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

Primary Purpose

HIV Infections

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Risk Factors, Behavior Therapy, Substance-Related Disorders, Feasibility Studies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Anne Colletti

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 2000
Last Updated
October 27, 2016
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00006440
Brief Title
A Test of Behavioral Intervention for Women at High Risk for HIV Infection
Official Title
Feasibility Study of a Behavioral Intervention for Women at Persistent High Risk for HIV Infection
Study Type
Observational

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Risk Factors, Behavior Therapy, Substance-Related Disorders, Feasibility Studies

7. Study Design

Enrollment
180 (false)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Gollub
Official's Role
Study Chair
Facility Information:
Facility Name
Anne Colletti
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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