Clinical trial NCT03199027: Timing of Referral to Adherence Clubs for Antiretroviral Therapy
Official title: Timing of Referral to Adherence Clubs for Antiretroviral Therapy - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: Adherence
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2017-06-26
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Viral suppression
timeFrame: Up to 12 months post-ART initiation
Secondary outcomes:
measure: Retention in care
timeFrame: Up to 12 months post-ART initiation
measure: Physical and Mental Health
timeFrame: Up to 12 months post-ART initiation
measure: Acceptability of the ART service
timeFrame: Up to 12 months post-ART initiation
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Gugulethu Community Health Centre
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Landon Myer, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.