Effectiveness of Inpatient Voluntary Counseling and Testing (VCT) in Uganda

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00972192
First received: September 3, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

This study compared the effectiveness of inpatient routine VCT to referral for post-discharge VCT in terms of the number of new HIV infections identified, linkage to care for HIV infected individuals and reduction in HIV risk behavior.


Condition Intervention
HIV
Behavioral: Inpatient HIV testing
Behavioral: Outpatient HIV testing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Effectiveness of Inpatient HIV Voluntary Counseling and Testing in Uganda

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Number of HIV infections newly identified [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV risk behavior and linkage to follow-up HIV care and support [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: February 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Inpatient HIV testing
Participants who were randomized to the intervention group received free HIV testing and counseling immediately after the baseline interview. Patients underwent phlebotomy and serologic testing and results were disclosed the following day with post-test counseling (before they were discharged from the hospital).
Behavioral: Inpatient HIV testing
Participants who were randomized to the intervention group received free HIV testing and their results before they were discharged from the hospital.
Other Name: Inpatient VCT
No Intervention: HIV testing post-discharge
Participants who were randomized to the control group were given a referral card and an appointment, by the interviewers, to return for free HIV testing and counseling at Mulago hospital one week after discharge. Participants who returned had their transport reimbursed.
Behavioral: Outpatient HIV testing
Participants randomised to the control arm received referral for testing post-discharge
Other Name: Oupatient VCT

Detailed Description:

Ambulatory HIV voluntary testing and counseling (VCT) has become a mainstay of HIV prevention and linkage to care efforts. Despite expansion of these services in sub-Saharan Africa, most individuals admitted for acute illnesses arrive in hospital unaware of their HIV serostatus. Even then, inpatient risk reduction counseling services are not widely available and utilization of HIV testing services in the hospital is rare; most HIV diagnoses are made clinically without the benefit of counseling or antibody testing. The effectiveness of VCT during hospitalization in high-prevalence, resource poor settings has never been formally studied. It has been argued that the circumstances of hospitalization for HIV-associated illness do not allow for the provision of VCT services in this setting: Patients may be too sick to participate meaningfully in risk reduction counseling and the inpatient medical management of acute illness may leave little time for the provision of VCT. There are also several potentially significant differences between ambulatory and inpatient VCT that may limit efficacy in the latter case. First, inpatient counseling during an acute illness may not reduce risk behavior significantly due to competing priorities and messages communicated to patients while in the hospital. Second, HIV risk behavior may already be so infrequent among individuals with complications of advanced HIV disease that there is little margin for further risk reduction. Third, providing VCT during acute hospitalization may not result in effective linkage to existing outpatient follow-up medical care or community-based support services. It may prove very difficult to bridge the gap between the hospital setting and ongoing outpatient care resources. If this is not accomplished, a major goal of the provision of inpatient VCT will be unmet.

This randomized trial compared the impact of free, routine, VCT during hospitalization for acute illness at Mulago Hospital with referral for ambulatory VCT immediately following hospital discharge (which was the current standard of care). We assessed HIV risk behavior and linkage to care outcomes at 3 and 6 months. The following specific aims were addressed:

Aim 1: To determine the number of HIV infections newly identified by offering free VCT routinely to hospitalized patients.

Aim 2: To determine whether routine VCT in hospitalized patients increases partner disclosure and reduces risk behavior at 3 and 6 months.

Aim 3: To determine whether routine VCT in hospitalized patients increases linkage to follow-up HIV care, including available opportunistic infection prophylaxis, antiretroviral treatment, hospice services, and other community-based social services.

  Eligibility

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

Inclusion Criteria:

  • Age over 18 years
  • Undocumented HIV status
  • Fluency in Luganda or English
  • Residence within 20 kilometers of Mulago Hospital
  • Able to provide informed consent

Exclusion Criteria:

  • Patients with altered mental status or who are too ill to participate in the consent process
  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: NCT00972192

Locations
Uganda
Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
Makerere University
University of California, San Francisco
Investigators
Principal Investigator: Moses Kamya, MBCHB Makerere University School of Medicine
Principal Investigator: David Bangsberg, MD University of California, San Francisco
  More Information

Publications:
Responsible Party: Prof. Moses Kamya, Makerere University School of Medicine
ClinicalTrials.gov Identifier: NCT00972192     History of Changes
Other Study ID Numbers: 23193
Study First Received: September 3, 2009
Last Updated: September 3, 2009
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
HIV testing
HIV risk behavior
access to care

Additional relevant MeSH terms:
HIV Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014