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Increasing Condom Use in People at Risk for HIV Infection

Increasing Condom Use With a Stage-Matched Intervention

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00080093
Enrollment
534
Registered
2004-03-24
Start date
2006-01-31
Completion date
2008-12-31
Last updated
2008-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Condom, HIV Seronegativity, HIV Prevention, Behavioral Intervention

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.

Interventions

BEHAVIORALIndividual feedback and specially-tailored manuals

Individual feedback and specially-tailored manuals

BEHAVIORALGeneral HIV information feedback and the best-available information

General HIV information feedback and the best-available information

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Frequency of condom useAt 30 days and 2 months before each assessment
Number of occurances of unprotected sexAt 30 days before each assessment
Stage of change for condom use with main and nonmain partners, and men and womenThroughout study

Secondary

MeasureTime frame
Frequency of condom use with main and nonmain partners, and men and womenThroughout Study
Number and ratios of protected sex occasions with main and nonmain partners, and men and womenThroughout study
Stage of change for condom use with main and nonmain partners, and men and womenThroughout Study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026