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Clinical trialNCT01872390CompletedInterventional

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

SponsorColumbia UniversityEnrollment415HIVTuberculosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Lesotho
  • Koali Health Center

    Koali, Lesotho

  • Maluti Hospital

    Mafeteng, Lesotho

  • St. Magdalena Health Center

    Mafeteng, Lesotho

  • Khubetsoana Health Center

    Maseru, Lesotho

  • Pilot Health Center

    Maseru, Lesotho

  • Berea Hospital

    Teyateyaneng, Lesotho

  • Good Shepherd Health Center

    Teyateyaneng, Lesotho

  • Holy Family Health Center

    Teyateyaneng, Lesotho

  • Kolojane Health Center

    Teyateyaneng, Lesotho

  • Sebedia Health Center

    Teyateyaneng, Lesotho

  • St. David Health Center

    Teyateyaneng, Lesotho

  • St. Theresa Health Center

    Teyateyaneng, Lesotho

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Apr 2013
Primary completion
31 Jan 2016
Completion
7 May 2021
Last update posted
14 Jul 2021
Registered enrollment
415
Registry id
NCT01872390

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.