Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments individual feedback and specially-tailored manuals, general hiv information feedback and the best-available information
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Start date January 2006
End date October 2007
Trial size 534 participants
Trial identifier NCT00080093, R01 AI41323, R01AI41323

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4
individual feedback and specially-tailored manuals
Individual feedback and specially-tailored manuals
(Experimental)
Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4
general hiv information feedback and the best-available information
General HIV information feedback and the best-available information

Primary Outcomes

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

Secondary Outcomes

Measure
Frequency of condom use with main and nonmain partners, and men and women
time frame: Throughout Study
Number and ratios of protected sex occasions with main and nonmain partners, and men and women
time frame: Throughout study
Stage of change for condom use with main and nonmain partners, and men and women
time frame: Throughout Study

Eligibility Criteria

Male or female participants from 18 years up to 44 years old.

Inclusion Criteria - HIV uninfected - Sexually active - At risk for HIV (as determined by study officials) - Speaks English - Seen at a participating clinic Exclusion Criteria - Pregnant

Additional Information

Official title Increasing Condom Use With a Stage-Matched Intervention
Principal investigator Patricia Morokoff, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).