ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Test of Behavioral Intervention for Women at High Risk for HIV Infection

This study is ongoing, but not recruiting participants.

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

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

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):

Estimated Enrollment:   180
Study Start Date:   March 2000

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 2.5 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
Ages Eligible for Study:   18 Years and older
Genders 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

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

Investigators
Study Chair:     Erica Gollub    
  More Information


Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 
Click here for more information on understanding HIV prevention  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   HIVNET 029
First Received:   November 3, 2000
Last Updated:   September 8, 2008
ClinicalTrials.gov Identifier:   NCT00006440
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Risk Factors  
Behavior Therapy  
Substance-Related Disorders  
Feasibility Studies  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 03, 2008




Links to all studies - primarily for crawlers