Bacterial InfectionNCT01892358
Preventing Bacterial and Viral Infections Among Injection Drug Users
A study testing SKIN Intervention and Treatment as Usual in people with Bacterial Infection and HIV, run by Butler Hospital at 2 sites in United States.
Trial summary
We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bacterial Infection, HIV
- What is being tested?
- SKIN Intervention and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2013to Jan 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- report injection of heroin, cocaine, or methamphetamine (meth) on at least three different days in the week prior to admission
- have injected heroin, cocaine, or meth for at least three months
- positive urine screen for heroin, cocaine, or meth
Who cannot join
- currently psychotic (e.g., responding to internal stimuli through observed hallucinations or delusions), homicidal or suicidal
- cannot provide informed consent
- not able to complete interviews in English (expected to exclude <5% of IDUs)
- in police custody, expecting incarceration
- unable to provide names and contact information for at least two verifiable locator persons who will know where to find them for retention/follow-up purposes
- plan to move out of the Boston area in the next 12 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts
Butler Hospital
Providence, Rhode Island, 02906
About this study
We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.
- Conditions
- Bacterial Infection, HIV
- Being tested
- SKIN Intervention, Treatment as Usual
- Keywords
- injection drug use
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKIN InterventionBehavioural
Treatment as UsualOther
| Study group | Role | What they receive |
|---|---|---|
| SKIN Intervention | Active comparator | Participants will receive the SKIN intervention at Baseline and 1-mo interviews. Receives: Behavioral: SKIN Intervention |
| Assessment-Only | Placebo comparator | Participants in this arm will receive treatment-as-usual Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial infections
Measured: one year
high-risk behavior
Measured: one year
health service use
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 posted4 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bacterial 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892358
- Sponsor's protocol ID
- DA034957
- Other IDs
- 1210-003
- Status last verified
- Jun 2020
- First submitted
- 1 Jul 2013
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Freibott CE, Phillips KT, Anderson BJ, Stewart C, Liebschutz JM, Stein MD. Under the Skin: The Relationship Between Subcutaneous Injection and Skin Infections Among People Who Inject Drugs. J Addict Med. 2022 Mar-Apr 01;16(2):164-168. doi: 10.1097/ADM.0000000000000844.
PubMed 33813580Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21.
PubMed 32830383
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Bacterial and Viral Infections Among Injection Drug Users
- ClinicalTrials.gov ID
- NCT01892358
- Acronym / sponsor ID
- DA034957
- Conditions
- Bacterial Infection, HIV
- Keywords
- injection drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 4 Jul 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.
We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SKIN Intervention | Active comparator | Behavioral: SKIN InterventionParticipants will receive the SKIN intervention at Baseline and 1-mo interviews. |
| Assessment-Only | Placebo comparator | Other: Treatment as UsualParticipants in this arm will receive treatment-as-usual |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- report injection of heroin, cocaine, or methamphetamine (meth) on at least three different days in the week prior to admission
- have injected heroin, cocaine, or meth for at least three months
- positive urine screen for heroin, cocaine, or meth
Key exclusion criteria (6 listed)
- currently psychotic (e.g., responding to internal stimuli through observed hallucinations or delusions), homicidal or suicidal
- cannot provide informed consent
- not able to complete interviews in English (expected to exclude <5% of IDUs)
- in police custody, expecting incarceration
- unable to provide names and contact information for at least two verifiable locator persons who will know where to find them for retention/follow-up purposes
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 |
|---|---|---|
| SKIN Intervention | Behavioural | SKIN Intervention |
| Treatment as Usual | Other | Assessment-Only |
Primary outcome
bacterial infections
Time frame: one year
high-risk behavior
Time frame: one year
health service use
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 9 Jun 2020.
- Derived from this study: PubMed 33813580Freibott CE, Phillips KT, Anderson BJ, Stewart C, Liebschutz JM, Stein MD. Under the Skin: The Relationship Between Subcutaneous Injection and Skin Infections Among People Who Inject Drugs. J Addict Med. 2022 Mar-Apr 01;16(2):164-168. doi: 10.1097/ADM.0000000000000844.
- Derived from this study: PubMed 32830383Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21.
Related trials for Bacterial Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SKIN Intervention and Treatment as Usual in people with Bacterial Infection and HIV, run by Butler Hospital at 2 sites 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 4 inclusion and 6 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
bacterial infections (time frame: one year). The study lists 3 primary outcomes in all. 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 NCT01892358, which also lists 2 linked publications.
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 Jun 2020.