This trial is active, not recruiting.

Conditions tuberculosis, hiv
Treatments combination intervention package, standard of care
Sponsor Columbia University
Collaborator United States Agency for International Development (USAID)
Start date April 2013
End date January 2016
Trial size 415 participants
Trial identifier NCT01872390, AAAK7103, AID-OAA-A-12-00022


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
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.
combination intervention package CIP
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.
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.
standard of care SOC
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.

Primary Outcomes

Percentage of TB/HIV patients newly registered during period of observation who initiate ART during TB treatment
time frame: Up to 9 months
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
Participants with cure + treatment completion at end of TB treatment
time frame: Up to 9 months

Secondary Outcomes

Days from TB treatment initiation to date of ART initiation
time frame: Up to 9 months
Percentage of total prescribed doses ingested for ART
time frame: Up to 9 months
Change in CD4+ count
time frame: 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
time frame: Up to 8 weeks from initiation of TB treatment
Percentage of total prescribed doses ingested for TB treatment
time frame: Up to 9 months
Ratio of the incremental costs of the CIP to incremental effectiveness
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Andrea A Howard, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Columbia University.