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

University of Washington

Status: Completed

Conditions: Engagement in HIV Care

Treatments: Behavioral: Expedited CD4 testing; Behavioral: Supplemental peer counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02718456

STUDY00000059

Details and patient eligibility

About

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.

Enrollment: 315 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

315 participants in 3 patient groups

Standard of care

No Intervention group

Description:

Standard HIV counseling and referral to care

CD4 testing

Experimental group

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.

Treatment:

Behavioral: Expedited CD4 testing

CD4 testing plus peer counseling

Experimental group

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.

Treatment:

Behavioral: Supplemental peer counseling

Behavioral: Expedited CD4 testing