Timing of Referral to Adherence Clubs for Antiretroviral Therapy

NCT03199027 | Completed DMC

• 1 other identifier: 764/2016
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv

Keywords

Adherence

Outcome Measures

Primary Outcomes (1)

• Viral suppression

  Viral load \<400 copies/ml with secondary analyses at other thresholds

  Up to 12 months post-ART initiation

Secondary Outcomes (3)

• Retention in care

  Up to 12 months post-ART initiation

• Physical and Mental Health

  Up to 12 months post-ART initiation

• Acceptability of the ART service

  Up to 12 months post-ART initiation

Study Arms (2)

Clinic-based Care

NO INTERVENTION

Clinic-based care is the current Standard-of-Care whereby newly initiated ART patients attend the ART clinic.

Adherence Club Care

EXPERIMENTAL

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

Interventions

Adherence Club OTHER

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.

Adherence Club Care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead
• Medical Research Council: collaborator

Study Sites (1)

Gugulethu Community Health Centre

Cape Town, Western Cape, 7750, South Africa

Location

Related Publications (4)

• Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernan MA, Boulle A. Effectiveness of patient adherence groups as a model of care for stable patients on antiretroviral therapy in Khayelitsha, Cape Town, South Africa. PLoS One. 2013;8(2):e56088. doi: 10.1371/journal.pone.0056088. Epub 2013 Feb 13.

  PMID: 23418518 BACKGROUND

• Grimsrud A, Sharp J, Kalombo C, Bekker LG, Myer L. Implementation of community-based adherence clubs for stable antiretroviral therapy patients in Cape Town, South Africa. J Int AIDS Soc. 2015 May 27;18(1):19984. doi: 10.7448/IAS.18.1.19984. eCollection 2015.

  PMID: 26022654 BACKGROUND

• Grimsrud A, Lesosky M, Kalombo C, Bekker LG, Myer L. Implementation and Operational Research: Community-Based Adherence Clubs for the Management of Stable Antiretroviral Therapy Patients in Cape Town, South Africa: A Cohort Study. J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e16-23. doi: 10.1097/QAI.0000000000000863.

  PMID: 26473798 BACKGROUND

• Takuva S, Brown AE, Pillay Y, Delpech V, Puren AJ. The continuum of HIV care in South Africa: implications for achieving the second and third UNAIDS 90-90-90 targets. AIDS. 2017 Feb 20;31(4):545-552. doi: 10.1097/QAD.0000000000001340.

  PMID: 28121668 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Landon Myer, MBChB PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 26, 2017
• Study Start: January 18, 2017
• Primary Completion: October 6, 2018
• Study Completion: January 31, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)