Increasing Condom Use in People at Risk for HIV Infection

Not Applicable

• Conditions: HIV Infections
• Interventions: Behavioral: Individual feedback and specially-tailored manuals; Behavioral: General HIV information feedback and the best-available information

• Registration Number: NCT00080093
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

This study will evaluate a new program designed to increase condom use in both women and men.

Detailed Description

As heterosexual HIV transmission increases, effective behavioral interventions to increase condom use are needed. Interventions should be low cost and accessible to large segments of the at-risk population. This study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. The intervention is computer-delivered and will be provided in health care settings. The study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the Multifaceted Model of HIV Risk.

Participants will be recruited from four health clinic sites that serve local ethnic minority communities. The participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an HIV information comparison group. All participants will receive comparable group-specific informational materials at study entry and at Months 2 and 4. Participants in the intervention group will receive individualized feedback and specially-tailored manuals. Participants in the HIV information comparison group will receive general HIV information feedback and the best-available informational manual.

Assessments for both groups will be conducted at study entry and at Months 6, 12, and 18. At study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. There will also be computer question sessions at study entry and at Months 2 and 4. Participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (STD) history, and personal relationships. Telephone follow-ups at Months 6, 12, and 18 will take approximately 20 to 30 minutes.

Study Timeline

• Study First Submitted: 2004-03-23
• Study First Submitted QC: 2004-03-23
• Study First Posted: 2004-03-24
• Study Start: 2006-01
• Primary Completion: 2007-10
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-25
• Last Update Posted: 2008-09-26
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 534

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Individual feedback and specially-tailored manuals	Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4
2	General HIV information feedback and the best-available information	Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4

Primary Outcome Measures

Name	Time	Method
Frequency of condom use	At 30 days and 2 months before each assessment
Number of occurances of unprotected sex	At 30 days before each assessment
Stage of change for condom use with main and nonmain partners, and men and women	Throughout study

Secondary Outcome Measures

Name	Time	Method
Number and ratios of protected sex occasions with main and nonmain partners, and men and women	Throughout study
Stage of change for condom use with main and nonmain partners, and men and women	Throughout Study
Frequency of condom use with main and nonmain partners, and men and women	Throughout Study