Clinical Trials

MainTitle

A Test of Behavioral Intervention for Women at High Risk for HIV Infection

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00006440

First received: November 3, 2000
Last updated: October 27, 2016
Last Verified: October 2012
History of Changes
Purpose

Purpose

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.

Condition
HIV Infections

Study Type: Observational
Official Title: Feasibility Study of a Behavioral Intervention for Women at Persistent High Risk for HIV Infection

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 180
Study Start Date: March 2000
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)

Detailed Description:

Women have constituted the fastest-growing group of persons with new AIDS diagnoses for several years. The need to develop and evaluate interventions to reduce the incidence of HIV infection among women is urgent. The behavioral intervention method tested in this study integrates elements from diverse theories and empirical evidence for women to feel empowered to use methods of protection against disease. Although the overall objective of the study intervention is to reduce the risk of HIV infection through sexual contact, the intervention must also address drug usage among women.
Women are randomized in a 1 to 1 ratio to either the intervention or control condition. The Intervention Group participates in 4 group sessions over the course of 1 month and then in an additional reunion session approximately 1 month after the 4th group session. Sessions are

  1. 5 hours long and include 6 to 10 participants. The sessions involve talking about HIV, ways
to avoid HIV, and ways women can support each other. All participants complete a short-term assessment visit 1 week after the 4th group intervention session. The Control Group does not participate in group sessions. All participants are paid for their time and effort.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria
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.

  • Exclusion Criteria
    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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006440

Locations

United States, Massachusetts
Anne Colletti
Cambridge, Massachusetts, United States, 02138

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Erica Gollub
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00006440   History of Changes  
Other Study ID Numbers: HIVNET 029  
Study First Received: November 3, 2000  
Last Updated: October 27, 2016  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Risk Factors
Behavior Therapy
Substance-Related Disorders
Feasibility Studies

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this data on May 25, 2018
This information is provided by ClinicalTrials.gov.