Timing of Referral to Adherence Clubs for Antiretroviral Therapy (TRAC)
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|ClinicalTrials.gov Identifier: NCT03199027|
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hiv||Other: Adherence Club||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Timing of Referral to Adherence Clubs for Antiretroviral Therapy - a Randomised Controlled Trial|
|Actual Study Start Date :||January 18, 2017|
|Actual Primary Completion Date :||October 6, 2018|
|Actual Study Completion Date :||January 31, 2019|
No Intervention: Clinic-based Care
Clinic-based care is the current Standard-of-Care whereby newly initiated ART patients attend the ART clinic.
Experimental: Adherence Club Care
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.
Other: Adherence 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.
- Viral suppression [ Time Frame: Up to 12 months post-ART initiation ]Viral load <400 copies/ml with secondary analyses at other thresholds
- Retention in care [ Time Frame: Up to 12 months post-ART initiation ]Numbers of missed visits and loss-to-follow up
- Physical and Mental Health [ Time Frame: Up to 12 months post-ART initiation ]As captured in the study visit questionnaires
- Acceptability of the ART service [ Time Frame: Up to 12 months post-ART initiation ]As captured in the study visit questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199027
|Gugulethu Community Health Centre|
|Cape Town, Western Cape, South Africa, 7750|
|Principal Investigator:||Landon Myer, MBChB PhD||University of Cape Town|