Effectiveness of Inpatient Voluntary Counseling and Testing (VCT) in Uganda
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|ClinicalTrials.gov Identifier: NCT00972192|
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : September 4, 2009
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Inpatient HIV testing Behavioral: Outpatient HIV testing||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness of Inpatient HIV Voluntary Counseling and Testing in Uganda|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
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
- Number of HIV infections newly identified [ Time Frame: 6 months ]
- HIV risk behavior and linkage to follow-up HIV care and support [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972192
|Principal Investigator:||Moses Kamya, MBCHB||Makerere University School of Medicine|
|Principal Investigator:||David Bangsberg, MD||University of California, San Francisco|