Skip to main content
OpenTrials
Completed

NCT Number: NCT03199027

Timing of Referral to Adherence Clubs for Antiretroviral Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gugulethu Community Health Centre

Cape Town, Western Cape, 7750, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Viral suppression

    Time frame: Up to 12 months post-ART initiation

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Collaborators

  • Medical Research Council

Registry information

Official study title

Timing of Referral to Adherence Clubs for Antiretroviral Therapy - a Randomised Controlled Trial

Acronym: TRAC

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 26, 2017
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.