HIV InfectionNCT01362634
A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
A study testing Trans-theoretical Process of Change Model-self and Trans-theoretical Process of Change Model - interviewer in people with HIV Infection and Substance Abuse, run by Nova Southeastern University at 1 site in United States.
Trial summary
The proposed study is a three-armed randomized clinical trial. A total of 750 clients will be randomly assigned (using a random number table) to the interviewer-administered intervention, the self-administered intervention, and waitlist control conditions upon completion of screening, informed consent, HIV pretest… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- HIV Infection, Substance Abuse
- What is being tested?
- Trans-theoretical Process of Change Model-self and Trans-theoretical Process of Change Model - interviewer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 31 Jul 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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- heterosexually active
- ongoing club and prescription drug use
- between 18-39 years of age
- must go to local clubs at least two times per month
Who cannot join
- no current working phone number or e-mail address
- no intention to remain in South Florida for the next 12 months
- new HIV diagnosis in the past 90 days
- currently participating in a drug treatment program (excluding 12-step programs such as Alcoholics Anonymous)
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study is a three-armed randomized clinical trial. A total of 750 clients will be randomly assigned (using a random number table) to the interviewer-administered intervention, the self-administered intervention, and waitlist control conditions upon completion of screening, informed consent, HIV pretest counseling and test administration, and collection of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12 months.
Read the detailed description
The specific aims of the 5-year study are to:
- identify the covariates of baseline substance abuse and sexual risks (including demographics, social risk measures, peer norms, abuse history, and mental health status) among a sample of 750 heterosexually active, not-in-treatment, club and prescription drug users ages 18 to 39 in Miami, Florida.
- evaluate, through random assignment, the relative effectiveness of two intervention conditions and a waitlist control in reducing sex risks and drug use, as measured at 3-, 6- and 12-month follow-ups:
- Arm 1, an interviewer-administered comprehensive health and social risk assessment intervention (CAPI Intervention) similar to the baseline instrument used in the parent grant;
- Arm 2, an identical self-administered comprehensive assessment intervention (ACASI Intervention); and
- Arm 3, a waitlist control condition (Control). Outcome measures, including past 90-day counts of unprotected sex acts and days' drug use, will be obtained from brief risk behavior inventories at baseline and follow-ups.
- conduct qualitative process evaluation research with 40 participants in each study arm to contextualize the study findings and intervention outcomes.
- Conditions
- HIV Infection, Substance Abuse
- Being tested
- Trans-theoretical Process of Change Model-self, Trans-theoretical Process of Change Model - interviewer
- Keywords
- HIV/AIDS, substance use, club drugs, sexual risk
- Medical subject headings
- HIV Infections, Substance-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-theoretical Process of Change Model-selfBehavioural
self-administered, computer-based intervention
Trans-theoretical Process of Change Model - interviewerBehavioural
interviewer-administered intervention
| Study group | Role | What they receive |
|---|---|---|
| CAPI Intervention | Experimental | an interviewer-administered comprehensive health and social risk assessment intervention Receives: Behavioral: Trans-theoretical Process of Change Model - interviewer |
| ACASI Intervention | Experimental | self-administered comprehensive health and social risk assessment intervention Receives: Behavioral: Trans-theoretical Process of Change Model-self |
| Control | No intervention | waitlist control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
unprotected sexual intercourse events outside of primary relationships
Measured: 3 months
unprotected sexual intercourse events outside of primary relationship
Measured: 6 months
unprotected sexual intercourse events outside of primary relationship
Measured: 12 months
Days drug use in the past 90 days
Measured: 3 months
Days drug use in the past 90 days
Measured: 6 months
Days drug use in the past 90 days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2015
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Steven Kurtz, Ph.D., Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362634
- Sponsor's protocol ID
- 7R01DA019048
- Status last verified
- Dec 2017
- First submitted
- 26 May 2011
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
- ClinicalTrials.gov ID
- NCT01362634
- Acronym / sponsor ID
- 7R01DA019048
- Conditions
- HIV Infection, Substance Abuse
- Keywords
- HIV/AIDS, substance use, club drugs, sexual risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 30 May 2011 (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 proposed study is a three-armed randomized clinical trial. A total of 750 clients will be randomly assigned (using a random number table) to the interviewer-administered intervention, the self-administered intervention, and waitlist control conditions upon completion of screening, informed consent, HIV pretest counseling and test administration, and collection of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12 months.
Detailed description
The specific aims of the 5-year study are to:
- identify the covariates of baseline substance abuse and sexual risks (including demographics, social risk measures, peer norms, abuse history, and mental health status) among a sample of 750 heterosexually active, not-in-treatment, club and prescription drug users ages 18 to 39 in Miami, Florida.
- evaluate, through random assignment, the relative effectiveness of two intervention conditions and a waitlist control in reducing sex risks and drug use, as measured at 3-, 6- and 12-month follow-ups:
- Arm 1, an interviewer-administered comprehensive health and social risk assessment intervention (CAPI Intervention) similar to the baseline instrument used in the parent grant;
- Arm 2, an identical self-administered comprehensive assessment intervention (ACASI Intervention); and
- Arm 3, a waitlist control condition (Control). Outcome measures, including past 90-day counts of unprotected sex acts and days' drug use, will be obtained from brief risk behavior inventories at baseline and follow-ups.
- conduct qualitative process evaluation research with 40 participants in each study arm to contextualize the study findings and intervention outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAPI Intervention | Experimental | Behavioral: Trans-theoretical Process of Change Model - intervieweran interviewer-administered comprehensive health and social risk assessment intervention |
| ACASI Intervention | Experimental | Behavioral: Trans-theoretical Process of Change Model-selfself-administered comprehensive health and social risk assessment intervention |
| Control | No intervention | –waitlist control condition |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- heterosexually active
- ongoing club and prescription drug use
- between 18-39 years of age
- must go to local clubs at least two times per month
Key exclusion criteria (4 listed)
- no current working phone number or e-mail address
- no intention to remain in South Florida for the next 12 months
- new HIV diagnosis in the past 90 days
- currently participating in a drug treatment program (excluding 12-step programs such as Alcoholics Anonymous)
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 |
|---|---|---|
| Trans-theoretical Process of Change Model-selfself-administered, computer-based intervention | Behavioural | ACASI Intervention |
| Trans-theoretical Process of Change Model - interviewerinterviewer-administered intervention | Behavioural | CAPI Intervention |
Primary outcome
unprotected sexual intercourse events outside of primary relationships
Time frame: 3 months
unprotected sexual intercourse events outside of primary relationship
Time frame: 6 months
unprotected sexual intercourse events outside of primary relationship
Time frame: 12 months
Days drug use in the past 90 days
Time frame: 3 months
Days drug use in the past 90 days
Time frame: 6 months
Days drug use in the past 90 days
Time frame: 12 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 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-theoretical Process of Change Model-self and Trans-theoretical Process of Change Model - interviewer in people with HIV Infection and Substance Abuse, run by Nova Southeastern University 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 4 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 Dec 2017. 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?
unprotected sexual intercourse events outside of primary relationships (time frame: 3 months). The study lists 6 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 Dec 2017.