TuberculosisSTARTNCT01872390
Start TB Patients on ART and Retain on Treatment (START Study)
A study testing Combination Intervention Package in people with Tuberculosis and HIV, run by Columbia University at 12 sites in Lesotho.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, HIV
- What is being tested?
- Combination Intervention Package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 12 sitesLesotho
- Study dates
- Apr 2013to 7 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Measurement Cohort Participant Inclusion Criteria:
- 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
Measurement Cohort Participant Exclusion Criteria:
- 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.
- Key Informants ART Early-Initiators Inclusion Criteria:
- A measurement cohort participant
- Initiaing ART within the first 8 weeks of TB treatment
- Key Informants ART Non/Late-Initiators Inclusion Criteria:
- A measurement cohort participant
- did not initiate ART during TB treatment or initiating ART >= 2 months after TB treatment initiation
- Key Informants Healthcare Workers Inclusion Criteria:
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Lesotho12 sites
Koali Health Center
Koali
Maluti Hospital
Mafeteng
St. Magdalena Health Center
Mafeteng
Khubetsoana Health Center
Maseru
Pilot Health Center
Maseru
Berea Hospital
Teyateyaneng
Good Shepherd Health Center
Teyateyaneng
Holy Family Health Center
Teyateyaneng
Kolojane Health Center
Teyateyaneng
Sebedia Health Center
Teyateyaneng
St. David Health Center
Teyateyaneng
St. Theresa Health Center
Teyateyaneng
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Combination Intervention Package, Standard of Care
- Keywords
- Lesotho, TB, tuberculosis, HIV, antiretroviral therapy, ART, adherence, combination intervention package, retention
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination Intervention PackageOther
Also called 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.
Standard of CareOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 9 months
Secondary outcomes (6)
Days from TB treatment initiation to date of ART initiation
To examine Time to ART initiation
Measured: Up to 9 months
Percentage of total prescribed doses ingested for ART
To examine ART adherence, averaged across medicines for each month of treatment, from the unannounced pill counts.
Measured: Up to 9 months
Change in CD4+ count
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.
Measured: 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
To examine sputum smear conversion
Measured: Up to 8 weeks from initiation of TB treatment
Percentage of total prescribed doses ingested for TB treatment
To examine TB treatment adherence, from unannounced pill counts.
Measured: Up to 9 months
Ratio of the incremental costs of the CIP to incremental effectiveness
To examine incremental cost-effectiveness of CIP (per ART initiation, retention, and TB treatment completion)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2016
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Andrea A Howard, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872390
- Sponsor's protocol ID
- AAAK7103
- Other IDs
- AID-OAA-A-12-00022
- Acronym
- START
- Status last verified
- Jul 2021
- First submitted
- 31 May 2013
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01872390
- Acronym / sponsor ID
- START / AAAK7103
- Conditions
- Tuberculosis, HIV
- Keywords
- Lesotho, TB, tuberculosis, HIV, antiretroviral therapy, ART, adherence, combination intervention package
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- Apr 2013 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIP Participants | Experimental | Other: Combination Intervention PackageParticipants 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. |
| SOC Participants | Other | Other: Standard of CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination Intervention PackageAlso: CIPCIP 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 | CIP Participants |
| Standard of CareAlso: SOCUsual 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 | SOC Participants |
Primary outcome
Percentage of TB/HIV patients newly registered during period of observation who initiate ART during TB treatment
Time frame: Up to 9 months
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
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
To examine TB treatment success as defined by WHO, based on review of TB register and treatment cards.
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea A Howard, MD principal investigator
Columbia University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination Intervention Package in people with Tuberculosis and HIV, run by Columbia University at 12 sites in Lesotho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Lesotho. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.