Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil

March 8, 2012 updated by: New York State Psychiatric Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

460

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sexual Risk Behavior Assessment Schedule (SERBAS)
Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention
Measured at baseline and 3, 6, and 12 months post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Brief HIV Knowledge Questionnaire (Brief HIV-KQ)
Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention
Measured at baseline and 3, 6, and 12 months post-intervention
Brief Psychiatric Rating Scale (BPRS)
Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention
Measured at baseline and 3, 6, and 12 months post-intervention
Stigma and Discrimination Questionnaire
Time Frame: Measured at baseline and 3, 6, and 12 months post-intervention
Measured at baseline and 3, 6, and 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Milton L. Wainberg, MD, Columbia University and New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 14, 2009

First Submitted That Met QC Criteria

April 14, 2009

First Posted (Estimate)

April 15, 2009

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #5264
  • DAHBR 9A-ASPI
  • R01MH065163 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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