Clinical trial NCT00881699: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection
HIV Infections
Keywords: HIV Information
HIV Prevention
Severe Mental Illness
HIV seronegativity
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-04-15
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Sexual Risk Behavior Assessment Schedule (SERBAS)
timeFrame: Measured at baseline and 3, 6, and 12 months post-intervention
Secondary outcomes:
measure: Brief HIV Knowledge Questionnaire (Brief HIV-KQ)
timeFrame: Measured at baseline and 3, 6, and 12 months post-intervention
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: Measured at baseline and 3, 6, and 12 months post-intervention
measure: Stigma and Discrimination Questionnaire
timeFrame: Measured at baseline and 3, 6, and 12 months post-intervention
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
state: RJ
Study officials:
affiliation: Columbia University and New York State Psychiatric Institute
name: Milton L. Wainberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.