TRP Clarifications Form

SECTION 1: Overview

Applicant Information

Country Pakistan Currency US$

Applicant type CCM Component(s) TB
Envisioned grant(s) Envisioned grant(s) end
1/1/2018 31/12/2020
start date date
Ministry of National
Mercy Corps
Principal Recipient 1 Health Services, Common Principal Recipient 2
GF Management Unit
Principal Recipient 3 The Indus Hospital

SECTION 2: Issues to be addressed during grant-making and/or grant implementation

Issue 1: Insufficient details on involvement and oversight of private practitioners

TRP input and requested actions

Issue: The TRP commends the expansion plans involving the private sector that are based on current evidence
and experience in the overall response to the TB epidemic in the Pakistan context. However, the TRP notes that
information on PPM models, including alignment with standards for care, recording and reporting for both case
notifications and treatment outcomes, implementation plans for mandatory notification, financial and non-financial
incentives within PPM models and their cost-effectiveness are not sufficiently described. The funding request
describes the introduction of a “mandatory TB Notification system” with no indication of how confidentiality and
anonymity will be assured in this system.
Action: The TRP requests the CCM to provide a succinct plan (<6 pages) with information on the current models
of private provider engagement addressing the above concerns, as well as the projected activities to monitor,
supervise and oversee the quality of TB case management in the private sector, including plans for an impact
assessment of private sector engagement. Clear indication should be given as to how patient anonymity will be
assured in the mandatory reporting system.
This action will be relevant for the interventions proposed under the allocation as well as under matching funds for
finding missing TB cases (refer to ANNEX 1).

Applicant’s response

The PPM-1 model (engaging private general practitioners) proposed in New Funding Request (NFR)
is the continuation of current model being implemented under NFM grant. Mercy Corps through its six
Sub Recipients (SRs) will provide TB case management services through 1,692 General Physicians
(GPs) and 285 private labs in 65 districts of Pakistan. This would be strengthened by providing
trainings, anti TB drugs, reagents and incentives to the private GPs and the labs, covering 44%of the
country’s population. The following are the main components of this model:

1. Engaging Private General Physicians:

In PPM-1 model, we engage private GPs and laboratories in TB care and management. The GPs,
paramedics and lab technicians are trained on national TB case management guidelines to ensure
standardized TB care services throughout the target districts.

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 The engagement starts with the mapping exercise. It is done to identify and select private healthcare
providers and laboratories that are available and willing to participate in TB DOTS activities. The
process of mapping is done under the stewardship of the district health department (Executive District
Officer-Health (EDO-H)/District Health Officer (DHO)/ and District TB Coordinator (DTC) and
priority geographic locations for PPM are selected on a district map in the urban and rural tehsils. The
identification and selection is based on criteria agreed by National and provincial TB Control Programs.
After selection, the private GPs and laboratories are engaged by signing a Letter of Understanding
(Lou).

Around 6-8 GPs are linked to one PPM lab. The GPs identify the presumptive TB case through
symptomatic screening and then refer them to the PPM labs for sputum smear microscopy. If the patient
results are positive they report back to their respective GP and get registered for further treatment.
However, if the patient’s microscopy results are negative, following the NTP algorithm they are further
evaluated clinically to be registered as TB patients

In order to minimize the out of pocket cost by the patients GPs and labs are given incentives. Each GP
gets PKR 400 for the registration of one TB patient. The incentive is paid in two instalments, initially
at the time of patient’s registration and finally at treatment completion. Similarly, lab technicians are
paid PKR 50 for each slide prepared for sputum smear microscopy. These incentives are paid on
quarterly basis during Quarterly Review Meetings (QRMs) after verification of patient data. The data
verification is mainly done by District TB Coordinator (DTC) and District Lab Supervisor (DLS) with
the support of Regional Coordinator (RC) and District Field Supervisor (DFS). All GPs & labs are
provided with display boards at their sites and small scale campaigns through print and electronic media
and cable network.

The record of patients is maintained on the standardized Reporting and Recording (R&R) tools
approved by NTP. The paramedic working in the GP clinic maintains the data under the direct
supervision of GP. The DFS routinely visit the clinic and facilitates the data entry on the R&R tools.
The regional coordinators (RCs) supervise the DFSs and visit the clinics routinely. The GPs and lab
technician bring the complete record of the patient in QRMs which is verified by DTC and DLS.

Mercy Corps will continue to implement this intervention in 65 districts during the three years
of NFR. Through this intervention 97,684 all type TB cases and 352 RR cases are expected
to be registered in 3 years

2. Engaging private hospitals:

In addition to private GPs, Mercy Corps also works in 15 large private hospitals in 6 districts of Punjab
through the Enhanced Case Finding (ECF) intervention. The hospitals have been mapped and selected
as described above. In each hospital two doctors, two paramedics and a lab technician are trained to
engage them in TB case management services. Additionally, in each district, one Xpert testing facility
is established in one of the selected hospitals. An Xpert testing in-charge is responsible for the running
of machine and maintenance of data. All bacteriologically positive patients are tested on Xpert to
identify the rifampicin resistance (RR). Those found resistant to rifampicin are referred to nearby
Programmatic Management of Drug Resistance Treatment (PMDT) sites. Additionally, one TB
screener is placed in each hospital to verbally screen all the patients reporting to OPD clinics in the
hospital.
Mercy Corps will continue this intervention in 15 large private hospitals in six districts of Punjab in
NFR.

3. Active Case Finding (ACF):

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 Under the ACF component the following three interventions are proposed:
i) Engaging Lady Health Workers (LHWs): Mercy Corp will conduct active case
finding through engagement of 1,785 LHWs in three districts of Sindh. These
LHWs will be engaged in identification and referral of presumptive TB cases
through training and continuous supervision. Moreover, incentives will be given
to the LHWs when their referred case is registered.
The training will be conducted in two steps. In the first step, Lady Health
Supervisors (LHS) will be trained as master trainers on identification and
referral of presumptive TB cases by DTC. These trained LHSs will then train
respective LHWs in their health facilities. These trainings will be facilitated by
the project team comprising of male and female community mobilizers. These
mobilizers will in turn be supervised by their Project Managers.
These LHWs will also be responsible to conduct verbal screening of all the
household members in their catchment population as well as contact screening
of all household members of index cases. These activities will be conducted
during their routine household visits. LHWs will use standardized verbal and
contact screening tools. Moreover, they will also create awareness among
community members through their routine Community Support Group (CSG)
and Village Health Committee (VHC) meetings. These activities target women
and men respectively. The presumptive TB cases will be referred to nearby
public and private BMUs.
The LHS will supervise the LHW as per her routine practice. The overall
intervention will be supervised by the District Coordinator National Program
(DCNP) in the district.
Through this intervention, we expect to register and treat 8,742 all type TB
cases, out of these 90 percent will be registered in public health facilities and
the remaining 10% (874) will be registered by Mercy Corps.

ii) Outreach Chest Camps: Mercy Corps organises quarterly outreach chest
camps for active case finding of symptomatic patients through verbal screening
followed by sputum smear microscopy in 46 districts. These chest camps are
organised at high burden settings identified through epi data analysis and prior
mapping. A publicity campaign and community awareness session precedes
the chest camp. The DOTS trained GPs and lab technician accompanies the
DFS to conduct the camp. The local NGO's/CBO's and LHWs are engaged to
increase service utilization. The project staff with the support of community
volunteers ensures the registration of all diagnosed TB cases at nearest public
of private BMU.
A total of 552 camps will be conducted during grant period, that is, one camp
per district per quarter. Around 30 to 40 people will be screened per camps and
the expected yield is 2 cases per camp. Through this intervention, 1,104 cases
will be registered.

iii) Screening and intensified Case Finding Activities (Asymptomatic Mainly)

Mercy Corps will conduct screening camps through 07 vans equipped with
digital X-ray with CAD4TB in 19 districts. Four of these vans will also have Xpert
testing facility. These camps will be conducted in the outreach and also in the
near vicinity of PPM private hospitals and clinics. The diagnosed patients will
be registered at the nearest private or public healthcare facility, using screening

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 algorithm 2d; (X-ray CAD4TB – Xpert). Once registered, the patients will be
followed for treatment adherence and completion by the PPM field staff.
It is expected that on an average 50 persons will be screened per camp, and
the estimated yield will be 2 cases per camp. Overall 235,248 people screened,
and 74,520 Xpert tests (16 Xpert tests per camp) will be conducted. Through
this intervention, 9,504 DSTB cases and 231 RR cases will be detected.

Monitoring and Supervision:

As mentioned above, the PPM activities are conducted by DFS and monitored by the RCs in each
district. These are in turn supervised by the Program Mangers of the SRs. In addition, the monitoring
is further strengthened by the regular visits by M&E officers of PR unit. It is ensured that about 2/3rd
of the total districts are monitored at least once in a quarter. Some percentage of these activities is also
monitored by NTP and PTP on quarterly basis.

The specific activities that are being regularly monitored by the PR Unit as well as SR staff includes
Quarterly Review Meetings (QRMs), Chest Camps, and Community Gatherings. In addition, the
monitoring staff regularly visits the GP clinics, where the staff verifies the number of cases registered,
recording and reporting tools, drug utilization and stocks. The monitoring staff ensures that contact
screening of the registered bacteriologically positive patients and routine follow up is being practiced.
The staff also monitors the PPM labs to assess the status of reagents and monitors the basic lab
indicators such as Diagnostic sputum smear positivity rate (DSPR) and follow up sputum smear
positivity rate (FSPR). Any discrepancy is noted and recommendations are made accordingly. .During
each visit to the district, the PR monitoring staff verifies 3-4 patients by visiting their homes, ensure
treatment compliance and get first-hand information about any issues faced by the patients and their
families.

At the district level DTC conducts monitoring visits of PPM clinics as well as PPM labs. The DTC is
also responsible for the verification of cases registered at PPM clinics. He leads the quarterly data
validation exercise during QRMs. The lab performance is monitored by the DLS with the support of
cross checker; together they ensure the quality of smear microscopy through External Quality
Assurance (EQA) of each lab on quarterly basis. EQA is a routine activity that is conducted every
quarter during which a certain percentage of smear slides from each lab are collected and results are
verified by the cross checker. Written feedback report is also given to the lab staff. It is mandatory for
all the PPM labs to be under EQA.

Mercy Corps also does project evaluations to assess the overall impact of the program. For NFM grant,
mid-term project evaluation was conducted and now we are in the process of conducting end term
evaluation of NFM grant. This exercise is helpful to assess our performance, identify the challenges
and to decide the way forward. This also serves as a basis for the planning for the next round of funding
and project activities are planned accordingly.

The PPM-2 model (engagement of NGOs with health outlets) is managed by provincial TB control
programs and act as TB care facility with lab. The engaged NGO’s health centers are provided with
training of all staff engaged in service delivery at standard NTP training modules developed for each
carder, anti TB drugs , lab reagents & supplies and one time microscope ( if required)and supervisory
support from district TB coordinator and provincial program officers. These paramedics and lab
technicians of these centers are provided with small incentive of 5400 PKR every quarter.

PPM-3 model ( engaging Large private hospitals ) is managed by the provincial programs with The
implementation arrangement & incentives are same as of PPM-2
PPM-4 ( Parastatal sector /other public sector) is also managed by the provincial programs and include
health centers of those public sector organizations which have their own health care system which is
not under department of health like Armed forces, social security etc. The implementation arrangement
& incentives are same as of PPM-2.

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 TIH model social business & PPM-1:
The implementation of case management interventions i.e. screening, diagnosis and treatment will take
place based on the NTP guidelines and Algorithms. The care providers involved in the TB control
activities will be provided training on the case management guidelines and R&R tools as per the
standard formats nationally agreed.

The section below provides the details of the PPM intervention model of TIH SRs to be implemented
under the GF grant period 2018-20. This includes the details of DS and MDR-TB cases detection and
enrollment.

Community Health Solutions (SR1):

The PPM initiative being implemented by CHS, particularly in urban centers, is meant to;
a. comprehensively cover most private health providers,
b. expand active case finding in marginalized populations and high risk areas, such as urban slums,
c. ascertain the quality of service provision such as, patient counseling, diagnosis and treatment of
co-morbidities, ensuring treatment adherence and psychosocial support are largely entrusted to
the partnering GPs approach towards patient care ,
d. increasing sustainability over time by establishing permanent capacity for private sector TB care
and prevention and
e. expanding access to drug-susceptibility testing for these patients through Genexpert machines
installed in the centers.
Under the Global Fund proposal, CHS will be working in 19 districts in 3 provinces of Pakistan. The
Sehatmand Zindgi Centers as Basic Management Units are currently working as clinics and collection
points for clinical exams, sputum collection and case-management and will be expanded. They will
provide quality of TB services in the private sector through training and development of a dedicated
team of clinicians, treatment supporters, and counselors for comprehensive case-management,
treatment compliance and psychosocial support to TB patients. Through a network of trained doctors,
General Practitioners and specialists they will carry out systematic screening for TB in their clinics
and refer TB suspects for diagnostic evaluation at the centers and will help enhance case-detection
and community-based treatment through passive case-finding. Will train additional practitioners from
the informal health sector and pharmacies on TB screening. These practitioners will refer TB suspects
from their facilities for TB diagnostics, clinical evaluation and treatment at the centers.

Greenstar Social Marketing (SR2)

Key Strategies

1. PPM 1 intervention (Adult and childhood)

2. Active Case Detection (Meeting with notables, community gathering meeting, chest
camp)
3. Referral linkages with informal providers
4. Pharmacy engagement
5. Rural Intervention
6. Universal GP Coverage

1. PPM 1 intervention (In existing PPM implementation districts & additional proposed
districts)
• Network expansion in private sector of target districts and enhanced involvement of general
physicians and consultants for adult and childhood TB case management. Following
sequence of tasks would be followed:

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 • Enhanced role of GSM existing network of health facilities (in existing districts only)
• Expansion of private health facility network
• Provision of WHO recommended diagnostic facilities for all patients especially for
those who are living in hard to reach areas with limited access to standardized health
care facilities
• Registration and further follow up of detected TB patients and primary default
• Contact tracing of all B +ve patients
• Childhood initiative

Enhanced role of existing network of health facilities

Greenstar have a network of 1500 providers which include general physicians, consultants (chest
specialists and pediatricians). Very limited number of health facilities (300) have been trained on child
TB management and being offered free diagnostic services for treating childhood TB cases under
current NFM grant. The remaining facilities are catering child TB cases but not following National
guidelines, nor reporting child TB case to national data as they are not trained on child TB (missing
cases at national level). Training all potential networking providers on childhood TB management will
not only bring these child TB cases under standard TB management protocol but would also reduce
missing cases from national grid.
Refresher training of existing providers on adult TB management based on the latest TB management
guidelines is mandatory for provision of standardized treatment.

Expansion of private health facility network

This includes; Mapping and selection of additional potential private providers including general
practitioners, and consultants treating TB patients in new districts as well as existing districts. Trainings
of doctors/paramedics and Labs staff and MOUs (agreements) signed with the newly onboard health
facilities.
Currently GSM is implementing DOTS strategy in 13 districts with a network of 1500 providers which
are mainly in cities with expansion at Tehsil level. The remaining potential private providers including
general practitioners and consultants would be mapped for identification of potential resource (the
facilities which are already being trained and/or in follow up of partner organization working for TB
control would be spared and would not be further followed). The selection criterion would be based on
the outpatient load as well as the geographical location of provider. After mapping and selection, newly
recruited health care worker will be trained on TB DOTS. Training on management and treatment of
TB cases will be organized by Greenstar as per National Guidelines and protocols defined by GF/
NTP/PR. After training, memorandum of understanding will be signed with the health facility. The
facility will be provided with free TB diagnostic services through a trained private laboratory.

Registration and further follow up of detected TB patients and primary default

All the confirmed TB cases would be followed for verification of their address and treatment supporter,
follow up of patient for medicines and lab tests till completion of treatment. Further in case of primary
default the patient will be motivated to seek medical care. Patient will be followed till registration at
private clinic.

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 Contact Screening of All Newly B +ve Registered Cases

GSM would confirm the contact information of all new registered cases by physical verification and
then would follow up the contact for screening the primary contacts of the cases.

Childhood Initiative Same as PPM 1 for adults with following amendment

• Mapping of GPs/consultants/paediatricians managing childhood TB cases

• Round table discussion with all the selected childhood Tb care providers with MOU signing
• Case detection and registration and further follow up of detected TB patients at doorstep
• Screening for TB in schools, madrassas, orphanages of congested and low socioeconomic
health deprived areas with involvement of Mobile Digital X ray for screening program

2. Active Case Detection

Community Mobilization for TB Suspect Referral through Outreach Camp:

Focused community mobilization activities will be carried for vulnerable population in urban slums /
high risk group for TB. IEC material will be used for targeted population for information and educating
community about TB diseases and its sign & symptom with treatment.

In Orientation meetings (OM) IPC staff will identify a community influencer of that area that might be
leader of community/ Imam Masjid / counselor / political or religious figure having say in that
community. IPC staff will put in the picture the purpose of holding community mobilization activities,
and then would give orientation about organization’s objective for stopping TB in Pakistan. IPC team
will request for support of community influencer for its ongoing activity offering searching for suspects
leading to diagnosis and free treatment.

Visits in the community will be carried by IPC staff right after orientation meeting. Household visits
will be conducted for three days prior to camp. All the IPC activities will be clearly linked with the
defined, tangible and measurable outcomes to ensure effectiveness. These will a 03 day activities
followed by chest camp on the fourth day.

It will be mandatory for each designated staff members to make twenty five (25) contacts per day for
three consecutive days before the 4th day, when the free chest camp will be arranged in the community
in selected districts. As mentioned earlier, these camps would be organized after detailed mapping of
the potential high risk site (urban poor) i.e place where poor nutrition and crowded living conditions
compound the disease risk. It is therefore expected that the missed TB cases, which are concentrated
in these localities and are source of spreading disease in community would be diagnosed and managed.
With the help of IEC material they will share information regarding sign & symptoms of TB, its
prevention, treatment and the availability of free diagnosis and treatment. If IPC team will find suspects
of TB (as per protocol given by NTP’s guidelines), they will keep record of suspect and ensure his/her
participation in camp through active follow up.

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 Chest Camp/ Mobile Camp for Hard to Reach/vulnerable/Urban Poor

Outreach camp will be arranged on 4th day after completion of community mobilization activities for
consecutive 3 days within the community or selected setup. On the day of outreach chest camp GS
team will display a banner on proposed site for outreach camp along with the name of doctor/ health
care provider present in the camp. Trained TB care provider will ensure his/ her presence in the chest
camp during the OPD timings. Basic information about the suspects and his contact will be documented
on a pre designed format.

Mobile lab (X ray with CAD 4) will be used for screening the intended population along with the
sputum sample collection of all those who are either suggestive of TB or have chest findings. Sputum
sample will be sent to nearby public or private gene X pert facility (precious sample)

3. Referral linkages with informal providers

• Mapping, training/orientation and MOU signing with informal providers on referral

of presumptive TB patient to DOTs diagnostic center for lab investigation and
registration.
• Development of referral mechanics
• Coordination and follow up for presumptive case referral to private DOTs facility

4. Pharmacy engagement

• Mapping, selection and training of focal pharmacy staff on referral mechanism

• Presumptive case identification with referral to trained TB care provider
• Follow up of referred suspect
• Develop and strengthen referral mechanism from pharmacies to networking
providers
• Orientation existing and new Pharmacy Staff on:
o Initial screening of patients
o Identification of suspects
o Record basic contact information of patient
o Referral to formal provider for diagnosis and treatment

5. Rural Intervention Outreach

• Increased access to TB diagnostic and treatment facility for rural communities in the PPM
intervention districts

• Mapping and selection of potential private providers including general practitioners

and labs in the villages
• Trainings of doctors/paramedics and Labs staff and MOUs (agreements) signing
• Training potential private providers working within or nearby community will be
formally trained on TB diagnosis / treatment as per national protocols.

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 • Mapping of informal providers in the nearby community and villages
• Orientation informal providers: Informal providers will be trained on:
o Initial screening of patients
o Identification of suspects
o Record basic contact information of patient
o Referral to formal provider for diagnosis and treatment
• TB Diagnostics: Private/public lab working within or nearest point will be trained on
microscopy and will be used for diagnosis. Mobile lab will be present in chest camps
organized within the community and provide results at spot. Patients picked up as
suspects at informal provider will be called in the chest camp for immediate diagnosis
or will be send to lab working in collaboration.
• TB Treatment: Registration and further follow up of TB patient at trained formal
provider.

6. Universal GP Coverage and Universal Lab Coverage/Legislation

• Listing of GPs in project implementation districts for probable collaboration with TB

control
• Orientation of non-collaborating GPs on following:
o Initial screening of patients – national protocol
o Identification of suspects
o Standard diagnosis and treatment
o Record basic contact information of patient
o Referral protocol
• Development of referral mechanism
• Establishment of drug collection points where GPs will refer patients for drug
collection where possible
• Referral to formal provider for diagnosis and treatment

The Indus Hospital (PR):

• The major set of responsibilities of TIH as an implementing PR is to manage Zero TB
cities interventions and PMDT sites (14). In addition, the Indus hospital will also
screen, detect and enroll 7,000 DS TB cases over 3 years in Indus Hospital campus
Korangi Karachi.

The assessment of cost effectiveness of PPM approacheds is planned in 2019&2020 reference

responses to issue 7

Mandatory case notification:

The confidentiality and anonymity of TB patients will be ensured by implementing the following
features in Mandatory Notification System:
1. Hierarchy based user access control
a. All users of this system will follow a strict hierarchy and may only access
relevant patient records. The following is a list of users and their access:

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 i. GP – may only view TB-01, TB-03, TB-04 records of his/her own
patients.
ii. DFS – may only view TB-03 records of those TB patients, which he/she
has electronically entered in the database.
iii. DTC – may only view records of those TB patients which belong to
his/her district.
iv. NPO – may only view records of patients of his/her assigned districts.
v. PTP – may only view records of respective province/region.
vi. NTP – may view all patients’ record.
2. Encryption of electronic data
a. Mandatory notification system will have full SSL encryption and all patients’
data and reports will be encrypted while they travel over the Internet.
3. All qualified doctors are registered with Pakistan Medical and Dental council and take
an oath to observe all ethical principles of medical practice including keeping
confidentiality and anonymity of the patients. Under code of ethics 2001 at PMDC web
site www.pmdc.org.pk . The Ministry of health also has its code of ethics for
Government service which in general speaks for maintaining confidentialities of all
matters. NTP has its policy and procedure of sharing data. The private partners Mercy
Corps and The Indus Hospital have their own policies addressing the confidentiality of
information about patients and data security.
TRP comments and/or request for further clarifications:

TRP’s comments on the applicant’s response

The TRP is satisfied with the response. The TRP acknowledges the clarification provided by the applicant providing
information on several PPM models for TB care in the country. However, engagement strategies under each PPM
model are insufficiently articulated and clarity around how these models for TB care will be eventually assessed
through a PPM framework capturing case notifications, or contributions to the overall TB burden in the country
remains unaddressed.

The TRP recommends follow-up actions as indicated under Section 3 below.

Issue 2: MDR-TB TB diagnostic and treatment targets are not aligned with the scale-up of access to rapid
diagnostic tests

TRP input and requested actions

Issue: The funding request includes the scale-up of rapid molecular tests for the detection of RR-TB (scale up from
64 to 410 GeneXpert machines) and resistance to second line anti-TB drugs, potentially leading to increased DR-TB
case detection. However, the diagnostic and treatment targets for RR/MDR are not aligned with the proposed scale
up of diagnostic capacity. The DR-TB treatment access is planned to only increase from 22 percent to 32 percent by
the end of 2020.
In addition, the calculation of needs for different DR-TB treatment regimens is not clearly described. The TRP also
notes that the potential of cost savings of the short-term regimens are not maximized as the scale of implementation
is limited to 30 percent of MDR-TB patients.
Action:
1. The applicant is requested to:
Provide the baseline data and estimates for the scale up of access to GeneXpert MTB Rif testing (percentage of
TB patients tested by GeneXpert) as well as for SL DST (including rapid molecular tests) coverage among RR-TB
patients with an estimation of needs for different DR-TB treatment regimens (short, standard, individualized) aligned
with the scale-up of diagnostic capacity.
Provide an operational action plan (max 4 pages) on active drug safety monitoring and management (aDSM)
2. The TRP recommends the applicant to develop a plan for the introduction of new and repurposed drugs and short-
term regimens for the treatment of DR-TB, in order to inform revision of quantification of drugs and budget as
appropriate.

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 Applicant’s response:

In year 2016, total of 127,775 presumptive/TB cases were tested using GeneXpert.
Among those tested 35,984 (28.2%) were confirmed to have MTB and 3331 (9.3%)
were rifampicin resistant (Ref.figure 7 in grant application). Deployment of additional
GeneXpert machines will start by end of 2017 and impact of improved coverage of
Xpert testing will be visible by end of 2018. However yield of RR cases detected by
testing of presumptive TB cases and New smear positive TB cases will be
understandably lower then testing of TB patient at high risk of MDR.

It is estimated that with this scale up, by third year (2020) of the grant, 85% of Re-
treatment cases and 60% of B+ve cases PTB patient will have Rifampicin result at
time of notification (101894/442250. Denominator is all form TB cases notified)

The expansion of Xpert network across the country has a throughput to test additional
B-positive. We have placed as top priority for above allocation to reach up to 90% of B
positives cases. This will give a yield of additional 16% of RR-TB cases. The major
reason for putting it into PAAR being requirement of additional resources for Xpert
cartridges and second line Drugs and social support to reach 55% of all pulmonary
MDR cases ( which is 70%.(2019) 90% (2020) of B positive cases, 1000 + 2150
=3150 additional Cases over three years).

SL DST (including rapid molecular tests) coverage among RR-TB patients: In 2016,
80% of the RR/MDR patient enrolled on treatment had second line DST results
reported, with introduction and with scale up of rapid second line DST using SL-LPA
this proportion is estimated to improve further.

Estimation of needs for different DR-TB treatment regimens: (short, standard,

individualized) aligned with the scale-up of diagnostic capacity.

In Pakistan 50% of MDR/RR patient are resistant to FQ including pre-XDR and XDR
(Reference table 2 page 9 of grant application). Proportion of patient (30%) for Short course
treatment by year three has been estimated keeping in view FQ resistance, proportion of valid
results on SL-LPA (80%) and scale up of SL LPA.

Operational & action plan Active Drug Safety Monitoring and Management (aDSM)
NTP plans to scale up New Drugs (BDQ and DLM) through its 34 PMDT sites. It also plans to
initiate Shorter Treatment regimen for eligible DR TB cases in a phased manner. aDSM is an
important prerequisite to ensure patients safety and timely management of side effects.

aDSM is defined as the active and systematic clinical and laboratory assessment of patients on treatment
with new TB drugs, novel MDR-TB regimens or XDR-TB regimens to detect, manage and report
suspected or confirmed drug toxicities. The ultimate aim of aDSM is for the safety of patients.

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 The process of a DSM starts from the patient and through a well-coordinated and structured mechanism
is reported to various layers of health care system and to DRAP.

NTP has developed an aDSM plan, keeping in view global experiences and learning. The following table
describes the various steps that constitutes the core of aDSM.
Create a national NTP has formed an aDSM coordination unit as mentioned below
coordination and MDR TB focal will act as secretariat.
mechanism for aDSM

Develop a plan for It is to embedded within NTP and an SOP on aDSM has been
aDSM combined in updated national PMDT guidelines.

Define management The outline of main responsibilities for the main actors has been
and supervision roles defined.
and responsibilities

Create standard data The updating of treatment card, monitoring tools and adaptation of
collection materials SAE/AE form and instruction to fill the forms have been done.

Train staff on the A training in basic of aDSM has been done. It is planned to include
collection of data a further training in identification of SAE and recording in the SAE
form in the next month (December 2017.

Define schedules and The route of data collection, recording and reporting has been
routes for data defined
collection and reporting

Consolidate aDSM data Will develop excel database capturing important data while paper
electronically records are maintained properly. It is planned to look at possibility
of integration within TB MIS system.

Develop capacity for This will usually require specialist skills and is only expected to be
signal detection and developed with time within the TB and/or drug safety monitoring
causality assessment programs. It has been trained to a few key staff from NTP and focal
NGO representative who will be doing causality analysis with the
assistance from external expert in the beginning.

Roles and responsibility in aDSM

The following table shows the roles and responsibilities of the NTP and implementing staff in
aDSM.

Table 2. Roles and responsibilities in aDSM

Role/responsibility Responsible person(s)

Identification of AE/SAEs Nurses, medical doctors (MDs), field
partners, DOT watchers

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 Ensuring timely baseline and follow-up MDs, nurses, DOT watchers, filed partners
examinations

Recording of monthly results into the Form MDs, nurses, filed partners

Reporting of SAE/AEs to NTP ( by email) Focal Persons of PMDT in the facility (e.g
within 24-48 official working hours by e-mail MDs/nurses/MIS assistant)

ECG reading Specialists/MDs

Severity assessment and management of Mild-moderate: MDs in PMDT sites

AE/SAE
Moderate-severe: in consultation with
clinical advisory team or MMC

Review SEA reports and causality analysis
aDSM coordination unit in NTP
MDR TB focal – to coordinate for convening
of review and analysis of report within 3 days
of receiving the report
Monthly convene: to review any outstanding
SAE/AE cases for completion of causality
analysis

Consolidation of AE reports and reporting to NTP-PMDT Focal Person

National PV Center (DDF) by email

Uploading/reporting to Uppsala Monitoring NPV Center staff(DRAP)

Center (global database) through
Vigiflow/PVIM

Levels of aDSM monitoring

There are three levels of monitoring aDSM, namely, a) core package, requiring monitoring for
and reporting all SAEsl b) intermediate package, including SAEs as well as AEs of special
interest; and c) advanced package, including all AEs of clinical significance.
aDSM Components
There are three components in aDSM. These are a) clinical monitoring (active and systematic
clinical safety monitoring and management (aDSM) and laboratory assessment during treatment
to detect drug toxicity and AEs); b) management of AEs/SAEs effectively c) systematic and
standardized recording and reporting of AEs/SAEs which includes data collection to include
safety data; SAEs and AEs of special interest to be reported to the aDSM coordination unit in NTP
for causality assessment.
aDSM coordination unit in NTP will be composed with the following members whereas MDR
TB focal point in NTP will act as secretariat to coordinate and ensure implementation of aDSM.

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 NTP Partners

1. National Coordinator for MDR TB Representative of Pakistan Chest society

2. Advisor National reference Lab

3. MDR Focal Point (secretariat)

4. Representative of DRAP

5. Chief Drug Management unit

PTP Partner

MDR Coordinator PTP Provincial representative of Pakistan Chest

Society

Provincial Pharmacist

Provincial reference Lab representative

5.1 Clinical and laboratory monitoring and management of adverse events (AE)

AEs should be monitored in a systematic and timely manner. At every DOT encounter, health
workers should ask the patient about clinical symptoms of common AEs including skin rashes,
gastrointestinal disturbances, psychiatric disturbance (headache, anxiety, depression, irritability,
behavior change), jaundice, vestibular toxicity (nausea, vertigo, ataxia), peripheral neuropathy
and symptoms of electrolyte wasting (muscle cramping, palpitations). Ototoxicity (hearing loss)
needs particular attention. A set of laboratory tests will be performed according to schedule
mentioned in PMDT guidelines. For management of AE/SEAs with likely responsible drugs, refer
to PMDT guidelines for further details.

5.2 Recording and reporting of adverse events (AEs)

The data on effectiveness, data on safety will be collected from routinely used paper based
recording and reporting system or electronic recording and reporting systems (i.e. eTB manager,
PVIMS,) or from routine registers (laboratory registers, TB registers) and patients’ medical

TRP Clarifications Form Page 14 of 22

 records as necessary. Patient treatment cards will be updated so they are in accordance with
WHO’s PMDT and aDSM guidelines [3].

Each PMDT site shall collect individual patient data to enable programmatic analysis on the
indicators. Standard variable definitions will be used across all PMDT sites to allow for national
analysis.

Forms used in aDSM

The following forms will be used to carry out aDSM activities:
A. Pre-treatment:
1. Patient Triage Form or aDSM Form A (Inclusion and Exclusion Criteria): RR-/MDR-
TB patients detected by Xpert will undergo assessment for inclusion and exclusion criteria
using this form.

2. Clinical and Laboratory monitoring sheet: RR-/MDR-TB patients who are eligible for
SL-LPA will undergo baseline examinations guided by this table. (Table 13 & 14)

B. During treatment (initiation and follow-up)

1. DR-TB Treatment Card: DR-TB Treatment Card records the following
a) previous use and exposure to SL drugs and indicate which drugs and for how long
b) STR and New Drugs as among the options under Treatment Regimen will be added
to the cards

2. Clinical and Laboratory monitoring sheet: will be visited monthly or more frequently
for guidance on the examinations that are scheduled during the treatment period.
3. ADR Section of the Treatment Card (aDSM routine form). This is considered
extension of the DR-TB Treatment Card which allows health workers to document any
kind of AEs.

4. Suspected Adverse Event Reporting Form (SAE/AE form) –, with instructions on

filling out: This form will be used for SAE that will be encountered during treatment in
PMDT site or in MDR TB ward/hospital. This form will contain the following: a) patient
information, b) suspected AE information (suspected product, event description, dates of
event start and end, intervention, and outcome, seriousness), c) concomitant drugs used
for adverse event management and comorbidity and relevant results of laboratory
investigation and reporter information.

- SAEs are to be reported with a completed form within 24-48 hours after detection, and
even upon suspicion of seriousness.

- The report is to be sent even if not all details are available and regardless of certainty
of association with any particular medicine. The essential details are the identifiers of
the patient and the reported; the name of the suspected medicine(s) and the basic details
on the serious AE.

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 - All health care professional are encouraged to report. Patients and relatives may also
report to CHW and community based nurses or PMDT site verbally. The doctor in
charge in PMDT site is responsible to ensure recoding in SAE form and email to the
PTP and NTP MDR TB focal point, who will then circulate to the members of NTP
aDSM coordination unit by e-mail for review and causality analysis to get done within
3 days. MDR TB focal point will also consolidate all forms and email to National PV
unit.
The aDSM coordination unit in NTP will review the information and contact the reported PMDT site if
required. All information, including identity of the patient and reported, will be handled in strict
confidence. Apart from action to protect public health, anonymized statistics from these sites.

Uppsala GDSM

National PV unit /DRAP GDF (for new

drugs)

National and Provincial

aDSM Unit

Community based
nurse/DOT watchers/CHW

PMDT site

Patient and family

(e.g. bed ridden or died at home)

Plan for the introduction of new and repurposed drugs:

NTP is managing MDR through 34 tertiary hospitals across the country both in public and private sector
and all these hospitals are labelled as Programmatic management of Drug-resistant tuberculosis sites
(PMDT sites). MDR is being managed at these sites under programmatic conditions in accordance with
WHO recommendations. WHO advisories/ updates regarding clinical management issued from time to
time are regularly incorporated in National guidelines for the programmatic management of drug
resistant tuberculosis, a guide for management of Dr-TB in the country. The management strategy is
modified/ updated regularly.

In compliance with WHO updated treatment strategies 2016, NTP planned for introduction and scale-up
of new drugs and short treatment regimen in the country. The plan was developed by MDR unit and

TRP Clarifications Form Page 16 of 22

 National Reference laboratory network after detailed deliberations. The plan is tabulated as under;

Total courses
Year 2016 2017 2018 2019 2020 budgeted in
NFR
Enrolment 2881 3169 3500 4500 5500 13500

FQ Res( 40%) 1400 1800 2200 5400

Bedaquiline ( 23%) 490 900 1650 3040
Delamanid (8%) 210 360 550 1120
Total on New Drug 700 1260 2200 4160

STR 400 700 1125 1650 3475

The same plan was shared with visiting GDF mission( May 2017)and the drug quantification for NFR
was done accordingly and the second line drug orders were placed. The drugs have been budgeted in the
way in New Funding Request (NFR) to Global Fund.

The ordered quantity of the drugs Bedaquiline and Delamanid have been received in the country. The
training of the PMDT staff on new guidelines is planned in this month and the site wise implementation
plan will be developed after this and we expect to start with new drugs and short course by the end of this
year.

TRP comments and/or request for further clarifications:

TRP’s comments on the applicant’s response:

The TRP is partially satisfied with the clarifications. The TRP acknowledges the clarifications provided by the applicant,
however Xpert testing and SL DST coverage indicators are not provided. The estimation of needs for different DR-TB
treatment regimens most likely are based on incorrect assumptions (the denominator for the proportion of FQ
resistance is number of strains and not patients).

• Applicants response does not provide clear information on current and planned coverage of Xpert testing
among all TB patients. “yield of RR cases detected by testing of presumptive TB cases and New smear
positive TB cases will be understandably lower then testing of TB patient at high risk of MDR. It is estimated
that with this scale up, by third year (2020) of the grant, 85% of Re-treatment cases and 60% of B+ve
cases PTB patient will have Rifampicin result at time of notification (101894/442250. Denominator is all
form TB cases notified)”.
• Response on coverage of SL DST for RR-TB patients and estimation of needs for different DR-TB
treatment regimens is based on figure 5 and table 2 of the FR. The calculation is based on the assumption
that 80% of RR-TB were tested for SL resistance in 2016 and that 50% of tested had FQ resistance.
However, the table 2 provides information on strains (not RR-TB patients) tested for SL resistance. For
example, in 2013 there were 1570 MDR-TB patients enrolled in treatment and there were 2213 strains
tested for SL resistance, which indicates that most likely for some patients multiple strains were tested and
therefore the proportion of FQ resistance among tested strains does not reflect the FQ resistance rates
among MDR-TB patients tested for SL DST.

The TRP recommends follow-up actions as indicated under Section 3 below.

Issue 4: Lack of clarity of TB screening approaches targeting presumptive TB patients

TRP input and requested actions

Issue: The TRP notes that the applicant intends to undertake systematic TB screening through chest camps
targeting presumptive TB patients in high-risk populations in pre-identified and mapped populations, which is
appropriate for increased TB case finding. However, the funding request does not clearly describe which high-risk

TRP Clarifications Form Page 17 of 22

 population groups will be targeted in these settings. In addition, the funding request adopts different approaches
for screening of presumptive TB patients by implementing partners.

Action: The TRP requests that the applicant provides an outline (4 pages) of the process of prioritization in active
case finding efforts among presumptive TB patients, approaches for targeting vulnerable groups and the screening
algorithms that will be adopted for targeting symptomatic cases in various risk groups.

Applicant’s response:

People with decreased access to quality services, people who have or have survived TB are considered
as a key population for TB. To address these key populations for TB, Mercy Corps organizes chest
camps in the hard to reach and high burden areas (hot spots) in each district as a part of Active Case
Finding (ACF) intervention. These areas are usually selected through the coordinated efforts by the
DTC, Regional Coordinator, General Physicians and the DFS after careful review of hospital and health
facility records and epi data analysis. The district and facility wise TB03 is analysed and high burden
areas are identified for organizing outreach chest camps. The distance of the identified areas from the
health facilities is also considered and preference is given to those areas that are distant to the health
facilities (public and private).

In addition, we have recently started screening of industrial workers for tuberculosis, in Punjab (Lahore
and Gujranwala) in collaboration with the provincial TB control Program.

In NFR, Mercy Corps is proposing chest camps via two algorithms:

1. Conventional chest camps (verbal screening and sputum smear microscopy) in 46 out
of 65 districts will be organized in far-flung areas with expected high yield of
tuberculosis patients. These areas are identified by field teams in close coordination
with District TB Coordinators (DTCs), using epi data. All the symptomatic patients
reporting to these chest camps are verbally screened for symptoms and those identified
as presumptive TB cases are further tested for sputum smear microscopy. Those who
are found bacteriologically positive on sputum microscopy are further tested on Xpert
using the NTP algorithm (Scenario 3). We expect to register 1,104 all types TB cases
through this intervention.
2. Chest camps through mobile screening vans in 19 out of 65 districts using NTP
algorithm (Scenario 1). In these districts chest camps will be organized in far-flung
areas and outside the GP clinics. All the persons reporting to chest camp having any
TB symptom will be screened via chest x-rays. Those having high scores on CAD4TB
are further tested by Xpert and diagnosis is confirmed. We expect to register 9,504 all
types TB cases and 160 RR cases through this intervention.
The Indus Hospital is doing Active case finding which includes searching for presumptive patients in
the communities, on spot diagnosis through mobile diagnostic facilities and registering the diagnosed
case to the health facilities for treatment and follow up till completion of treatment. Community based
activities will be conducted in high risk & vulnerable urban poor’s and slums, in tehsils and towns
where the incidence is high because of congested and close living, unhygienic environment, contact
transmission, poor sanitation and less health awareness and access. Following sequence of events
would be followed under active case detection model
• Community awareness starting with orientation meetings with community influencers
• Community mobilization sessions
• Chest camps

TRP Clarifications Form Page 18 of 22

 NTP approved algorithms will be used for screening presumptive TB cases to address various scenarios
where GeneXpert machine is present on the site, X-ray machine is present on site followed by
Genexpert testing and where only smear microscopy is available.

TRP comments and/or request for further clarifications:

TRP’s comments on the applicant’s response

The TRP is satisfied with the response with no additional follow-up action requested.

Issue 6: Uncertain maintenance of price, quality and secure supply of FLDs while transitioning to
domestic finance
TRP input and requested actions

Issue: The TRP notes the plan for health commodities, including up to 80 percent of FLDs, will be financed by the
end of year 3 with funds from provincial health departments. At present, Global Fund financing is used to procure
FLDs through the Global Drug Facility (GDF). With the transition to government financing, it is not clear how
procurement will be handled in a decentralized health planning and budgeting environment, and what the
implications will be for assured quality, competitive pricing and security of supply.

Action: To ensure continued quality, competitive pricing and steady supply of health commodities, including FLDs:

1. The TRP recommends that the applicant continues to procure FLDs through the GDF with Global Fund financing

2. The TRP requests the applicant to provide a detailed note (5 pages) on i) current provincial capacities, gaps and
proposed plans for how the provinces will safeguard predictable release of finances, ii) procurement capacities
such that comparable pricing, quality and supply security of health commodities will be ensured under a transitional
domestic financing environment and iii) agreed sourcing arrangements for FLD under GF funding and plans for
FLD procurement during the remainder of the grant life cycle under domestic financing.

Applicant’s response:

The provincial programs do their regular procurements through domestic funding up to 50% of the
provincial needs. There are comprehensive guidelines and laid down procedures for the procurements
called (PPRA) www.ppra.org.pk/Rules.asp The PPRA rules ensures a competitive bidding process
for all procurements including drugs. The provinces follow the PPRS rules and advertise in the news
paper, call tenders, there are 12 committees of senior level academic persons(professors)who evaluate
the technical capability of firms, their production units , and sampling is asked if necessary after
technical evaluation the result is announced and financial bids are invited. The lowest bidder is asked
to submit their performance guarantee and supply medicines with certified test reports.

In the province of Punjab all the procurements made by Provincial TB control program are incurred
as per Public Procurement Rules, 2004 (PEPRA). PTP Punjab Keeps a vigilant track of all the stocks
and demands throughout the province through a well-established supply chain mechanism and stock
reporting on regular basis.

A proper consumption report is submitted by each Health facility for further releases of medicines.
10% reserved stock is frequently replaced. District wise consumption statement is generated and
projections are made for upcoming consumptions depending on the statistical case identification in
each district.

Drug procurements are conducted in a fair and transparent manner; the object of procurement brings
value for money to program. The procurement process is efficient and economical. The allocated
budget for drugs procurement are prioritized as per need of the program/ patients. The Procurement
department at the DOH carry forward the estimated quantity and quality specified and call for bids.
All proposed procurements are realistically determined, within available resources, and also
mentioned the delivery time or completion date in each bid.

TRP Clarifications Form Page 19 of 22

 A technical and financial committee oversees the proves of procurement and finalize the lowest bid
after approvals from Drug Testing Laboratory (DTL) Punjab.
The Drug Testing Laboratories Punjab, is a state of the art laboratory, affiliated with Primary &
Secondary Healthcare Department Punjab and is certified by global inspection, verification, testing
and certification companies.
The approval of the quality of the medicine depends upon efficacy and quality of drugs as per DTL
standards, having a shelf life of more than 2 years. Once procurement is made, it is stored as per stock
management protocols.

The provinces have a drug testing mechanism through provincial drug testing laboratories in each
province which provide the report at the quality of medicines. Each supplier also provides a quality
certificate from the manufacturers. Although none of the manufacturer of the ATT in Pakistan is at
WHO white list but the treatment outcome of the patients put at ATT procured by the provincial
program is comparable with those consuming ATT provided through GDF see link for evidence –a
study conducted in Pakistan
http://dx.plos.org/10.1371/journal.pone.0126099

TRP comments and/or request for further clarifications:

TRP’s comments on the applicant’s response

The TRP is not satisfied with the applicant’s response.

The applicant has focused only on sub-question ii) under #2, explaining in very general terms the procurement
capacity, or how procurement works, at decentralised level. The other questions remain unaddressed, in
particular the potential impact of the provincial finance insecurity on ability to engage in predictable and effective
procurement.

With regard to the study referenced, it shows that locally procured TB drugs produced comparable outcomes in
TB patients vs. TB drugs procured via GLC. However, the TRP’s focus is more on the risks associated with
transitioning to 100% local procurement with local finances, in a situation where finance release is
unpredictable. If only 50% of the drugs coming into provinces come in at unpredictable intervals, at least there is
the GLC steady supply and the buffer stock to hedge that risk. Plans to transition a larger proportion of (finance
and procurement) TB FLDs to provinces require deliberate transition planning and a risk mitigation plan before
a move to 100% local procurement of FLDs can be contemplated The applicant’s response does not give the
TRP confidence that the risks have been thoroughly evaluated.

In addition, the applicant has not verified whether they will in fact (as TRP has requested) continue procuring
through GDF with Global Fund finance for now, while transition and risk mitigation plans are being formed. TRP
rather expected a response explaining that provinces will instead take over budget of xyz while 50% of FLDs will
continue to be Global Fund financed and GDF procured during this grant timeframe.

Additional follow-up actions are requested as indicated under Section 3 below.

Issue 7: Insufficient data on cost/yield ratio of innovative screening and case finding approaches
TRP input and requested actions

Issue: Given the limited resource envelope, difficult decisions are being made in rationing access to GeneXpert to
smear positive patients and coverage of DR-TB treatment. Nonetheless, the current request wishes to invest in
piloting and/or scaling up various costly interventions to screen and find asymptomatic cases.

Action: The TRP recommends that the full costs and yield of various asymptomatic screening and case detection
approaches being piloted and scaled up during this grant period be evaluated, including capital costs, consumables
and human resource expenditures per TB case detected. This should be used as a basis for evidence-based
decision making for prioritization of resource allocation in the subsequent funding request.

TRP Clarifications Form Page 20 of 22

 Applicant’s response:

Mercy Corps has planned to conduct the impact assessment in mid 2019; chest camps and other active
case finding interventions during NFR will be evaluated in the grant period as a basis for evidence
based decision making for prioritization of resource allocation in the subsequent funding request.

Through TIH there is a baseline survey currently on-going in Karachi from the current TIH GF grant.
During the start of year 2020 there is an endline survey being planned by TIH-NFR grant 2018-20
which will provide evidence on the impact of active case finding and mass screening approaches
being carried out by TIH in Karachi.
TRP comments and/or request for further clarifications:

TRP’s comments on the applicant’s response.

The TRP is satisfied with the response and notes that the applicant will be requested to conduct cost-analysis
during grant-implementation as originally recommended by TRP.

Issue 8: Matching Funds - Lack of clarity of service delivery model for MDR-TB in the private sector
TRP input and requested actions

Issue: The TRP notes that the proposed interventions include establishing private sector PMDT sites to support
MDR-TB management across 5 private hospitals. There is limited information around how patients in the private
sector will have access to rapid diagnostics and second line DST, access to new drugs including shorter
regimens and new drugs, treatment and social support and, overall, how standards of MDR-TB care will align
with the public sector/NTP standards for care. It is also unclear how patients in the private sector will be
monitored during the course of treatment and if patients will be required to pay user fees for accessing MDR-TB
treatment in the private sector.

Action: The TRP recommends the applicant to provide a service delivery model for MDR-TB care to be adopted
in the private hospitals addressing the concerns raised above.

Applicant’s response:

The DR TB cases detected by CHS and GSM through its network will be referred to nearest PMDT
sites. The cash incentive and travel support will also be provided through the current mechanism.
Certain sites will continue providing the treatment to DR TB cases with new drugs. Cases identified
with Rifampicin resistance will be referred to Programmatic Management of Drug Resistant TB
(PMDT) sites for culture, Drug Susceptibility Testing (DST) and MDR-TB treatment. Support the
Zero-TB Cities initiative in Karachi and Peshawar by integrating TB treatment services. Structured
patient referral system is being used to refer the patients found RIF+ from the private sector sites to
the nearest PMDT site and is reviewed on regular basis.

TRP comments and/or request for further clarifications:

TRP’s comments on the applicant’s response

The TRP is satisfied with the response, conditional to the assumption that the referred PMDT site providing culture,
DST and MDR-TB treatment services is managed by NTP/DOH. This is indicated as a follow-up action under
Section 3 below.

TRP Clarifications Form Page 21 of 22

 SECTION 3: TRP Approval of Clarifications

TRP approval
The TRP is partially satisfied with the responses provided to the clarifications/adjustments requested by the TRP
and to be cleared by the TRP.

As part of the sign off, the TRP notes the following actions that the TRP requires to be fulfilled:

• Issue 1: The TRP recommends that the applicant conducts a formal situational assessment of public-
private mix activities for TB care in the country, assess their contributions to case notifications and case
holding to set a baseline, and develop an action-plan for 2018-22 that integrates PPM partners and their
models of care. The action plan needs to include a clear PPM M&E framework that links provider (both
individual and institutional) engagement with PPM targets and consequently with the national
notifications/targets. Lastly, the action plan needs to articulate a strategy for sustaining PPM activities
beyond the life-line of the Global Fund’s NFR. This recommendation is to be cleared by the TRP within
9 months of grant-implementation

• Issue 2: The TRP recommends the secretariat to set related coverage targets or work plan tracking
measures as applicable, in consultation with the applicant.
- Percentage of new and relapse TB patients tested using WHO recommended rapid tests at the
time of diagnosis – baseline and estimates by the end of 2020
- Percentage of TB patients with DST result for at least Rifampicin among the total number of
notified (new and retreatment) cases in the same year
- Percentage of confirmed MDR-TB cases tested for susceptibility to any fluoroquinolone and any
second-line injectable drug – baseline and estimates by the end of 2020
- Which proportion of RR-TB PATIENTS tested for SL DST had resistance to FQ?
- Calculation of needs for different DR-TB treatment regimens should be based estimation of SL
DST coverage and on recalculation of the FQ resistance rates as mentioned above.
This recommendation is to be cleared by the Secretariat during grant-making and implementation.

• Issue 6:
1. The TRP recommends that the applicant continues to procure FLDs through the GDF with Global Fund
financing – confirmation from the applicant is required. This recommendation is to be cleared by the
Secretariat during grant making.

2. The TRP requests the applicant to provide a detailed note (5 pages) on i) current provincial health
financing capacities, gaps and proposed plans for how the provinces will ensure predictable release of
finances, ii) procurement capacities such that comparable pricing, quality and supply security of health
commodities will be ensured under a transitional domestic financing environment and iii) agreed sourcing
arrangements for FLD under GF funding and plans for FLD procurement during the remainder of the
grant life cycle under domestic financing. The requested recommendation is to be provided to the TRP
within 9 months of grant implementation.

• Issue 7: As originally recommended per the TRP Recommendation and Review Form, the TRP
recommends that the applicant conducts a cost-analysis during grant implementation. A status report for
course correction should be provided to the TRP.

• Issue 8: The TRP recommends that NTP/DOH manages the referred PMDT site providing culture, DST
and MDR-TB treatment services. This recommendation is to be cleared by the Secretariat during grant-
making.

Approved on behalf of the TRP by the TRP Chair

Jeremiah Chakaya

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