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

NCT ID: NCT01872390

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2021-05-07

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.

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.

Conditions

Tuberculosis; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Combination Intervention Package

Intervention Type: 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.

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.

Group Type: OTHER

Standard of Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

CIP; SOC

Eligibility Criteria

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

1. A measurement cohort participant

2. Initiaing ART within the first 8 weeks of TB treatment

1. A measurement cohort participant

2. did not initiate ART during TB treatment or initiating ART >= 2 months after TB treatment initiation

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea A Howard, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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

Countries

Lesotho

Other Identifiers

AID-OAA-A-12-00022

Identifier Type: OTHER

Identifier Source: secondary_id

AAAK7103

Identifier Type: -

Identifier Source: org_study_id