Overcoming Barriers to HIV/AIDS Care and ART Initiation (LINC)
Primary Purpose
Engagement in HIV Care
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Expedited CD4 testing
Supplemental peer counseling
Sponsored by
About this trial
This is an interventional health services research trial for Engagement in HIV Care
Eligibility Criteria
Inclusion Criteria:
- At least 18 years or older and
- Testing HIV-positive for the first time at a voluntary counseling and testing (VCT) center.
- Willing to receive counseling to encourage linkage to care at a comprehensive care center (CCC).
- Willing to have a CD4 count test conducted at the enrollment visit.
- Willing to have a telephone follow-up where they may receive additional counseling and/or have their CD4 count results returned to them.
- Willing to be contacted over 1 year to determine if they linked to care.
Exclusion Criteria:
- Previous positive HIV test.
- Currently taking antiretroviral medications.
- Currently pregnant (females only).
- Currently participating in another research study or trial.
- Not planning to remain in Nairobi for the next 12 months (not including short trips out of Nairobi).
Sites / Locations
- Karen Health Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Standard of care
CD4 testing
CD4 testing plus peer counseling
Arm Description
Standard HIV counseling and referral to care
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis. CD4 results are reported to participants via telephone within 1 week.
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis. CD4 results are reported to participants via telephone within 1 week. Additionally, a trained peer counselor provides supplemental counseling at the time of diagnosis and at the 1 week telephone follow-up.
Outcomes
Primary Outcome Measures
Number of days from study enrollment until first visit to a comprehensive care center for HIV care.
An interviewer administered questionnaire will be used to determine if each participant visited a comprehensive care center. Is so, the date of the first visit will be recorded. From this, the time from enrollment until first visit to a comprehensive care center will be calculated.
Number of days from study enrollment until initiation of antiretroviral therapy.
An interviewer administered questionnaire will be used to determine if each participant started antiretroviral therapy. Is so, the date of treatment initiation will be recorded. From this, the time from enrollment until treatment initiation will be calculated.
Secondary Outcome Measures
Interviewer-administered questionnaire to determine the number of visits made to a comprehensive care center for HIV care.
Measurement of the number of visits to a comprehensive care center will be made questionnaire administered in an in-person interview at 12 months after enrollment. The total number of visits will be recorded.
Measurement of CD4+ T-cell count.
Each participant's CD4 count will be measure at 1 year after enrollment.
Full Information
NCT ID
NCT02718456
First Posted
March 11, 2016
Last Updated
March 12, 2019
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT02718456
Brief Title
Overcoming Barriers to HIV/AIDS Care and ART Initiation
Acronym
LINC
Official Title
Overcoming Barriers to HIV/AIDS Care and ART Initiation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will evaluate interventions to improve engagement in HIV care following HIV diagnosis through a voluntary counseling and testing program. The specific aims are to (1) determine if a VCT-based intervention of CD4 count testing, alone or in combination with peer counseling, improves linkage to HIV/AIDS care; (2) assess the impact of the intervention on ART initiation. The study will recruit 450 HIV-positive individuals from VCTs and randomize a third to standard counseling and referral, a third to receive CD4 testing at the VCT with results return by phone after 1 weeks, and a third to receive the same CD4 testing combined with peer counseling. These combined investigations will create a comprehensive understanding of obstacles to appropriate HIV/AIDS care and result in new interventions to achieve measurable outcomes in applied settings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Engagement in HIV Care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
315 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard HIV counseling and referral to care
Arm Title
CD4 testing
Arm Type
Experimental
Arm Description
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis. CD4 results are reported to participants via telephone within 1 week.
Arm Title
CD4 testing plus peer counseling
Arm Type
Experimental
Arm Description
Standard HIV counseling and testing plus blood drawn for CD4 testing at time of HIV diagnosis. CD4 results are reported to participants via telephone within 1 week. Additionally, a trained peer counselor provides supplemental counseling at the time of diagnosis and at the 1 week telephone follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Expedited CD4 testing
Intervention Type
Behavioral
Intervention Name(s)
Supplemental peer counseling
Primary Outcome Measure Information:
Title
Number of days from study enrollment until first visit to a comprehensive care center for HIV care.
Description
An interviewer administered questionnaire will be used to determine if each participant visited a comprehensive care center. Is so, the date of the first visit will be recorded. From this, the time from enrollment until first visit to a comprehensive care center will be calculated.
Time Frame
1 year
Title
Number of days from study enrollment until initiation of antiretroviral therapy.
Description
An interviewer administered questionnaire will be used to determine if each participant started antiretroviral therapy. Is so, the date of treatment initiation will be recorded. From this, the time from enrollment until treatment initiation will be calculated.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Interviewer-administered questionnaire to determine the number of visits made to a comprehensive care center for HIV care.
Description
Measurement of the number of visits to a comprehensive care center will be made questionnaire administered in an in-person interview at 12 months after enrollment. The total number of visits will be recorded.
Time Frame
1 year
Title
Measurement of CD4+ T-cell count.
Description
Each participant's CD4 count will be measure at 1 year after enrollment.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years or older and
Testing HIV-positive for the first time at a voluntary counseling and testing (VCT) center.
Willing to receive counseling to encourage linkage to care at a comprehensive care center (CCC).
Willing to have a CD4 count test conducted at the enrollment visit.
Willing to have a telephone follow-up where they may receive additional counseling and/or have their CD4 count results returned to them.
Willing to be contacted over 1 year to determine if they linked to care.
Exclusion Criteria:
Previous positive HIV test.
Currently taking antiretroviral medications.
Currently pregnant (females only).
Currently participating in another research study or trial.
Not planning to remain in Nairobi for the next 12 months (not including short trips out of Nairobi).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon L Guthrie, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karen Health Center
City
Nairobi
Country
Kenya
12. IPD Sharing Statement
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Overcoming Barriers to HIV/AIDS Care and ART Initiation
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