Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil

HIV Infections Clinical Trial

Official title:

Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881699
• Other study ID #: #5264
• Secondary ID: R01MH065163DAHBR
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2009
• Last updated: March 8, 2012
• Start date: September 2006
• Est. completion date: August 2011

Study information

• Verified date: March 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Risk Behavior Assessment Schedule (SERBAS)		Measured at baseline and 3, 6, and 12 months post-intervention	No
Secondary	Brief HIV Knowledge Questionnaire (Brief HIV-KQ)		Measured at baseline and 3, 6, and 12 months post-intervention	No
Secondary	Brief Psychiatric Rating Scale (BPRS)		Measured at baseline and 3, 6, and 12 months post-intervention	No
Secondary	Stigma and Discrimination Questionnaire		Measured at baseline and 3, 6, and 12 months post-intervention	No