HIVPhase 2NCT01172704
HIV/AIDS, Severe Mental Illness and Homelessness
A Phase 2 study testing Skills Building - Motivational Interviewing in people with HIV and AIDS, run by Boston Medical Center at 1 site in United States.
Trial summary
This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and secondary prevention intervention [Skills building and Motivational Interviewing (SB-MI) to Care as Usual (CAU)]. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- What is being tested?
- Skills Building - Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2016
- 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
- Meet criteria for a serious mental illness (SMI)
- Engaged in HIV risk behavior during the previous 3 months
- Able to attend assessment and intervention appointments
- Have receptive and expressive English language skills sufficient for meaningful participation
- Are 19 years of age or older.
- Capable of providing informed consent.
Who cannot join
- Unable to comprehend the assessment and/or intervention materials.
- Unable to provide independent consent and/or under a full guardianship.
- Do not meet criteria for a serious mental illness (SMI)
- Have not engaged in HIV risk behavior during the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and secondary prevention intervention [Skills building and Motivational Interviewing (SB-MI) to Care as Usual (CAU)]. The study setting is a large urban safety net Medical Center and outcomes will be measured at 3, 6, and 12 months. The SB-MI intervention (3 sessions + booster) was initially developed as the experimental condition in an R34 pilot project which demonstrated its feasibility and promise. For the proposed project, the investigators will recruit a larger sample which includes men and women with and without HIV, from various ethnic and racial groups, sexual orientations and housing arrangements, as well as a range of psychiatric disorders and functional capacities. In this way the investigators can more rigorously demonstrate the promise of SB-MI with SMI. The investigators will also conduct a sub-study after the 6 month follow-up to examine the impact at 12 months of an additional booster session for SB-MI participants. The investigators specific aims are:
- To examine the effectiveness of a brief, tailored primary and secondary risk reduction strategy to CAU for people with serious mental illness. The desired outcomes include:
Read more
- Decreased frequency of risk behaviors (number of partners, number of encounters)
- Increased use of barrier precautions and IV needle cleaning
- Positive changes in information and motivation, as well as risk behaviors
- Increased HIV Counseling and Testing for those who do not know their HIV status
- To examine the effectiveness of a 2nd booster session after the 6 month follow-up for ½ of participants randomized to SB-MI. The primary outcome will be:
- Decreased frequency of risk behaviors and increased use of barrier precautions at the 12 month follow-up
Read the detailed description
Our long-term objective is to reduce the incidence of HIV risk behavior for SMI by developing an intervention that can be easily translated and adapted to "real world" settings. Our proposed project is designed to augment previously-developed research on HIV risk reduction interventions for SMI. The innovations the investigators have developed include: 1) SB-MI intervention design that can be utilized with diverse participants with SM in contrast to other research which has focused on either primary or secondary prevention with a fairly discrete population, such as women of color, patients in a drug recovery program etc. The investigators will examine treatment response as a function of diverse participant characteristics; 2) SB-MI intervention is delivered in an individual format to provides a flexible structure for tailoring strategies and techniques for each participant's complex cognitive and psychosexual functioning, as well as his/her needs and values in contrast to research on HIV prevention in SMI which generally occurs in group and does not allow for individualized tailoring. In addition, our experience with group interventions is they do not easily allow for discussions of risk related to complex sexual and physical abuse histories, sex trading and other stigmatized activities characteristic of SMI. Our individualized approach affords maximum flexibility and privacy in selecting topics of intervention, which the investigators also believe to be essential to the spirit of Motivational Interviewing; 3) Previous interventions have typically been either very brief (e.g. one half-hour session) or time-intensive. In contrast, our intervention (3 sessions + 1 or 2 Booster(s)) is long enough to allow participants to form a working alliance with providers, but not so lengthy as to be burdensome or non-translatable for the real-world settings in which patients routinely seek care such as urban safety net Medical Center's; 4) a review of the literature suggests that many health behavior changes fade within a fairly short period of time; our inclusion of booster session and a sub-study examining the effect of a 2nd booster after the 6 month follow-up is a novel way of strengthening the effects of our intervention. The investigators will also be extending our follow-up period to 12 months, to allow us to further assess long-term change; and 5) No study to date has examined HIV counseling and testing as an outcome for this population (Senn \& Carey, 2009). The investigators believe this represents a significant deficit in attending to the needs of SMI, given that testing and access to life-extending treatment should be an essential component to prevention interventions for SMI. Both our SB-MI and CAU conditions will include referrals for HIV testing where indicated, although the SB-MI intervention systematically supports motivation for participants seeking HIV counseling and testing services, whereas CAU provides information and general support for testing. The investigators hope to see that the attention paid to this issue in SB-MI yields greater access to HIV testing services.
- Being tested
- Skills Building - Motivational Interviewing
- Keywords
- Motivational Interviewing, Serious Mental Illness, HIV/AIDS, HIV Testing
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills Building - Motivational InterviewingBehavioural
SB-MI incorporates Motivational Interviewing strategies into a psycho-educational HIV risk reduction protocol to help participants identify high-risk behaviors, reduce ambivalence about these behaviors, increase motivation to change behaviors, and develop a specific plan of action for risk reduction. Consistent with MI, information gathered at baseline regarding HIV risk behaviors is systematically reviewed in a personalized way with each participant at the outset of the intervention. This is designed to engage participants in becoming active agents in the change process and to assist participants in recognizing discrepancies between their current risk behaviors and goals and values, which typically do not include HIV infection or transmitting HIV to others. Also consistent with the principles of MI, participants are empowered to choose those educational and skills-based modules which "fit" their personal risk profile and values.
| Study group | Role | What they receive |
|---|---|---|
| Care as Usual | Active comparator | Participants randomized to CAU receive the standard care given to patients of the Boston Medical Center who are interested in learning more about HIV/AIDS. Included in this care would be referrals for HIV counseling and testing. Receives: Behavioral: Skills Building - Motivational Interviewing |
| Skills Building - Motivational Interviewing | Experimental | Participants randomized to SB-MI will receive three individual sessions and a booster. Content of the sessions are as follows; Session 1: Risk Behavior Feedback \& Building Motivation; Session 2: Building Motivation \& Skill Selection and Practice; Session 3: Developing Change Plan \& Skill Practice and Booster Session(s): Review Change Plan Implementation, Maintaining Motivation \& Skill Practice. Receives: Behavioral: Skills Building - Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Risk Taking Behavior
Mean Changes from baseline to follow-ups at 6 and 12 months for constructs of the IMB (Information Motivation Behavior) Model will be larger for participants randomized to the SB-MI condition compared to CAU.
Measured: One year
Secondary outcomes (1)
HIV Counseling & Testing
Participants in SB-MI will demonstrate higher rates of accessing HIV counseling and testing at 6 month follow-up, as compared to participants in CAU.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2015
- Study completionJan 2016
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.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Brady, Boston Medical Center
- Investigators
- Stephen Brady, PhD, Principal investigator, Boston UniversityJori Berger-Greenstein, PhD, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172704
- Sponsor's protocol ID
- BMC HIV Prevention
- Status last verified
- Mar 2016
- First submitted
- 9 Jun 2010
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV/AIDS, Severe Mental Illness and Homelessness
- ClinicalTrials.gov ID
- NCT01172704
- Acronym / sponsor ID
- BMC HIV Prevention
- Keywords
- Motivational Interviewing, Serious Mental Illness, HIV/AIDS, HIV Testing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Jul 2010 (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 is a two-arm randomized controlled trial (RCT) for 308 seriously mentally ill adults (SMI) engaging in risky sexual and/or drug use behavior, comparing a brief HIV primary and secondary prevention intervention [Skills building and Motivational Interviewing (SB-MI) to Care as Usual (CAU)]. The study setting is a large urban safety net Medical Center and outcomes will be measured at 3, 6, and 12 months. The SB-MI intervention (3 sessions + booster) was initially developed as the experimental condition in an R34 pilot project which demonstrated its feasibility and promise. For the proposed project, the investigators will recruit a larger sample which includes men and women with and without HIV, from various ethnic and racial groups, sexual orientations and housing arrangements, as well as a range of psychiatric disorders and functional capacities. In this way the investigators can more rigorously demonstrate the promise of SB-MI with SMI. The investigators will also conduct a sub-study after the 6 month follow-up to examine the impact at 12 months of an additional booster session for SB-MI participants. The investigators specific aims are:
- To examine the effectiveness of a brief, tailored primary and secondary risk reduction strategy to CAU for people with serious mental illness. The desired outcomes include:
- Decreased frequency of risk behaviors (number of partners, number of encounters)
- Increased use of barrier precautions and IV needle cleaning
- Positive changes in information and motivation, as well as risk behaviors
- Increased HIV Counseling and Testing for those who do not know their HIV status
- To examine the effectiveness of a 2nd booster session after the 6 month follow-up for ½ of participants randomized to SB-MI. The primary outcome will be:
- Decreased frequency of risk behaviors and increased use of barrier precautions at the 12 month follow-up
Detailed description
Our long-term objective is to reduce the incidence of HIV risk behavior for SMI by developing an intervention that can be easily translated and adapted to "real world" settings. Our proposed project is designed to augment previously-developed research on HIV risk reduction interventions for SMI. The innovations the investigators have developed include: 1) SB-MI intervention design that can be utilized with diverse participants with SM in contrast to other research which has focused on either primary or secondary prevention with a fairly discrete population, such as women of color, patients in a drug recovery program etc. The investigators will examine treatment response as a function of diverse participant characteristics; 2) SB-MI intervention is delivered in an individual format to provides a flexible structure for tailoring strategies and techniques for each participant's complex cognitive and psychosexual functioning, as well as his/her needs and values in contrast to research on HIV prevention in SMI which generally occurs in group and does not allow for individualized tailoring. In addition, our experience with group interventions is they do not easily allow for discussions of risk related to complex sexual and physical abuse histories, sex trading and other stigmatized activities characteristic of SMI. Our individualized approach affords maximum flexibility and privacy in selecting topics of intervention, which the investigators also believe to be essential to the spirit of Motivational Interviewing; 3) Previous interventions have typically been either very brief (e.g. one half-hour session) or time-intensive. In contrast, our intervention (3 sessions + 1 or 2 Booster(s)) is long enough to allow participants to form a working alliance with providers, but not so lengthy as to be burdensome or non-translatable for the real-world settings in which patients routinely seek care such as urban safety net Medical Center's; 4) a review of the literature suggests that many health behavior changes fade within a fairly short period of time; our inclusion of booster session and a sub-study examining the effect of a 2nd booster after the 6 month follow-up is a novel way of strengthening the effects of our intervention. The investigators will also be extending our follow-up period to 12 months, to allow us to further assess long-term change; and 5) No study to date has examined HIV counseling and testing as an outcome for this population (Senn \& Carey, 2009). The investigators believe this represents a significant deficit in attending to the needs of SMI, given that testing and access to life-extending treatment should be an essential component to prevention interventions for SMI. Both our SB-MI and CAU conditions will include referrals for HIV testing where indicated, although the SB-MI intervention systematically supports motivation for participants seeking HIV counseling and testing services, whereas CAU provides information and general support for testing. The investigators hope to see that the attention paid to this issue in SB-MI yields greater access to HIV testing services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as Usual | Active comparator | Behavioral: Skills Building - Motivational InterviewingParticipants randomized to CAU receive the standard care given to patients of the Boston Medical Center who are interested in learning more about HIV/AIDS. Included in this care would be referrals for HIV counseling and testing. |
| Skills Building - Motivational Interviewing | Experimental | Behavioral: Skills Building - Motivational InterviewingParticipants randomized to SB-MI will receive three individual sessions and a booster. Content of the sessions are as follows; Session 1: Risk Behavior Feedback \& Building Motivation; Session 2: Building Motivation \& Skill Selection and Practice; Session 3: Developing Change Plan \& Skill Practice and Booster Session(s): Review Change Plan Implementation, Maintaining Motivation \& Skill Practice. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet criteria for a serious mental illness (SMI)
- Engaged in HIV risk behavior during the previous 3 months
- Able to attend assessment and intervention appointments
- Have receptive and expressive English language skills sufficient for meaningful participation
- Are 19 years of age or older.
Key exclusion criteria (4 listed)
- Unable to comprehend the assessment and/or intervention materials.
- Unable to provide independent consent and/or under a full guardianship.
- Do not meet criteria for a serious mental illness (SMI)
- Have not engaged in HIV risk behavior during the previous 3 months
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 - Motivational InterviewingSB-MI incorporates Motivational Interviewing strategies into a psycho-educational HIV risk reduction protocol to help participants identify high-risk behaviors, reduce ambivalence about these behaviors, increase motivation to change behaviors, and develop a specific plan of action for risk reduction. Consistent with MI, information gathered at baseline regarding HIV risk behaviors is systematically reviewed in a personalized way with each participant at the outset of the intervention. This is designed to engage participants in becoming active agents in the change process and to assist participants in recognizing discrepancies between their current risk behaviors and goals and values, which typically do not include HIV infection or transmitting HIV to others. Also consistent with the principles of MI, participants are empowered to choose those educational and skills-based modules which "fit" their personal risk profile and values. | Behavioural | Care as Usual, Skills Building - Motivational Interviewing |
Primary outcome
Frequency of Risk Taking Behavior
Time frame: One year
Mean Changes from baseline to follow-ups at 6 and 12 months for constructs of the IMB (Information Motivation Behavior) Model will be larger for participants randomized to the SB-MI condition compared to CAU.
1 secondary outcome
HIV Counseling & Testing
Time frame: One year
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 1 Apr 2016.
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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, PhD principal investigator
Boston University
Jori Berger-Greenstein, PhD study director
Boston University
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 - Motivational Interviewing in people with HIV and AIDS, 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 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 1 Apr 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 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?
Frequency of Risk Taking Behavior (time frame: One year). 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 1 Apr 2016.