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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2015
• Main ID: NCT02515149
• Date of registration: 03/08/2015
• Prospective Registration: No
• Primary sponsor: Centers for Disease Control and Prevention
• Public title: Impact on Linkage to HIV Care With Point of Care CD4 Testing and Home-based HIV Testing in Kenya CD4-POC
• Scientific 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
• Date of first enrolment: July 2013
• Target sample size: 770
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02515149
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
• Phase: N/A

Countries of recruitment

Kenya

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Device: Point of care CD4 device (Alere PIMA)

Primary Outcome(s)

ART initiation [Time Frame: Within six months from date of study enrollment]

Linkage to HIV care [Time Frame: Within six months from date of study enrollment]

Secondary ID(s)

CDC - NCHHSTP - 6382

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

US President's Emergency Plan for AIDS Relief

Kenya Medical Research Institutue