Hiv Clinical Trial
— TRACOfficial title:
Timing of Referral to Adherence Clubs for Antiretroviral Therapy - a Randomised Controlled Trial
Verified date | September 2019 |
Source | University of Cape Town |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | January 31, 2019 |
Est. primary completion date | October 6, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
South Africa | Gugulethu Community Health Centre | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town | Medical Research Council |
South Africa,
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. — View 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;18:19984. doi: 10.7448/IAS.18.1.19984. eCollection 2015. — View Citation
Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernán 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Viral suppression | Viral load <400 copies/ml with secondary analyses at other thresholds | Up to 12 months post-ART initiation | |
Secondary | Retention in care | Numbers of missed visits and loss-to-follow up | Up to 12 months post-ART initiation | |
Secondary | Physical and Mental Health | As captured in the study visit questionnaires | Up to 12 months post-ART initiation | |
Secondary | Acceptability of the ART service | As captured in the study visit questionnaires | Up to 12 months post-ART initiation |
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