HIVNCT01880489
Multicomponent Intervention to Reduce Sexual Risk and Substance Use
A study testing MI + CBST Intervention in people with HIV and Sexually Transmitted Infections, run by Hunter College of City University of New York at 1 site in United States.
Trial summary
The objective is to expand and refine an intervention for transgender women (TW) into a 7-session individual- and group-based intervention that is scalable for community settings to reduce sexual risk and substance use and to increase stigma-coping and risk-buffering behaviors among TW in NYC. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Infections, Substance Use
- What is being tested?
- MI + CBST Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 2 Nov 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Identify as a transgender woman (assigned male at birth and currently identify as female)
- Report 3 or more acts of unprotected anal or vaginal sex in the past 90 days and at least 1 in the past 30 days
- Report 5 or more days of illicit drug use in the past 90 days and at least 2 in the past 30
- Provide contact information
- Reside in the NYC metropolitan area
- Able to complete a survey in English (Spanish-language assistance can be provided by bilingual staff)
- Provide informed consent
Who cannot join
- Unstable, serious psychiatric symptoms
- Current suicidal/homicidal ideation
- Evidence of gross cognitive impairment
- Currently enrolled in a drug abuse treatment or enrolled in an HIV risk or drug use intervention study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
New York, New York, 10018
About this study
The objective is to expand and refine an intervention for transgender women (TW) into a 7-session individual- and group-based intervention that is scalable for community settings to reduce sexual risk and substance use and to increase stigma-coping and risk-buffering behaviors among TW in NYC. The investigators will pilot test the intervention with 20 TW and subsequently, conduct a randomized controlled trial with 240 TW to compare the intervention to a wait list control condition.
- Conditions
- HIV, Sexually Transmitted Infections, Substance Use
- Being tested
- MI + CBST Intervention
- Keywords
- transgender women, sexual risk, substance use, HIV prevention, behavioral 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.
MI + CBST InterventionBehavioural
The intervention focuses on exploring health goals, creating an action plan, learning about the impact stress, stigma, and substance use can have on health, improving personal growth and social support, and connecting with resources. The first two sessions will be primarily Motivational Interviewing and will explore participants' feelings about their sexual risk, substance use, non-medically monitored hormone and silicone use, and any other issues. Group sessions (Sessions 3-6) will incorporate Cognitive Behavioral Skills Training focusing barriers to physical and mental health. The last session will focus on reviewing progress toward health goals, identifying barriers to change, and generating a plan for connection to ongoing care to reach target health goals.
| Study group | Role | What they receive |
|---|---|---|
| MI + CBST Intervention | Experimental | Seven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training Receives: Behavioral: MI + CBST Intervention |
| Wait List Control Condition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Unprotected Sex Acts in the Past 90 Days
Decreases from Baseline in the Number of Unprotected Sex Acts in the past 90 days at 4 and 8 months
Measured: every 4 months over the course of 8 months
Number of Days of Drug Use in the Past 90 Days
Decreases from Baseline in the Number of Days of Drug Use in the past 90 days at 4 and 8 months
Measured: every 4 months over the course of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, H. Jonathon Rendina, Hunter College of City University of New York
- Investigators
- H. Jonathon Rendina, Ph.D., Principal investigator, Hunter College of City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880489
- Sponsor's protocol ID
- R01DA034661
- Other IDs
- R01DA034661
- Status last verified
- Aug 2018
- First submitted
- 13 Jun 2013
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Intervention to Reduce Sexual Risk and Substance Use
- ClinicalTrials.gov ID
- NCT01880489
- Acronym / sponsor ID
- R01DA034661
- Conditions
- HIV, Sexually Transmitted Infections, Substance Use
- Keywords
- transgender women, sexual risk, substance use, HIV prevention, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2013 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 19 Jun 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.
The objective is to expand and refine an intervention for transgender women (TW) into a 7-session individual- and group-based intervention that is scalable for community settings to reduce sexual risk and substance use and to increase stigma-coping and risk-buffering behaviors among TW in NYC. The investigators will pilot test the intervention with 20 TW and subsequently, conduct a randomized controlled trial with 240 TW to compare the intervention to a wait list control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI + CBST Intervention | Experimental | Behavioral: MI + CBST InterventionSeven sessions of Motivational Interviewing and Cognitive Behavioral Skills Training |
| Wait List Control Condition | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Identify as a transgender woman (assigned male at birth and currently identify as female)
- Report 3 or more acts of unprotected anal or vaginal sex in the past 90 days and at least 1 in the past 30 days
- Report 5 or more days of illicit drug use in the past 90 days and at least 2 in the past 30
- Provide contact information
Key exclusion criteria (4 listed)
- Unstable, serious psychiatric symptoms
- Current suicidal/homicidal ideation
- Evidence of gross cognitive impairment
- Currently enrolled in a drug abuse treatment or enrolled in an HIV risk or drug use intervention study
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 |
|---|---|---|
| MI + CBST InterventionThe intervention focuses on exploring health goals, creating an action plan, learning about the impact stress, stigma, and substance use can have on health, improving personal growth and social support, and connecting with resources. The first two sessions will be primarily Motivational Interviewing and will explore participants' feelings about their sexual risk, substance use, non-medically monitored hormone and silicone use, and any other issues. Group sessions (Sessions 3-6) will incorporate Cognitive Behavioral Skills Training focusing barriers to physical and mental health. The last session will focus on reviewing progress toward health goals, identifying barriers to change, and generating a plan for connection to ongoing care to reach target health goals. | Behavioural | MI + CBST Intervention |
Primary outcome
Number of Unprotected Sex Acts in the Past 90 Days
Time frame: every 4 months over the course of 8 months
Decreases from Baseline in the Number of Unprotected Sex Acts in the past 90 days at 4 and 8 months
Number of Days of Drug Use in the Past 90 Days
Time frame: every 4 months over the course of 8 months
Decreases from Baseline in the Number of Days of Drug Use in the past 90 days at 4 and 8 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 7 Aug 2018.
- Individual participant dataSharing planned: No
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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.
H. Jonathon Rendina, Ph.D. principal investigator
Hunter College of City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI + CBST Intervention in people with HIV and Sexually Transmitted Infections, run by Hunter College of City University of New York 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 8 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 7 Aug 2018. 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.
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?
Number of Unprotected Sex Acts in the Past 90 Days (time frame: every 4 months over the course of 8 months). The study lists 2 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 7 Aug 2018.