Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil

New York State Psychiatric Institute

Status and phase: Completed; Phase 3

Conditions: HIV Infection; HIV Infections

Treatments: Behavioral: HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you; Behavioral: Health Promotion Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00881699

R01MH065163 (U.S. NIH Grant/Contract)

DAHBR 9A-ASPI

#5264

Details and patient eligibility

About

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

Full 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.

Enrollment: 460 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 2 patient groups

1

Experimental group

Description:

Participants will complete HIV risk reduction group meetings.

Treatment:

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

2

Active Comparator group

Description:

Participants will complete health promotion group meetings.

Treatment:

Behavioral: Health Promotion Intervention