Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00881699
First received: April 14, 2009
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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
HIV Infection
HIV Infections
Behavioral: HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you
Behavioral: Health Promotion Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Sexual Risk Behavior Assessment Schedule (SERBAS) [ Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brief HIV Knowledge Questionnaire (Brief HIV-KQ) [ Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
  • Stigma and Discrimination Questionnaire [ Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]

Enrollment: 460
Study Start Date: September 2006
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will complete HIV risk reduction group meetings.
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.
Active Comparator: 2
Participants will complete health promotion group meetings.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881699

Locations
Brazil
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Rio de Janeiro, RJ, Brazil
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Milton L. Wainberg, MD Columbia University and New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00881699     History of Changes
Other Study ID Numbers: #5264, R01MH065163, DAHBR 9A-ASPI
Study First Received: April 14, 2009
Last Updated: March 8, 2012
Health Authority: United States: Federal Government
Brazil: National Committee of Ethics in Research

Keywords provided by New York State Psychiatric Institute:
HIV Information
HIV Prevention
Severe Mental Illness
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014