Start TB Patients on ART and Retain on Treatment (START Study)

Summary

The purpose of the START Study is to identify an effective, cost-effective, acceptable intervention that addresses programmatic, structural and psychosocial barriers to ART initiation and retention during TB treatment, with the ultimate goal of improving health outcomes among HIV-infected TB patients in Lesotho. The study is a two-arm cluster randomized trial, randomized at the TB/HIV clinic level, which includes twelve TB/HIV clinics in Berea district. Clinics are randomized to deliver the combination intervention package (CIP) or standard of care (SOC), with stratification by facility type. The experimental intervention will be delivered to all HIV-infected TB patients in TB/HIV clinics randomly assigned to CIP. In TB/HIV clinics assigned to SOC, usual care procedures for ART initiation and retention will be delivered.

Study hypotheses focus on the effectiveness of the CIP on HIV- and TB-related outcomes.

Compared to HIV-infected TB patients attending SOC clinics, HIV-infected TB patients at CIP clinics will have superior HIV- and TB-related outcomes, including:

* Greater ART initiation during TB treatment
* Shorter time to ART initiation
* Greater retention in ART care
* Higher adherence to ART
* Greater change in CD4+ count
* Greater TB treatment success (completion and cure)
* Greater sputum smear conversion
* Higher adherence to TB treatment

Additionally, CIP delivery will have an incremental cost-effectiveness ratio more favorable than alternative resource uses.

Conditions

• Tuberculosis
• HIV

Interventions

OTHER

Combination Intervention Package

CIP will contain programmatic, structural and psychosocial components including: 1) nurse training and mentorship in TB/HIV cotreatment using a clinical algorithm; 2) reimbursement of transportation costs to monthly clinic visits for patients and treatment supporters; 3) health education using a TB and HIV treatment literacy curriculum for patients and treatment supporters; and 4) real-time adherence support using short message service (SMS) text messaging and trained village health workers (VHW). These components were selected for their promise, practicality, and feasibility of implementation and scale-up in HIV programs in diverse settings - in addition to SOC.

OTHER

Standard of Care

Usual procedures for management of HIV-infected TB patients will be followed: Three I's training, ART provision to TB patients in integrated clinics, and treatment supporter for TB treatment.

Sponsors & Collaborators

• United States Agency for International Development (USAID)

  collaborator FED

• Columbia University

  lead OTHER

Principal Investigators

• Andrea A Howard, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2016-01-31

Completion

2021-05-07

Countries

• Lesotho

Study Locations