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
  Purpose

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.


Condition Intervention
Tuberculosis
HIV
Other: Combination Intervention Package
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Start TB Patients on ART and Retain on Treatment: Combination Intervention Package to Enhance Antiretroviral Therapy Uptake and Retention During TB Treatment in Lesotho

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 415
Study Start Date: April 2013
Estimated Study Completion Date: December 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872390

Locations
Lesotho
Koali Health Center
Berea, Berea District, Lesotho
Good Shepherd Health Center
Berea, Berea District, Lesotho
Holy Family Health Center
Berea, Berea District, Lesotho
Khubetsoana Health Center
Berea, Berea District, Lesotho
St. Theresa Health Center
Berea, Berea District, Lesotho
Kolojane Health Center
Berea, Berea District, Lesotho
Maluti Hospital
Berea, Berea District, Lesotho
Pilot Health Center
Berea, Berea District, Lesotho
Sebedia Health Center
Berea, Berea District, Lesotho
St Magdalena Health Center
Berea, Berea District, Lesotho
St. David Health Center
Berea, Berea District, Lesotho
Berea Hospital
Berea, Berea District, Lesotho
Sponsors and Collaborators
Columbia University
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Andrea A Howard, MD Columbia University
  More Information

Responsible Party: Andrea Howard, Associate Professor of Clinical Epidemiology (in ICAP), Columbia University
ClinicalTrials.gov Identifier: NCT01872390     History of Changes
Other Study ID Numbers: AAAK7103  AID-OAA-A-12-00022 
Study First Received: May 31, 2013
Last Updated: May 17, 2016
Health Authority: United States: Institutional Review Board
Lesotho: National Health Research Ethics Committee
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Columbia University:
Lesotho
TB
tuberculosis
HIV
antiretroviral therapy
ART
adherence
combination intervention package
retention

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 28, 2016