- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03200054
Postpartum Adherence Clubs for Antiretroviral Therapy (PACART)
17. mai 2022 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
412
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Western Cape
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Cape Town, Western Cape, Sør-Afrika, 7750
- Gugulethu Community Health Centre
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Viral suppression
Tidsramme: 24 months
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Time to viral load >1000 copies per ml
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24 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Maternal retention in care
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 months
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Use of health facilities including hospitalization
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24 months
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Infant death
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 months
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Mother-to-child transmission of HIV
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24 months
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Infant feeding
Tidsramme: 24 months
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Breastfeeding practices
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24 months
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Cost and cost-effectiveness
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 24 months
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Time to VL >50 copies/mL
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24 months
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Virologic Failure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Landon Myer, MBChB PhD, University of Cape Town
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2016
Primær fullføring (Faktiske)
1. januar 2020
Studiet fullført (Faktiske)
1. november 2020
Datoer for studieregistrering
Først innsendt
21. mars 2017
Først innsendt som oppfylte QC-kriteriene
23. juni 2017
Først lagt ut (Faktiske)
27. juni 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. mai 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mai 2022
Sist bekreftet
1. mai 2022
Mer informasjon
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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