Increasing Condom Use in People at Risk for HIV Infection

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Unknown

Conditions: HIV Infections

Treatments: Behavioral: General HIV information feedback and the best-available information; Behavioral: Individual feedback and specially-tailored manuals

Study type: Interventional

Funder types: NIH

Identifiers

NCT00080093

R01AI041323 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 534 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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534 participants in 2 patient groups

1

Experimental group

Description:

Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4

Treatment:

Behavioral: Individual feedback and specially-tailored manuals

2

Experimental group

Description:

Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4

Treatment:

Behavioral: General HIV information feedback and the best-available information