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Postpartum Adherence Clubs for Antiretroviral Therapy (PACART)

17. maj 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

412

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydafrika
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7750
        • Gugulethu Community Health Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Andet: Adherence Clubs
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Viral suppression
Tidsramme: 24 months
Time to viral load >1000 copies per ml
24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal retention in care
Tidsramme: 24 months
Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)
24 months
Maternal death
Tidsramme: 24 months
Maternal deaths over the study period
24 months
Maternal mental health
Tidsramme: 24 months
Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
24 months
Maternal health care service use
Tidsramme: 24 months
Use of health facilities including hospitalization
24 months
Infant death
Tidsramme: 24 months
Infant deaths over the study period
24 months
Infant health care service use
Tidsramme: 24 months
Use of health facilities including hospitalization
24 months
Infant HIV testing
Tidsramme: 24 months
Uptake of routine infant HIV testing
24 months
Infant HIV infection
Tidsramme: 24 months
Mother-to-child transmission of HIV
24 months
Infant feeding
Tidsramme: 24 months
Breastfeeding practices
24 months
Cost and cost-effectiveness
Tidsramme: 24 months
Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
24 months
Acceptability of each ART service
Tidsramme: 24 months
Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants
24 months
Viral suppression at other cutpoints (>400 copies/mL)
Tidsramme: 24 months
Time to VL >400 copies/mL
24 months
Viral suppression at other cutpoints (>50 copies/mL)
Tidsramme: 24 months
Time to VL >50 copies/mL
24 months
Virologic Failure
Tidsramme: 24 months
Time to clinical definition of virologic failure (two consecutive VLs >1000 copies/mL)
24 months
Combined retention/VL outcome
Tidsramme: 24 months
Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL >50 or 1000 copies/mL)
24 months
Viral suppression at each study visit
Tidsramme: 24 months
VL >50 copies/mL or >1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)
24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Cape Town

Samarbejdspartnere

Medical Research Council

Efterforskere

  • Ledende efterforsker: Landon Myer, MBChB PhD, University of Cape Town

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2016

Primær færdiggørelse (Faktiske)

1. januar 2020

Studieafslutning (Faktiske)

1. november 2020

Datoer for studieregistrering

Først indsendt

21. marts 2017

Først indsendt, der opfyldte QC-kriterier

23. juni 2017

Først opslået (Faktiske)

27. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 195/2015

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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