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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Andrea Howard, Columbia University
ClinicalTrials.gov Identifier:
NCT01872390
First received: May 31, 2013
Last updated: May 17, 2016
Last verified: May 2016

May 31, 2013
May 17, 2016
April 2013
January 2016   (final data collection date for primary outcome measure)
  • Percentage of TB/HIV patients newly registered during period of observation who initiate ART during TB treatment [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    To examine ART initiation based on review of clinic registers.
  • Percentage of participants who attended 6 month clinic visit (within 1 month window) and reported ART use [ Time Frame: Up to 6 months after TB treatment initiation ] [ Designated as safety issue: No ]
    To examine ART retention. Deaths and transfers will be considered not retained.
  • Participants with cure + treatment completion at end of TB treatment [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    To examine TB treatment success as defined by WHO, based on review of TB register and treatment cards.
  • ART initiation [ Time Frame: follow up during TB treatment (approximately 6-9 months) ] [ Designated as safety issue: No ]
    Percentage of TB/HIV patients newly registered during period of observation who initiate ART during TB treatment, based on review of clinic registers.
  • ART retention [ Time Frame: 6 months after TB treatment initiation ] [ Designated as safety issue: No ]
    Percentage of participants who attended 6 month clinic visit (within 1 month window) and reported ART use. Deaths and transfers will be considered not retained.
  • TB treatment success [ Time Frame: end of TB treatment (6-9 months) ] [ Designated as safety issue: No ]
    Cure and treatment completion at end of TB treatment as defined by WHO, based on review of TB register and treatment cards.
Complete list of historical versions of study NCT01872390 on ClinicalTrials.gov Archive Site
  • Days from TB treatment initiation to date of ART initiation [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    To examine Time to ART initiation
  • Percentage of total prescribed doses ingested for ART [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    To examine ART adherence, averaged across medicines for each month of treatment, from the unannounced pill counts.
  • Change in CD4+ count [ Time Frame: Up to 6 months after initial CD4 count ] [ Designated as safety issue: No ]
    To examine change in CD4 count over 6 months (from initiation of TB treatment to 6 months later). Routine clinical CD4 test results will be used by study staff and no additional blood draw will be required.
  • Percentage of smear positive pulmonary TB cases that converted to smear negative after eight weeks of treatment [ Time Frame: Up to 8 weeks from initiation of TB treatment ] [ Designated as safety issue: No ]
    To examine sputum smear conversion
  • Percentage of total prescribed doses ingested for TB treatment [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    To examine TB treatment adherence, from unannounced pill counts.
  • Ratio of the incremental costs of the CIP to incremental effectiveness [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    To examine incremental cost-effectiveness of CIP (per ART initiation, retention, and TB treatment completion)
  • Time to ART initiation [ Time Frame: during TB treatment (6-9 months) ] [ Designated as safety issue: No ]
    Days from TB treatment initiation to date of ART initiation.
  • ART adherence [ Time Frame: during TB treatment (6-9 months) ] [ Designated as safety issue: No ]
    Percentage of total prescribed doses ingested, averaged across medicines for each month of treatment, from the unannounced pill counts.
  • Change in CD4+ count [ Time Frame: 6 months after initial CD4 count ] [ Designated as safety issue: No ]
    Change in CD4 count over 6 months (from initiation of TB treatment to 6 months later). Routine clinical CD4 test results will be used by study staff and no additional blood draw will be required.
  • Sputum smear conversions [ Time Frame: within 8 weeks of initiation of TB treatment ] [ Designated as safety issue: No ]
    Percentage of smear positive pulmonary TB cases that converted to smear negative after eight weeks of treatment.
  • TB treatment adherence [ Time Frame: duration of TB treatment (6-9 months) ] [ Designated as safety issue: No ]
    Percentage of total prescribed doses ingested, from unannounced pill counts
  • Cost-effectiveness (incremental cost per health adjusted life-year gained) of the CIP program [ Time Frame: period of data collection to 5 years, 10 years, 20 years, and lifetime ] [ Designated as safety issue: No ]
    incremental change in costs divided by incremental change in effects
Not Provided
Not Provided
 
Start TB Patients on ART and Retain on Treatment (START Study)
Start TB Patients on ART and Retain on Treatment: Combination Intervention Package to Enhance Antiretroviral Therapy Uptake and Retention During TB Treatment in Lesotho

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.

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. Initiating antiretroviral therapy (ART) early during TB treatment significantly increases survival, and World Health Organization (WHO) guidelines recommend ART initiation for all PLWH as soon as possible after TB treatment initiation, regardless of CD4+ count. Yet in the African Region, only 42% of TB patients known to be living with HIV were on ART in 2010, and retention in ART programs has been limited. In Lesotho, only 27% of HIVinfected TB patients received ART in 2010. There is an urgent need to identify programmatic interventions that increase the proportion of HIV-infected TB patients on ART, shorten the duration between TB diagnosis and ART initiation, and improve adherence to medications and retention in care amongst HIV-infected TB patients in Lesotho.

Lesotho, a small, landlocked country completely surrounded by South Africa, is among the world's poorest nations with one of the world's most severe epidemics of HIV and tuberculosis (TB). There is strong evidence that TB patients who are also infected with HIV have better survival rates if they begin antiretroviral therapy (ART) soon after starting TB treatment; however, there are many patients who do not initiate ART within the recommended timeframe, and who do not remain in care.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Tuberculosis
  • HIV
  • 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 Name: CIP
  • 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.
    Other Name: SOC
  • Experimental: CIP Participants
    Participants will receive the usual procedures (standard of care) for management of HIV-infected TB patients, and in addition the Combination Intervention Package (CIP) with the programmatic, structural, and psychosocial components.
    Intervention: Other: Combination Intervention Package
  • SOC Participants
    Participants will receive the usual procedures (standard of care) for management of HIV-infected TB patients. TB and HIV services are fully integrated in a one-stop model, while at hospitals, ART is provided in the TB clinic for TB/HIV coinfected patients.
    Intervention: Other: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
415
December 2016
January 2016   (final data collection date for primary outcome measure)

Measurement Cohort Participant Inclusion Criteria:

  1. HIV-infected
  2. On TB treatment
  3. Initiating ART within 2 months of TB treatment initiation
  4. Aged 18 or older
  5. English- or Sesotho-speaking
  6. Capable of informed consent

Measurement Cohort Participant Exclusion Criteria:

  1. Children under age of 18
  2. 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:

    1. A measurement cohort participant
    2. Initiaing ART within the first 8 weeks of TB treatment
  • Key Informants ART Non/Late-Initiators Inclusion Criteria:

    1. A measurement cohort participant
    2. did not initiate ART during TB treatment or initiating ART >= 2 months after TB treatment initiation
  • Key Informants Healthcare Workers Inclusion Criteria:

    1. Nurse or VHW working in a CIP clinic or VHW working in the community and affiliated with CIP clinic
    2. Aged 18 or older
    3. English- or Sesotho‐speaking
    4. Capable informed consent
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Lesotho
 
NCT01872390
AAAK7103, AID-OAA-A-12-00022
No
Undecided
Not Provided
Andrea Howard, Columbia University
Columbia University
United States Agency for International Development (USAID)
Principal Investigator: Andrea A Howard, MD Columbia University
Columbia University
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP