NCT00881699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

4.8 years

First QC Date

April 14, 2009

Last Update Submit

March 8, 2012

Conditions

HIV InfectionHIV Infections

Keywords

HIV InformationHIV PreventionSevere Mental IllnessHIV seronegativity

Outcome Measures

Primary Outcomes (1)

  • Sexual Risk Behavior Assessment Schedule (SERBAS)

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

Secondary Outcomes (3)

  • Brief HIV Knowledge Questionnaire (Brief HIV-KQ)

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

  • Brief Psychiatric Rating Scale (BPRS)

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

  • Stigma and Discrimination Questionnaire

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

Study Arms (2)

1

EXPERIMENTAL

Participants will complete HIV risk reduction group meetings.

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

2

ACTIVE COMPARATOR

Participants will complete health promotion group meetings.

Behavioral: Health Promotion Intervention

Interventions

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

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.

1
Health Promotion InterventionBEHAVIORAL

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.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being treated as a patient in one of the study psychiatric clinics
  • Sexually active in the past 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 31994641DERIVED

MeSH Terms

Conditions

HIV InfectionsMental Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Milton L. Wainberg, MD

    Columbia University and New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

September 1, 2006

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

BR(1)