Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil
Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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RJ
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Rio de Janeiro, RJ, Brasile
- Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Sexual Risk Behavior Assessment Schedule (SERBAS)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Brief HIV Knowledge Questionnaire (Brief HIV-KQ)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Milton L. Wainberg, MD, Columbia University and New York State Psychiatric Institute
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Infezioni da virus a RNA
- Malattie virali
- Infezioni a trasmissione ematica
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie del sistema immunitario
- Attributi della malattia
- Malattie da virus lenti
- Infezioni da HIV
- Infezioni
- Malattie trasmissibili
- Sindrome da immunodeficienza acquisita
Altri numeri di identificazione dello studio
- #5264
- DAHBR 9A-ASPI
- R01MH065163 (Sovvenzione/contratto NIH degli Stati Uniti)
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