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

Sponsor

Makerere University (Other)

Overall Status

Completed

CT.gov ID

NCT00972192

Collaborator

University of California, San Francisco (Other)

500

Enrollment

Location

Arms

Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV	Behavioral: Inpatient HIV testing Behavioral: Outpatient HIV testing	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

Effectiveness of Inpatient HIV Voluntary Counseling and Testing in Uganda

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Oupatient VCT

Arm

Intervention/Treatment

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 Names:

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 Names:

Oupatient VCT

Outcome Measures

Primary Outcome Measures

Number of HIV infections newly identified [6 months]

Secondary Outcome Measures

HIV risk behavior and linkage to follow-up HIV care and support [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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