Status:

COMPLETED

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

Lead Sponsor:

Columbia University

Collaborating Sponsors:

United States Agency for International Development (USAID)

Conditions:

Tuberculosis

HIV

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 du...

Detailed Description

Among people living with HIV (PLWH), tuberculosis (TB) is the most common opportunistic illness and a leading cause of death, accounting for nearly a quarter of HIV-related deaths worldwide. Initiatin...

Eligibility Criteria

Inclusion

  • Measurement Cohort Participant
  • HIV-infected
  • On TB treatment
  • Initiating ART within 2 months of TB treatment initiation
  • Aged 18 or older
  • English- or Sesotho-speaking
  • Capable of informed consent
  • Measurement Cohort Participant

Exclusion

  • Children under age of 18
  • Patients diagnosed with Multi Drug Resistant-TB (MDR-TB)
  • Key Informats: Three groups of key informats (KI) will be recruited.
  • Key Informants ART Early-Initiators Inclusion Criteria:
  • A measurement cohort participant
  • Initiaing ART within the first 8 weeks of TB treatment
  • Key Informants ART Non/Late-Initiators Inclusion Criteria:
  • A measurement cohort participant
  • did not initiate ART during TB treatment or initiating ART \>= 2 months after TB treatment initiation
  • Key Informants Healthcare Workers Inclusion Criteria:
  • Nurse or VHW working in a CIP clinic or VHW working in the community and affiliated with CIP clinic
  • Aged 18 or older
  • English- or Sesotho-speaking
  • Capable informed consent

Key Trial Info

Start Date :

April 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 7 2021

Estimated Enrollment :

415 Patients enrolled

Trial Details

Trial ID

NCT01872390

Start Date

April 1 2013

End Date

May 7 2021

Last Update

July 14 2021

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Koali Health Center

Koali, Lesotho

2

Maluti Hospital

Mafeteng, Lesotho

3

St. Magdalena Health Center

Mafeteng, Lesotho

4

Khubetsoana Health Center

Maseru, Lesotho