NCT00006440

Brief Summary

The purpose of this study is to find out if it is possible to conduct a group counseling program for women at risk for HIV infection. Women have been the fastest-growing group with new AIDS diagnoses. The need for ways to reduce HIV infection in women is urgent. It is important to reduce the risk of HIV infection through sexual contact, but it is also important to address drug use. Group counseling may be an effective method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2000

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2000

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2012

Enrollment Period

8.2 years

First QC Date

November 3, 2000

Last Update Submit

October 27, 2016

Conditions

Keywords

Risk FactorsBehavior TherapySubstance-Related DisordersFeasibility Studies

Eligibility Criteria

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

You may qualify if:

  • Women may be eligible for this study if they:
  • Are at least 18 years old.
  • Took part in the VPS2 study and completed 12 months of follow-up, or each participant must meet at least 1 of the following conditions: 1) has sex with an HIV-infected male; 2) has sex with a male who has injected drugs in the last 5 years; 3) has had sex with 5 or more male partners in the last year; 4) exchanged sex for money or drugs in the last year; 5) was diagnosed with syphilis, chlamydia, gonorrhea, first episode herpes, pelvic inflammatory disease, and/or trichomonas in the last year; or 6) used crack cocaine in the last year.
  • Can speak English.
  • Can give information for the purpose of locating.
  • Have had at least 30 percent of vaginal or anal intercourse unprotected by condoms in the 6 months before the study.
  • Are HIV-negative.

You may not qualify if:

  • Women will not be eligible for this study if they:
  • Have had sex with only 1 man for 2 years or more who is HIV-negative and does not inject drugs. The man should not have had sex with anyone else during this time.
  • Have a mental condition that would interfere with the study.
  • Have any other condition that would interfere with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anne Colletti

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

HIV InfectionsSubstance-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Erica Gollub

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2000

First Posted

August 31, 2001

Study Start

March 1, 2000

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 31, 2016

Record last verified: 2012-10

Locations