HIVNCT02271074
Thol'Impilo: Bringing People Into Care
A study testing Point of care CD4 testing, Care Facilitation and Transport support in people with HIV, run by The Aurum Institute NPC at 1 site in South Africa.
Trial summary
The main objective of this study is to compare the effectiveness of combinations of three patient-oriented strategies, compared to the standard of care, to increase the proportion of patients who enter-into-care for HIV within 90 days of testing HIV positive. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Point of care CD4 testing, Care Facilitation and Transport support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,398 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jun 2012to Jul 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years and older, diagnosed HIV positive at enrolling mobile HCT units, no prior self-reported registration at a health care facility for HIV care, provide consent for participation
Who cannot join
- self-reported prior or current registration as an HIV patient at a healthcare facility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Strategies to Accelerate Entry-into-care Following HIV Diagnosis Among Adults in Gauteng and Limpopo Provinces, South Africa
The main objective of this study is to compare the effectiveness of combinations of three patient-oriented strategies, compared to the standard of care, to increase the proportion of patients who enter-into-care for HIV within 90 days of testing HIV positive.
Read the detailed description
Background:
Mortality remains high among individuals with HIV in South Africa largely due to low CD4 at initiation of combination antiretroviral therapy (cART) or failure to initiate cART altogether. The problem of advanced HIV at the time of entry-into-care persists despite increases in CD4 count initiation thresholds and higher CD4 counts among individuals testing HIV positive at HIV counselling and testing services (HCT). A reason for the discord between CD4 at HCT and CD4 at cART initiation is a failure to effectively link people who test positive into HIV care; less than half of individuals testing HIV positive enter HIV care within 3-6 month of HIV diagnosis. However, not only do these delays increase HIV associated mortality, delays from testing positive to entry-into-care for HIV also reduces the ability of test-and-treat strategies to reduce HIV transmission through HIV treatment.
Study Design:
Thol'impilo is an open (non-masked) individually-randomized implementation science evaluation of the effectiveness and cost-effectiveness of combinations of three strategies to increase timely entry-into-care for HIV compared to the standard of care. Participants are randomly assigned to one of four arms to increase timely entry into care: (1) standard of care, (2) point-of-care CD4 and transport assistance, (3) point-of-care CD4 and care facilitator and (4) point-of-care CD4 alone.
Sample size:
The study aims to enrol 2500 participants (i.e. 650 participants per arm).
Setting:
The study is built onto the current community-based HIV Counselling and Testing (HCT) services. The HCT units serve peri-urban townships and informal settlements, rural farm workers, and both urban and rural communities.
- Conditions
- HIV
- Being tested
- Point of care CD4 testing, Care Facilitation, Transport support
- Keywords
- HIV, Care, Treatment, Retention, Implementation Science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care CD4 testingOther
Participants in this arm will receive POC CD4 testing using the PIMA™ CD4 test system. Results will be made available to the participant within 20 to 25 minutes, before the participant leaves the HCT room. Participants will be given a copy of their results, which will be affixed to their referral letter, and they will be educated on the meaning of the CD4 results in relation to their health. This session will only be performed once at the time of issuing POC CD4 results.
Care FacilitationBehavioural
The goal of this intervention is to provide on-going counselling using a combination of motivational and strengths-based counselling approaches.This is a time limited intervention with a maximum of 5 client sessions over a 90-day period. Participants will also be transitioned out of the intervention upon successful entry into HIV care. Sessions will be done using both face-to-face and telephonic approaches, although the former is more preferred.
Transport supportOther
The goal of this intervention is to address one of the most frequently noted structural barrier to entry-into-care in resource constrained settings: prohibitive distance or transport cost to reach a health facility.This is a time limited intervention with a maximum of 3 transport assists for healthcare visits over a 90-day period. Transport assistance is provided in the form of reimbursements to claims submitted by the participant after a self-reported HIV care clinic visits. Participants in this arm, receive their transport support through in-person collection or via cell phone transfer. Transport support amounts are standardised according to geographical area.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | The role of this arm is to provide a baseline measure that can be used to assess the effectiveness of the combination interventions in improving the proportion of individuals entering care within 3 months. Participants in this arm only receive standard post-test counselling after they are issued with a positive HIV result. They are counselled on possible emotional resources, and given information on how to reduce risk of HIV transmission, ongoing positive living, nutrition and healthy lifestyles. These clients are given referral letters and referred to health facilities of their choice that offer HIV care/treatment. They are then followed up at the designated study time points to ascertain entry into care. |
| Point of care CD4 testing | Experimental | Participants in this arm will receive point of care (POC) cluster differentiation 4 (CD4) testing using the PIMA™ CD4 test system. Receives: Other: Point of care CD4 testing |
| Care facilitation | Experimental | Participants receive a combination of POC CD4 testing and care facilitation. Receives: Other: Point of care CD4 testing; Behavioral: Care Facilitation |
| Transport support | Experimental | Participants receive a combination of POC CD4 testing and transport support. Receives: Other: Point of care CD4 testing; Other: Transport support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to entry into HIV care
To compare the time to entering HIV care in each intervention arm against the standard of care arm over a 90 day period from study enrolment.
Measured: 90 days
Secondary outcomes (4)
Proportion entering care
To compare the proportion of participants in each arm entering care by 90 days from study enrolment
Measured: 90 days
Time to entry into HIV care
To compare the time to entering HIV care in each intervention arm against the standard of care over a 180 day period from study enrolment.
Measured: 180 days
Mortality
To compare time to mortality from enrolment by arm over a 12 month period
Measured: 6 and 12 months
Cost per additional participant entering into care
To evaluate the incremental cost effectiveness (cost per additional participant entering into care by 90 days) for each intervention arm compared to the standard-of-care
Measured: Costs will be measured over a 12 month horizon and entry into care will be measured over a 90 day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startJun 2012
- Primary completionJul 2016
- Study completionJul 2016
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,398 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Aurum Institute NPC
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Johns Hopkins University, London School of Hygiene and Tropical Medicine, University of Witwatersrand, South Africa
- Responsible party
- Sponsor
- Investigators
- Violet Chihota, PhD, Study director, The Aurum Institute NPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271074
- Sponsor's protocol ID
- AUR5-9-119
- Other IDs
- AID-OAA-A-12-00028
- Status last verified
- Jan 2016
- First submitted
- 14 Oct 2014
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared through identified USAID -PEPFAR Platforms.
Publications
Hoffmann CJ, Mabuto T, Ginindza S, Fielding KL, Kubeka G, Dowdy DW, Churchyard GJ, Charalambous S. Strategies to Accelerate HIV Care and Antiretroviral Therapy Initiation After HIV Diagnosis: A Randomized Trial. J Acquir Immune Defic Syndr. 2017 Aug 15;75(5):540-547. doi: 10.1097/QAI.0000000000001428.
PubMed 28471840
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Strategies to Accelerate Entry-into-care Following HIV Diagnosis Among Adults in Gauteng and Limpopo Provinces, South Africa
- ClinicalTrials.gov ID
- NCT02271074
- Acronym / sponsor ID
- AUR5-9-119
- Conditions
- HIV
- Keywords
- HIV, Care, Treatment, Retention, Implementation Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,398 participants (actual)
- Lead sponsor
- The Aurum Institute NPCUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Johns Hopkins University, London School of Hygiene and Tropical Medicine, University of Witwatersrand, South Africa
- Study start
- Jun 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Oct 2014 (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 main objective of this study is to compare the effectiveness of combinations of three patient-oriented strategies, compared to the standard of care, to increase the proportion of patients who enter-into-care for HIV within 90 days of testing HIV positive.
Detailed description
Background:
Mortality remains high among individuals with HIV in South Africa largely due to low CD4 at initiation of combination antiretroviral therapy (cART) or failure to initiate cART altogether. The problem of advanced HIV at the time of entry-into-care persists despite increases in CD4 count initiation thresholds and higher CD4 counts among individuals testing HIV positive at HIV counselling and testing services (HCT). A reason for the discord between CD4 at HCT and CD4 at cART initiation is a failure to effectively link people who test positive into HIV care; less than half of individuals testing HIV positive enter HIV care within 3-6 month of HIV diagnosis. However, not only do these delays increase HIV associated mortality, delays from testing positive to entry-into-care for HIV also reduces the ability of test-and-treat strategies to reduce HIV transmission through HIV treatment.
Study Design:
Thol'impilo is an open (non-masked) individually-randomized implementation science evaluation of the effectiveness and cost-effectiveness of combinations of three strategies to increase timely entry-into-care for HIV compared to the standard of care. Participants are randomly assigned to one of four arms to increase timely entry into care: (1) standard of care, (2) point-of-care CD4 and transport assistance, (3) point-of-care CD4 and care facilitator and (4) point-of-care CD4 alone.
Sample size:
The study aims to enrol 2500 participants (i.e. 650 participants per arm).
Setting:
The study is built onto the current community-based HIV Counselling and Testing (HCT) services. The HCT units serve peri-urban townships and informal settlements, rural farm workers, and both urban and rural communities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –The role of this arm is to provide a baseline measure that can be used to assess the effectiveness of the combination interventions in improving the proportion of individuals entering care within 3 months. Participants in this arm only receive standard post-test counselling after they are issued with a positive HIV result. They are counselled on possible emotional resources, and given information on how to reduce risk of HIV transmission, ongoing positive living, nutrition and healthy lifestyles. These clients are given referral letters and referred to health facilities of their choice that offer HIV care/treatment. They are then followed up at the designated study time points to ascertain entry into care. |
| Point of care CD4 testing | Experimental | Other: Point of care CD4 testingParticipants in this arm will receive point of care (POC) cluster differentiation 4 (CD4) testing using the PIMA™ CD4 test system. |
| Care facilitation | Experimental | Other: Point of care CD4 testing, Behavioral: Care FacilitationParticipants receive a combination of POC CD4 testing and care facilitation. |
| Transport support | Experimental | Other: Point of care CD4 testing, Other: Transport supportParticipants receive a combination of POC CD4 testing and transport support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18 years and older, diagnosed HIV positive at enrolling mobile HCT units, no prior self-reported registration at a health care facility for HIV care, provide consent for participation
Key exclusion criteria (1 listed)
- self-reported prior or current registration as an HIV patient at a healthcare facility
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 testingParticipants in this arm will receive POC CD4 testing using the PIMA™ CD4 test system. Results will be made available to the participant within 20 to 25 minutes, before the participant leaves the HCT room. Participants will be given a copy of their results, which will be affixed to their referral letter, and they will be educated on the meaning of the CD4 results in relation to their health. This session will only be performed once at the time of issuing POC CD4 results. | Other | Care facilitation, Point of care CD4 testing, Transport support |
| Care FacilitationThe goal of this intervention is to provide on-going counselling using a combination of motivational and strengths-based counselling approaches.This is a time limited intervention with a maximum of 5 client sessions over a 90-day period. Participants will also be transitioned out of the intervention upon successful entry into HIV care. Sessions will be done using both face-to-face and telephonic approaches, although the former is more preferred. | Behavioural | Care facilitation |
| Transport supportThe goal of this intervention is to address one of the most frequently noted structural barrier to entry-into-care in resource constrained settings: prohibitive distance or transport cost to reach a health facility.This is a time limited intervention with a maximum of 3 transport assists for healthcare visits over a 90-day period. Transport assistance is provided in the form of reimbursements to claims submitted by the participant after a self-reported HIV care clinic visits. Participants in this arm, receive their transport support through in-person collection or via cell phone transfer. Transport support amounts are standardised according to geographical area. | Other | Transport support |
Primary outcome
Time to entry into HIV care
Time frame: 90 days
To compare the time to entering HIV care in each intervention arm against the standard of care arm over a 90 day period from study enrolment.
4 secondary outcomes
Proportion entering care
Time frame: 90 days
Time to entry into HIV care
Time frame: 180 days
Mortality
Time frame: 6 and 12 months
Cost per additional participant entering into care
Time frame: Costs will be measured over a 12 month horizon and entry into care will be measured over a 90 day period
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 20 Jul 2016.
- Derived from this study: PubMed 28471840Hoffmann CJ, Mabuto T, Ginindza S, Fielding KL, Kubeka G, Dowdy DW, Churchyard GJ, Charalambous S. Strategies to Accelerate HIV Care and Antiretroviral Therapy Initiation After HIV Diagnosis: A Randomized Trial. J Acquir Immune Defic Syndr. 2017 Aug 15;75(5):540-547. doi: 10.1097/QAI.0000000000001428.
- Individual participant dataSharing planned: Yes. Data will be shared through identified USAID -PEPFAR Platforms.
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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.
Violet Chihota, PhD study director
The Aurum Institute NPC
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 testing, Care Facilitation and Transport support in people with HIV, run by The Aurum Institute NPC at 1 site in South Africa.
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 1 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 20 Jul 2016. 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 South Africa. 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?
Time to entry into HIV care (time frame: 90 days). 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 NCT02271074, 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 20 Jul 2016.