HIV InfectionPhase 3NCT00881699
Testing an HIV Prevention Intervention for Psychiatric Patients in Brazil
A Phase 3 study testing HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you and Health Promotion Intervention in people with HIV Infection and HIV Infections, run by New York State Psychiatric Institute at 1 site in Brazil.
Trial summary
This study will test the effectiveness of a program aimed at reducing behaviors that increase HIV risk among people with severe mental illnesses. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infection, HIV Infections
- What is being tested?
- HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you and Health Promotion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2006to Aug 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being treated as a patient in one of the study psychiatric clinics
- Sexually active in the past 3 months
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
About this study
Official title: Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill
This study will test the effectiveness of a program aimed at reducing behaviors that increase HIV risk among people with severe mental illnesses.
Read the 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
- Being tested
- HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you, Health Promotion Intervention
- Keywords
- HIV Information, HIV Prevention, Severe Mental Illness, HIV seronegativity
- Medical subject headings
- HIV Infections, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on youBehavioural
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.
Health Promotion InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will complete HIV risk reduction group meetings. Receives: Behavioral: HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you |
| 2 | Active comparator | Participants will complete health promotion group meetings. Receives: Behavioral: Health Promotion Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Risk Behavior Assessment Schedule (SERBAS)
Measured: Measured at baseline and 3, 6, and 12 months post-intervention
Secondary outcomes (3)
Brief HIV Knowledge Questionnaire (Brief HIV-KQ)
Measured: Measured at baseline and 3, 6, and 12 months post-intervention
Brief Psychiatric Rating Scale (BPRS)
Measured: Measured at baseline and 3, 6, and 12 months post-intervention
Stigma and Discrimination Questionnaire
Measured: Measured at baseline and 3, 6, and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startSep 2006
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Milton L. Wainberg, MD, Principal investigator, Columbia University and New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881699
- Sponsor's protocol ID
- #5264
- Other IDs
- R01MH065163, DAHBR 9A-ASPI
- Status last verified
- Mar 2012
- First submitted
- 14 Apr 2009
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31994641
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of a Brazilian HIV Prevention Intervention for the Severely Mentally Ill
- ClinicalTrials.gov ID
- NCT00881699
- Acronym / sponsor ID
- #5264
- Conditions
- HIV Infection, HIV Infections
- Keywords
- HIV Information, HIV Prevention, Severe Mental Illness, HIV seronegativity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on youParticipants will complete HIV risk reduction group meetings. |
| 2 | Active comparator | Behavioral: Health Promotion InterventionParticipants will complete health promotion group meetings. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being treated as a patient in one of the study psychiatric clinics
- Sexually active in the past 3 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on youEight 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. | Behavioural | 1 |
| Health Promotion InterventionEight 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. | Behavioural | 2 |
Primary outcome
Sexual Risk Behavior Assessment Schedule (SERBAS)
Time frame: Measured at baseline and 3, 6, and 12 months post-intervention
3 secondary outcomes
Brief HIV Knowledge Questionnaire (Brief HIV-KQ)
Time frame: Measured at baseline and 3, 6, and 12 months post-intervention
Brief Psychiatric Rating Scale (BPRS)
Time frame: Measured at baseline and 3, 6, and 12 months post-intervention
Stigma and Discrimination Questionnaire
Time frame: Measured at baseline and 3, 6, and 12 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Derived from this study: PubMed 31994641Wainberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milton L. Wainberg, MD principal investigator
Columbia University and New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HIV Prevention Intervention - Project PRISSMA - HIV I have my eye on you and Health Promotion Intervention in people with HIV Infection and HIV Infections, run by New York State Psychiatric Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Risk Behavior Assessment Schedule (SERBAS) (time frame: Measured at baseline and 3, 6, and 12 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00881699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.