HIVPhase 1/2STYLEnSNCT01383837
HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment
A Phase 1/2 study testing STYLEnS and Health Promotion in people with HIV and Sexually Transmitted Diseases, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Adolescents with substance use disorders (SUD) are at substantial risk for contracting HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction interventions have been developed to meet their unique needs, and none use a family-based intervention approach, which the literature… Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- HIV, Sexually Transmitted Diseases
- What is being tested?
- STYLEnS and Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2015
- Phase
- Phase 1/2
- 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
- are in care at the pilot sites;
- are ages 13-24 years;
- meet criteria for (Diagnostic Statistical Manual) DSM-IV substance abuse diagnosis (patient record);
- have a caregiver who will consent to their study participation,
- have a parent/family member willing to enter treatment and participate in study
Who cannot join
- have mental retardation or pervasive developmental disorder as primary diagnosis;
- have a medical or psychiatric illness requiring hospitalization;
- have current psychotic features, or current suicidality;
- are not English- or Spanish-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Lukes-Roosevelt Hospital
New York, New York, 10025
About this study
Adolescents with substance use disorders (SUD) are at substantial risk for contracting HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction interventions have been developed to meet their unique needs, and none use a family-based intervention approach, which the literature recommends as the focus for intervention for youth. Current state policies neither require providers in clinics delivering substance use treatment to offer HIV/STI sexual risk reduction nor offer providers tools or training for HIV/STI prevention. There is clear public health need to develop innovative methods of service delivery and effective strategies of HIV/STI sexual risk reduction that address multiple contexts of risk (i.e. family) for this high risk population. The current proposal addresses this need by developing a provider-delivered HIV sexual risk reduction intervention to be implemented in outpatient SUD treatment that: 1) builds the clinics' capacity to help families under their care to more comfortably address the adolescent's sexuality; 2) promotes youth's safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents with SUD in care.
Read the detailed description
The incidence of HIV and (sexually transmitted infections) STI continues to rise in the US among youth, and rates of HIV/STI sexual risk behaviors among adolescents with substance use disorders (SUD) are significantly higher compared with their counterparts without SUD. Yet HIV/STI sexual risk reduction is not regularly implemented within adolescent SUD treatment programs. To address this urgent public health priority, the investigators propose first to develop a manualized sexual risk reduction intervention that 1) builds community clinics' capacity to help families in their care to address systematically adolescents' sexuality; 2) promotes the youths' safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents with SUD in treatment. Second, the investigators propose to pilot test the manualized intervention to examine feasibility and acceptability of implementation in real-world settings and determine optimal research parameters for such settings in preparation for a randomized clinical trial (RCT). The intervention development process will use a Community Based Participatory Research model of adaptation and development that has been successfully implemented by the PI in other settings. The investigators will conduct formative work to guide adaptation of a multi-family group HIV/STI sexual risk reduction intervention that has demonstrated efficacy with youth, ages 13-18, who have non-SUD psychiatric disorders (Project STYLE: Strengthening Today's Youth Life Experience; R01 MH63008; PI: Brown). This formative work (Phase 1 - protocol 6183) will leverage the research sample of CASALEAP, an ongoing NIDA-funded, large-scale naturalistic study of the effectiveness of outpatient SUD treatment for adolescent (R01 DA019607; PI: Hogue). The resulting new manualized intervention (STYLEnS: STYLE and Substance) then will be pilot-tested (Phase 2 - protocol 6622) with a sample of male and female adolescents with SUD (n=60) in treatment in three well-established New York City mental health outpatient treatment programs which are typical of those for adolescents with SUD and in which the investigators have active partnerships. Pilot participants will be randomly assigned to either STYLEnS or an attention control intervention (Health Promotion). Participants will receive a full-day group intervention on the day of randomization (multi-family, caregivers alone and adolescents alone), return in two weeks for an individual adolescent/caregiver dyad session, and participate in a half-day booster group session three months later. The pilot test will evaluate the feasibility and acceptability of conducting an intervention in outpatient clinics treating adolescents with SUD, examine optimal factors influencing research methods, and estimate intervention parameters for a RCT. Acceptability and feasibility will be assessed using process measures following each session as well as after the intervention is completed. The investigators will assess change in sexual risk behavior outcomes from baseline to 3 months post-intervention. This study will lay the groundwork for refining the design of a RCT of the new intervention. Implementing a HIV/STI sexual risk reduction intervention in clinics providing SUD treatment represents an innovative and potentially cost-effective approach to enable typically overburdened SUD treatment providers to address the heightened HIV/STI risk in SUD youth. This proposal responds to the need to develop HIV/STI sexual risk reduction intervention services for adolescents with SUD that can be applied in and easily disseminated to clinical settings.
- Conditions
- HIV, Sexually Transmitted Diseases
- Being tested
- STYLEnS, Health Promotion
- Keywords
- HIV/STI, Prevention, Adolescents, Substance Use Disorders, Family-based intervention
- Medical subject headings
- Sexually Transmitted Diseases, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STYLEnSBehavioural
Multifamily group HIV/STI Prevention Intervention or Single Family Dyad (youth and a parent)
Health PromotionBehavioural
Health Promotion Intervention
| Study group | Role | What they receive |
|---|---|---|
| STYLEnS | Experimental | Multifamily Group HIV/STI Prevention intervention or Single Family Dyad (youth and a parent) Receives: Behavioral: STYLEnS |
| 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.
Unprotected vaginal or anal sex occasions
Measured: 3-months look back
Secondary outcomes (4)
Caregiver-youth communication about sex
The Parent-Adolescent Sexual Communication Scale assesses the process and content of sexual communication between parents and adolescents. Youth and parents complete separate versions.
Measured: 3-months look back
Caregiver-youth communication about sexual risk behaviors
The Parent-Adolescent HIV Preventive Communication Skills Scale assesses the quality and process of parent-child communication; parents and adolescents are videotaped discussing a difficult topic for 5 minutes. An observational coding system is used to match the behavior and interactive changes targeted by the Family-Based component of our intervention (e.g. I-Statements, Negative Vocalizations, and Relationship Quality). Coders will be trained and inter-rater reliability will be assessed.
Measured: 5-minutes
Feasibility of conducting the intervention
Determined (yes/no) if the parent and youth attended the intervention sessions
Measured: 3-months
Acceptability of the intervention
Adolescent and caregiver will fill out a structured post-session process measure that assesses adolescent and caregiver feedback specifically regarding intervention content, materials, format, exercises, treatment motivation, personal reactions (strengths and weaknesses, relevance, interest, satisfaction, and comfort) to receiving the interventions.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startAug 2010
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milton L Wainberg, MD, Principal investigator, New York State Psychiatric Institute, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383837
- Sponsor's protocol ID
- 6183/6622
- Acronym
- STYLEnS
- Status last verified
- Aug 2015
- First submitted
- 18 Aug 2010
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV/STI Prevention for Adolescents With Substance Use Disorders in Treatment
- ClinicalTrials.gov ID
- NCT01383837
- Acronym / sponsor ID
- STYLEnS / 6183/6622
- Conditions
- HIV, Sexually Transmitted Diseases
- Keywords
- HIV/STI, Prevention, Adolescents, Substance Use Disorders, Family-based intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Jun 2011 (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 substance use disorders (SUD) are at substantial risk for contracting HIV/STIs compared to their counterparts without SUD, yet few HIV/STI sexual risk reduction interventions have been developed to meet their unique needs, and none use a family-based intervention approach, which the literature recommends as the focus for intervention for youth. Current state policies neither require providers in clinics delivering substance use treatment to offer HIV/STI sexual risk reduction nor offer providers tools or training for HIV/STI prevention. There is clear public health need to develop innovative methods of service delivery and effective strategies of HIV/STI sexual risk reduction that address multiple contexts of risk (i.e. family) for this high risk population. The current proposal addresses this need by developing a provider-delivered HIV sexual risk reduction intervention to be implemented in outpatient SUD treatment that: 1) builds the clinics' capacity to help families under their care to more comfortably address the adolescent's sexuality; 2) promotes youth's safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents with SUD in care.
Detailed description
The incidence of HIV and (sexually transmitted infections) STI continues to rise in the US among youth, and rates of HIV/STI sexual risk behaviors among adolescents with substance use disorders (SUD) are significantly higher compared with their counterparts without SUD. Yet HIV/STI sexual risk reduction is not regularly implemented within adolescent SUD treatment programs. To address this urgent public health priority, the investigators propose first to develop a manualized sexual risk reduction intervention that 1) builds community clinics' capacity to help families in their care to address systematically adolescents' sexuality; 2) promotes the youths' safer sex practices; and 3) reduces HIV/STI sexual risk behaviors among adolescents with SUD in treatment. Second, the investigators propose to pilot test the manualized intervention to examine feasibility and acceptability of implementation in real-world settings and determine optimal research parameters for such settings in preparation for a randomized clinical trial (RCT). The intervention development process will use a Community Based Participatory Research model of adaptation and development that has been successfully implemented by the PI in other settings. The investigators will conduct formative work to guide adaptation of a multi-family group HIV/STI sexual risk reduction intervention that has demonstrated efficacy with youth, ages 13-18, who have non-SUD psychiatric disorders (Project STYLE: Strengthening Today's Youth Life Experience; R01 MH63008; PI: Brown). This formative work (Phase 1 - protocol 6183) will leverage the research sample of CASALEAP, an ongoing NIDA-funded, large-scale naturalistic study of the effectiveness of outpatient SUD treatment for adolescent (R01 DA019607; PI: Hogue). The resulting new manualized intervention (STYLEnS: STYLE and Substance) then will be pilot-tested (Phase 2 - protocol 6622) with a sample of male and female adolescents with SUD (n=60) in treatment in three well-established New York City mental health outpatient treatment programs which are typical of those for adolescents with SUD and in which the investigators have active partnerships. Pilot participants will be randomly assigned to either STYLEnS or an attention control intervention (Health Promotion). Participants will receive a full-day group intervention on the day of randomization (multi-family, caregivers alone and adolescents alone), return in two weeks for an individual adolescent/caregiver dyad session, and participate in a half-day booster group session three months later. The pilot test will evaluate the feasibility and acceptability of conducting an intervention in outpatient clinics treating adolescents with SUD, examine optimal factors influencing research methods, and estimate intervention parameters for a RCT. Acceptability and feasibility will be assessed using process measures following each session as well as after the intervention is completed. The investigators will assess change in sexual risk behavior outcomes from baseline to 3 months post-intervention. This study will lay the groundwork for refining the design of a RCT of the new intervention. Implementing a HIV/STI sexual risk reduction intervention in clinics providing SUD treatment represents an innovative and potentially cost-effective approach to enable typically overburdened SUD treatment providers to address the heightened HIV/STI risk in SUD youth. This proposal responds to the need to develop HIV/STI sexual risk reduction intervention services for adolescents with SUD that can be applied in and easily disseminated to clinical settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STYLEnS | Experimental | Behavioral: STYLEnSMultifamily Group HIV/STI Prevention intervention or Single Family Dyad (youth and a parent) |
| 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 (5 listed)
- are in care at the pilot sites;
- are ages 13-24 years;
- meet criteria for (Diagnostic Statistical Manual) DSM-IV substance abuse diagnosis (patient record);
- have a caregiver who will consent to their study participation,
- have a parent/family member willing to enter treatment and participate in study
Key exclusion criteria (4 listed)
- have mental retardation or pervasive developmental disorder as primary diagnosis;
- have a medical or psychiatric illness requiring hospitalization;
- have current psychotic features, or current suicidality;
- are not English- or Spanish-speaking
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 |
|---|---|---|
| STYLEnSMultifamily group HIV/STI Prevention Intervention or Single Family Dyad (youth and a parent) | Behavioural | STYLEnS |
| Health PromotionHealth Promotion Intervention | Behavioural | Health Promotion |
Primary outcome
Unprotected vaginal or anal sex occasions
Time frame: 3-months look back
4 secondary outcomes
Caregiver-youth communication about sex
Time frame: 3-months look back
Caregiver-youth communication about sexual risk behaviors
Time frame: 5-minutes
Feasibility of conducting the intervention
Time frame: 3-months
Acceptability of the intervention
Time frame: 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 28 Aug 2015.
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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
New York State Psychiatric Institute, 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 1/2 study testing STYLEnS and Health Promotion in people with HIV and Sexually Transmitted Diseases, run by New York State Psychiatric Institute at 1 site in United States.
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 5 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 28 Aug 2015. 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 United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Unprotected vaginal or anal sex occasions (time frame: 3-months look back). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2015.