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

Completed

• Conditions: HIV Infections

• Registration Number: NCT00006440
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2000-11-03
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2012-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Anne Colletti; 🇺🇸 Cambridge, Massachusetts, United States