Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil
Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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RJ
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Rio de Janeiro, RJ, 브라질
- Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Being treated as a patient in one of the study psychiatric clinics
- Sexually active in the past 3 months
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
Participants will complete HIV risk reduction group meetings.
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Eight weekly 2-hour HIV risk reduction intervention sessions, with three weekly 2-hour booster sessions completed 6 months after the initial intervention.
Specific goals of the intervention are to (1) increase information about HIV risk behaviors and safer sex options; (2) increase identification of personal risk of HIV and enhance the motivation to engage in safer sex behaviors; and (3) enhance skills to achieve safer sex, particularly negotiating safer sex, using condoms, and communicating within a relationship.
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활성 비교기: 2
Participants will complete health promotion group meetings.
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Eight weekly 2-hour health promotion intervention sessions with three weekly 2-hour booster sessions completed 6 months after the initial intervention.
Specific goals of the intervention are to (1) increase information about health issues specific to psychiatric patients, (2) increase identification of personal health risks and enhance motivation to engage in healthier behaviors, and (3) enhance skills to achieve healthier behaviors.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Sexual Risk Behavior Assessment Schedule (SERBAS)
기간: Measured at baseline and 3, 6, and 12 months post-intervention
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Measured at baseline and 3, 6, and 12 months post-intervention
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2차 결과 측정
결과 측정 |
기간 |
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Brief HIV Knowledge Questionnaire (Brief HIV-KQ)
기간: Measured at baseline and 3, 6, and 12 months post-intervention
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Measured at baseline and 3, 6, and 12 months post-intervention
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Brief Psychiatric Rating Scale (BPRS)
기간: Measured at baseline and 3, 6, and 12 months post-intervention
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Measured at baseline and 3, 6, and 12 months post-intervention
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Stigma and Discrimination Questionnaire
기간: Measured at baseline and 3, 6, and 12 months post-intervention
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Measured at baseline and 3, 6, and 12 months post-intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Milton L. Wainberg, MD, Columbia University and New York State Psychiatric Institute
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- #5264
- DAHBR 9A-ASPI
- R01MH065163 (미국 NIH 보조금/계약)
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