HIV Prevention in the Primary Care Setting
|ClinicalTrials.gov Identifier: NCT00381524|
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : June 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Behavioral: Increase condom use||Not Applicable|
Goals of the Demonstration Project. The goals of this project are as follows:
Goal 1: To utilize recent technological advances and refine a theory-based, computerized intervention system currently being evaluated in a Birmingham STD clinic. Our proposed interventions will target men-who-have-sex-with-men (MSM) and will be designed to: increase condom use for specific sexual activities with both main and casual (other) partners; decrease numbers of sexual partners among those reporting multiple partners; and increase the frequency of HIV serostatus disclosure to sexual partners.
Goal 2: To evaluate a computer-guided, theory-based, provider-delivered intervention in the context of standard care in an HIV primary care facility in collaboration with the Center for AIDS Prevention Studies (CAPS). We will test the following hypotheses after 18 months of follow-up:
Hypothesis 1: That the proportion of HIV-positive MSM reporting 100% condom use with main partners will be significantly increased in the intervention group compared to the usual care group.
Hypothesis 2: That the proportion of patients reporting 100% condom use with casual partners will be significantly increased among patients in the intervention group compared to the usual care group.
Hypothesis 3: That the proportion of patients with multiple sexual partners will be significantly reduced among intervention group participants compared with the usual care group.
Hypothesis 4: That the proportion of HIV-positive MSM who disclose their HIV status to sex partners who are HIV-negative or are of unknown HIV status will be significantly increased among the patients receiving the intervention compared to the patients in the usual care group.
Goal 3: In collaboration with the Center and SPNS program, to conduct a holistic evaluation of the intervention program.
Goal 4: To compare the cumulative incidence of symptomatic and asymptomatic treatable STDs (gonococcal and chlamydial infections) between patients in the intervention and usual care groups.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||234 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Special Projects of National Significance|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
- Behavioral: Increase condom use
Voluntary increase in condom use
- Proportion of participants reporting 100% condom use preintervention versus post intervention [ Time Frame: End of enrollment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381524
|United States, Alabama|
|UAB 1917 Clinic|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Edward W Hook, MD||University of Alabama at Birmingham|