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

April 14, 2009
March 8, 2012
September 2006
July 2011   (final data collection date for primary outcome measure)
Sexual Risk Behavior Assessment Schedule (SERBAS) [ Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00881699 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil
Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infection
  • HIV Infections
  • 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.
  • 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.
  • Experimental: 1
    Participants will complete HIV risk reduction group meetings.
    Intervention: Behavioral: HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you
  • Active Comparator: 2
    Participants will complete health promotion group meetings.
    Intervention: Behavioral: Health Promotion Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
August 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00881699
#5264, R01MH065163, DAHBR 9A-ASPI
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Milton L. Wainberg, MD Columbia University and New York State Psychiatric Institute
New York State Psychiatric Institute
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP