Simplified Isoniazid Preventive Therapy (SPIRIT) Strategy to Reduce TB Burden by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO (The Research University TRU)



ABSTRACTThe failure to use isoniazid (INH) preventative therapy (IPT) in persons living with HIV (PLHIV) in Sub-SaharanAfrica represents one of the single biggest implementation gaps between evidence and practice in today’sresponse to the HIV epidemic. In PLHIV, TB is a lead cause of death, and IPT reduces TB incidence by 40%.Yet in Africa, less than 2% of eligible individuals receive IPT. Given the existence of both country guidelinesrecommending IPT, as well as simple clinical algorithms to identify IPT eligible persons, a remaining criticalrequirement for scale-up is strengthening the link – mediated by middle management in most health systems -between health ministry policy and clinics. In Uganda, District Health Officers (DHOs) serve as key middlemanagers working at the nexus between policy and implementation. We propose to test a countrywide multi-component ?SPIRIT? (Simplified INH Preventive Therapy) intervention targeting DHOs ? whom we view ascritical dissemination agents. SPIRIT is based on the PRECEDE model of behavioral change that deployspredisposing (teaching collaborative); enabling (INH/B6/septrin single pill combination and SMS from DHO toprovider); and reinforcing (reporting collaborative) components. For this resubmission, we provide data to showfeasibility of SPIRT through a pilot study of 5 DHOs and their clinics. The DHOs engaged in the mini-collaborative and implemented key components of SPIRIT including bidirectional text messaging to front lineproviders. The number of HIV+ adults prescribed IPT increased from zero at baseline to 300 at 8 weeks.Aim 1: Determine if the SPIRIT intervention increases IPT initiation. We will form 20 groups of 5 DistrictHealth Officers and randomize 10 to the SPIRIT intervention and 10 to control (country standard) in a cluster-randomized trial. The primary outcome is proportion of IPT-eligible adults initiating IPT. For secondaryoutcomes, we will measure changes in knowledge, attitudes and practices regarding IPT among DHOs andfront line health workers to assess mechanisms through which the intervention achieves outcomes.Aim 2: Evaluate the effect of the SPIRIT intervention on IPT completion and TB incidence. Even if theintervention increases IPT use, quantifying actual use of IPT by patients and effects on population healthstatus (e.g. reduction in TB), provides an important impact measure that can enable policy makers to prioritizethis intervention more widely. A two-stage survey sampling approach will be used to identify a probabilitysample of patients eligible for IPT in which to measure adherence through hair levels of INH (direct measure ofpill consumption/adherence) and TB incidence (population health measure)Aim 3: Assess the cost and cost-effectiveness of SPIRIT. Using effectiveness measures obtained in Aims1 and 2, standard time and motion and costing methods, we will estimate the cost and cost-effectiveness ofSPIRIT vs standard of care in our sampled population from Aim 2. Outcomes of interest will include programcosts per: a) IPT initiation; b) IPT completion; and c) TB case averted.


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