Effectiveness of Inpatient Voluntary Counseling and Testing (VCT) in Uganda
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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 |
- Number of HIV infections newly identified [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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| Uganda | |
| Mulago Hospital | |
| Kampala, Uganda | |
| 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 Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013