Stimulant AbuseNCT03175159
Integrated BA and HIV RR Counseling for MSM With Stimulant Abuse
A study testing IMPACT in people with Stimulant Abuse and HIV Prevention, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the efficacy of Project IMPACT, an intervention that integrates Behavioral Activation (BA) with HIV risk reduction (RR) counseling for HIV-uninfected men who have sex with men (MSM) with stimulant use disorder at risk for HIV via… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stimulant Abuse, HIV Prevention, Substance Abuse
- What is being tested?
- IMPACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2018to 1 Mar 2024
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Assigned male at birth
- HIV-uninfected verified via rapid HIV test
- Self-reports in the past four months: CAS receptive or insertive with a cisgender male sexual partner, while using stimulants and without the protection of Pre-Exposure Prophylaxis (PrEP)*
- Able to read, speak, and understand English
- Willing and able to provide informed consent
Who cannot join
- Does not live in the greater Boston or Miami areas, or will move away from Boston or Miami within the next 12 months
- Self-reports being 100% adherent to PrEP in the last four months
- Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- Discovery of active suicidal ideation at the time of interview (participants will be referred immediately for treatment, but may join the study once resolved)-
- Involvement in any other HIV Prevention study that may interfere with the ability to test major study outcomes (e.g. another sexual risk reduction intervention or PrEP adherence intervention)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fenway Community Health Center
Boston, Massachusetts, 022154302
University of Miami
Miami, Florida, 331462926
About this study
Official title: Integrated Behavioral Activation and HIV Risk Reduction Counseling for Men Who Have Sex With Men (MSM) With Stimulant Abuse
This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the efficacy of Project IMPACT, an intervention that integrates Behavioral Activation (BA) with HIV risk reduction (RR) counseling for HIV-uninfected men who have sex with men (MSM) with stimulant use disorder at risk for HIV via sexual behavior. HIV-uninfected MSM with a diagnosis of stimulant use disorder will be equally randomized to one of two study arms: (1) the Project IMPACT intervention, BA-RR counseling, which lasts ten sessions; and (2) the standard of care (SOC) comparison condition, including two equivalent sexual risk-reduction counseling sessions. Participants will be followed for one year post-randomization, with assessments at months four, eight, and 12.
Read the detailed description
Project IMPACT targets both stimulant use and sexual risk reduction in effort to help individuals relearn how to enjoy safe but pleasurable activities. The intervention integrates BA, an evidence-based cognitive behavior therapy for improving mood and increasing activity, incorporated with RR counseling aimed to reduce risky sexual practices, and potential HIV acquisition. This RCT is a two-arm efficacy trial, comparing the Project IMPACT Intervention with a SOC arm. All participants will receive HIV testing, pre-/post-test risk reduction counseling, oral swab toxicology test at baseline and 12 months, assessment of interest/indication for Pre-Exposure Prophylaxis (PrEP) per Center for Disease Control guidelines, and active referral to local PrEP services as standard-of-care. Finally, the RCT will integrate resource utilization and cost-effectiveness analyses to examine cost efficiency of the Project IMPACT Intervention as a component of data analysis.
- Conditions
- Stimulant Abuse, HIV Prevention, Substance Abuse
- Being tested
- IMPACT, Standard of Care
- Keywords
- Risk Reduction, Crystal Methamphetamine, Cocaine, Stimulant Abuse, HIV, Behavioral Activation
- Medical subject headings
- Substance-Related Disorders, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACTBehavioural
Ten counseling sessions
Standard of CareBehavioural
Two counseling sessions
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Sexual risk-reduction counseling sessions. Receives: Behavioral: Standard of Care |
| Behavioral Activation & Risk Reduction Counseling | Experimental | Behavioral activation with risk reduction counseling. Receives: Behavioral: IMPACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Condomless Anal Sex Acts (CAS) over study follow-up
A self reported change in the number of CAS with men without protection of PrEP
Measured: Baseline, 4 month, 8 month, 12 month
Secondary outcomes (1)
Reduction in the number of stimulant use episodes over study follow-up
A self reported change in the number of stimulant use episodes over study follow-up
Measured: Baseline, 4 month, 8 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Mar 2018
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
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 Stimulant AbuseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm RTC, equally randomized between two arms: (1) the Project IMPACT intervention, "BA-RR" (behavioral activation and HIV risk reduction) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent sexual risk reduction counseling sessions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, The Fenway Institute, Brown University
- Responsible party
- Principal investigator, Matthew Mimiaga, ScD, MPH, MA, University of California, Los Angeles
- Investigators
- Matthew J Mimiaga, ScD, MPH, Principal investigator, University of California, Los Angeles, Fielding School of Public HealthSteve Safren, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175159
- Sponsor's protocol ID
- 1R01DA042805-01A1
- Status last verified
- Jul 2024
- First submitted
- 1 Jun 2017
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data for additional analysis will be available to outside individuals through contacting the Multiple Principal Investigators (MPI) at two different times. The first will be after all of the baseline data is collected. We will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, we will welcome this collaboration. A similar process will happen for outcome data; however, this will not be possible until the publication and release of the outcome paper(s). The MPIs (Mimiaga and Safren) will store the data indefinitely and allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the MPIs' program's web page. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
Publications
Klasko-Foster LB, Biello KB, Lodge W 2nd, Olson J, Mimiaga MJ. Transitioning from Face to Face to the Digital Space: Best Practices and Lessons Learned Leveraging Technology to Conduct HIV-Focused Interventions. Telemed J E Health. 2022 Jul;28(7):1070-1073. doi: 10.1089/tmj.2021.0190. Epub 2022 Jan 6.
PubMed 34995162Mimiaga MJ, Pantalone DW, Biello KB, Glynn TR, Santostefano CM, Olson J, Pardee DJ, Hughto JMW, Garcia Valles J, Carrico AW, Mayer KH, Safren SA. A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: project IMPACT study protocol. BMC Public Health. 2018 Jul 25;18(1):914. doi: 10.1186/s12889-018-5856-0.
PubMed 30045702
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Behavioral Activation and HIV Risk Reduction Counseling for Men Who Have Sex With Men (MSM) With Stimulant Abuse
- ClinicalTrials.gov ID
- NCT03175159
- Acronym / sponsor ID
- 1R01DA042805-01A1
- Conditions
- Stimulant Abuse, HIV Prevention, Substance Abuse
- Keywords
- Risk Reduction, Crystal Methamphetamine, Cocaine, Stimulant Abuse, HIV, Behavioral Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Miami, The Fenway Institute, Brown University
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 5 Jun 2017 (actual)
- 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 study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the efficacy of Project IMPACT, an intervention that integrates Behavioral Activation (BA) with HIV risk reduction (RR) counseling for HIV-uninfected men who have sex with men (MSM) with stimulant use disorder at risk for HIV via sexual behavior. HIV-uninfected MSM with a diagnosis of stimulant use disorder will be equally randomized to one of two study arms: (1) the Project IMPACT intervention, BA-RR counseling, which lasts ten sessions; and (2) the standard of care (SOC) comparison condition, including two equivalent sexual risk-reduction counseling sessions. Participants will be followed for one year post-randomization, with assessments at months four, eight, and 12.
Detailed description
Project IMPACT targets both stimulant use and sexual risk reduction in effort to help individuals relearn how to enjoy safe but pleasurable activities. The intervention integrates BA, an evidence-based cognitive behavior therapy for improving mood and increasing activity, incorporated with RR counseling aimed to reduce risky sexual practices, and potential HIV acquisition. This RCT is a two-arm efficacy trial, comparing the Project IMPACT Intervention with a SOC arm. All participants will receive HIV testing, pre-/post-test risk reduction counseling, oral swab toxicology test at baseline and 12 months, assessment of interest/indication for Pre-Exposure Prophylaxis (PrEP) per Center for Disease Control guidelines, and active referral to local PrEP services as standard-of-care. Finally, the RCT will integrate resource utilization and cost-effectiveness analyses to examine cost efficiency of the Project IMPACT Intervention as a component of data analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm RTC, equally randomized between two arms: (1) the Project IMPACT intervention, "BA-RR" (behavioral activation and HIV risk reduction) counseling, which lasts ten sessions; and (2) the standard of care comparison condition, including two equivalent sexual risk reduction counseling sessions.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Behavioral: Standard of CareSexual risk-reduction counseling sessions. |
| Behavioral Activation & Risk Reduction Counseling | Experimental | Behavioral: IMPACTBehavioral activation with risk reduction counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Assigned male at birth
- HIV-uninfected verified via rapid HIV test
- Self-reports in the past four months: CAS receptive or insertive with a cisgender male sexual partner, while using stimulants and without the protection of Pre-Exposure Prophylaxis (PrEP)*
- Able to read, speak, and understand English
Key exclusion criteria (5 listed)
- Does not live in the greater Boston or Miami areas, or will move away from Boston or Miami within the next 12 months
- Self-reports being 100% adherent to PrEP in the last four months
- Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- Discovery of active suicidal ideation at the time of interview (participants will be referred immediately for treatment, but may join the study once resolved)-
- Involvement in any other HIV Prevention study that may interfere with the ability to test major study outcomes (e.g. another sexual risk reduction intervention or PrEP adherence intervention)
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 |
|---|---|---|
| IMPACTTen counseling sessions | Behavioural | Behavioral Activation & Risk Reduction Counseling |
| Standard of CareTwo counseling sessions | Behavioural | Standard of Care (SOC) |
Primary outcome
Reduction in Condomless Anal Sex Acts (CAS) over study follow-up
Time frame: Baseline, 4 month, 8 month, 12 month
A self reported change in the number of CAS with men without protection of PrEP
1 secondary outcome
Reduction in the number of stimulant use episodes over study follow-up
Time frame: Baseline, 4 month, 8 month, 12 month
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 25 Jul 2024.
- Derived from this study: PubMed 34995162Klasko-Foster LB, Biello KB, Lodge W 2nd, Olson J, Mimiaga MJ. Transitioning from Face to Face to the Digital Space: Best Practices and Lessons Learned Leveraging Technology to Conduct HIV-Focused Interventions. Telemed J E Health. 2022 Jul;28(7):1070-1073. doi: 10.1089/tmj.2021.0190. Epub 2022 Jan 6.
- Derived from this study: PubMed 30045702Mimiaga MJ, Pantalone DW, Biello KB, Glynn TR, Santostefano CM, Olson J, Pardee DJ, Hughto JMW, Garcia Valles J, Carrico AW, Mayer KH, Safren SA. A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: project IMPACT study protocol. BMC Public Health. 2018 Jul 25;18(1):914. doi: 10.1186/s12889-018-5856-0.
- Individual participant dataSharing planned: Yes. Raw data for additional analysis will be available to outside individuals through contacting the Multiple Principal Investigators (MPI) at two different times. The first will be after all of the baseline data is collected. We will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, we will welcome this collaboration. A similar process will happen for outcome data; however, this will not be possible until the publication and release of the outcome paper(s). The MPIs (Mimiaga and Safren) will store the data indefinitely and allow access for pooled data analysis projects, or projects for outside individuals. Information regarding the availability of data for analysis will be listed on the MPIs' program's web page. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
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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.
Matthew J Mimiaga, ScD, MPH principal investigator
University of California, Los Angeles, Fielding School of Public Health
Steve Safren, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT in people with Stimulant Abuse and HIV Prevention, run by University of California, Los Angeles 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 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 25 Jul 2024. 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. 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?
Reduction in Condomless Anal Sex Acts (CAS) over study follow-up (time frame: Baseline, 4 month, 8 month, 12 month). 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 NCT03175159, 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 25 Jul 2024.