Thol'Impilo: Bringing People Into Care

Not Applicable

Completed

• Conditions: HIV
• Interventions: Other: Point of care CD4 testing; Behavioral: Care Facilitation; Other: Transport support

• Registration Number: NCT02271074
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-22
• Status Verified: 2016-01
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2398

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Point of care CD4 testing	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.
Care facilitation	Care Facilitation	Participants receive a combination of POC CD4 testing and care facilitation.
Care facilitation	Point of care CD4 testing	Participants receive a combination of POC CD4 testing and care facilitation.
Transport support	Point of care CD4 testing	Participants receive a combination of POC CD4 testing and transport support.
Transport support	Transport support	Participants receive a combination of POC CD4 testing and transport support.

Primary Outcome Measures

Name	Time	Method
Time to entry into HIV care	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

Name	Time	Method
Proportion entering care	90 days	To compare the proportion of participants in each arm entering care by 90 days from study enrolment
Time to entry into HIV care	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.
Mortality	6 and 12 months	To compare time to mortality from enrolment by arm over a 12 month period
Cost per additional participant entering into care	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

Trial Locations

Locations (1)

The Aurum Institute NPC; 🇿🇦 Johannesburg, Gauteng, South Africa