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

HIV Clinical Trial

— START  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872390
• Other study ID #: AAAK7103
• Secondary ID: AID-OAA-A-12-000
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: May 7, 2021

Study information

• Verified date: July 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: May 7, 2021
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Tuberculosis

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Lesotho	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

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Lesotho, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 9 months
Primary	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.	Up to 6 months after TB treatment initiation
Primary	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.	Up to 9 months
Secondary	Days from TB treatment initiation to date of ART initiation	To examine Time to ART initiation	Up to 9 months
Secondary	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.	Up to 9 months
Secondary	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.	Up to 6 months after initial CD4 count
Secondary	Percentage of smear positive pulmonary TB cases that converted to smear negative after eight weeks of treatment	To examine sputum smear conversion	Up to 8 weeks from initiation of TB treatment
Secondary	Percentage of total prescribed doses ingested for TB treatment	To examine TB treatment adherence, from unannounced pill counts.	Up to 9 months
Secondary	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)	Up to 2 years