A Phase 3 interventional study of HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you and Health Promotion Intervention in HIV Infection and HIV Infections, sponsored by New York State Psychiatric Institute. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-03-09.
Sponsored by New York State Psychiatric Institute · Phase 3, Interventional, and Prevention
This study will test the effectiveness of a program aimed at reducing behaviors that increase HIV risk among people with severe mental illnesses.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 460 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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Exclusion Criteria:
Participants will complete HIV risk reduction group meetings.
Behavioral: HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you
Participants will complete health promotion group meetings.
Behavioral: Health Promotion Intervention
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.
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
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute