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Timing of Referral to Adherence Clubs for Antiretroviral Therapy (TRAC)

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ClinicalTrials.gov Identifier: NCT03199027
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Professor Landon Myer, University of Cape Town

Brief Summary:
Following the announcement of the global "90-90-90" strategy, there is a huge need in South Africa for effective well-developed scaled-up models of ART (anti-retroviral therapy) delivery that aim to improve patient adherence and viral suppression. The ART adherence club is one such model of service delivery. The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 12 months post-ART initiation between arms: individuals referred to the Adherence club at 4 months post-ART initiation (early referral) and individuals referred to the Adherence club at 12 months post-ART initiation (delayed referral). Individuals with delayed Adherence club referral will continue to attend the ART clinic as per the Standard-of-Care.

Condition or disease Intervention/treatment Phase
Hiv Other: Adherence Club Not Applicable

Detailed Description:

Following on from the huge need for scaled-up models of ART (anti-retroviral therapy) delivery to improve patient adherence and viral suppression, the ART adherence club model was piloted from 2007 with the aim of assessing whether this group-based, lay-counsellor led service, with an emphasis on social support and adherence, could help address retention in care and viral suppression. Since the initial pilots, the club model has been scaled up rapidly with more than 400 clubs meeting in the Cape Town metro. As this model is being scaled-up and implemented rapidly, there is an urgent necessity to further assess its effectiveness.

Whilst adherence clubs have been shown to be locally implementable, popular (with buy-in by clinic staff and patients) and cost-effective, and whilst community-based interventions have been shown to improve retention, evidence of local adherence club effectiveness in improving viral suppression and retention has only been observationally obtained. This observational evidence is highly subject to selection bias.

This trial aims to address this by using a randomised controlled trial design with two arms - ART patients receiving care in clinic as per the Standard-of-Care (this arm will have delayed referral to Adherence clubs at 12 months post-initiation) and ART patients receiving care in Adherence clubs (this arm will have early referral to Adherence clubs at 4 months post-initiation). By doing this the investigators hope to generate robust evidence regarding both the effectiveness of clubs and the optimal timing of club referral.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Timing of Referral to Adherence Clubs for Antiretroviral Therapy - a Randomised Controlled Trial
Actual Study Start Date : January 18, 2017
Actual Primary Completion Date : October 6, 2018
Actual Study Completion Date : January 31, 2019

Arm Intervention/treatment
No Intervention: Clinic-based Care
Clinic-based care is the current Standard-of-Care whereby newly initiated ART patients attend the ART clinic.
Experimental: Adherence Club Care
Adherence club care involves referral to community-based ART services in the form of Adherence clubs, which are led by community health workers and supported by ART clinic nurses.
Other: Adherence Club
Participants will be referred to an Adherence Club at 4 months post-ART initiation. Adherence club visits occur 2-4 monthly at a community hall near the Community Health Centre (CHC). At routine visits, which last 1-2 hours, community health workers provide health education, weigh patients, ask about symptoms and dispense pre-packed ART. Symptomatic patients are sent back to the ART clinic for clinician assessment. An assigned nurse takes blood tests annually at each club, and then returns on the subsequent visit to perform a clinical assessment and check the results. Patients requiring more follow-up or with high viral loads are referred back to the ART clinic at the CHC by the nurse.




Primary Outcome Measures :
  1. Viral suppression [ Time Frame: Up to 12 months post-ART initiation ]
    Viral load <400 copies/ml with secondary analyses at other thresholds


Secondary Outcome Measures :
  1. Retention in care [ Time Frame: Up to 12 months post-ART initiation ]
    Numbers of missed visits and loss-to-follow up

  2. Physical and Mental Health [ Time Frame: Up to 12 months post-ART initiation ]
    As captured in the study visit questionnaires

  3. Acceptability of the ART service [ Time Frame: Up to 12 months post-ART initiation ]
    As captured in the study visit questionnaires



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented HIV infection with ART initiation 4 months ago
  • Suppressed viral load at 4 months post-initiation (<400 copies/ml)
  • All other month 4 blood results within normal limits
  • Willingness to be randomised and return for study measurement visits
  • Able to willing to attend service visits at either the clinic or a club
  • Able to provide informed consent for research

Exclusion Criteria:

  • Intention to relocate out of Cape Town permanently during the study period
  • Any medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study
  • Pregnant
  • Current co-morbidity requiring additional health care, either acutely eg tuberculosis or chronically eg hypertension

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): NCT03199027


Locations
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South Africa
Gugulethu Community Health Centre
Cape Town, Western Cape, South Africa, 7750
Sponsors and Collaborators
University of Cape Town
Medical Research Council
Investigators
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Principal Investigator: Landon Myer, MBChB PhD University of Cape Town

Publications:
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Responsible Party: Professor Landon Myer, Professor, University of Cape Town
ClinicalTrials.gov Identifier: NCT03199027     History of Changes
Other Study ID Numbers: 764/2016
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Landon Myer, University of Cape Town:
Adherence
Additional relevant MeSH terms:
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Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents