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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,500
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.
Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital
Kisumu, Kenya
TB preventive therapy completion
Proportion of participants completing 11 out of 12 weeks of TPT within 16 weeks
Time frame: 16 weeks
IGRA conversion
Proportion of child household contacts (age \<15 years) who convert their IGRA result from negative to positive.
Time frame: 9 months
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