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

NCT01872390 | Completed

• 2 other identifiers: AAAK7103AID-OAA-A-12-00022
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 12

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 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

Keywords

Lesotho; TB; tuberculosis; HIV; antiretroviral therapy; ART; adherence; combination intervention package; retention

Outcome Measures

Primary Outcomes (3)

• Percentage of TB/HIV patients newly registered during period of observation who initiate ART during TB treatment

  To examine ART initiation based on review of clinic registers.

  Up to 9 months

• Percentage of participants who attended 6 month clinic visit (within 1 month window) and reported ART use

  To examine ART retention. Deaths and transfers will be considered not retained.

  Up to 6 months after TB treatment initiation

• Participants with cure + treatment completion at end of TB treatment

  To examine TB treatment success as defined by WHO, based on review of TB register and treatment cards.

  Up to 9 months

Secondary Outcomes (6)

• Days from TB treatment initiation to date of ART initiation

  Up to 9 months

• Percentage of total prescribed doses ingested for ART

  Up to 9 months

• Change in CD4+ count

  Up to 6 months after initial CD4 count

• Percentage of smear positive pulmonary TB cases that converted to smear negative after eight weeks of treatment

  Up to 8 weeks from initiation of TB treatment

• Percentage of total prescribed doses ingested for TB treatment

  Up to 9 months

Study Arms (2)

CIP Participants

EXPERIMENTAL

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

SOC Participants

OTHER

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

Interventions

Combination Intervention Package OTHER

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.

Also known as: CIP

CIP Participants

Standard of Care OTHER

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.

Also known as: SOC

SOC Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• A measurement cohort participant
• Initiaing ART within the first 8 weeks of TB treatment
• A measurement cohort participant
• did not initiate ART during TB treatment or initiating ART \>= 2 months after TB treatment initiation
• 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

Sponsors & Collaborators

• Columbia University: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (12)

Koali Health Center

Koali, Lesotho

Location

Maluti Hospital

Mafeteng, Lesotho

Location

St. Magdalena Health Center

Mafeteng, Lesotho

Location

Khubetsoana Health Center

Maseru, Lesotho

Location

Pilot Health Center

Maseru, Lesotho

Location

Berea Hospital

Teyateyaneng, Lesotho

Location

Good Shepherd Health Center

Teyateyaneng, Lesotho

Location

Holy Family Health Center

Teyateyaneng, Lesotho

Location

Kolojane Health Center

Teyateyaneng, Lesotho

Location

Sebedia Health Center

Teyateyaneng, Lesotho

Location

St. David Health Center

Teyateyaneng, Lesotho

Location

St. Theresa Health Center

Teyateyaneng, Lesotho

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andrea A Howard, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 7, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: May 7, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

LE (12)