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OpenTrials
Completed

NCT Number: NCT02718456

Overcoming Barriers to HIV/AIDS Care and ART Initiation

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.

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Key information

Conditions

Engagement in HIV Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karen Health Center

Nairobi, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Expedited CD4 testing

Behavioral

Supplemental peer counseling

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Acronym: LINC

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2016
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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