Thol'Impilo: Bringing People Into Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Evaluation of Strategies to Accelerate Entry-into-care Following HIV Diagnosis Among Adults in Gauteng and Limpopo Provinces, South Africa

Conditions
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HIV

Intervention / Treatment
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* Other: Point of care CD4 testing
* Behavioral: Care Facilitation
* Other: Transport support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: self-reported prior or current registration as an HIV patient at a healthcare facility

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>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. | |
| Experimental: Point of care CD4 testing<br>Participants in this arm will receive point of care (POC) cluster differentiation 4 (CD4) testing using the PIMA™ CD4 test system. | Other: Point of care CD4 testing<br>* 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.<br>|
| Experimental: Care facilitation<br>Participants receive a combination of POC CD4 testing and care facilitation. | Other: Point of care CD4 testing<br>* 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.<br>Behavioral: Care Facilitation<br>* 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.<br>|
| Experimental: Transport support<br>Participants receive a combination of POC CD4 testing and transport support. | Other: Point of care CD4 testing<br>* 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.<br>Other: Transport support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion entering care | To compare the proportion of participants in each arm entering care by 90 days from study enrolment | 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. | 180 days | 
| Mortality | To compare time to mortality from enrolment by arm over a 12 month period | 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 | Costs will be measured over a 12 month horizon and entry into care will be measured over a 90 day period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Care, Treatment, Retention, Implementation Science