Increasing Condom Use in People at Risk for HIV Infection

HIV Infections Clinical Trial

Official title:

Increasing Condom Use With a Stage-Matched Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00080093
• Other study ID #: R01AI041323
• Secondary ID: R01AI041323
• Status: Active, not recruiting
• Phase: N/A
• First received: March 23, 2004
• Last updated: September 25, 2008
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2008
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 534
• Est. completion date: December 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

References & Publications (2)

Cho S, Harlow L, Morokoff P, Redding C, Rossi J, Mayer K, Koblin B. Predicting 3-Wave LGCM of Condom Use in High-Risk Community Sample. Annual Meeting of the American Psychological Association, San Francisco, CA, 2007.

Cho S, Morokoff P, Redding C, Harlow L, Rossi J, Mayer K, Koblin B. Empirically Investigating Gender in a Multifaceted Model of HIV Risk. 19th Annual Meeting of the American Psychological Society, Washington, DC, 2007.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of condom use		At 30 days and 2 months before each assessment	No
Primary	Number of occurances of unprotected sex		At 30 days before each assessment	No
Primary	Stage of change for condom use with main and nonmain partners, and men and women		Throughout study	No
Secondary	Frequency of condom use with main and nonmain partners, and men and women		Throughout Study	No
Secondary	Number and ratios of protected sex occasions with main and nonmain partners, and men and women		Throughout study	No
Secondary	Stage of change for condom use with main and nonmain partners, and men and women		Throughout Study	No