HIV Prevention in the Primary Care Setting

This study has been completed.
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00381524
First received: September 26, 2006
Last updated: November 12, 2009
Last verified: November 2009
  Purpose

In the third decade of the HIV pandemic, what was once a uniformly and rapidly fatal disease has been transformed into a chronic illness by advances in the understanding of HIV pathogenesis and therapeutics. As a result, HIV-infected individuals are living longer and better lives. This phenomenon, coupled with a continued steady rate of new HIV infections in this country, has led to the highest U.S. HIV prevalence rates since the beginning of the epidemic. In the past, HIV prevention efforts were separate from routine primary care delivery due to multiple factors including stigma and time constraints. Recent events, including increases in sexually transmitted disease (STD) rates among HIV-infected persons and evidence that infected individuals can be super-infected by HIV strains resistant to antiretroviral therapy, have inspired the SPNS program initiative to develop demonstration projects for interventions to reduce risky sexual exposures among HIV-infected patients receiving primary care.


Condition Intervention
Human Immunodeficiency Virus
Behavioral: Increase condom use

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Special Projects of National Significance

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Proportion of participants reporting 100% condom use preintervention versus post intervention [ Time Frame: End of enrollment ] [ Designated as safety issue: No ]

Enrollment: 234
Study Start Date: June 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Increase condom use
    Voluntary increase in condom use
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active male patients over the age of 16 receiving routine primary care at the 1917 Clinic, reporting sexual contact with another man in the previous 6 months. Active patients will be defined as new patients (patients' first visit) with plans to continue follow-up at 1917 Clinic or an established patient seen at least once during the past year
  • Willingness to follow-up for at least 18 months
  • Ability to sign informed consent.

Exclusion Criteria:

  • Female patient
  • Male patient who is unwilling to follow-up for at least 18 months
  • Male patient who is not a primary care patient at the clinic
  • Unwillingness or inability to sign informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381524

Locations
United States, Alabama
UAB 1917 Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Edward W Hook, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Edward W. Hook, III, M.D., UAB
ClinicalTrials.gov Identifier: NCT00381524     History of Changes
Other Study ID Numbers: F040223020, 6 H97HA01191-03-02 (HRSA)
Study First Received: September 26, 2006
Last Updated: November 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
human immunodeficiency virus
behavior change

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014