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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00881699 |
This study will test the effectiveness of a program aimed at reducing behaviors that increase HIV risk among people with severe mental illnesses.
Condition | Intervention | Phase |
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HIV Infection HIV Infections |
Behavioral: HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you Behavioral: Health Promotion Intervention |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill |
Estimated Enrollment: | 448 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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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2: Active Comparator
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.
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Milton L. Wainberg, MD | 212-543-6175 | mlw35@columbia.edu |
Brazil, RJ | |
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro | Recruiting |
Rio de Janeiro, RJ, Brazil | |
Contact: Paulo E. Mattos, MD 011-55-212-295-3796 paulomattosmd@gmail.com | |
Principal Investigator: Paulo E. Mattos, MD |
Principal Investigator: | Milton L. Wainberg, MD | Columbia University and New York State Psychiatric Institute |
Responsible Party: | Columbia University and New York State Psychiatric Institute ( Milton L. Wainberg, MD ) |
Study ID Numbers: | R01 MH065163, DAHBR 9A-ASPI |
Study First Received: | April 14, 2009 |
Last Updated: | May 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00881699 History of Changes |
Health Authority: | United States: Federal Government; Brazil: National Committee of Ethics in Research |
HIV Information HIV Prevention Severe Mental Illness HIV seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral Mental Disorders HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |