HIVCD4-POCNCT02515149
Impact on Linkage to HIV Care With Point of Care CD4 Testing and Home-based HIV Testing in Kenya
A study testing Point of care CD4 device (Alere PIMA) in people with HIV, run by Centers for Disease Control and Prevention at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV
- What is being tested?
- Point of care CD4 device (Alere PIMA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 1 siteKenya
- Study dates
- Jul 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- current HIV care or HIV care within last six months
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- HIV
- Being tested
- Point of care CD4 device (Alere PIMA)
- Keywords
- linkage to care, point of care diagnostics, point of care CD4, HIV care cascade, Kenya
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care CD4 device (Alere PIMA)Device
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Referral laboratory based CD4 measurement after home-based HIV testing |
| Point of care | Experimental | POC CD4 testing after home-based HIV testing Receives: Device: Point of care CD4 device (Alere PIMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to HIV care
As ascertained from clinic charts
Measured: Within six months from date of study enrollment
ART initiation
As ascertained from clinic charts
Measured: Within six months from date of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Kenya Medical Research Institute, United States President's Emergency Plan for AIDS Relief
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515149
- Sponsor's protocol ID
- CDC - NCHHSTP - 6382
- Acronym
- CD4-POC
- Status last verified
- Apr 2025
- First submitted
- 3 Aug 2015
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Desai MA, Okal DO, Rose CE, Ndivo R, Oyaro B, Otieno FO, Williams T, Chen RT, Zeh C, Samandari T. Effect of point-of-care CD4 cell count results on linkage to care and antiretroviral initiation during a home-based HIV testing campaign: a non-blinded, cluster-randomised trial. Lancet HIV. 2017 Sep;4(9):e393-e401. doi: 10.1016/S2352-3018(17)30091-7. Epub 2017 May 31.
PubMed 28579225
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02515149
- Acronym / sponsor ID
- CD4-POC / CDC - NCHHSTP - 6382
- Conditions
- HIV
- Keywords
- linkage to care, point of care diagnostics, point of care CD4, HIV care cascade, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Kenya Medical Research Institute, United States President's Emergency Plan for AIDS Relief
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Referral laboratory based CD4 measurement after home-based HIV testing |
| Point of care | Experimental | Device: Point of care CD4 device (Alere PIMA)POC CD4 testing after home-based HIV testing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- current HIV care or HIV care within last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care CD4 device (Alere PIMA)Also: Alere Pimafor 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 | Device | Point of care |
Primary outcome
Linkage to HIV care
Time frame: Within six months from date of study enrollment
As ascertained from clinic charts
ART initiation
Time frame: Within six months from date of study enrollment
As ascertained from clinic charts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 28579225Desai MA, Okal DO, Rose CE, Ndivo R, Oyaro B, Otieno FO, Williams T, Chen RT, Zeh C, Samandari T. Effect of point-of-care CD4 cell count results on linkage to care and antiretroviral initiation during a home-based HIV testing campaign: a non-blinded, cluster-randomised trial. Lancet HIV. 2017 Sep;4(9):e393-e401. doi: 10.1016/S2352-3018(17)30091-7. Epub 2017 May 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of care CD4 device (Alere PIMA) in people with HIV, run by Centers for Disease Control and Prevention at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to HIV care (time frame: Within six months from date of study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.