Engagement in HIV CareLINCNCT02718456
Overcoming Barriers to HIV/AIDS Care and ART Initiation
A study testing Expedited CD4 testing and Supplemental peer counseling in people with Engagement in HIV Care, run by University of Washington at 1 site in Kenya.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Engagement in HIV Care
- What is being tested?
- Expedited CD4 testing and Supplemental peer counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteKenya
- Study dates
- Aug 2013to 22 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Engagement in HIV Care
- Being tested
- Expedited CD4 testing, Supplemental peer counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expedited CD4 testingBehavioural
Supplemental peer counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Standard HIV counseling and referral to care |
| CD4 testing | Experimental | 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. Receives: Behavioral: Expedited CD4 testing |
| CD4 testing plus peer counseling | Experimental | 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. Receives: Behavioral: Expedited CD4 testing; Behavioral: Supplemental peer counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days from study enrollment until first visit to a comprehensive care center for HIV care.
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.
Measured: 1 year
Number of days from study enrollment until initiation of antiretroviral therapy.
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.
Measured: 1 year
Secondary outcomes (2)
Interviewer-administered questionnaire to determine the number of visits made to a comprehensive care center for HIV care.
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.
Measured: 1 year
Measurement of CD4+ T-cell count.
Each participant's CD4 count will be measure at 1 year after enrollment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startAug 2013
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Engagement in HIV CareStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon Guthrie, University of Washington
- Investigators
- Brandon L Guthrie, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718456
- Sponsor's protocol ID
- STUDY00000059
- Acronym
- LINC
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Barriers to HIV/AIDS Care and ART Initiation
- ClinicalTrials.gov ID
- NCT02718456
- Acronym / sponsor ID
- LINC / STUDY00000059
- Conditions
- Engagement in HIV Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 24 Mar 2016 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Standard HIV counseling and referral to care |
| CD4 testing | Experimental | Behavioral: Expedited CD4 testingStandard 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. |
| CD4 testing plus peer counseling | Experimental | Behavioral: Expedited CD4 testing, Behavioral: Supplemental peer counselingStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| Expedited CD4 testing | Behavioural | CD4 testing, CD4 testing plus peer counseling |
| Supplemental peer counseling | Behavioural | CD4 testing plus peer counseling |
Primary outcome
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.
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.
2 secondary outcomes
Interviewer-administered questionnaire to determine the number of visits made to a comprehensive care center for HIV care.
Time frame: 1 year
Measurement of CD4+ T-cell count.
Time frame: 1 year
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 13 Mar 2019.
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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.
Brandon L Guthrie, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expedited CD4 testing and Supplemental peer counseling in people with Engagement in HIV Care, run by University of Washington 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 6 inclusion and 5 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 13 Mar 2019. 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?
Number of days from study enrollment until first visit to a comprehensive care center for HIV care. (time frame: 1 year). 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?
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 13 Mar 2019.