Hiv Clinical Trial
Official title:
Timing of Referral to Adherence Clubs for Antiretroviral Therapy - a Randomised Controlled Trial
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.
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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