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Overcoming Barriers to HIV/AIDS Care and ART Initiation (LINC)

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ClinicalTrials.gov Identifier: NCT02718456
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Brandon Guthrie, University of Washington

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.

Condition or disease Intervention/treatment Phase
Engagement in HIV Care Behavioral: Expedited CD4 testing Behavioral: Supplemental peer counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Overcoming Barriers to HIV/AIDS Care and ART Initiation
Study Start Date : August 2013
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Standard of care
Standard HIV counseling and referral to care
Experimental: CD4 testing
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.
Behavioral: Expedited CD4 testing
Experimental: CD4 testing plus peer counseling
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.
Behavioral: Expedited CD4 testing
Behavioral: Supplemental peer counseling



Primary Outcome Measures :
  1. Number of days from study enrollment until first visit to a comprehensive care center for HIV care. [ Time Frame: 1 year ]
    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.

  2. Number of days from study enrollment until initiation of antiretroviral therapy. [ Time Frame: 1 year ]
    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 :
  1. Interviewer-administered questionnaire to determine the number of visits made to a comprehensive care center for HIV care. [ Time Frame: 1 year ]
    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.

  2. Measurement of CD4+ T-cell count. [ Time Frame: 1 year ]
    Each participant's CD4 count will be measure at 1 year after enrollment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718456


Locations
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Kenya
Karen Health Center
Nairobi, Kenya
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Brandon L Guthrie, PhD University of Washington

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Responsible Party: Brandon Guthrie, Assistant Professor, Global Health, University of Washington
ClinicalTrials.gov Identifier: NCT02718456     History of Changes
Other Study ID Numbers: STUDY00000059
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019