Increasing Condom Use in People at Risk for HIV Infection

Study Overview
=================
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.

Official Title
-----------------
Increasing Condom Use With a Stage-Matched Intervention

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Individual feedback and specially-tailored manuals
* Behavioral: General HIV information feedback and the best-available information


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4 | Behavioral: Individual feedback and specially-tailored manuals<br>* Individual feedback and specially-tailored manuals<br>|
| Experimental: 2<br>Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4 | Behavioral: General HIV information feedback and the best-available information<br>* General HIV information feedback and the best-available information<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of condom use |  | At 30 days and 2 months before each assessment | 
| Number of occurances of unprotected sex |  | At 30 days before each assessment | 
| Stage of change for condom use with main and nonmain partners, and men and women |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of condom use with main and nonmain partners, and men and women |  | Throughout Study | 
| Number and ratios of protected sex occasions with main and nonmain partners, and men and women |  | Throughout study | 
| Stage of change for condom use with main and nonmain partners, and men and women |  | Throughout Study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Condom, HIV Seronegativity, HIV Prevention, Behavioral Intervention