# Options for Delivery of Short-Course Tuberculosis Preventive Therapy: The 3HP Options Trial

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2021 · $597,392

## Abstract

PROJECT SUMMARY
Isoniazid preventive therapy (IPT) is known to reduce tuberculosis (TB) incidence among people living with HIV
(PLHIV) and is considered a core service of National AIDS Programs. Yet, few PLHIV in sub-Saharan Africa
have received IPT. Many historical roadblocks to IPT scale-up are being addressed, but critical barriers remain,
including the long duration of therapy (6-9 months), high pill burden (180-270 doses) and concerns about toxicity.
In most settings, less than half of PLHIV initiating IPT complete the full course. A new 12-dose, once-weekly
regimen of isoniazid and rifapentine (3HP) was recently shown to have similar efficacy, higher completion rates,
and a better safety profile relative to nine months of IPT. But to achieve utilization and impact, it is essential to
implement 3HP in a fashion that works for PLHIV in sub-Saharan Africa.
The overall objective of this proposal is to identify a patient-centered delivery strategy that will facilitate 3HP
uptake by PLHIV in sub-Saharan Africa. 3HP can either be directly observed by a healthcare worker (DOT) or
self-administered (SAT); both options have relative advantages and disadvantages. We therefore propose to
focus on shared decision-making as a method to optimize 3HP acceptance and completion. Our central
hypothesis is that offering PLHIV an informed choice between theory-informed DOT and SAT strategies
optimized to overcome key barriers to adherence will result in greater 3HP initiation and completion.
In Aim 1, we will test our hypothesis by conducting a randomized trial among 1656 PLHIV in Kampala, Uganda,
to compare acceptance and completion of 3HP using the following delivery strategies: 1) Facilitated DOT; 2)
Facilitated SAT; and 3) Patient choice (using a decision aid) between facilitated DOT and facilitated SAT. These
interventions were specifically designed to overcome patient-level barriers to adherence using a new theoretical
model of behavior change (COM-B). Facilitation of both DOT and SAT will include standardized counseling,
streamlined clinic visits, reimbursement of visit-related costs, and SMS-based communication. Secondary
outcomes include adverse events and TB incidence over one year following 3HP treatment. In Aim 2, we will
employ a mixed methods approach to assess the implementation of core components of each delivery strategy,
and whether or not they modified targeted barriers. Last, in Aim 3, we will perform empiric costing of each
strategy and construct economic models to compare the costs and cost-effectiveness of the 3HP delivery
strategies relative to each other, no preventive therapy and IPT.
3HP – the most promising intervention for TB prevention – will not be scaled up unless it can be delivered
effectively and in a patient-centered fashion. Our proposed study employs an innovative approach of shared
decision-making with a novel regimen to deliver a life-saving intervention (TB preventive therapy) that has been
poorly adopted to date. This t...

## Key facts

- **NIH application ID:** 10212447
- **Project number:** 5R01HL144406-04
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Adithya Cattamanchi
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $597,392
- **Award type:** 5
- **Project period:** 2018-08-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10212447

## Citation

> US National Institutes of Health, RePORTER application 10212447, Options for Delivery of Short-Course Tuberculosis Preventive Therapy: The 3HP Options Trial (5R01HL144406-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10212447. Licensed CC0.

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