HIV, Tuberculosis Prevention
Conditions
Keywords
tuberculosis, household contact, TB preventive therapy, 3HP, HIV, contact investigation, multi-month dispensing, differentiated service delivery
Brief summary
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.
Detailed description
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.
Interventions
OTHERDifferentiated service delivery (DSD) of TB preventive therapy (TPT)
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.
Sponsors
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TB preventive therapy completion | 16 weeks | Proportion of participants completing 11 out of 12 weeks of TPT within 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IGRA conversion | 9 months | Proportion of child household contacts (age \<15 years) who convert their IGRA result from negative to positive. |
Countries
Kenya
Contacts
CONTACTGillian O'Bryan
CONTACTAdrienne Shapiro, MD, PhD
PRINCIPAL_INVESTIGATORAdrienne Shapiro, MD, PhD
University of Washington
Outcome results
None listed