NCT00150098

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

4.8 years

First QC Date

September 6, 2005

Last Update Submit

April 7, 2014

Conditions

HIV InfectionsHepatitis B

Keywords

HIVvaccineswomensubstance use

Outcome Measures

Primary Outcomes (2)

  • - an HIV risk score, the Vaginal Episode Equivalent (VEE)

    approved prior to 12-1-12

  • - understanding assessment for HIV vaccines.

    approved prior to 12-1 2012

Secondary Outcomes (6)

  • -frequency of use of specific drugs

    approved prior to 12-1-12

  • -knowledge of HB vaccine acceptance of hepatitis B vaccine among those susceptible

    approved prior to 12-1-12

  • -adherence to hepatitis B vaccination schedule

    approved prior to 12-1-12

  • -willingness to participate in HIV vaccine trials

    approved prior to 12-1-12

  • -measures of motivators and barriers to receiving hepatitis B vaccine and a candidate HIV vaccine

    approved prior to 12-1-12

  • +1 more secondary outcomes

Study Arms (1)

lifestyle counselling

EXPERIMENTAL

Education

Behavioral: Enhanced HIV risk reduction and HIV vaccine education

Interventions

Enhanced HIV risk reduction and HIV vaccine educationBEHAVIORAL
lifestyle counselling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • agree to be randomized;
  • willing to return for visits at 1, 6, and 12 months post-enrollment;
  • willing and able to provide informed consent.

You may not qualify if:

  • history of injection drug use in the previous 3 years;
  • pregnant;
  • intending to become pregnant in the next 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York Blood Center

New York, New York, 10021, United States

Location

New York Blood Center - Project Achieve

The Bronx, New York, 10455, United States

Location

Related Publications (1)

  • 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.

    PMID: 20190585DERIVED

MeSH Terms

Conditions

HIV InfectionsHepatitis BSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesChemically-Induced DisordersMental Disorders

Study Officials

  • Beryl A Koblin, Ph.D.

    New York Blood Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

February 1, 2005

Primary Completion

November 1, 2009

Study Completion

October 1, 2010

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

US(2)