Kulindana: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission
Kulindana: Expanding Access and Impact of Tuberculosis Preventative Therapy: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission
The goal of this clinical trial is to learn if differentiated service delivery (DSD) of TB preventive therapy (TPT) improves uptake and completion of TPT in two populations: household contacts (HHC) of index TB patients and people living with HIV (PWH). The main questions it aims to answer are:
- Is community-based and multi-month dispensing of short-course TPT with minimal clinic and laboratory monitoring associated with higher rates of initiation and completion of TPT, compared to standard of care, in both HHC and PWH?
- Does community-based and DSD TPT reduce household and community TB transmission?
Researchers will compare DSD TPT delivery to standard of care (SoC) to see if DSD TPT delivery has an effect on TPT uptake and completion.
Participants will:
- Be assessed for TPT eligibility through either DSD TPT service delivery of SoC including differentiated TB screening procedures.
- If eligible, receive DSD TPT service delivery or SoC TPT service delivery.
- Over 12 weeks receive either DSD or SoC TPT adherence assessment and follow-up.
- Have TPT completion assessed at 12 weeks following enrolment.
- A subset of participants will be assess for TB incidence at 9 months following enrolment.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The investigators will conduct a two-arm, non-blinded, randomized controlled trial (RCT) comparing differentiated TPT delivery to standard of care (SOC) clinic-based TPT. The central hypothesis is that decentralized, differentiated-service delivery approaches to TPT will improve TPT uptake and completion in Kenya. This study will be conducted in seven HIV clinics in Kisumu County, a high HIV/TB burden region in western Kenya. This study has two populations:
(A) Household contacts (HHC) of Index TB patients (Index patients: any age, diagnosed with pulmonary TB (or any TB if <18 years), who live with at least one other person not currently taking TB treatment). The TB index patients and household contacts include children.
(B) People living with HIV (PWH), aged 15+ who are eligible for TPT per Kenyan guidelines.
The primary outcome, 3 months after enrollment, is completion of a course of TPT, defined as taking 11 weeks of TPT within 16 weeks.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Gillian O'Bryan
- Telefonnummer: 240-444-0098
- E-post: gilliano@uw.edu
Studer Kontakt Backup
- Navn: Adrienne Shapiro, MD, PhD
- E-post: aeshapir@uw.edu
Studiesteder
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Kisumu, Kenya
- Rekruttering
- Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital
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Ta kontakt med:
- Celestine Atieno
- Telefonnummer: +254 713 053766
- E-post: catien00@uw.edu
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Household contacts (HHC) are eligible for enrolment if the participant shares a residential dwelling with an index TB patient and can provide informed consent (or parental consent, with assent if appropriate).
- People living with HIV (PWH) are eligible for enrolment if the participant is an adult aged 15 and over, is eligible for TPT according to Kenyan National Guidelines, and can provide informed consent.
Exclusion Criteria:
- HHC will be excluded if the participant plans on permanently relocating from the area within the next three months, is not willing to receive TPT screening and initiation at home, or is enrolled in any other investigational/interventional HIV or TB study.
- PWH will be excluded if the participant plans on permanently relocating from the area within the next three months, has contraindications for TPT according to the Kenyan National Guidelines, or is enrolled in any other investigational/interventional HIV or TB study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Differentiated service delivery (DSD) of TPT
In the household contact (HHC) population DSD TPT will be delivered at home in a single dispense of a full course of TPT; in the people living with HIV (PWH) population DSD TPT will be delivered at the clinic in a single dispense of a full course of TPT.
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TPT is normally provided at clinics with monthly visits for refills, but the full course of TPT can also be provided all at once through differentiated service delivery (DSD) of TPT.
By doing the Kulindana study, the investigators hope to learn which way of delivering TPT to participants (through usual clinic practice, or all at once) is best for helping participants finish a full course of TPT.
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Ingen inngripen: Clinic-based standard of care
Both the household contact (HHC) population and the people living with HIV (PWH) population have TPT dispensed at the clinic according to standard practice, typically one month at a time.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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TB preventive therapy completion
Tidsramme: 16 weeks
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Proportion of participants completing 11 out of 12 weeks of TPT within 16 weeks
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16 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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IGRA conversion
Tidsramme: 9 months
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Proportion of child household contacts (age <15 years) who convert their IGRA result from negative to positive.
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9 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Adrienne Shapiro, MD, PhD, University of Washington
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00024388
- R01AI183979-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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