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- Essai clinique NCT03200054
Postpartum Adherence Clubs for Antiretroviral Therapy (PACART)
17 mai 2022 mis à jour par: Professor Landon Myer, University of Cape Town
Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial
South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+").
There is a recognised need for innovative models of service delivery to support adherence and retention in care in this group, particularly during the postpartum period.
The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 24 months postpartum in two models of service delivery for provision of HIV care and treatment services postpartum in women who initiated ART during pregnancy: local adult ART clinics and community-based adherence clubs.
Aperçu de l'étude
Description détaillée
South Africa is implementing the policy of universal initiation of lifelong ART in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+") and given the high antenatal HIV seroprevalence, HIV-infected pregnant women represent the largest group of patients initiating ART in primary care facilities.
However, there are few well developed models of service delivery to support implementation.
There are particular concerns regarding the postpartum period, with multiple studies indicating high levels of non-retention in care and/or inadequate adherence to treatment postnatally.
Adherence Clubs (ACs) are an innovative but untested model of care based on chronic disease management strategies that emphasize social support, adherence to treatment and retention in care, rather than intensive clinical management, as the most important determinant of long-term health outcomes in stable patients in chronic care.
ACs have preliminarily been shown to to result in virologic outcomes that are similar to routine clinic services in patients stable on ART.
The investigators are conducting a pragmatic, randomised controlled trial to evaluate two different strategies for delivering HIV care and treatment services during the postpartum period to HIV-infected women who initiated ART during pregnancy.
Participants will be allocated to receive ART care at either local adult ART clinics, following the current standard of care, or the community-based adherence club system.
Type d'étude
Interventionnel
Inscription (Réel)
412
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Western Cape
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Cape Town, Western Cape, Afrique du Sud, 7750
- Gugulethu Community Health Centre
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- Documented HIV infection with ART initiation during the preceding antenatal period
- Within 70 days post-delivery
- Viral suppression documented in pregnancy with the most recent viral load <400 copies/mL within the last 3 months
- Willingness to be randomised and return for study measurement visits
- Able and willing to attend service visits at either a local ART treatment centre or the adherence club at Ikhwezi centre
- 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 including: refusal to take ART/antiretrovirals (ARVs) and/or denial of HIV status
- Loss of pregnancy/neonate at the time of eligibility determination
- Current co-morbidity requiring additional health care attention, including opportunistic infections such as tuberculosis (TB) disease or any chronic condition or other condition that is not controlled or stable
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Clinic-based Care
Clinic-based care is the current standard of care and is defined as referral of women on antiretroviral therapy (ART) to general primary care adult ART services.
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Expérimental: Adherence Club Care
Adherence club care involves referral of women on ART to community-based ART services in the form of adherence clubs, which are led by community health workers and supported by ART clinic nurses.
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Women will be referred to the ACs at their postpartum ART clinic visit at the midwife obstetric unit (MOU) at the Gugulethu community health centre (CHC).
AC visits occur 2-4 monthly at a community hall near the CHC.
At routine visits, which last ~1 hour, community health workers provide health education, weigh participants, ask about symptoms, and dispense pre-packed ART.
Symptomatic participants are referred back to the main ART facility at the CHC for assessment by a nurse.
A nurse performs routine phlebotomy at an annual club visit, and does a clinical assessment and reviews blood results at the subsequent visit.
Participants requiring more regular follow-up and those with raised viral loads are referred back to the ART clinic at the CHC by the nurse.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Viral suppression
Délai: 24 months
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Time to viral load >1000 copies per ml
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24 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Maternal retention in care
Délai: 24 months
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Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)
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24 months
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Maternal death
Délai: 24 months
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Maternal deaths over the study period
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24 months
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Maternal mental health
Délai: 24 months
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Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
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24 months
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Maternal health care service use
Délai: 24 months
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Use of health facilities including hospitalization
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24 months
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Infant death
Délai: 24 months
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Infant deaths over the study period
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24 months
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Infant health care service use
Délai: 24 months
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Use of health facilities including hospitalization
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24 months
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Infant HIV testing
Délai: 24 months
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Uptake of routine infant HIV testing
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24 months
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Infant HIV infection
Délai: 24 months
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Mother-to-child transmission of HIV
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24 months
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Infant feeding
Délai: 24 months
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Breastfeeding practices
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24 months
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Cost and cost-effectiveness
Délai: 24 months
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Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
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24 months
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Acceptability of each ART service
Délai: 24 months
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Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants
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24 months
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Viral suppression at other cutpoints (>400 copies/mL)
Délai: 24 months
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Time to VL >400 copies/mL
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24 months
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Viral suppression at other cutpoints (>50 copies/mL)
Délai: 24 months
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Time to VL >50 copies/mL
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24 months
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Virologic Failure
Délai: 24 months
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Time to clinical definition of virologic failure (two consecutive VLs >1000 copies/mL)
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24 months
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Combined retention/VL outcome
Délai: 24 months
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Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL >50 or 1000 copies/mL)
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24 months
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Viral suppression at each study visit
Délai: 24 months
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VL >50 copies/mL or >1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)
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24 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Landon Myer, MBChB PhD, University of Cape Town
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- Nachega JB, Uthman OA, Anderson J, Peltzer K, Wampold S, Cotton MF, Mills EJ, Ho YS, Stringer JS, McIntyre JA, Mofenson LM. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS. 2012 Oct 23;26(16):2039-52. doi: 10.1097/QAD.0b013e328359590f.
- Kaplan R, Orrell C, Zwane E, Bekker LG, Wood R. Loss to follow-up and mortality among pregnant women referred to a community clinic for antiretroviral treatment. AIDS. 2008 Aug 20;22(13):1679-81. doi: 10.1097/QAD.0b013e32830ebcee.
- Coutsoudis A, Goga A, Desmond C, Barron P, Black V, Coovadia H. Is Option B+ the best choice? Lancet. 2013 Jan 26;381(9863):269-71. doi: 10.1016/S0140-6736(12)61807-8. No abstract available.
- Chi BH, Stringer JS, Moodley D. Antiretroviral drug regimens to prevent mother-to-child transmission of HIV: a review of scientific, program, and policy advances for sub-Saharan Africa. Curr HIV/AIDS Rep. 2013 Jun;10(2):124-33. doi: 10.1007/s11904-013-0154-z.
- Provincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2016
Achèvement primaire (Réel)
1 janvier 2020
Achèvement de l'étude (Réel)
1 novembre 2020
Dates d'inscription aux études
Première soumission
21 mars 2017
Première soumission répondant aux critères de contrôle qualité
23 juin 2017
Première publication (Réel)
27 juin 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 mai 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 mai 2022
Dernière vérification
1 mai 2022
Plus d'information
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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