Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care

NCT03066128 | Completed

• 2 other identifiers: STUDY00001466R21AI124719
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

Effective management of patients on antiretroviral therapy (ART) is essential to improve clinical outcomes and prevent HIV transmission, but monitoring life-long ART for over 15 million HIV-infected people has become a challenge, particularly in low- and middle-income countries (LMICs). As programs continue to focus on identifying HIV-infected people and starting ART at higher CD4 thresholds, HIV providers have been overburdened, which has resulted in falling retention rates. As ART coverage scales up to include millions more people, additional strain will be placed on HIV clinicians and laboratories to manage stable patients on chronic ART. Implementing point-of-care HIV VL testing to enable task shifting to nurses for chronic HIV care may help mitigate these burdens. Point-of-care Viral Load (VL) testing is intended to differentiate patients who are potentially failing on their ART, so that they can be referred to the next level of care for possible ART regiment change, from patients who are virally suppressed on ART and can be managed by nurses. The investigator's scientific objective is to test the clinical equivalence and reduced cost of implementing a model for chronic HIV care that uses a point-of-care HIV VL assay to enable streamlined care and task shifting among healthcare workers at an urban clinic in South Africa. The central hypothesis is that rapid HIV VL testing, implemented by nurses, is an effective and cost-efficient strategy for management of chronic HIV infection in the majority of patients, thereby allowing more resources to be directed at the minority of patients who need greater attention. This work is innovative because it uses a randomized evaluation of an implementation model that combines a novel diagnostic point-of-care test with streamlined care and task shifting among healthcare workers compared to standard of care for chronic HIV care in a resource-limited setting. This randomized trial will then form the basis of a larger, multicountry proposal to demonstrate the clinical equivalence and cost-effectiveness of implementing an integrated point-of-care HIV VL testing and streamlined care model for chronic HIV care in LMICs. If nurses using clinic-based HIV VL testing are cost-effective for achieving both viral suppression and retention in care among patients on ART, then implementation of this chronic HIV care model would alleviate the strain on existing HIV providers and laboratories in LMICs.

Conditions

Chronic HIV Infection

Keywords

Task shifting; HIV care

Outcome Measures

Primary Outcomes (1)

• Composite measure of virological suppression and retention in care

  HIV VL \<200 copies/mL at 12-month study visit

  12 months post enrollment

Secondary Outcomes (8)

• Proportion retained in care

  12 months post enrollment

• Time to detection

  Every 2 months within the 12-month follow up period

• Entry into CCMDD

  Every 2 months between 6 and 12 months post enrollment

• Average cost per HIV-positive client

  12 months post enrollment

• Number of clinical visits

  12 months post enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the Intervention Group will receive chronic ART management from a Professional Nurse and/or Enrolled Nurse every 2 months, and if stable after 6 months, community pharmacy ART collection through CCMDD. Viral load monitoring will be by a point-of-care viral load testing.

Diagnostic Test: Point-of-care viral load testing

Standard of Care

EXPERIMENTAL

Participants in the Standard-of-Care control arm will receive the standard-of-care for the clinic consisting of visits with a professional clinician (Physician or Professional Nurse) and once stable, community pharmacy ART collection through CCMDD.Viral load monitoring will be by lab-based viral load testing

Other: Lab-based viral load testing

Interventions

Point-of-care viral load testing DIAGNOSTIC_TEST

Point-of-care viral load testing will be performed while the participant is in the clinic to ensure that participants receive the viral load results on the same day

Intervention

Lab-based viral load testing OTHER

Viral load testing will be lab based and follow standard of care procedures

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected and receiving antiretroviral therapy (ART)
• Receiving care at Prince Cyril Zulu Clinic in Durban
• Stable on Current ART Regimen and due the 6 month follow-up visit post ART initiation
• Willing/able to provide written informed consent to participate in the stud

You may not qualify if:

• Have significant signs/symptoms of illness that requires active medical care by a clinic doctor.
• Does not plan to receive HIV care at the Prince Cyril Zulu Communicable Diseases Clinic for the following 12 months.
• Currently pregnant

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal

Durban, KwaZulu-Natal, 4013, South Africa

Location

Related Publications (7)

• Dorward J, Garrett N, Quame-Amaglo J, Samsunder N, Ngobese H, Ngomane N, Moodley P, Mlisana K, Schaafsma T, Donnell D, Barnabas R, Naidoo K, Abdool Karim S, Celum C, Drain PK. Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study. BMJ Open. 2017 Sep 27;7(9):e017507. doi: 10.1136/bmjopen-2017-017507.

  PMID: 28963304 BACKGROUND

• Wang M, Violette LR, Dorward J, Ngobese H, Sookrajh Y, Bulo E, Quame-Amaglo J, Thomas KK, Garrett N, Drain PK. Delivery of Community-based Antiretroviral Therapy to Maintain Viral Suppression and Retention in Care in South Africa. J Acquir Immune Defic Syndr. 2023 Jun 1;93(2):126-133. doi: 10.1097/QAI.0000000000003176.

  PMID: 36796353 DERIVED

• Msimango L, Gibbs A, Shozi H, Ngobese H, Humphries H, Drain PK, Garrett N, Dorward J. Acceptability of point-of-care viral load testing to facilitate differentiated care: a qualitative assessment of people living with HIV and nurses in South Africa. BMC Health Serv Res. 2020 Nov 25;20(1):1081. doi: 10.1186/s12913-020-05940-w.

  PMID: 33239012 DERIVED

• Dorward J, Msimango L, Gibbs A, Shozi H, Tonkin-Crine S, Hayward G, Butler CC, Ngobese H, Drain PK, Garrett N. Understanding how community antiretroviral delivery influences engagement in HIV care: a qualitative assessment of the Centralised Chronic Medication Dispensing and Distribution programme in South Africa. BMJ Open. 2020 May 15;10(5):e035412. doi: 10.1136/bmjopen-2019-035412.

  PMID: 32414827 DERIVED

• Drain PK, Dorward J, Violette LR, Quame-Amaglo J, Thomas KK, Samsunder N, Ngobese H, Mlisana K, Moodley P, Donnell D, Barnabas RV, Naidoo K, Abdool Karim SS, Celum C, Garrett N. Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial. Lancet HIV. 2020 Apr;7(4):e229-e237. doi: 10.1016/S2352-3018(19)30402-3. Epub 2020 Feb 24.

  PMID: 32105625 DERIVED

• Dorward J, Drain PK, Osman F, Sookrajh Y, Pillay M, Moodley P, Garrett N. Short Communication: Early Antiretroviral Therapy Is Associated with Better Viral Suppression and Less HIV Drug Resistance After Implementation of Universal Treatment in South Africa. AIDS Res Hum Retroviruses. 2020 Apr;36(4):297-299. doi: 10.1089/AID.2019.0206. Epub 2019 Dec 4.

  PMID: 31663368 DERIVED

• Dorward J, Yende-Zuma N, Samsunder N, Karim QA, Drain PK, Garrett N. Clinic-Based Evaluation of a Point-of-Care Creatinine Assay to Screen for Renal Impairment Among HIV-Positive Patients Receiving Tenofovir Disoproxil Fumarate. J Acquir Immune Defic Syndr. 2018 Apr 1;77(4):e36-e39. doi: 10.1097/QAI.0000000000001613. No abstract available.

  PMID: 29271830 DERIVED

Study Officials

• Paul Drain, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Nigel Garrett, MBBS, MSc

  Centre for the AIDS Programme of Research in South Africa (CAPRISA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 28, 2017
• Study Start: February 24, 2017
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

ZA (1)