Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil
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| ClinicalTrials.gov Identifier: NCT00881699 |
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Recruitment Status :
Completed
First Posted : April 15, 2009
Last Update Posted : March 9, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infection HIV Infections | Behavioral: HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you Behavioral: Health Promotion Intervention | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 460 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill |
| Study Start Date : | September 2006 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | August 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Participants will complete HIV risk reduction group meetings.
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Behavioral: HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you
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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Active Comparator: 2
Participants will complete health promotion group meetings.
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Behavioral: Health Promotion Intervention
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. |
- Sexual Risk Behavior Assessment Schedule (SERBAS) [ Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention ]
- Brief HIV Knowledge Questionnaire (Brief HIV-KQ) [ Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention ]
- Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention ]
- Stigma and Discrimination Questionnaire [ Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881699
| Brazil | |
| Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro | |
| Rio de Janeiro, RJ, Brazil | |
| Principal Investigator: | Milton L. Wainberg, MD | Columbia University and New York State Psychiatric Institute |
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00881699 History of Changes |
| Other Study ID Numbers: |
#5264 R01MH065163 ( U.S. NIH Grant/Contract ) DAHBR 9A-ASPI |
| First Posted: | April 15, 2009 Key Record Dates |
| Last Update Posted: | March 9, 2012 |
| Last Verified: | March 2012 |
Keywords provided by New York State Psychiatric Institute:
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HIV Information HIV Prevention Severe Mental Illness HIV seronegativity |
Additional relevant MeSH terms:
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Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |