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Completed

NCT Number: NCT00881699

Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

Rio de Janeiro, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Sexual Risk Behavior Assessment Schedule (SERBAS)

    Time frame: Measured at baseline and 3, 6, and 12 months post-intervention

Secondary outcomes

  1. Brief HIV Knowledge Questionnaire (Brief HIV-KQ)

    Time frame: Measured at baseline and 3, 6, and 12 months post-intervention

  2. Brief Psychiatric Rating Scale (BPRS)

    Time frame: Measured at baseline and 3, 6, and 12 months post-intervention

  3. Stigma and Discrimination Questionnaire

    Time frame: Measured at baseline and 3, 6, and 12 months post-intervention

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2009
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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