Clinical trial NCT00080093: Increasing Condom Use in People at Risk for HIV Infection
Official title: Increasing Condom Use With a Stage-Matched Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Keywords: Condom
HIV Seronegativity
HIV Prevention
Behavioral Intervention
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2004-03-24
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Frequency of condom use
timeFrame: At 30 days and 2 months before each assessment
measure: Number of occurances of unprotected sex
timeFrame: At 30 days before each assessment
measure: Stage of change for condom use with main and nonmain partners, and men and women
timeFrame: Throughout study
Secondary outcomes:
measure: Frequency of condom use with main and nonmain partners, and men and women
timeFrame: Throughout Study
measure: Number and ratios of protected sex occasions with main and nonmain partners, and men and women
timeFrame: Throughout study
measure: Stage of change for condom use with main and nonmain partners, and men and women
timeFrame: Throughout Study
Other outcomes:
Locations:
Study officials:
affiliation: University of Rhode Island
name: Patricia Morokoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.