Impact on Linkage to HIV Care With Point of Care CD4 Testing and Home-based HIV Testing in Kenya

HIV Clinical Trial

— CD4-POC  

Official title:

Randomized Controlled Trial to Assess Accuracy, Feasibility, Acceptability, Cost Effectiveness and Impact of Point of Care CD4 Testing on HIV Diagnosis, Linkage to Care and Time to Antiretroviral Therapy Initiation Among HIV Infected Patients in Rural Western Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515149
• Other study ID #: CDC - NCHHSTP - 6382
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: August 3, 2015
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review CommitteeUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Randomised Controlled Trial to Assess Accuracy, Feasibility, Acceptability, Cost Effectiveness and Impact of Point of Care CD4 Testing on HIV Diagnosis, Linkage to Care and Time to Antiretroviral Therapy Initiation among HIV Infected Patients in Rural Western Kenya.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria: adults living in the study catchment area (Gem Village, Nyanza province Western Kenya) served by one of 23 HIV clinics and 3 referral labs

• Not having received HIV care in prior 6 months if known HIV+

Exclusion Criteria:

• current HIV care or HIV care within last six months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV

Intervention

Device:
• Point of care CD4 device (Alere PIMA)
for persons testing + with home-based HIV testing using Kenya's two rapid test algorithm, intervention arm participants received point of care CD4 testing followed by counseling on results which included their treatment eligibility

Locations

Country	Name	City	State
Kenya	CDC - KEMRI Field Research Station	Kisumu	Nyanza

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Kenya Medical Research Institutue, United States President's Emergency Plan for AIDS Relief

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkage to HIV care	As ascertained from clinic charts	Within six months from date of study enrollment	No
Primary	ART initiation	As ascertained from clinic charts	Within six months from date of study enrollment	No