NCT00972192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

Enrollment Period

4.1 years

First QC Date

September 3, 2009

Last Update Submit

September 3, 2009

Conditions

Keywords

HIV testingHIV risk behavioraccess to care

Outcome Measures

Primary Outcomes (1)

  • Number of HIV infections newly identified

    6 months

Secondary Outcomes (1)

  • HIV risk behavior and linkage to follow-up HIV care and support

    6 months

Study Arms (2)

Inpatient HIV testing

ACTIVE COMPARATOR

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

HIV testing post-discharge

NO INTERVENTION

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

Interventions

Participants who were randomized to the intervention group received free HIV testing and their results before they were discharged from the hospital.

Also known as: Inpatient VCT
Inpatient HIV testing

Participants randomised to the control arm received referral for testing post-discharge

Also known as: Oupatient VCT
HIV testing post-discharge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago Hospital

Kampala, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 16395619BACKGROUND

Study Officials

  • Moses Kamya, MBCHB

    Makerere University School of Medicine

    PRINCIPAL INVESTIGATOR
  • David Bangsberg, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

February 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations