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Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil

Phase 3
Completed
Conditions
HIV Infection
HIV Infections
Interventions
Behavioral: HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you
Behavioral: Health Promotion Intervention
Registration Number
NCT00881699
Lead Sponsor
New York State Psychiatric Institute
Brief Summary

This study will test the effectiveness of a program aimed at reducing behaviors that increase HIV risk among people with severe mental illnesses.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
460
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on youParticipants will complete HIV risk reduction group meetings.
2Health Promotion InterventionParticipants will complete health promotion group meetings.
Primary Outcome Measures
NameTimeMethod
Sexual Risk Behavior Assessment Schedule (SERBAS)Measured at baseline and 3, 6, and 12 months post-intervention
Secondary Outcome Measures
NameTimeMethod
Brief HIV Knowledge Questionnaire (Brief HIV-KQ)Measured at baseline and 3, 6, and 12 months post-intervention
Brief Psychiatric Rating Scale (BPRS)Measured at baseline and 3, 6, and 12 months post-intervention
Stigma and Discrimination QuestionnaireMeasured at baseline and 3, 6, and 12 months post-intervention

Trial Locations

Locations (1)

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

🇧🇷

Rio de Janeiro, RJ, Brazil

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