An interventional study of Combination Intervention Package and Standard of Care in Tuberculosis and HIV, sponsored by Columbia University. Completed at 12 sites in Lesotho. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by Columbia University · Not applicable, Interventional, and Other
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:
Additionally, CIP delivery will have an incremental cost-effectiveness ratio more favorable than alternative resource uses.
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 415 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Measurement Cohort Participant Inclusion Criteria:
Measurement Cohort Participant Exclusion Criteria:
Key Informats: Three groups of key informats (KI) will be recruited.
Key Informants ART Early-Initiators Inclusion Criteria:
Key Informants ART Non/Late-Initiators Inclusion Criteria:
Key Informants Healthcare Workers Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 9 months
Days from TB treatment initiation to date of ART initiation
To examine Time to ART initiation
Time frame: 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.
Time frame: 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.
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
To examine sputum smear conversion
Time frame: 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.
Time frame: 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)
Time frame: Up to 2 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2013 to primary completion in Jan 2016, 33 months.
Of 169 non-industry interventional studies with no phase under Tuberculosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 41. This study's 33 months is above that.
Counting every sponsor, half of 171 studies reached it within 25 months; a quarter within 14 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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