HIV InfectionsNCT00150098
Project UNITY - HIV Risk Reduction and Vaccine Education Interventions
A study testing Enhanced HIV risk reduction and HIV vaccine education in people with HIV Infections and Hepatitis B, run by New York Blood Center at 2 sites in United States.
Trial summary
To determine the efficacy of an enhanced HIV risk reduction intervention delivered concurrently with a vaccination schedule to reduce the number of unprotected vaginal and anal sex acts among HIV-negative, high-risk non-injection drug-using (NIDU) women. 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 Infections, Hepatitis B
- What is being tested?
- Enhanced HIV risk reduction and HIV vaccine education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2005to Oct 2010
- 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
- at least 18 years of age;
- non-injecting use of heroin, cocaine or crack cocaine in the last six months;
- unprotected vaginal sex in the last three months;
- test HIV antibody negative;
- agree to provide specimens for testing (HIV, HBV and pregnancy) and be willing to learn the results of these tests;
- ability to understand spoken English or Spanish;
Show all 9Show fewer
- agree to be randomized;
- willing to return for visits at 1, 6, and 12 months post-enrollment;
- willing and able to provide informed consent.
Who cannot join
- history of injection drug use in the previous 3 years;
- pregnant;
- intending to become pregnant in the next 12 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York Blood Center
New York, New York, 10021
New York Blood Center - Project Achieve
The Bronx, New York, 10455
About this study
Official title: Project UNITY - A Randomized Trial of Enhanced HIV Risk Reduction and Vaccine Education Interventions in Reducing Sexual Risk and Increasing Vaccine Trial Knowledge Among HIV-negative, High-risk Women Who Use Non-injection Drugs
To determine the efficacy of an enhanced HIV risk reduction intervention delivered concurrently with a vaccination schedule to reduce the number of unprotected vaginal and anal sex acts among HIV-negative, high-risk non-injection drug-using (NIDU) women. To determine the efficacy of an enhanced vaccine education intervention delivered at baseline to increase vaccine knowledge and understanding of a potential HIV vaccine among HIV-negative, high-risk NIDU women.
Read the detailed description
We are currently screening women (approximately 535) from whom we expect 400 HIV-negative high-risk, non-pregnant NIDU women will be enrolled to participate in a two-arm randomized trial of an enhanced HIV risk reduction intervention plus an enhanced vaccine education intervention compared to controls. At screening, women complete an assessment, receive HIV and HBV pre-test counseling, and are tested for HIV antibody, markers of hepatitis B virus (HBV) infection and pregnancy. At the enrollment visit (2 weeks later), eligible and willing participants are randomized to receive either the enhanced HIV risk reduction intervention plus the enhanced vaccine education intervention or control conditions. Enrolled women provide urine for pregnancy testing. Enrolled women found to be susceptible to HBV are offered hepatitis B (HB) vaccine at the enrollment visit. Follow-up visits coincide with the HB vaccine schedule (1 and 6 months post enrollment) for all women, regardless of whether or not they received HB vaccine. Pregnancy testing is conducted at these follow-up visits. Participants provide sera for HIV antibody testing at the 6- and 12-months visits. A final visit will occur at 12 months post enrollment to assess longer term effects on risk behaviors and knowledge and understanding of vaccine concepts. All standardized interviews are conducted using Audio Computer Assisted Self-Interview (ACASI) technology.
The enhanced HIV risk reduction intervention is a series of three, interactive, individually-delivered, counseling sessions. The enhanced sessions also include tailored male and female condom demonstrations to build skills, and each session concludes with a client-initiated sexual risk reduction goal. The follow-up sessions (at 1 and 6 months) resume by reviewing goal attainment, exploring the reasons and beliefs associated with progress toward that goal. The control group receives the client-centered HIV counseling based on the Centers for Disease Control and Prevention (CDC) Project RESPECT model. Both the control and enhanced risk reduction counseling are delivered at the baseline (time 0) and at follow up visits (1 month and 6 months).
The enhanced vaccine education component will test the two-session model informed consent process outlined by Coletti et al but enhanced with simplified illustrated educational material delivered through flipcharts, video and individual counseling at baseline and 1 week later. The control condition is based on the Coletti two-session informed consent process.
- Conditions
- HIV Infections, Hepatitis B
- Being tested
- Enhanced HIV risk reduction and HIV vaccine education
- Keywords
- HIV, vaccines, women, substance use
- Medical subject headings
- HIV Infections, Hepatitis B, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced HIV risk reduction and HIV vaccine educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| lifestyle counselling | Experimental | Education Receives: Behavioral: Enhanced HIV risk reduction and HIV vaccine education |
What is being measured
The primary outcome is the main question the study is designed to answer.
- an HIV risk score, the Vaginal Episode Equivalent (VEE)
Measured: approved prior to 12-1-12
- understanding assessment for HIV vaccines.
Measured: approved prior to 12-1 2012
Secondary outcomes (6)
-frequency of use of specific drugs
Measured: approved prior to 12-1-12
-knowledge of HB vaccine acceptance of hepatitis B vaccine among those susceptible
Measured: approved prior to 12-1-12
-adherence to hepatitis B vaccination schedule
Measured: approved prior to 12-1-12
-willingness to participate in HIV vaccine trials
Measured: approved prior to 12-1-12
-measures of motivators and barriers to receiving hepatitis B vaccine and a candidate HIV vaccine
Measured: approved prior to 12-1-12
-incidence of pregnancy
Measured: approved prior to 12-1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionNov 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Blood Center
- Sponsor type
- University, hospital or other
- Collaborators
- The New York Academy of Medicine, Rutgers University
- Investigators
- Beryl A Koblin, Ph.D., Principal investigator, New York Blood Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150098
- Sponsor's protocol ID
- IRB 406-04
- Other IDs
- 5R01DA017482-03
- Status last verified
- Apr 2014
- First submitted
- 6 Sep 2005
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Koblin BA, Bonner S, Hoover DR, Xu G, Lucy D, Fortin P, Putnam S, Latka MH. A randomized trial of enhanced HIV risk-reduction and vaccine trial education interventions among HIV-negative, high-risk women who use noninjection drugs: the UNITY study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):378-87. doi: 10.1097/QAI.0b013e3181b7222e.
PubMed 20190585
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project UNITY - A Randomized Trial of Enhanced HIV Risk Reduction and Vaccine Education Interventions in Reducing Sexual Risk and Increasing Vaccine Trial Knowledge Among HIV-negative, High-risk Women Who Use Non-injection Drugs
- ClinicalTrials.gov ID
- NCT00150098
- Acronym / sponsor ID
- IRB 406-04
- Conditions
- HIV Infections, Hepatitis B
- Keywords
- HIV, vaccines, women, substance use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- New York Blood CenterUniversity, hospital or other
- Collaborators
- The New York Academy of Medicine, Rutgers University
- Study start
- Feb 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Sep 2005 (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.
To determine the efficacy of an enhanced HIV risk reduction intervention delivered concurrently with a vaccination schedule to reduce the number of unprotected vaginal and anal sex acts among HIV-negative, high-risk non-injection drug-using (NIDU) women. To determine the efficacy of an enhanced vaccine education intervention delivered at baseline to increase vaccine knowledge and understanding of a potential HIV vaccine among HIV-negative, high-risk NIDU women.
Detailed description
We are currently screening women (approximately 535) from whom we expect 400 HIV-negative high-risk, non-pregnant NIDU women will be enrolled to participate in a two-arm randomized trial of an enhanced HIV risk reduction intervention plus an enhanced vaccine education intervention compared to controls. At screening, women complete an assessment, receive HIV and HBV pre-test counseling, and are tested for HIV antibody, markers of hepatitis B virus (HBV) infection and pregnancy. At the enrollment visit (2 weeks later), eligible and willing participants are randomized to receive either the enhanced HIV risk reduction intervention plus the enhanced vaccine education intervention or control conditions. Enrolled women provide urine for pregnancy testing. Enrolled women found to be susceptible to HBV are offered hepatitis B (HB) vaccine at the enrollment visit. Follow-up visits coincide with the HB vaccine schedule (1 and 6 months post enrollment) for all women, regardless of whether or not they received HB vaccine. Pregnancy testing is conducted at these follow-up visits. Participants provide sera for HIV antibody testing at the 6- and 12-months visits. A final visit will occur at 12 months post enrollment to assess longer term effects on risk behaviors and knowledge and understanding of vaccine concepts. All standardized interviews are conducted using Audio Computer Assisted Self-Interview (ACASI) technology.
The enhanced HIV risk reduction intervention is a series of three, interactive, individually-delivered, counseling sessions. The enhanced sessions also include tailored male and female condom demonstrations to build skills, and each session concludes with a client-initiated sexual risk reduction goal. The follow-up sessions (at 1 and 6 months) resume by reviewing goal attainment, exploring the reasons and beliefs associated with progress toward that goal. The control group receives the client-centered HIV counseling based on the Centers for Disease Control and Prevention (CDC) Project RESPECT model. Both the control and enhanced risk reduction counseling are delivered at the baseline (time 0) and at follow up visits (1 month and 6 months).
The enhanced vaccine education component will test the two-session model informed consent process outlined by Coletti et al but enhanced with simplified illustrated educational material delivered through flipcharts, video and individual counseling at baseline and 1 week later. The control condition is based on the Coletti two-session informed consent process.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle counselling | Experimental | Behavioral: Enhanced HIV risk reduction and HIV vaccine educationEducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- at least 18 years of age;
- non-injecting use of heroin, cocaine or crack cocaine in the last six months;
- unprotected vaginal sex in the last three months;
- test HIV antibody negative;
- agree to provide specimens for testing (HIV, HBV and pregnancy) and be willing to learn the results of these tests;
Key exclusion criteria (3 listed)
- history of injection drug use in the previous 3 years;
- pregnant;
- intending to become pregnant in the next 12 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 |
|---|---|---|
| Enhanced HIV risk reduction and HIV vaccine education | Behavioural | lifestyle counselling |
Primary outcome
- an HIV risk score, the Vaginal Episode Equivalent (VEE)
Time frame: approved prior to 12-1-12
- understanding assessment for HIV vaccines.
Time frame: approved prior to 12-1 2012
6 secondary outcomes
-frequency of use of specific drugs
Time frame: approved prior to 12-1-12
-knowledge of HB vaccine acceptance of hepatitis B vaccine among those susceptible
Time frame: approved prior to 12-1-12
-adherence to hepatitis B vaccination schedule
Time frame: approved prior to 12-1-12
-willingness to participate in HIV vaccine trials
Time frame: approved prior to 12-1-12
-measures of motivators and barriers to receiving hepatitis B vaccine and a candidate HIV vaccine
Time frame: approved prior to 12-1-12
-incidence of pregnancy
Time frame: approved prior to 12-1-12
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 8 Apr 2014.
- Derived from this study: PubMed 20190585Koblin BA, Bonner S, Hoover DR, Xu G, Lucy D, Fortin P, Putnam S, Latka MH. A randomized trial of enhanced HIV risk-reduction and vaccine trial education interventions among HIV-negative, high-risk women who use noninjection drugs: the UNITY study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):378-87. doi: 10.1097/QAI.0b013e3181b7222e.
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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.
Beryl A Koblin, Ph.D. principal investigator
New York Blood Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced HIV risk reduction and HIV vaccine education in people with HIV Infections and Hepatitis B, run by New York Blood Center 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 9 inclusion and 3 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 8 Apr 2014. 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?
- an HIV risk score, the Vaginal Episode Equivalent (VEE) (time frame: approved prior to 12-1-12). 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?
On the ClinicalTrials.gov record for NCT00150098, which also lists 1 linked publication.
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 8 Apr 2014.