Start TB Patients on ART and Retain on Treatment (START Study)
|First Received Date ICMJE||May 31, 2013|
|Last Updated Date||September 15, 2014|
|Start Date ICMJE||April 2013|
|Estimated Primary Completion Date||June 2015 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT01872390 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Start TB Patients on ART and Retain on Treatment (START Study)|
|Official Title ICMJE||Start TB Patients on ART and Retain on Treatment: Combination Intervention Package to Enhance Antiretroviral Therapy Uptake and Retention During TB Treatment 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.
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.
The study intervention, combination intervention package (CIP), will contain multiple components, including: 1) nurse training and mentorship in TB/HIV co-treatment using a clinical algorithm; 2) reimbursement of transportation costs to monthly clinic visits for patients and their 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). Nurses and VHW will be trained to deliver the intervention to all TB/HIV patients in CIP clinics. Participants in this study will complete their monthly clinic visits with clinic staff, per routine care.
Data will be collected from all HIV-infected TB patients newly enrolled in care; from a subset of patients enrolled into a measurement cohort (MC); from program characteristics surveys conducted at the study sites; and from key informant groups. Routine clinic data from all HIV-infected TB patients newly registered at the 12 participating clinics during the period of observation will be used to measure the following outcomes: ART initiation, time to ART initiation, TB treatment success, and sputum smear conversion. These data will be collected by Research Assistants by abstracting the following information from the clinic TB and ART registers during the period of observation on all newly registered TB/HIV patients: date of TB treatment initiation; ART initiation (yes/no); date of ART initiation (if applicable); TB treatment outcomes (completion, cure, failure, death, default); TB type; and all sputum smear results.
A measurement cohort (MC) of 384 HIV-infected TB patients initiating ART will be recruited from the 12 clinics (n=192 per study arm). MC participants will be assessed at baseline (enrollment) and monthly intervals for six to nine months, depending on the duration of TB treatment. Outcomes to be measured among MC participants include: retention in ART care, adherence to ART, change in CD4+ count, adherence to TB treatment, and side effects/adverse events. MC participants at both SOC and CIP sites will receive the same assessments. Research Assistants will administer assessments on the day of regularly scheduled clinic visits, including a Baseline interview administered on the day of enrollment (which coincides with the day a participant initiates ART), Monthly Follow-Up interviews completed throughout TB treatment on a monthly basis, and an End of Treatment interview that is completed on the day the participant ends TB treatment. Participants who miss a study visit will be contacted by study staff and administered the questionnaire over the phone within a 1-week window period. Research Assistants will also call the MC participants between clinic visits to conduct unannounced pill counts to assess medication adherence.
Cost drivers associated with CIP, including program, medical, and patient costs, will be collected.
Research Assistants (RAs) will conduct an assessment of programmatic activities at each TB/HIV clinic prior to study implementation and on a monthly basis thereafter. Clinics in both conditions will receive the same assessments. The RA will administer a brief semi-structured Program Characteristics survey to the nurse in charge, who will be most familiar with the day-to-day operations of the TB/HIV clinic. The survey will assess nurse training and mentorship in TB/HIV cotreatment, availability and use of a TB/HIV clinical algorithm, TB/HIV adherence training for VHW, TB/HIV health education for patients and treatment supporters, availability and use of a TB/HIV treatment literacy curriculum, reimbursement for transportation costs for patients and treatment supporters, provision of air-time vouchers for TB/HIV patients on ART, use of SMS messaging for adherence support and appointment reminders, and provision of community-based adherence and side effect monitoring by VHW. These data will be used to assess fidelity with the intervention at CIP sites, as well as to measure any potential contamination at SOC sites. Additional cost information will be analyzed from the expenditures associated with parts of the CIP, as paid for by the study budget.
Three key informant (KI) groups will be recruited from CIP clinics: ART early-initiators (n=30), ART non/late-initiators (n=30), and health care workers (including nurses and VHW) (n=30). KI interviews will assess: acceptability and preferences of intervention components, as well as reasons for ART non/late-initiation. Senior Research Assistants will use Key Informant interview (KII) guides developed by the investigators to conduct semi-structured interviews with KI recruited from CIP sites. Each interview will be digitally recorded, transcribed verbatim, and translated to English. Acceptability, preferences and utilization of intervention components will be explored among CIP participants in the measurement cohort at the end of TB treatment. Reasons for non/late-initiation of ART will be explored among TB/HIV patients who have completed TB treatment and have never initiated ART or who initiated ART two months after TB treatment initiation at a CIP site. Healthcare worker experiences delivering the intervention, perceived barriers and facilitators, perceptions about acceptability and ease of uptake and delivery of the various components of the intervention will be explored among nurses and VHW at CIP sites.
All clinical care, including implementation of the combination intervention package at sites randomized to CIP, will be performed by Lesotho Ministry of Health clinic staff (nurses and VHW). All study procedures, including participant interviews, pill counts, medical record abstraction, and program characteristics surveys will be performed by study staff (Research Assistants). Following routine clinic visits, clinic staff will refer potentially eligible patients to study staff, who will screen for eligibility, obtain informed consent, and enroll consenting eligible patients into the measurement cohort.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||444|
|Estimated Completion Date||July 2015|
|Estimated Primary Completion Date||June 2015 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Measurement Cohort Inclusion Criteria:
Measurement Cohort Exclusion Criteria:
Key Informants ART Early-Initiators Inclusion Criterion:
Key Informants ART Non/Late-Initiators Inclusion Criteria:
Key Informants ART Non/Late-Initiators Exclusion Criteria:
Key Informants Healthcare Workers Inclusion Criteria:
Key Informants Healthcare Workers Exclusion Criteria
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||Lesotho|
|Removed Location Countries|
|NCT Number ICMJE||NCT01872390|
|Other Study ID Numbers ICMJE||AAAK7103, AID-OAA-A-12-00022|
|Has Data Monitoring Committee||No|
|Responsible Party||Andrea Howard, Columbia University|
|Study Sponsor ICMJE||Columbia University|
|Collaborators ICMJE||United States Agency for International Development (USAID)|
|Information Provided By||Columbia University|
|Verification Date||September 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP