HIVPhase 1NCT01854853
Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health Disorder
A Phase 1 study testing STYLE Brazil and Health Promotion in people with HIV and Sexually Transmitted Infection, run by New York State Psychiatric Institute at 1 site in Brazil.
Trial summary
Adolescents with mental health (MH) disorders (MHD) have higher rates of HIV/STI sexual risk behaviors than those in the general population. In Brazil, among youth seeking HIV testing, those testing positive had more MH problems than HIV-negative youth; HIV/STI sexual risk reduction is not regularly implemented within… Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- HIV, Sexually Transmitted Infection, Pregnancy
- What is being tested?
- STYLE Brazil and Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to May 2016
- Phase
- Phase 1
- 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 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent with a mental health disorder in any of the four pilot sites;
- Ages 13-24;
- having a caregiver who is willing to participate and sign consent for their adolescent's involvement in the study.
Who cannot join
- primary alcohol or other drug use disorder (AOD);
- mental retardation or pervasive developmental disorder as primary diagnosis;
- a medical or psychiatric illness requiring hospitalization; and
- currently psychotic or suicidal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health
Adolescents with mental health (MH) disorders (MHD) have higher rates of HIV/STI sexual risk behaviors than those in the general population. In Brazil, among youth seeking HIV testing, those testing positive had more MH problems than HIV-negative youth; HIV/STI sexual risk reduction is not regularly implemented within MH care for adolescents. Our NIMH-funded RCT in Rio de Janeiro (Rio; R01MH065163; PI: Wainberg) promises to provide such intervention for adults with MHD. A comparable evidence-based HIV/STI prevention intervention for adolescents is not available in Brazil; this application targets this need.
Using quantitative and qualitative methods we will explore the contextual influences on sexual risk behavior of Brazilian youth ages 13-24 with MHD to inform intervention adaptation. The investigators will then pilot-test the family-based (parent-adolescent dyad) intervention HIV, STI and pregnancy prevention intervention with a sample of male and female youth age 13-24 years (n=144) with MHD who are in MH treatment in four community-based sites in preparation for the RCT.
Read the detailed description
Adolescents with mental health (MH) disorders (MHD) have higher rates of HIV/STI sexual risk behaviors than those in the general population. In Brazil, among youth seeking HIV testing, those testing positive had more MH problems than HIV-negative youth; HIV/STI sexual risk reduction is not regularly implemented within MH care for adolescents. Our NIMH-funded RCT in Rio de Janeiro (Rio; R01MH065163; PI: Wainberg) promises to provide such intervention for adults with MHD. A comparable evidence-based HIV/STI prevention intervention for adolescents is not available in Brazil; this application targets this need. To address this public health need and opportunity, we propose to a) adapt a U.S. efficacious family-based HIV prevention intervention for youth with MHD (STYLE; R01MH63008; PI: Brown) within the three types of settings providing most of the care to adolescents with MHD in Brazil; and b) pilot test the intervention to examine the acceptability, feasibility, and implementation parameters of the resulting Brazil intervention (STYLE-B) within these settings, and to determine key research parameters in preparation for an implementation randomized clinical trial (RCT). Using quantitative and qualitative methods we will explore the contextual influences on sexual risk behavior of Brazilian youth ages 13-24 with MHD to inform intervention adaptation. The investigators will then pilot-test STYLE-B with a sample of male and female youth age 13-24 years (n=144) with MHD who are in MH treatment in four community-based sites. Youth/caregiver dyads will receive a full-day group session, return in two weeks for an adolescent/caregiver dyad session, and participate in a half-day group session three months later. Acceptability and feasibility will be assessed using process measures after each session. The investigators will assess change in sexual risk behavior outcomes from baseline to 3-months post-intervention. The investigators will elucidate factors influencing intervention adoption (e.g., recruitment, referrals; resources; climate, readiness and capacity for intervention) within the three service systems for youth with MHD in Brazil. The investigators will develop digital web-based interactive technology to train intervention facilitators in preparation for the RCT.
- Conditions
- HIV, Sexually Transmitted Infection, Pregnancy
- Being tested
- STYLE Brazil, Health Promotion
- Keywords
- unsafe sex, safer sex, HIV, STI, Pregnancy
- Medical subject headings
- Sexually Transmitted Diseases, Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STYLE BrazilBehavioural
Multifamily group HIV/STI Prevention Intervention
Health PromotionBehavioural
Health promotion intervention
| Study group | Role | What they receive |
|---|---|---|
| STYLE Brazil | Experimental | STYLE-BRazil Multifamily Group HIV/STI Prevention intervention Receives: Behavioral: STYLE Brazil |
| Health Promotion | Active comparator | Health Promotion Intervention - Adolescents only Receives: Behavioral: Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
AIDS Risk Behavior Assessment (ARBA)
We will assess sexual activity, unprotected sex acts and number of sexual partners (if sexually active) or delay sexual debut (if not sexually active) in the last 3 months at baseline and 3 months post intervention
Measured: In the past 3 months
Secondary outcomes (1)
Parent-adolescent communication about sex scale
The measure assess parent adolescent communication about sex in the last 3 months
Measured: Past 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startAug 2012
- Primary completionMay 2016
- Study completionMay 2016
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 HIVStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 305 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, NYSPI/Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854853
- Sponsor's protocol ID
- 6394
- Other IDs
- R34MH094163
- Status last verified
- Oct 2016
- First submitted
- 2 May 2013
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wainberg ML, McKinnon K, Mattos PE, Pinto D, Mann CG, de Oliveira CS, de Oliveira SB, Remien RH, Elkington KS, Cournos F; PRISSMA Project. A model for adapting evidence-based behavioral interventions to a new culture: HIV prevention for psychiatric patients in Rio de Janeiro, Brazil. AIDS Behav. 2007 Nov;11(6):872-83. doi: 10.1007/s10461-006-9181-8. Epub 2007 Jan 10.
PubMed 17216334
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health
- ClinicalTrials.gov ID
- NCT01854853
- Acronym / sponsor ID
- 6394
- Conditions
- HIV, Sexually Transmitted Infection, Pregnancy
- Keywords
- unsafe sex, safer sex, HIV, STI, Pregnancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 May 2013 (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.
Adolescents with mental health (MH) disorders (MHD) have higher rates of HIV/STI sexual risk behaviors than those in the general population. In Brazil, among youth seeking HIV testing, those testing positive had more MH problems than HIV-negative youth; HIV/STI sexual risk reduction is not regularly implemented within MH care for adolescents. Our NIMH-funded RCT in Rio de Janeiro (Rio; R01MH065163; PI: Wainberg) promises to provide such intervention for adults with MHD. A comparable evidence-based HIV/STI prevention intervention for adolescents is not available in Brazil; this application targets this need.
Using quantitative and qualitative methods we will explore the contextual influences on sexual risk behavior of Brazilian youth ages 13-24 with MHD to inform intervention adaptation. The investigators will then pilot-test the family-based (parent-adolescent dyad) intervention HIV, STI and pregnancy prevention intervention with a sample of male and female youth age 13-24 years (n=144) with MHD who are in MH treatment in four community-based sites in preparation for the RCT.
Detailed description
Adolescents with mental health (MH) disorders (MHD) have higher rates of HIV/STI sexual risk behaviors than those in the general population. In Brazil, among youth seeking HIV testing, those testing positive had more MH problems than HIV-negative youth; HIV/STI sexual risk reduction is not regularly implemented within MH care for adolescents. Our NIMH-funded RCT in Rio de Janeiro (Rio; R01MH065163; PI: Wainberg) promises to provide such intervention for adults with MHD. A comparable evidence-based HIV/STI prevention intervention for adolescents is not available in Brazil; this application targets this need. To address this public health need and opportunity, we propose to a) adapt a U.S. efficacious family-based HIV prevention intervention for youth with MHD (STYLE; R01MH63008; PI: Brown) within the three types of settings providing most of the care to adolescents with MHD in Brazil; and b) pilot test the intervention to examine the acceptability, feasibility, and implementation parameters of the resulting Brazil intervention (STYLE-B) within these settings, and to determine key research parameters in preparation for an implementation randomized clinical trial (RCT). Using quantitative and qualitative methods we will explore the contextual influences on sexual risk behavior of Brazilian youth ages 13-24 with MHD to inform intervention adaptation. The investigators will then pilot-test STYLE-B with a sample of male and female youth age 13-24 years (n=144) with MHD who are in MH treatment in four community-based sites. Youth/caregiver dyads will receive a full-day group session, return in two weeks for an adolescent/caregiver dyad session, and participate in a half-day group session three months later. Acceptability and feasibility will be assessed using process measures after each session. The investigators will assess change in sexual risk behavior outcomes from baseline to 3-months post-intervention. The investigators will elucidate factors influencing intervention adoption (e.g., recruitment, referrals; resources; climate, readiness and capacity for intervention) within the three service systems for youth with MHD in Brazil. The investigators will develop digital web-based interactive technology to train intervention facilitators in preparation for the RCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STYLE Brazil | Experimental | Behavioral: STYLE BrazilSTYLE-BRazil Multifamily Group HIV/STI Prevention intervention |
| Health Promotion | Active comparator | Behavioral: Health PromotionHealth Promotion Intervention - Adolescents only |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescent with a mental health disorder in any of the four pilot sites;
- Ages 13-24;
- having a caregiver who is willing to participate and sign consent for their adolescent's involvement in the study.
Key exclusion criteria (4 listed)
- primary alcohol or other drug use disorder (AOD);
- mental retardation or pervasive developmental disorder as primary diagnosis;
- a medical or psychiatric illness requiring hospitalization; and
- currently psychotic or suicidal.
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 |
|---|---|---|
| STYLE BrazilMultifamily group HIV/STI Prevention Intervention | Behavioural | STYLE Brazil |
| Health PromotionHealth promotion intervention | Behavioural | Health Promotion |
Primary outcome
AIDS Risk Behavior Assessment (ARBA)
Time frame: In the past 3 months
We will assess sexual activity, unprotected sex acts and number of sexual partners (if sexually active) or delay sexual debut (if not sexually active) in the last 3 months at baseline and 3 months post intervention
1 secondary outcome
Parent-adolescent communication about sex scale
Time frame: Past 3 months
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 12 Oct 2016.
- Background: PubMed 17216334Wainberg ML, McKinnon K, Mattos PE, Pinto D, Mann CG, de Oliveira CS, de Oliveira SB, Remien RH, Elkington KS, Cournos F; PRISSMA Project. A model for adapting evidence-based behavioral interventions to a new culture: HIV prevention for psychiatric patients in Rio de Janeiro, Brazil. AIDS Behav. 2007 Nov;11(6):872-83. doi: 10.1007/s10461-006-9181-8. Epub 2007 Jan 10.
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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
NYSPI/Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STYLE Brazil and Health Promotion in people with HIV and Sexually Transmitted Infection, 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 3 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 12 Oct 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AIDS Risk Behavior Assessment (ARBA) (time frame: In the past 3 months). 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 NCT01854853, 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 12 Oct 2016.