HIV Counseling and Testing and Linkage to Care in Uganda
NCT ID: NCT00648232
Last Updated: 2013-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3415 participants
INTERVENTIONAL
2008-05-31
2011-06-30
Brief Summary
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Detailed Description
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Participation in this study will last 12 months. All participants will undergo an initial interview to obtain basic information on previous HIV testing and status. Participants will then be assigned randomly to receive a brief or more detailed counseling session given before and after HIV testing. Participants assigned to the brief counseling session will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and available services for people infected with HIV. Participants assigned to the detailed counseling session will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants in both groups will undergo a blood draw for HIV testing. All participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Participants who are found to be infected with HIV will be assigned randomly to receive enhanced referrals to HIV-specific medical care or referrals to usual care. Participants receiving the enhanced referrals 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 first scheduled visits at the HIV clinics. Participants receiving referrals to usual care will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services. At Months 3, 6, 9, and 12, participants in both groups will be interviewed about contact information, overall health, current medications, sexual history, health services utilized, and any repeat HIV tests. Participants who are not infected with HIV may be randomly selected to undergo the same follow-up interviews as the HIV infected participants.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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A
Participants will receive voluntary brief HIV counseling and testing plus enhanced linkage to care.
Voluntary brief HIV counseling and testing
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.
Enhanced linkage to care
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.
B
Participants will receive voluntary brief HIV counseling and testing plus routine referral to care.
Voluntary brief HIV counseling and testing
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.
Routine referral to care
Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
C
Participants will receive voluntary longer, more detailed HIV counseling and testing plus enhanced linkage to care.
Voluntary longer, more detailed HIV counseling and testing
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.
Enhanced linkage to care
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.
D
Participants will receive voluntary longer, more detailed HIV counseling and testing plus routine referral to care.
Voluntary longer, more detailed HIV counseling and testing
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.
Routine referral to care
Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
E
Participants who are found to be healthy will receive voluntary brief HIV counseling and testing only.
Voluntary brief HIV counseling and testing
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.
F
Participants who are found to be healthy will receive voluntary longer, more detailed HIV counseling and testing only.
Voluntary longer, more detailed HIV counseling and testing
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.
Interventions
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Voluntary brief HIV counseling and testing
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.
Voluntary longer, more detailed HIV counseling and testing
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.
Enhanced linkage to care
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.
Routine referral to care
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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Thomas J. Coates
Professor
Principal Investigators
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Thomas J. Coates, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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Makerere University/Mulago Teaching Hospital, Uganda
Kampala, , Uganda
Countries
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References
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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.
Other Identifiers
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