  • Change in the number of sexual partners(Past 2 months (measured at baseline, post-treatment, and 3-month follow-up))
  • Change in HIV viral load status(Most recent viral load test (asked at baseline, post-treatment, and 3-month follow-up))
  • Change in the number of receptive condomless anal sex acts(Past 2 months (measured at baseline, post-treatment, and 3-month follow-up))
  • Change in the number of insertive condomless anal sex acts(Past 2 months (measured at baseline, post-treatment, and 3-month follow-up))
  • Change in use of HIV pre-exposure prophylaxis (PrEP)(Present use (asked at baseline, post-treatment, and 3-month follow-up))

研究者

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

Trevor Hart

Principal Investigator

Toronto Metropolitan University

研究点 (6)

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