Implementation Science Elaine Abrams, MD Senior Research Director.

Implementation Science Elaine Abrams, MD

Senior Research Director

Objectives

• Provide overview of Implementation Science Research approach and methods

• Overview of PEPFAR Implementation Science initiative

• Introduce ICAP’s new Implementation Science studies– Describe, in greater depth, a subset of these

studies

What is Implementation Research? • ‘Research to promote the uptake & successful implementation

of evidence-based interventions and policies’ (Sanders)

• ‘Evidence that informs effective, sustained & embedded adoption of interventions by health systems & communities’ (Allottey)

• ‘All aspects of research relevant to the scientific study of methods to promote the uptake of research findings into routine settings in clinical, community and policy contexts’

• ‘Research to significantly improve access to efficacious interventions by developing practical solutions to common implementation problems’ (WHO)

• ‘Scientific study of methods to promote the systematic uptake of research findings & evidence-based practices into routine practice, to improve the quality and effectiveness of health’

Sanders et al, PLOS Med, 3:e186; Allottey et al, BMC Pub Health 8:343, WHO; Remme et al, PLOS Med Nov 2010

Implementation Research• ‘Implementation research aims to develop new

strategies for available or new health interventions in order to improve access to, and the use of, these interventions by the populations in need’ (Remme)

• Seeks to address the “know-do gap’ – why and how best to successfully implement evidenced based interventions

Remme et al, PLOS Med Nov 2010

• IR tests practical solutions to service delivery and challenges in order to– Address problems specific to a health system or

environment or those that are common to a particular region

– Identify how evidence-based interventions, tools, and services should be modified to achieve sustained health impacts in real-world settings

– Determine the best way to introduce practical solutions into health systems and facilitate full-scale implementation, evaluation, modification

Implementation Research

• IR uses contextual knowledge to study processes to improve practice

• IR applies research findings and methods to real-world contexts and settings

• IR places particular emphasis on access to efficacious interventions, service delivery models, feasibility of interventions in different settings

• The outcome of a successful IR project is integration of findings into practice or policy

Implementation Research

Characteristics of Implementation Research

• Systematic– Adheres to norms of scientific inquiry– Specific intervention, specific setting– Balances relevance with rigor

• Multidisciplinary– Considers biological, social, economic, political,

system and environmental factors that impact implementation

– Collaborations between behavioral and social scientists, clinicians, epidemiologists, statisticians, policy makers, stakeholders

Characteristics of Implementation Research (continued)

• Contextual– Relevant to local circumstances and need– Generates generalizable knowledge that can be

applied across contexts• Complex

– Dynamic and adaptive– Occurs at multiple levels of health care system,

community– Analyzes multi-component programs

Defining research to improve systems

Research Domain Primary Characteristics

Focus of research Users of the Research Outputs

Utility of the Research Outputs

OperationalOperational issues of specific health programs

Health care providers program managers

Local

ImplementationImplementation strategies for specific product or services

Program managers, R&D managers Local/broad

Health SystemIssues affecting some or all of the building blocks of a health system

Health system managers, policy makers

Broad


Research Domain Research Questions

Operational Which locations should be targeted for delivering HIV prevention services in Kawempe district, Uganda?

Which of the current ART payment strategies in Nairobi should be retained for the new integrated program?

Implementation How to improve access to vaccination among children who are currently not reached by immunization services?

How to improve antenatal syphilis screening – one-stop versus conventional service?

Health System How effective are different policies for attracting nurses to rural areas?

What has been the impact of the rapid scale-up of HIV programs on fragile health systems?


PEPFAR Implementation Science Model

• PEPFAR implements scientific advances on a large scale through its programs

• PEPFAR has shifted towards an Implementation Science model as the scientific framework to guide program implementation and scale-up that focuses on effectiveness and efficiency to build the evidence base necessary to inform the best approaches to achieve sustainable prevention, care and treatment programs

PEPFAR Implementation Science Model & Initiative

• Current Implementation Science efforts include a range of funded evaluation activities including:– Implementation Science (IS) Awards– Basic Program Evaluations (BPE)– Impact Evaluations (IE)

• PEPFAR created a $60 million dollar initiative to support Implementation Science Research to evaluate PEPFAR programs. – The Initiative was funded through collaborations

with the CDC, NIH and USAID

ICAP’s ‘won’ 7 Implementation Science Awards

• USAID funded – Engage4Health (Ligações pela saúde), Mozambique – Safe Generations (Situkulwane Lesiphephile), Swaziland – START (Start TB patients on ART and Retain on Treatment),

Lesotho

• NIH funded – LINK4HEALTH, Swaziland– MCH-ART, South Africa– MIR4Health (Mother-Infant Retention for Health), Kenya– ENRICH (Enhance Initiation and Retention in IPT Care for HIV),

Ethiopia

ICAP’s Implementation Science Studies

• 7 different countries in Sub Saharan Africa• Represent productive collaborations between PI, NY

teams, and country teams• Address several key clinical domains: adult ART

linkage and retention, TB treatment and prevention IPT, and PMTCT including maternal and infant health

• Encompass a variety of scientific approaches, methodologies, patient populations, outcomes

• All grow out of the programmatic work leading to critical implementation questions around how best to successfully implement evidenced based interventions

Situkulwane LesiphephileSafe Generations

SAFE GENERATIONSSITUKULWANE LESIPHEPHILE

• Partnership in the Kingdom of Swaziland between:– MOH(Sexual and Reproductive Health Unit (SRHU)

and Swaziland National AIDS Program (SNAP)– ICAP– University of Cape Town – Elizabeth Glazer Pediatric AIDS Foundation– NERCHA

Background • There is sound scientific evidence on the efficacy of ARV

interventions during pregnancy, delivery and breastfeeding and enormous PMTCT success in high resource settings with MTCT rates ~ 1-2%

• However, despite major advances in PMTCT interventions in 2011, there were ~ 330,000 new pediatric infections worldwide, 90% of them attributable to MTCT.1,3

• Swaziland is currently implementing WHO ‘Option A’*– Lifelong treatment for ART-eligible women– Prophylaxis for non-eligible women: AZT from 14 weeks’ gestation

with sd-NVP at delivery plus a 7-day tail of twice daily AZT and 3TC postpartum, and daily NVP to the infant during breastfeeding

• Substantial implementation challenges have been encountered

*WHO Option B: lifelong ART for eligible women and triple ARV prophylaxis during pregnancy and breast feeding

Maternal PMTCT Cascade, Swaziland, 2011

Infant PMTCT Cascade Swaziland, 2011

Testing a New Strategy for PMTCT

• The country of Malawi adopted a new strategy for PMTCT – Option B+ : lifelong ART for all pregnant and breast feeding women

• Recognizing the complexity of Option A and considerable implementation challenges encountered in the field, WHO recently endorsed Options B+ and outlined considerable programmatic and implementation advantages of this approach

• However, there are limited data on Option B+ implementation and/or comparisons with other approaches

• The Swaziland MOH reluctant to adopt new approach without strong evidence of benefit

SITUKULWANE LESIPHEPHILE SAFE GENERATIONS: OBJECTIVES

• Primary Objective: To compare the impact of implementing Option A and Option B+ on the composite endpoints of infant HIV positive DNA PCR OR maternal loss to follow-up (LTFU) 6 months postpartum

• Secondary Objectives: To compare Option A and Option B+:

– Cost effectiveness– Patient and provider acceptability– Proportion of pregnant women CD4+<350 cells/mm3 who start ART– Proportion of women retained in HIV care at 12, and 18 months

postpartum

SITUKULWANE LESIPHEPHILE SAFE GENERATIONS: STUDY HYPOTHESIS

Option B+: integration of prevention and treatment into a uniform and streamlined treatment and retention approach modified for the continuum of perinatal maternal-child care will:

– Result in higher proportion of mother-child pairs completing the PMTCT cascade

– Fewer paediatric infections – Lead to higher proportion of women with CD4+<350

initiating ART earlier in pregnancy– Be more acceptable to staff and clients– Be more feasible and more cost-effective

SITUKULWANE LESIPHEPHILE SAFE GENERATIONS: STUDY COMPONENTS

• This study is comprised of three study components: 1) Option B+ evaluation 2) Acceptability evaluations with PMTCT clients and

health care workers3) Cost-effectiveness analysis

Study Design: Option B+ Intervention Evaluation

• Stepped wedge design: One facility per month will transition from Option A to Option B+ (total 10 facilities)

• Estimated 2,700 women enrolling into care during study period Month 1 2 3 4 5 6 7 8 9 10 11 12

Site 1 A T B+ B+ B+ B+ B+ B+ B+ B+ B+ B+Site 2 A A T B+ B+ B+ B+ B+ B+ B+ B+ B+Site 3 A A A T B+ B+ B+ B+ B+ B+ B+ B+Site 4 A A A A T B+ B+ B+ B+ B+ B+ B+Site 5 A A A A A T B+ B+ B+ B+ B+ B+Site 6 A A A A A A T B+ B+ B+ B+ B+Site 7 A A A A A A A T B+ B+ B+ B+Site 8 A A A A A A A A T B+ B+ B+Site 9 A A A A A A A A A T B+ B+

Site 10 A A A A A A A A A A T B+

Outcome Measurements: Option B+ Evaluation (1)

• PMTCT (A and B+) will be provided as standard of care at study sites. Women will be consented to allow chart review and abstraction of health records (for mom and baby)

• Primary outcome: Combined maternal-child endpoint at 6 months post partum of:– Infant HIV PCR positiveOR– Mother Lost To Follow-Up

Outcome Measurements: Option B+ Evaluation (2)

• Secondary outcomes:– Proportion of pregnant women with CD4+<350 initiating ART

during pregnancy – Duration of ART received prior to delivery for ART-eligible

pregnant women– Proportion of women and children retained in HIV care at 12,

and 18 months postpartum– Birth outcomes (birth weight, SGA, gestation age)– Infant feeding practices– Maternal health outcomes

Outcome Measurements: Option B+ Acceptability

• Interviews with PMTCT clients will focus on:– PMTCT and ART knowledge and beliefs– Barriers to PMTCT services– Perception of women’s uptake of services– Quality of care that the receive

• Interviews with HCWs will focus on:– Barriers to PMTCT implementation– Understanding and attitude towards B+

intervention– Perceptions of PMTCT client uptake

Outcome Measurements: Option B+ Cost Effectiveness Assessment

• Cost-effectiveness assessment will be lead by UCT collaborators– Data on unit costs including human resources costs will be abstracted

from the following sources:• Routine facility and MOH accounts• Facility utilization data and staffing plans, and pharmacy accounts maintained

by the MOH

– Data on service utilization by participants will come directly from the evaluation

– Program costs will be based on local standards for training and materials development

– Outcome data will be used to calculate the incremental cost required to improve patient outcomes of infant HIV PCR positivity, maternal retention, and their combination, all assessed at 6 months postpartum.

the start study

Andrea HowardYael Hirsch-MovermanSuzue SaitoWafaa El-SadrYingfeng WuAmrita DaftaryTal GrossKoen FrederixMaama-Maime

Llang Bridget Mabatloung

StartTB patients onART andRetain onTreatment

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

1Karim 2011; 2Havlir 2011; 3Blanc 2011

Background & Rationale (2)• Barriers to early ART initiation and

retention include:– Health Care Workers

• Lack knowledge about benefits of early ART, guidelines for TB/HIV co-management (adverse events, IRIS)1,2

– Patients• Unaware of importance of early ART during TB

treatment3

• Fear of toxicity, side effects, death, concerns about pill burden3,4

• Lack funds for transportation to clinic1,3,5,6

• Lack social and family support4,5

• Urgent need to identify programmatic interventions that address these barriers to implementation

1Okot-Chono 2009; 2Dong 2007; 3Kumwenda 2011; 4Harris 2008; 5Chileshe 2010; 6Zachariah 2006

Study Aims

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 (2)

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 facilities 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 Village Health Care Workers

X

Study Participants

• All newly registered TB/HIV patients (~1200)

• 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/HIV Patient

s

Measurement Cohort

KIART

Initiators

KIART Non-Initiators

KIHealthcare 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

Innovation

• Combination approach: A combination of practical, feasible, scalable interventions targeting multiple barriers to timely ART initiation and retention among TB patients

• Rigorous study design: Two-arm site-randomized trial to rigorously assess whether CIP improves early ART initiation and retention compared to SOC

• Lesotho: Focus on a country with one of the highest burdens of TB and HIV

• Research capacity: A key study component is building partner research capacity

• Collaboration: Strong collaboration with public, private, and non-profit sector partners in Lesotho

ENhanceInitiation andRetention inIPTCare for HIV

ENRICH study

Andrea HowardYael Hirsch-MovermanSuzue SaitoWafaa El-SadrYingfeng WuZenebe MelakuTsigereda Gadisa

Background and Rationale

• IPT reduces TB risk by 33% overall, by 64% if TST+, in absence of ART1

• IPT reduces risk of death during early ART2

• IPT + ART results in greater reduction in TB risk than either alone3,4

• ~180,000 PLWH received IPT in 2010 (12% of 1.5 million PLWH newly enrolled in HIV care)5

• ProTEST project: IPT completion 24%-59%6

1Akolo 2010; 2Charalambous 2010; 3Golub 2007; 4Golub 2009; 5WHO 2011; 6WHO2004

Background & Rationale (2)• Barriers to IPT implementation include:

– Health Care Workers• Lack of knowledge/clarity on IPT benefits,

guidelines1,2 • Concern about toxicity, resistance, inadequate

adherence1,2,3

– Programs• Lack SOPs to assess IPT eligibility, monitoring for

AEs, adherence1,3

– Patients• Lack funds for transportation to clinic2,4

• Lack social and family support4,5

• Beliefs about IPT efficacy, side effects5

• Urgent need to identify programmatic interventions that address these barriers to implementation

1Getahun 2010; 2Lester 2010; 3Date 2010, 4Rowe 2005; 5WHO 2004

Study AimsSpecific Aim 1: • Characterize and compare the effectiveness of

CIP with SOC for IPT provision in Ethiopia– IPT initiation– IPT adherence– IPT completion

Specific Aim 2:• Assess the impact of CIP compared with SOC

on HIV-related outcomes– Retention in care– ART adherence– CD4+ count

Study Aims (2)

Specific Aim 3:• Assess safety and tolerability of IPT

among HIV-infected individuals under routine program conditions

Specific Aim 4:• Identify patient and program

characteristics associated with IPT adherence and completion at SOC sites

Study Design

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

• Ten HIV clinics at health centers in Dire Dawa and Harari, Ethiopia

• Clinics randomized to deliver CIP or SOC– Stratification by clinic size

Study Interventions: SOC vs. CIP

Comparison of SOC and CIP

SOC CIPTB screening questionnaire X X

Nurse counsels on IPT benefits, side effects, adherence

X X

Monthly clinic visits to monitor side effects, adherence

X X

Use of IPT clinical algorithm by HCW X

Use of family care enrollment form to identify family members eligible for IPT X

Review of monitoring data on IPT initiation and adherence during monthly MDT meetings

Reimbursement of transportation costs X

Real time adherence support using interactive voice response messaging and peer educators

X

Interactive Voice Response Messaging

• Prepaid mobile phones for patients starting IPT – Low mobile phone penetration

• Interactive Voice Response calls in local languages– Low literacy rate– PIN to protect confidentiality– Medication and appointment adherence

reminders– Call schedule tailored to patient’s

preferences– Monitoring messages to assess

adherence, side effects– Peer educators follow-up with patients

with difficulties

Study Participants

• All new HIV patients eligible for IPT (~1120)

• Measurement cohort of IPT initiators (with 6-9 months follow up)– CIP (n=250)– SOC (n=250)

Study Outcomes

All New HIV

Patients Eligible for IPT

Measurement

CohortIPT initiation X

Adherence to IPT X

Completion of IPT X

Retention in HIV Care X

Adherence to ART X

Side effects/adverse events X

Change in CD4+ count X

Study Measures All

New HIV

Patients

Eligible for IPT

Measurem

ent Cohort

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

CD4+ count

Clinic records review X

Program characteristics X

HIV Care ContinuumHIV Care/Prevention Continuum

ART Eligible

Link

McNairy, El-Sadr AIDS, 2012

• Failure of any one step results in overall system failure:

HIV transmission, morbidity, mortality

Rates of Linkage & RetentionMeta-Analysis: Testing to ART Initiation1

– 24 SSA studies 2009-2010

1.Rosen and Fox. From HIV testing to ART Initiation: the Missing Link. CROI March 1, 20112. Rosen et al. Plos 2007, 3.Fox et al Trop Med Intl Health 2010

Stage Definition Median[ range]

Linkage Attended HIV clinic at least once after HIV test

46%[31-68%]

Enrollment to ART Eligibility(* estimated)

a. Testing to Staging ( CD4 results)b. Remained in pre-ART care until

repeat CD4, ART initiation, or data censoring

55%[35-88%]

46%[42-95%]

Eligibility to Initiation Remained in pre-ART care until ART initiation

66%[14-85%]

ART retention Remain in care at 24 months after ART initiation

61-70%2-3

HIV Care Cascade in SSA29 studies included

Mugglin et al. CROI 2012, Figures from:

http://www.retroconference.org/2012b/PDFs/1143.pdf

Novel Approaches for Linkage & Retention

• Novel Interventions: POC CD41-2, case manager3, SMS, care bags, financial/transport incentive4

• Combination Interventions:– Must address multiple biomedical, structural and

psychosocial barriers to testing and care– Lessons learned from high-impact HIV prevention5-

7

5. Kurth et al.. Curr HIV/AIDS Rep 2011

6. Merson et al. Lancet 20087. Piot et al. Lancet 2008

1. Jani et al. Lancet 20112. Faal et al. JAIDS 20113. Gardner et al. AIDS 20054. Emenyonu et al. CROI 2010

LINK4HEALTH, Swaziland NIH-funded Implementation Science

Study design • Cluster site randomized trial (study unit = HIV testing + care site)• SOC vs combination intervention strategy (CIS)• CIS includes POC CD4, accelerated ART, care package, SMS

reminders, Financial incentivesInnovation • Combination strategy to match barriers

• Cost effectiveness evaluation

Primary Outcome

• Linkage at 1 month + Retention at 12 month after HIV testing

Anticipated Program & Policy Improvements

• Implementation of cost-effective interventions• Routine measurement of linkage and retention in facilities• Influence national policy recommendations for linkage/retention

targets and interventionsTimeline • July 2012-July 2015

Partners • NIH, MOH, CDC, MSF, URC, PSI

Study InterventionsIntervention Standard of Care Combination Intervention Strategy

(CIS)Barrier Targeted

by CIS intervention

CD4 Testing

Not available at HIV test sites.

CD4 (Cyflow, FACS Caliber) at HIV care site lab.

Turnaround time >1 day.

POC CD4 assays at HIV test sites. Turnaround time immediate.

Structural

ART Initiation

Within 1-2 months from testing

Requires: 3 counseling session, baseline lab tests.

Accelerated ART initiation within 1 weeks from testing.

2 counseling sessions, obtain lab tests, initiate ART prior to receipt of lab results in low-risk patients.

Biomedical

Care and Prevention Services

CTX. Condoms available.

Basic care and prevention package (BCPP) provided that includes: condoms; CTX; family HCT; soap, pillbox, appointment register calendar, pictorial education about use of materials.

Biomedicaland

Behavioral

Appointment Reminders and Follow-Up

Telephone call within 7 days of missed appointment for ART patients primarily.

SMS appointment reminders. Telephone call within 7 days of missed

appointment for all patients.Behavioral

Financial Incentive

None. Mobile phone monetary value transfer.Structural

Linkage to Care: Systematic Review

Govindasamy et al. AIDS June 2012

Financial incentives

POC CD4+ tests, accelerated ART

SMS, Care package

Care package

Interventions in LINK4HEALTH address common barriers

Study Unit Reflects Decentralization of HIV Care System in Swaziland

Proposed Map of Study Units

0 2 wks 1 mo 3 mo 6 mo 9 mo 12 mo

Informed consentContact informationInterview

Studymeasurements(CIS & SOC arms)

Interview InterviewCD4 testingMedical record abstraction

HIV testing

Study outcomes

Retention at 12 monthsLinkage at 1 monthPrimary outcome

Secondary outcomes

+

Proposed Study Flow & Outcomes

1. Linkage, any time2. Retention, any time3. Median time to linkage to care4. Time from linkage to ART eligibility assessment5. Time from HIV testing to ART eligibility6. Time from ART eligibility to ART initiation7. Consistent engagement in care (i.e. attend > 75% of scheduled

appointments)8. Proportion of participants with new WHO Stage III/IV event or

hospitalization9. Median CD4+ cell count 12 months after HIV diagnosis (by ART status)10. Mortality rate 12 months after HIV diagnosis11. Cost-effectiveness12. Feasibility, Acceptability

ENGAGE4HEALTHLIGAÇÕES PARA SAÚDE

Primary objective: Evaluate the effectiveness of a combination intervention strategy (CIS) of evidence-based interventions, compared to standard of care (SOC), on combined outcome of linkage to HIV care within 1 month and 12 month retention in care among adults newly testing positive for HIV.

Secondary objectives:Evaluate:

– Incremental effectiveness of CIS + financial incentives (FI) compared to CIS.

– Effectiveness of CIS and incremental effectiveness of CIS+FI on other measures of linkage and disease progression.

– Cost-effectiveness of CIS and incremental cost-effectiveness of CIS+FI. – Feasibility and participant acceptability of CIS and CIS+FI.

ENGAGE4HEALTH: OBJECTIVES

STUDY INTERVENTIONSInterventi

onStandard of Care

(SOC)

Combination Intervention

Strategy (CIS)

Targeted

barrier

CD4 testing

Not available at HIV testing points.

Available at HIV care clinic; results in >1 week.

POC CD4 at HIV testing points.

Immediate results. Structural

ART initiation (for eligible patients)

1-2 months from testing.

Requirements: 3 counseling sessions, baseline lab tests.

Accelerated ART initiation within 2 weeks from testing.

Requirements: 2 counseling sessions (first provided in testing point), obtain lab tests, initiate prior to results.

Biomedical

Appointment reminders and follow-up

Phone call after missed appointments for some ART patients only.

SMS reminders to link to care.

SMS appointment reminders for participants who link to care.

Behavioral

Non-cash financial incentive

None Pre-paid cellular air time cards (CIS+FI cohort only).

Structural

STUDY DESIGN• Two-arm pair-matched cluster site-randomized trial

comparing CIS to SOC. • Pre-post intervention two-sample design nested in CIS

arm to assess added effectiveness of CIS+FI.

10 study units, 3000 adults

Enrollment

Follow-up

Enrollment

Follow-up

Enrollment

Follow-up

Cohort 1 (SOC)

Cohort 2 (CIS)

Cohort 3 (CIS+FI)

• Individual tests HIV positive.• HIV test counselor provides routine post test counseling.HTC

• Client registers for HIV care.• Receptionist writes order for CD4 and routine baseline labs. • Receptionist gives appointment to return within 14 days to receive lab results

and have first clinical consultation .

• CD4 result reviewed, eligibility assessed.• ART eligible clients evaluated for medical ART readiness.• Clinician provides/refers for 1st session of ART counseling. • Client asked to return for 2nd and 3rd ART counseling sessions.• Client initiates ART only after completion of 2-3 ART counseling sessions and

receipt of baseline lab results.

Facility reception

First clinical consultation

STANDARD OF CARE

CIS AT INTERVENTION SITES

• For 1st month after diagnosis, weekly SMS reminders to link to care.• For clients who link to care (i.e. complete first clinical consultation), SMS

appointment reminders for all subsequent scheduled appointments.

Appointment reminders

• Client registers for enrollment into HIV care.• All clients ART eligible clients expedited for 1st clinical consultation within 3

days. • ART in-eligible clients given appointment for first clinical consultation within 7

days.

• ART eligible clients evaluated for medical ART readiness.• Clinician provides/refers for 2nd session of pre-ART counseling.• Client initiates ART- regardless of whether baseline lab results have been

received.

Facility reception

First clinical consultation

• Individual tests HIV positive.• HIV test counselor provides routine post test counseling.• HIV test counselor conducts PIMA CD4 test, receives immediate result. • HIV test counselor writes lab order for routine baseline labs. • For ART eligible clients: HIV test counselor provides first session of pre-ART

counseling.

HTC

Linkage to HIV care at assigned SU within 1 month and retention in care at designated SU 12 months after testing HIV positive.

PRIMARY OUTCOME

Outcome Definition Measurement

Linkage: Participant completes first clinical consultation visit for HIV care and treatment services.

Extraction of data from patient-level database used in HIV care and treatment clinic. Retention: ART patients: Participant alive and received HIV

care services at least once in the 2 months prior to end of study follow-up.

Pre-ART patients: Participant alive and received HIV care at least once in the 6 months prior to end of study follow-up.

PROJECT IMPLEMENTATION

Implementation Science Q&A

Implementation Science Elaine Abrams, MD Senior Research Director.

Documents

Transcript of Implementation Science Elaine Abrams, MD Senior Research Director.