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Thol'Impilo: Bringing People Into Care

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ClinicalTrials.gov Identifier: NCT02271074
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : July 20, 2016
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Johns Hopkins University
London School of Hygiene and Tropical Medicine
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
The Aurum Institute NPC

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Other: Point of care CD4 testing Behavioral: Care Facilitation Other: Transport support Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: An Evaluation of Strategies to Accelerate Entry-into-care Following HIV Diagnosis Among Adults in Gauteng and Limpopo Provinces, South Africa
Study Start Date : June 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Standard of Care
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
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
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.

Experimental: Care facilitation
Participants receive a combination of POC CD4 testing and care facilitation.
Other: Point of care CD4 testing
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.

Behavioral: Care Facilitation
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.

Experimental: Transport support
Participants receive a combination of POC CD4 testing and transport support.
Other: Point of care CD4 testing
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.

Other: Transport support
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Proportion entering care [ Time Frame: 90 days ]
    To compare the proportion of participants in each arm entering care by 90 days from study enrolment

  2. Time to entry into HIV care [ Time Frame: 180 days ]
    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.

  3. Mortality [ Time Frame: 6 and 12 months ]
    To compare time to mortality from enrolment by arm over a 12 month period

  4. 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 ]
    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


Other Outcome Measures:
  1. Time to ART initiation [ Time Frame: 90 days ]
    To compare the proportion of cART-eligible patients who initiate cART within 90 days of study enrolment in each study arm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271074


Locations
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South Africa
The Aurum Institute NPC
Johannesburg, Gauteng, South Africa, 2193
Sponsors and Collaborators
The Aurum Institute NPC
United States Agency for International Development (USAID)
Johns Hopkins University
London School of Hygiene and Tropical Medicine
University of Witwatersrand, South Africa
Investigators
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Study Director: Violet Chihota, PhD The Aurum Institute NPC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Aurum Institute NPC
ClinicalTrials.gov Identifier: NCT02271074     History of Changes
Other Study ID Numbers: AUR5-9-119
AID-OAA-A-12-00028 ( Other Grant/Funding Number: USAID )
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared through identified USAID -PEPFAR Platforms.
Keywords provided by The Aurum Institute NPC:
HIV
Care
Treatment
Retention
Implementation Science