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HIV Counseling and Testing and Linkage to Care in Uganda

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Voluntary brief HIV counseling and testing
Voluntary longer, more detailed HIV counseling and testing
Enhanced linkage to care
Routine referral to care
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, AIDS, Prevention, VCT, Voluntary Counseling and Testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Makerere University/Mulago Teaching Hospital, Uganda

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

A

B

C

D

E

F

Arm Description

Participants will receive voluntary brief HIV counseling and testing plus enhanced linkage to care.

Participants will receive voluntary brief HIV counseling and testing plus routine referral to care.

Participants will receive voluntary longer, more detailed HIV counseling and testing plus enhanced linkage to care.

Participants will receive voluntary longer, more detailed HIV counseling and testing plus routine referral to care.

Participants who are found to be healthy will receive voluntary brief HIV counseling and testing only.

Participants who are found to be healthy will receive voluntary longer, more detailed HIV counseling and testing only.

Outcomes

Primary Outcome Measures

Reduction in HIV risk behavior among inpatients after discharge
Receipt of opportunistic infection (OI) prophylaxis, adherence to antiretroviral therapy (ART), and reduction in mortality

Secondary Outcome Measures

Number of infections averted per patient randomized to each of the four intervention strategies

Full Information

First Posted
March 28, 2008
Last Updated
December 11, 2013
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00648232
Brief Title
HIV Counseling and Testing and Linkage to Care in Uganda
Official Title
HIV Counseling and Testing and Linkage to Care in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is a major global health concern, with countries in Africa undergoing a severe HIV/AIDS crisis. The number of new cases of HIV infection in Africa continues to rise, making disease prevention methods imperative. Important to the prevention process are early testing, educational counseling on HIV and how to reduce sexual-risk behavior, and connecting people with HIV infection to services that offer medical treatment and social support. However, the most effective strategy for fully integrating HIV counseling, testing, and medical care access is not known. This study will compare the effectiveness of brief versus detailed HIV counseling sessions, paired with either referrals to HIV-specific medical care or usual care, in reducing HIV risk behavior and in increasing treatment adherence in Uganda. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, AIDS, Prevention, VCT, Voluntary Counseling and Testing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Participants will receive voluntary brief HIV counseling and testing plus enhanced linkage to care.
Arm Title
B
Arm Type
Experimental
Arm Description
Participants will receive voluntary brief HIV counseling and testing plus routine referral to care.
Arm Title
C
Arm Type
Experimental
Arm Description
Participants will receive voluntary longer, more detailed HIV counseling and testing plus enhanced linkage to care.
Arm Title
D
Arm Type
Experimental
Arm Description
Participants will receive voluntary longer, more detailed HIV counseling and testing plus routine referral to care.
Arm Title
E
Arm Type
Active Comparator
Arm Description
Participants who are found to be healthy will receive voluntary brief HIV counseling and testing only.
Arm Title
F
Arm Type
Active Comparator
Arm Description
Participants who are found to be healthy will receive voluntary longer, more detailed HIV counseling and testing only.
Intervention Type
Behavioral
Intervention Name(s)
Voluntary brief HIV counseling and testing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Voluntary longer, more detailed HIV counseling and testing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced linkage to care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine referral to care
Intervention Description
Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
Primary Outcome Measure Information:
Title
Reduction in HIV risk behavior among inpatients after discharge
Time Frame
Measured at Months 3, 6, 9, and 12
Title
Receipt of opportunistic infection (OI) prophylaxis, adherence to antiretroviral therapy (ART), and reduction in mortality
Time Frame
Measured at Months 3, 6, 9, and 12
Secondary Outcome Measure Information:
Title
Number of infections averted per patient randomized to each of the four intervention strategies
Time Frame
Measured at Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J. Coates, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makerere University/Mulago Teaching Hospital, Uganda
City
Kampala
ZIP/Postal Code
7072
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
25104262
Citation
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.
Results Reference
derived

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HIV Counseling and Testing and Linkage to Care in Uganda

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