HIV InfectionsPhase 2NCT00643305
HIV Prevention With the Mentally Ill
A Phase 2 study testing Skills Building with Motivational Interviewing and Skills Building in people with HIV Infections, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether motivational interviewing and skills building interventions reduce HIV risk behavior for adults with serious and persistent mental illness. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Skills Building with Motivational Interviewing and Skills Building
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jan 2009
- Phase
- Phase 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19 and older
- Able to provide consent
- Able to understand and speak English
- Willing and able to participate
- Suffer from a serious and persistent mental illness (SMI)
- Have had at least one HIV risk behavior (unprotected sexual activity, sharing injection drug needles without following Center for Disease Control guidelines for needle-cleaning, sexual activity while under the influence of drugs or alcohol) during the three-month period prior to the baseline evaluation
Who cannot join
- Do not suffer from a serious mental illness
- Have not engaged in an HIV risk behavior during the three-month period prior to the baseline evaluation.
- Unable to provide consent
- Unable to understand and speak English
- Under the age of 19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIV Prevention With the Mentally Ill: Motivation-Skills
The purpose of this study is to determine whether motivational interviewing and skills building interventions reduce HIV risk behavior for adults with serious and persistent mental illness.
Read the detailed description
Our long-term objective is to reduce the incidence of HIV for people with serious and persistent mental illness (SMI) by developing an effective primary and secondary HIV risk reduction intervention for this population which can be easily delivered in the "real world" settings in which patients routinely receive care. Research findings document that the incidence of HIV infection, sexually transmitted diseases, and sexual and drug use behaviors are high among people with serious mental illness, as evidenced by rates of HIV infection and other sexually-transmitted diseases (STDs). A variety of factors underlie risky behaviors for the SMI, including cognitive impairment, poor judgment, affective instability and impulsiveness.
Skills-building (SB) HIV risk reduction interventions, typically delivered in a small group formats, have had modest success in increasing HIV-related knowledge and improving risk reduction skills for people with SMI, although these effects are transient. As skills-building interventions are currently the standard of care in most research and clinical settings for HIV prevention, it is important to identify new ways to augment these interventions.
A relatively new and promising addition to the armamentarium of individualized interventions is Motivational Interviewing (MI). MI is an approach designed to reduce ambivalence and enhance intrinsic motivation to change problematic behaviors. Previous researchers have noted effects for both SB and MI interventions independently, however, these effects tend to be fairly modest. Integrating these approaches in a systematized way allows us to test the degree to which this combination is useful, given that both motivation and skills are clearly important in effecting health behavior change.
Our specific primary aims are the following:
- To adapt SB and MI interventions for HIV risk reduction for men and women with serious and persistent mental illness (SMI). Interventions for HIV risk reduction for people with SMI are typically offered in a group format and focus primarily on skills-building. We have developed and refined a brief, individually-tailored skills-building intervention (SB Intervention), based on these existing manuals. We have also adapted and refined a brief individually-tailored Motivational Interviewing intervention to target HIV risk behaviors, incorporating skills-building techniques analogous to those in the SB intervention, resulting in a Motivational-Interviewing \& Skills-Building Intervention (SB-MI Intervention). Adaptation and refinement of the SB and SB-MI interventions was informed by consulting with experts in MI, SMI, and HIV risk reduction, eliciting feedback from advisory boards of providers and consumers, and conducting feedback interviews with participants who have completed participation in the study.
- To pilot test and obtain preliminary data with regard to the feasibility of our interventions and the differences in outcome associated with our SB and SB-MI interventions for reduction of HIV-related risk behaviors in a cohort of SMI adults. Comparison of SB and SB-MI interventions in the proposed pilot study will allow us to assess the degree to which incorporation of motivational techniques are helpful in augmenting skills-building interventions for HIV risk reduction for people with SMI. These preliminary analyses will inform our need to refine the adapted interventions (SB and SB-MI).
- To offer HIV counseling and testing for at-risk individuals with SMI, with an emphasis on connecting participants to appropriate medical and mental health services. To date, increasing rates of HIV counseling and testing for the SMI has not been a primary focus of clinical research, which we believe to be a significant public health deficit. As part of both of our interventions we are providing information about HIV counseling and testing services to those participants not identified as HIV-seropositive and encouraging them to access these services. We are then tracking the degree to which participants follow up on these referrals as part of our follow-up evaluations. This will allow us to test the degree to which our interventions are helpful in increasing rates of HIV testing.
- To begin to explore the relationships between participant characteristics, HIV risk behaviors, and response to our interventions.
One of the unique features of our intervention is that it assumes an individually-tailored approach, which can address unique patient characteristics inherent in a heterogeneous sample. Indeed, using a heterogeneous sample greatly facilitates our primary long-term objective, which is to develop useable interventions that can be adapted in real-world settings. This project will allow us to begin to identify those characteristics that are likely to be associated with more positive outcomes (i.e. greater risk reduction, increased rates of HIV testing).
- Conditions
- HIV Infections
- Being tested
- Skills Building with Motivational Interviewing, Skills Building
- Keywords
- HIV, Motivational Interviewing, Skills, Prevention, Mental illness, Risk reduction, HIV/AIDS, HIV Seronegativity
- Medical subject headings
- HIV Infections, Mental Disorders, Risk Reduction Behavior, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills Building with Motivational InterviewingBehavioural
Based on the Stages of Change model, participants are provided with feedback related to their current HIV risk and Motivational Interviewing strategies are used to increase motivation to decrease HIV risk behaviors. Participants are also provided with information and training in skills critical for reducing HIV risk
Skills BuildingBehavioural
Participants are provided with information and training in skills critical for reducing HIV risk.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Skills Building with Motivational Interviewing (SB-MI)- combines education and general skills-building participants can use to reduce their at-risk behavior for HIV with increasing motivation to change HIV risk behaviors Receives: Behavioral: Skills Building with Motivational Interviewing |
| 2 | Active comparator | Skills Building (SB) - provides education and general skills-building for reduction of HIV risk behaviors. Receives: Behavioral: Skills Building |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported reduction in HIV risk behavior for infection/re-infection of HIV, as measured by administration of the TimeLine Follow-Back.
Measured: 6 months
Skillfulness in behaviors critical for efficacious use of HIV risk reduction strategies, measured by standardized role-plays and demonstrations
Measured: 6 months
HIV-related knowledge, as measured by the HIV Knowledge Questionnaire (HIV-KQ)
Measured: 6 months
Accessing HIV counseling and testing, assessed by self-report
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startFeb 2006
- Primary completionOct 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Stephen Brady, Ph.D., Principal investigator, The Trustees of Boston University, BUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643305
- Sponsor's protocol ID
- Project HELP
- Other IDs
- 5R34MH075644-02
- Status last verified
- Mar 2008
- First submitted
- 20 Mar 2008
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Prevention With the Mentally Ill: Motivation-Skills
- ClinicalTrials.gov ID
- NCT00643305
- Acronym / sponsor ID
- Project HELP
- Conditions
- HIV Infections
- Keywords
- HIV, Motivational Interviewing, Skills, Prevention, Mental illness, Risk reduction, HIV/AIDS, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 26 Mar 2008 (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.
The purpose of this study is to determine whether motivational interviewing and skills building interventions reduce HIV risk behavior for adults with serious and persistent mental illness.
Detailed description
Our long-term objective is to reduce the incidence of HIV for people with serious and persistent mental illness (SMI) by developing an effective primary and secondary HIV risk reduction intervention for this population which can be easily delivered in the "real world" settings in which patients routinely receive care. Research findings document that the incidence of HIV infection, sexually transmitted diseases, and sexual and drug use behaviors are high among people with serious mental illness, as evidenced by rates of HIV infection and other sexually-transmitted diseases (STDs). A variety of factors underlie risky behaviors for the SMI, including cognitive impairment, poor judgment, affective instability and impulsiveness.
Skills-building (SB) HIV risk reduction interventions, typically delivered in a small group formats, have had modest success in increasing HIV-related knowledge and improving risk reduction skills for people with SMI, although these effects are transient. As skills-building interventions are currently the standard of care in most research and clinical settings for HIV prevention, it is important to identify new ways to augment these interventions.
A relatively new and promising addition to the armamentarium of individualized interventions is Motivational Interviewing (MI). MI is an approach designed to reduce ambivalence and enhance intrinsic motivation to change problematic behaviors. Previous researchers have noted effects for both SB and MI interventions independently, however, these effects tend to be fairly modest. Integrating these approaches in a systematized way allows us to test the degree to which this combination is useful, given that both motivation and skills are clearly important in effecting health behavior change.
Our specific primary aims are the following:
- To adapt SB and MI interventions for HIV risk reduction for men and women with serious and persistent mental illness (SMI). Interventions for HIV risk reduction for people with SMI are typically offered in a group format and focus primarily on skills-building. We have developed and refined a brief, individually-tailored skills-building intervention (SB Intervention), based on these existing manuals. We have also adapted and refined a brief individually-tailored Motivational Interviewing intervention to target HIV risk behaviors, incorporating skills-building techniques analogous to those in the SB intervention, resulting in a Motivational-Interviewing \& Skills-Building Intervention (SB-MI Intervention). Adaptation and refinement of the SB and SB-MI interventions was informed by consulting with experts in MI, SMI, and HIV risk reduction, eliciting feedback from advisory boards of providers and consumers, and conducting feedback interviews with participants who have completed participation in the study.
- To pilot test and obtain preliminary data with regard to the feasibility of our interventions and the differences in outcome associated with our SB and SB-MI interventions for reduction of HIV-related risk behaviors in a cohort of SMI adults. Comparison of SB and SB-MI interventions in the proposed pilot study will allow us to assess the degree to which incorporation of motivational techniques are helpful in augmenting skills-building interventions for HIV risk reduction for people with SMI. These preliminary analyses will inform our need to refine the adapted interventions (SB and SB-MI).
- To offer HIV counseling and testing for at-risk individuals with SMI, with an emphasis on connecting participants to appropriate medical and mental health services. To date, increasing rates of HIV counseling and testing for the SMI has not been a primary focus of clinical research, which we believe to be a significant public health deficit. As part of both of our interventions we are providing information about HIV counseling and testing services to those participants not identified as HIV-seropositive and encouraging them to access these services. We are then tracking the degree to which participants follow up on these referrals as part of our follow-up evaluations. This will allow us to test the degree to which our interventions are helpful in increasing rates of HIV testing.
- To begin to explore the relationships between participant characteristics, HIV risk behaviors, and response to our interventions.
One of the unique features of our intervention is that it assumes an individually-tailored approach, which can address unique patient characteristics inherent in a heterogeneous sample. Indeed, using a heterogeneous sample greatly facilitates our primary long-term objective, which is to develop useable interventions that can be adapted in real-world settings. This project will allow us to begin to identify those characteristics that are likely to be associated with more positive outcomes (i.e. greater risk reduction, increased rates of HIV testing).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Skills Building with Motivational InterviewingSkills Building with Motivational Interviewing (SB-MI)- combines education and general skills-building participants can use to reduce their at-risk behavior for HIV with increasing motivation to change HIV risk behaviors |
| 2 | Active comparator | Behavioral: Skills BuildingSkills Building (SB) - provides education and general skills-building for reduction of HIV risk behaviors. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 19 and older
- Able to provide consent
- Able to understand and speak English
- Willing and able to participate
- Suffer from a serious and persistent mental illness (SMI)
Key exclusion criteria (5 listed)
- Do not suffer from a serious mental illness
- Have not engaged in an HIV risk behavior during the three-month period prior to the baseline evaluation.
- Unable to provide consent
- Unable to understand and speak English
- Under the age of 19
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 |
|---|---|---|
| Skills Building with Motivational InterviewingBased on the Stages of Change model, participants are provided with feedback related to their current HIV risk and Motivational Interviewing strategies are used to increase motivation to decrease HIV risk behaviors. Participants are also provided with information and training in skills critical for reducing HIV risk | Behavioural | 1 |
| Skills BuildingParticipants are provided with information and training in skills critical for reducing HIV risk. | Behavioural | 2 |
Primary outcome
Self-reported reduction in HIV risk behavior for infection/re-infection of HIV, as measured by administration of the TimeLine Follow-Back.
Time frame: 6 months
Skillfulness in behaviors critical for efficacious use of HIV risk reduction strategies, measured by standardized role-plays and demonstrations
Time frame: 6 months
HIV-related knowledge, as measured by the HIV Knowledge Questionnaire (HIV-KQ)
Time frame: 6 months
Accessing HIV counseling and testing, assessed by self-report
Time frame: 6 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 3 May 2013.
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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.
Stephen Brady, Ph.D. principal investigator
The Trustees of Boston University, BUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Skills Building with Motivational Interviewing and Skills Building in people with HIV Infections, run by Boston Medical Center 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 6 inclusion and 5 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 3 May 2013. 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 phase mean?
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?
Self-reported reduction in HIV risk behavior for infection/re-infection of HIV, as measured by administration of the TimeLine Follow-Back. (time frame: 6 months). The study lists 4 primary outcomes in all. 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 3 May 2013.