Hiv
Conditions
Keywords
Adherence
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.
Interventions
OTHERAdherence 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.
Sponsors
Medical Research Council
University of Cape Town
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral suppression | Up to 12 months post-ART initiation | Viral load \<400 copies/ml with secondary analyses at other thresholds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention in care | Up to 12 months post-ART initiation | Numbers of missed visits and loss-to-follow up |
| Physical and Mental Health | Up to 12 months post-ART initiation | As captured in the study visit questionnaires |
| Acceptability of the ART service | Up to 12 months post-ART initiation | As captured in the study visit questionnaires |
Countries
South Africa
Outcome results
None listed