Evaluating Tuberculosis Preventive Treatment in People Living with HIV

Project Overview

The CDC Foundation is collaborating with CDC to implement the Preventing Occurrence of Tuberculosis by Expanding Coverage of Tuberculosis Preventive Treatment among People Living with HIV (PROTECT). With funding from the Bill & Melinda Gates Foundation, the CDC Foundation is working with CDC’s Division of Global HIV and Tuberculosis to evaluate the overall impact of the scale-up of Tuberculosis Preventive Therapy (TPT) on tuberculosis incidence and mortality among people living with HIV (PLHIV).

Tuberculosis (TB) remains the leading cause of morbidity and mortality among PLHIV. Despite advances in global HIV care and treatment and an extensive body of literature demonstrating the efficacy of TPT and antiretroviral therapy (ART) in PLHIV and the benefits of receiving both drugs in reducing TB-related morbidity and mortality, global scale-up of TPT has been minimal. In 2018, when TB accounted for one-third of all HIV-related deaths, the President’s Emergency Plan for AIDS Relief (PEPFAR) committed to providing at least one course of TPT to all 14.6 million PLHIV in care within three years. Though progress has been made towards that goal, with CDC providing technical assistance to several countries and their ministries of health, the overall impact of widescale TPT implementation in program settings on TB incidence and mortality is not known.

Project Goals:

The PROTECT study is a three-year programmatic assessment that seeks to evaluate the impact of TPT across six countries—Haiti, Kenya, Nigeria, Uganda, Ukraine, and Zimbabwe—among PLHIV, using individual-level clinical data to measure the following outcomes:

  • New TB diagnosis after TBT completion
  • Mortality among PLHIV who completed TPT

Additional objectives:

  • Mortality among PLHIV who completed TPT

  • To evaluate the prevalence of isoniazid resistance among PLHIV

  • To evaluate the effectiveness of isoniazid TPT in a setting with a high MDR TB burden

  • To evaluate the effectiveness of 36-months (or lifelong TPT) as compared to 6 months of isoniazid treatmen

This project draws on CDC’s expertise in TB surveillance and program evaluation, as well as its strong partnerships with countries and global partners. CDC and participating countries will share lessons learned and best practices with countries scaling up TPT for PLHIV through project-specific workshops and existing networks. Countries will work closely with CDC to share results in-country to guide program decisions and disseminated to the global community through abstracts, manuscripts, and other opportunities.

Program Partners

  • CDC's Division of Global HIV & TB (DGHT)
  • Emory University
  • CDC country offices
  • Ministries of Health
  • Implementing Partner Organizations:
    • Catholic Medical Mission Board – Haiti
    • Eastern Deanery AIDS Relief Program – Kenya
    • Georgetown Global Health Nigeria – Nigeria
    • Makerere University School of Public Health – Monitoring and Evaluation Technical Support (MakSPH-METS) – Uganda
    • Public Health Center, Ministry of Health – Ukraine
    • Zimbabwe Technical Assistance, Training and Education Center for Health (Zim-TTECH) - Zimbabwe

Read our recent blog highlighting the work we're doing to combat tuberculosis.

Program Description: To determine the impact of Tuberculosis preventative treatment among populations living with HIV.
Funding Partners:
  • Bill & Melinda Gates Foundation
Program Partners:
  • CDC’s Global Health Center
  • Emory University
Program Location:
  • Haiti
  • Kenya
  • Nigeria
  • Ukraine
  • Uganda
  • Zimbabwe
Tuberculosis
Global Health
Tuberculosis
the word PROTECT with a red ribbon as the letter O

Preventing TB with a safe and effective regimen: Tuberculosis (TB) is the leading cause of death in people living with HIV worldwide, accounting for one-fourth of all HIV-related deaths. TB can be prevented with a 3- or 6-month regimen of a safe and effective treatment.


Providing preventive treatment:The President’s Emergency Plan for AIDS Relief (PEPFAR) has committed to provide at least one course of TB preventive treatment (TPT) to all people living with HIV (PLHIV) in care. By the end of 2022, over 10 million PLHIV received TPT globally through PEPFAR programs.

Measuring the impact: PROTECT project will work to measure the impact of TPT on TB incidence and mortality. Additionally, some countries will evaluate the prevalence of isoniazid resistance and the added benefit of lifelong TPT (36 months).


Obtaining data: The estimated sample size ranges from 20,000 to 200,000 PLHIV per country. This evaluation includes an analysis of secondary data that was recorded electronically in routine programmatic conditions. Outcomes will be adjusted for age, sex, antiretroviral therapy, CD4 cell count, viral suppression, and TPT regimen.
 

Sharing lessons learned and best practices: Findings will be shared with national stakeholders, affected communities, and global programs to help inform additional scale-up of TPT for PLHIV.