Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil
Primary Purpose
HIV Infection, HIV Infections
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you
Health Promotion Intervention
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infection focused on measuring HIV Information, HIV Prevention, Severe Mental Illness, HIV seronegativity
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
Sites / Locations
- Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will complete HIV risk reduction group meetings.
Participants will complete health promotion group meetings.
Outcomes
Primary Outcome Measures
Sexual Risk Behavior Assessment Schedule (SERBAS)
Secondary Outcome Measures
Brief HIV Knowledge Questionnaire (Brief HIV-KQ)
Brief Psychiatric Rating Scale (BPRS)
Stigma and Discrimination Questionnaire
Full Information
NCT ID
NCT00881699
First Posted
April 14, 2009
Last Updated
March 8, 2012
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00881699
Brief Title
Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil
Official Title
Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, HIV Infections
Keywords
HIV Information, HIV Prevention, Severe Mental Illness, HIV seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will complete HIV risk reduction group meetings.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will complete health promotion group meetings.
Intervention Type
Behavioral
Intervention Name(s)
HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you
Intervention Description
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
Intervention Name(s)
Health Promotion Intervention
Intervention Description
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 Outcome Measure Information:
Title
Sexual Risk Behavior Assessment Schedule (SERBAS)
Time Frame
Measured at baseline and 3, 6, and 12 months post-intervention
Secondary Outcome Measure Information:
Title
Brief HIV Knowledge Questionnaire (Brief HIV-KQ)
Time Frame
Measured at baseline and 3, 6, and 12 months post-intervention
Title
Brief Psychiatric Rating Scale (BPRS)
Time Frame
Measured at baseline and 3, 6, and 12 months post-intervention
Title
Stigma and Discrimination Questionnaire
Time Frame
Measured at baseline and 3, 6, and 12 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton L. Wainberg, MD
Organizational Affiliation
Columbia University and New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
31994641
Citation
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.
Results Reference
derived
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Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil
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