HIV Counseling and Testing and Linkage to Care in Uganda
2 other identifiers
interventional
3,415
1 country
1
Brief Summary
This study will compare the effectiveness of brief versus detailed HIV counseling sessions, paired with referrals to either HIV-specific medical care or usual care, in reducing HIV risk behavior and in increasing treatment adherence in Uganda.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started May 2008
Typical duration for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 12, 2013
December 1, 2013
3.1 years
March 28, 2008
December 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction in HIV risk behavior among inpatients after discharge
Measured at Months 3, 6, 9, and 12
Receipt of opportunistic infection (OI) prophylaxis, adherence to antiretroviral therapy (ART), and reduction in mortality
Measured at Months 3, 6, 9, and 12
Secondary Outcomes (1)
Number of infections averted per patient randomized to each of the four intervention strategies
Measured at Month 12
Study Arms (6)
A
EXPERIMENTALParticipants will receive voluntary brief HIV counseling and testing plus enhanced linkage to care.
B
EXPERIMENTALParticipants will receive voluntary brief HIV counseling and testing plus routine referral to care.
C
EXPERIMENTALParticipants will receive voluntary longer, more detailed HIV counseling and testing plus enhanced linkage to care.
D
EXPERIMENTALParticipants will receive voluntary longer, more detailed HIV counseling and testing plus routine referral to care.
E
ACTIVE COMPARATORParticipants who are found to be healthy will receive voluntary brief HIV counseling and testing only.
F
ACTIVE COMPARATORParticipants who are found to be healthy will receive voluntary longer, more detailed HIV counseling and testing only.
Interventions
Participants will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and on available services for people infected with HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Participants will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Participants will be provided with more detailed counseling on how to access HIV services, will be introduced to a specific HIV clinic, and will be given a list of other HIV services available in the area. After leaving the hospital, participants will receive reminder telephone calls 1 week before their scheduled visits at the HIV clinics.
Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
Eligibility Criteria
You may qualify if:
- Willing to receive HIV test results
- Willing to provide adequate contact information
- Possesses sufficient cognitive ability to provide informed consent and participate in the interventions, as determined subjectively by the Regulatory Coordinator (patient with altered mental status or who is otherwise too ill to participate in the consent process will be excluded)
- Planned local residence over the next year after study entry (within a reasonable distance; approximate radius of 25 km of Kampala city center)
- Fluent in Luganda or English
You may not qualify if:
- Self-reported HIV-infected serostatus (defined as ever receiving an HIV-positive test result)
- Self-reported HIV test within the 12 months before study entry
- Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Makerere University/Mulago Teaching Hospital, Uganda
Kampala, 7072, Uganda
Related Publications (1)
Wanyenze RK, Kamya MR, Fatch R, Mayanja-Kizza H, Baveewo S, Szekeres G, Bangsberg DR, Coates T, Hahn JA. Abbreviated HIV counselling and testing and enhanced referral to care in Uganda: a factorial randomised controlled trial. Lancet Glob Health. 2013 Sep;1(3):e137-45. doi: 10.1016/S2214-109X(13)70067-6. Epub 2013 Aug 23.
PMID: 25104262DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas J. Coates, PhD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 1, 2008
Study Start
May 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
December 12, 2013
Record last verified: 2013-12