the start study

StartTB patients onART andRetain onTreatment

Outline

1. Background and Rationale2. Study Aims3. Study Design4. Study Interventions5. Study Sites6. Study Participants7. Study Measures and Outcomes8. Collaboration9. Capacity Building10.Progress to date11.Upcoming activities

Background and Rationale

• TB is a leading cause of death, accounts for nearly a quarter of HIV-related deaths worldwide

• Early initiation of ART during TB treatment significantly increases AIDS-free survival by 34-68%1-3

• In the African Region only 42% of TB patients were on ART in 2010– In Lesotho it was as low as 27% in 2010

• Need to identify programmatic interventions that can increase the number of TB/HIV patients starting ART early

1Karim 2011; 2Havlir 2011; 3Blanc 2011

Study Aims

Overall Aim:• To identify an effective, cost-

effective, acceptable intervention that addresses programmatic, structural and psychosocial barriers to ART initiation and retention during TB treatment

Study Aims (2)

Specific Aim 1:• To evaluate the effectiveness of

integrating a combination intervention package (CIP) for ART provision during TB treatmentHIV-related outcomes TB-related outcomes

1. ART initiation during TB treatment

2. Time to ART initiation3. Retention in ART care4. Adherence to ART5. Change in CD4+ count

1. TB treatment success (completion & cure)

2. Sputum smear conversion3. Adherence to TB treatment

Study Aims (3)

Specific Aim 2:• To assess the cost-effectiveness (incremental

cost per health adjusted life-year gained) of CIP

Specific Aim 3:• To assess provider and patient acceptability of

CIP for ART provision during TB treatmentSpecific Aim 4:• To describe the safety and tolerability of ART

during TB treatment under programmatic conditions

Study Design

• Two-arm cluster randomized trial, randomized at the TB/HIV clinic level

• Twelve TB/HIV clinics at health centers in Berea district, Lesotho

• Clinics randomized to deliver CIP or standard of care (SOC)– Stratification by facility type (hospital

or health center)

Study Interventions: SOC vs. CIP

Comparison of SOC and CIP

  SOC CIPThree I's training X X

ART provision to TB patients in integrated clinics

X X

Treatment supporter for TB treatment X X

TB/HIV training according to clinical algorithm

X

Health education for patients and treatment supporters using TB/HIV

treatment literacy curriculumX

Reimbursement of transportation costs X

Real time adherence support with SMS messaging and VHW

X

Study Sites

12 Study Sites in Berea District, Lesotho

Berea Hospital

Maluti Hospital

Good Shepherd HC

Holy Family HC

Khubetsoana HC

Koali HC

Kolojane HC

Pilot HC

Sebedia HC

St David HC

St Magdalena HC

St Theresa HC

HC=health center

Study Participants

• All newly registered TB/HIV patients

• Measurement cohort of ART initiators (with 6-9 months follow up)– CIP (n=192)– SOC (n=192)

• Key informant interviews at CIP sites– ART non-initiators (n=30)– ART initiators (n=30)– Health care workers

(n=30)

Study Outcomes

  All TB/HI

V Patien

ts

 Measurem

ent Cohort

KIART

Initiators

KIART Non-

Initiators

KIHealthca

re Workers

STUDY OUTCOMESART initiation X        Retention in ART care   X      Time to ART initiation X        Adherence to ART   X      Change in CD4+ count   X         TB treatment success X        Sputum smear conversion

X        

Adherence to TB treatment

  X      

Side effects/adverse events

  X      

Acceptability of intervention

    X X X

Reasons for ART non-initiation

      X  

Incremental cost per health adjusted life-year gained

X

Study Measures  All

TB/HIV

Patients

 Measurem

ent Cohort

KIART

Initiators

KIART Non-

Initiators

KIHealthca

re Workers

STUDY MEASURES

Participants’ contact information

  X      

Baseline interview   X      

Monthly interview   X      

End-of-treatment interview

  X      

Unannounced pill counts

  X      

Prescription refills   X      

Medical record abstraction

  X      

Clinic records review X        

Program characteristics X        

Key Informant Interview-Patient

    X X  

Key Informant Interview-HCW

        X

Collaboration

• Ministry of Health and Social Welfare

• National University of Lesotho (NUL)

• Stakeholders Advisory Group–MOHSW, Christian Health Association

of Lesotho, Lesotho Red Cross, NUL, USAID, PEPFAR, CDC, WHO, UNAIDS, Basotho community

Capacity Building

• Improve the research capacity of national and local institutions via training and mentorship– Situation analysis to identify gaps– Training and mentorship on:

• protocol development• data collection• data analysis, synthesis, and interpretation• scientific communication

– Opportunities to attend regional and international conferences

– Opportunities to attend Epidemiology and Population Health Summer Institute (EPIC) at Columbia University.

Progress to date

• Recruitment of study staff(Research Assistants)

• RAs have gone through motor bike training

• Received approval letter from NH-IRB & NH-ERC

• Procurement of all study equipment is in place (Vehicle, motor bikes, computers and Printers

• Sensitization of DHMT and selected • Selection of Lead VHWs •

Upcoming activities

• Training of Research Assistants• Training of VHWs • Training of Nurses• Deployment & Introduction of study

team in Berea DHMT and Study facilities

• Launch of the study and enrolment patients

TB Register

ART Register

ICAP Officials & START team after motor bike training