Timing of Referral to Adherence Clubs for Antiretroviral Therapy

Not Applicable

Completed

• Conditions: Hiv
• Interventions: Other: Adherence Club

• Registration Number: NCT03199027
• Lead Sponsor: University of Cape Town

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.

Study Timeline

• Study Start: 2017-01-18
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-23
• Study First Posted: 2017-06-26
• Primary Completion: 2018-10-06
• Study Completion: 2019-01-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adherence Club Care	Adherence Club	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.

Primary Outcome Measures

Name	Time	Method
Viral suppression	Up to 12 months post-ART initiation	Viral load \<400 copies/ml with secondary analyses at other thresholds

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gugulethu Community Health Centre; 🇿🇦 Cape Town, Western Cape, South Africa