Clinical trial NCT00972192: Effectiveness of Inpatient Voluntary Counseling and Testing (VCT) in Uganda
Official title: Effectiveness of Inpatient HIV Voluntary Counseling and Testing in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV testing
HIV risk behavior
access to care
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2009-09-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: Number of HIV infections newly identified
timeFrame: 6 months
Secondary outcomes:
measure: HIV risk behavior and linkage to follow-up HIV care and support
timeFrame: 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital
Study officials:
affiliation: Makerere University School of Medicine
name: Moses Kamya, MBCHB
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: David Bangsberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wanyenze R, Kamya M, Liechty CA, Ronald A, Guzman DJ, Wabwire-Mangen F, Mayanja-Kizza H, Bangsberg DR. HIV counseling and testing practices at an urban hospital in Kampala, Uganda. AIDS Behav. 2006 Jul;10(4):361-7. doi: 10.1007/s10461-005-9035-9.