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临床试验/NCT00881699
NCT00881699已完成3 期

Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
460
试验地点
1
主要终点
Sexual Risk Behavior Assessment Schedule (SERBAS)

研究概览

简要总结

This study will test the effectiveness of a program aimed at reducing behaviors that increase HIV risk among people with severe mental illnesses.

详细描述

HIV is a virus that weakens a person's immune system and can cause AIDS. It is most commonly transmitted through unprotected sexual contact. People with a mental illness who are sexually active may be at risk of HIV infection, but most interventions for reducing risk of HIV infection do not target this particular population. This study will test an intervention aimed at reducing behaviors with a high risk of causing HIV infection in sexually active people with a mental illness.

Participation in this study will last 15 months. At study entry, participants will complete a baseline interview with a research assistant. This interview will evaluate sexual activity, knowledge of HIV, the participant's psychiatric diagnosis and symptoms, attitude toward condoms, and stigma related to mental illness experienced by the participant.

Participants will then be randomly assigned to either an HIV risk reduction group or a general health group. Both of these groups will meet once a week for 8 weeks. Those in the HIV risk reduction group will learn information and take part in activities aimed at reducing behaviors that place people at a high risk of being infected with HIV. Those in the general health group will learn about long-term serious medical conditions, such as diabetes and high blood pressure, that may be common in people with a mental illness.

Participants will complete two follow-up visits after their 8-week intervention, one the week after and one 3 months after. Participants will then complete a "booster" of three weekly group sessions covering the same information from their 8-week intervention. More follow-up visits will occur 1 week and 6 months after participants complete the booster sessions. All follow-up visits will involve an interview similar to the one held at study entry. Additionally, feedback forms will be completed at the first interview at study entry, after the eight group sessions, after the three booster sessions, and at the last interview.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being treated as a patient in one of the study psychiatric clinics
  • Sexually active in the past 3 months

排除标准

  • Primary alcohol or other drug use disorder
  • Acutely psychotic or actively suicidal at the time of the screening interview
  • Developmental disability as a primary diagnosis
  • Unable to speak Portuguese

结局指标

主要结局

Sexual Risk Behavior Assessment Schedule (SERBAS)

时间窗: Measured at baseline and 3, 6, and 12 months post-intervention

次要结局

  • Brief HIV Knowledge Questionnaire (Brief HIV-KQ)(Measured at baseline and 3, 6, and 12 months post-intervention)
  • Brief Psychiatric Rating Scale (BPRS)(Measured at baseline and 3, 6, and 12 months post-intervention)
  • Stigma and Discrimination Questionnaire(Measured at baseline and 3, 6, and 12 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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