Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil

NCT ID: NCT00881699

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2011-08-31

Brief Summary

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

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.

Conditions

HIV Infection; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Participants will complete HIV risk reduction group meetings.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

2

Participants will complete health promotion group meetings.

Group Type: ACTIVE_COMPARATOR

Health Promotion Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Milton L. Wainberg, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University and New York State Psychiatric Institute

Locations

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

Wainberg ML, Mann CG, Norcini-Pala A, McKinnon K, Pinto D, Pinho V, Cavalcanti MT, Cheng-Shiun L, Guimaraes MD, Mattos P, Hughes E, Palinkas LA, Otto-Salaj L, Remien RH, Cournos F. Challenges and opportunities in the science of research to practice: lessons learned from a randomized controlled trial of a sexual risk-reduction intervention for psychiatric patients in a public mental health system. Braz J Psychiatry. 2020 Aug;42(4):349-359. doi: 10.1590/1516-4446-2019-0737. Epub 2020 Jan 24.

Reference Type: DERIVED

PMID: 31994641 (View on PubMed)

Other Identifiers

R01MH065163

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DAHBR 9A-ASPI

Identifier Type: -

Identifier Source: secondary_id

#5264

Identifier Type: -

Identifier Source: org_study_id