Thol'Impilo: Bringing People Into Care

NCT02271074 | Completed DMC

• 2 other identifiers: AUR5-9-119AID-OAA-A-12-00028
• Study Type: interventional
• Target: 2,398
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Care; Treatment; Retention; Implementation Science

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion entering care

  90 days

• Time to entry into HIV care

  180 days

• Mortality

  6 and 12 months

• 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

Other Outcomes (1)

• Time to ART initiation

  90 days

Study Arms (4)

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.

Other: Point of care CD4 testing

Care facilitation

EXPERIMENTAL

Participants receive a combination of POC CD4 testing and care facilitation.

Other: Point of care CD4 testing; Behavioral: Care Facilitation

Transport support

EXPERIMENTAL

Participants receive a combination of POC CD4 testing and transport support.

Other: Point of care CD4 testing; Other: Transport support

Interventions

Point of care CD4 testing OTHER

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 facilitation; Point of care CD4 testing; Transport support

Care Facilitation BEHAVIORAL

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.

Care facilitation

Transport support OTHER

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.

Transport support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• self-reported prior or current registration as an HIV patient at a healthcare facility

Sponsors & Collaborators

• The Aurum Institute NPC: lead
• United States Agency for International Development (USAID): collaborator
• Johns Hopkins University: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• University of Witwatersrand, South Africa: collaborator

Study Sites (1)

The Aurum Institute NPC

Johannesburg, Gauteng, 2193, South Africa

Location

Related Publications (1)

• 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.

  PMID: 28471840 DERIVED

Study Officials

• Violet Chihota, PhD

  The Aurum Institute NPC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 22, 2014
• Study Start: June 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)