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NAIIS PROJECT PLAN University of Maryland Baltimore - WBS

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NAIIS PROJECT PLAN University of Maryland Baltimore - WBS

3 years ago by: Cassandra Jackson

Overall USG Plan

NAIIS PROJECT PLAN

Initialization

Stakeholders meeting
Protocol development - PI; co-PI
Financial resources - provide guidance
Roles and responsibility
Technical guidance for all biomarker related activity

Pre-Implementation

Procurement - list customization; quantification and oversight
Laboratory Assessments - provide guidance and satellite and central lab
Development and Review of SOPs
Development training materials
Facilitate biomarker trainings
Logistics – training facility (guidance)
Site preparation/set-up - activitation of satellite labs
Tool box preparation

Implementation

Field practice
Monitoring and Evaluation
On-going QA/QC review
QA resolution
Data Review (VL/EID; LDMS)

Post-Implementation

Training and testing for incidence assay
Post-analysis and review
Scientific communication
Initial and final report.

HQ Detailed PHIA Timeline

Pre-Protocol development

Conduct initial PHIA HQ visit to meet local stakeholders
Organize local PHIA governance structure (Steering Committee & TWG)
Establish local Partner operations
Conduct sampling design
Form TWG subspecialialty working groups for sampling, lab & social mobilization, questionnaire review

Contractual Agreements

Identify survey implementing partner (field work) and lab partner (specimen testing & storage)
Establish the subcontract with survey partner
Establish the subcontract with lab partner

Protocol Development

Adapt the Questionnaire, forms (consent, referral, return of results, refusal) and fill the protocol template
Validate with the TWG the final version of the protocol, questionnaire and forms

Regulatory Approvals

Submit the protocol, questionnaires and consent forms to ADS (inclusing feedback and revision)
Incorporate ADS feedback and prepare protocol for submission to other IRBs
Submit the protocol, questionnaires and consent forms to IRBs for approval : CDC, Columbia and local IRB
Address IRB feedback and receive IRB approval
Tablet programming of questionnaire

Survey Preparation

Identify partner to implement household listing
Execute service level agreement to conduct HH listing
Select the Enumeration Areas (EA)
Develop the SOPs for HH listing (by sample sub TWG)
Recruit listers for household listing
Conduct cartography and HH listing
Develop detailed timeline for training
Adapt the manuals for the survey
Adapt training materials
Translate materials (if necessary)
Communications & Community Mobilization
Develop communications and community mobilization strategy
Hold national PHIA launch event
Hold sensitization meetings with regional administrative authorities
Conduct survey community mobilization activities in EAs

Procurement

Develop and finalize lab supply procurement list
Identify and set up rental agreement with warehouse
Order and ship lab supplies, equipment, etc.
Customs clearance and in-country distribution of procurement

Lab Preparation

Assess laboratory network (by ILB / CDC Atlanta)
Prepare capacity building of satellite labs - if necessary
Data Collection/Fieldwork
Recruit survey staff (interviewers/nurses)
Train survey staff (interviewers/nurses/lab), including field practice
Conduct the field main work (data collection, entering, samples transport, etc.)
Data Analysis & Dissemination
Data lock activities
Produce first data package for First Report
Organize First Report writing workshop
Finalize and submit First Report for ADS review
ADS review and approval
Disseminate First Report findings (after ADS approval)
Organize data analysis workshop
Produce data package for Final Report (6 months after first report data package)
Organize Final Report writing workshop
Finalize and submit Final Report for ADS review
ADS review and approval
Disseminate First Report findings (after ADS approval) 1 week

Protocol Development

Adapt PHIA survey protocol and questionnaires to local operational and epidemic context
Submit protocol to NHREC, CDC ADS, and CDC IRB
Develop comprehensive management plan to collect accurate data
Develop a comprehensive data management plan, prototype tools, and cloud-based data warehouse and interface
Develop a data sharing, governance, publication agreement
Design mechanisms for public dissemination, final report

Lab Preparation

Training of lab assessors
Assess and select satellite and central laboratories
Upgrade selected laboratories and ensure storage conditions that maintain sample integrity
Test the processes of a local specimen repository
Ensure institution of standard laboratory quality assurance
Develop guidelines for national specimen repository

Procurement

Develop and finalize lab supply procurement list
Review of draft procurement list with in-country team - confirm if anything needs to be bought locally
Identify and set up agreement for supply chain logistics
Source and confirm quotations
Order and ship lab supplies, equipment, etc.

Survey Preparation

Develop training materials for data collectors and laboratory
Recruit, train the senior survey staff for TOT
Develop a security plan for staff and participants
Recruit and train laboratory staff
Recruit and train field staff
Pilot test survey tools and processes
Comprehensive strategy, materials to sensitize community
Develop, conduct a plan to monitor community acceptance

Survey Collection

Survey Collection Round 1 - 6

1.5 Collect, process, test, transport, and store specimens
1.6 Provide all HH respondents HIV testing and counseling
1.7 Track, ensure linkage of HIV positive respondents
1.8 Track, ensure return of all clinically-actionable test results

Survey Collection Round 1

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Akwa Ibom

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Katsina

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Lagos

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Taraba

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Survey Collection Round 2

Nassarawa

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Delta

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Kano

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Ogun

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Anambra

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Gombe

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Survey Collection Round 3

Niger

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Bayelsa

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Kaduna

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Enugu

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Adamawa

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Survey Collection Round 4

Plateau

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Cross Rivers

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Jigawa

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Osun

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Ebonyi

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Bauchi

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Benue

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Survey Collection Round 5

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Kebbi

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Ondo

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Abia

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Yobe

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Survey Collection Round 6

Kogi

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys
Kwara

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Rivers

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Sokoto

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Zamfara

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Ekiti

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Borno

5.2 Communication and community mobilization
10.1 Map enumeration areas and list households
5.5 Implementation of state-level household-based surveys

Survey Monitoring

Plan for real-time and in-person monitoring of activities
Develop data technologies to ↑ response rate, accuracy, security
Monthly report human subject data, specimen, test quality
Develop a cost monitoring system for decision-making
Evaluate ongoing costs & identify opportunities for savings

Data Analysis and Dissemination

Report cost by activity throughout course of survey
Final economic analysis report on total, component costs
Facilitate data access with negotiated data release policies
Create datasets for analysis, metadata in 3+ common formats
Generate estimates of national and sub-national endpoints
Estimate key population size using NSUM
Share weighted analytical datasets by states
Produce national clean, weighted analytical dataset
Summary reports of survey results with GoN and CDC
Data analysis workshop
Writing workshop

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