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Clinical Trials/NCT02718456
NCT02718456
Completed
Not Applicable

Overcoming Barriers to HIV/AIDS Care and ART Initiation

University of Washington1 site in 1 country315 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Engagement in HIV Care
Sponsor
University of Washington
Enrollment
315
Locations
1
Primary Endpoint
Number of days from study enrollment until first visit to a comprehensive care center for HIV care.
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
December 22, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brandon Guthrie

Assistant Professor, Global Health

University of Washington

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).

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Interviewer-administered questionnaire to determine the number of visits made to a comprehensive care center for HIV care.(1 year)
  • Measurement of CD4+ T-cell count.(1 year)

Study Sites (1)

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