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Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women

17. maj 2022 opdateret af: Professor Landon Myer, University of Cape Town

Peer Support to Mitigate the Impact of Stigma in Young HIV+ Pregnant & Postpartum Women: A Pilot Study

Young pregnant and postpartum women living with HIV are at the greatest risk of disengagement from HIV services and suboptimal adherence to antiretroviral therapy (ART). Among young women, stigma is a major barrier to retention in services and adherence to ART, and interventions are needed to combat stigma and improve ART outcomes. The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in this population.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Despite major reductions in mother-to-child HIV transmission (MTCT), young pregnant and postpartum women living with HIV remain a vulnerable group and experience the greatest risk of disengagement from services and suboptimal adherence to antiretroviral therapy (ART). HIV-related and intersectional stigmas are major barriers to uptake and retention in prevention of mother-to-child transmission (PMTCT) services and drive suboptimal adherence, and young women experience unique stigmas. Despite this, there are no evidence-based interventions to combat stigma and improve ART outcomes in this group. Peer support group interventions have shown promise in other populations, but have not been examined in young pregnant and postpartum women living with HIV. The investigators are conducting a pilot study of a peer support intervention to mitigate the negative effects of stigma in young pregnant and postpartum women living with HIV in South Africa. Participants will be allocated to the standard of care, in which no standardized peer support groups exist for this patient population, or to a peer support intervention.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

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

16 år til 24 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Aged 16-24 years
  • Documented HIV infection
  • Confirmed pregnant or recently postpartum
  • Accessing antenatal or immediate postpartum PMTCT services at the study site
  • Planning on remaining a resident of Cape Town for at least 6 months after enrolment
  • Able to provide informed consent for research

Exclusion Criteria:

  • Significant pre-existing psychiatric comorbidity that may impact ability to consent
  • Stated intention to move outside of Cape Town during the 6 months after enrolment

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Local standard of care
Women receive integrated antenatal and HIV services during pregnancy and are referred to general adult HIV services after delivery; no standardized peer support groups exist for this patient population.
Eksperimentel: Peer support intervention
Women will be invited to attend monthly peer support groups during pregnancy and postpartum, separate from any routine health services.
Adfærdsmæssigt: Peer support intervention
Peer support groups will meet monthly for the duration of follow-up, with separate groups for pregnant and postpartum women. Groups will be facilitated by women who are living with HIV and have experience of PMTCT services in this setting. Group sessions will include brief information and a structured discussion about a relevant topic, followed by opportunities for unstructured discussion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Retention and viral suppression
Tidsramme: After 6 months of follow-up
Combined endpoint of (i) retention in HIV services and (ii) HIV viral suppression. Women will be considered to have achieved the primary outcome if they are both retained in care and virally suppressed.
After 6 months of follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Psychosocial outcomes
Tidsramme: 6 months
Psychosocial outcomes, including perceived social support and adherence self-efficacy, assessed using self-report questionnaires
6 months
Implementation of the intervention
Tidsramme: 6 months
Implementation of the peer support intervention including standardization, assessed using logs and process notes completed by counsellors who will deliver the intervention
6 months
Acceptability of the intervention
Tidsramme: 6 months
Acceptability of the peer support intervention, assessed as utilization and during in-depth interviews in a subset of participants
6 months
Health status
Tidsramme: 6 months
Maternal and infant health status, assessed using self-report and routine medical records
6 months
Health service use
Tidsramme: 6 months
Maternal and infant routine medical service use, assessed using self-report and routine medical records
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Cape Town

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)

30. august 2019

Primær færdiggørelse (Faktiske)

1. august 2020

Studieafslutning (Faktiske)

1. november 2021

Datoer for studieregistrering

Først indsendt

16. juli 2019

Først indsendt, der opfyldte QC-kriterier

25. juli 2019

Først opslået (Faktiske)

30. juli 2019

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

Andre undersøgelses-id-numre

  • 267/2019

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hiv

Kliniske forsøg med Peer support intervention

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sri Lanka

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner