Detailed Mechanism Funding and Narrative

Years of mechanism: 2008 2009

Details for Mechanism ID: 3440
Country/Region: Uganda
Year: 2009
Main Partner: Uganda Virus Research Institute
Main Partner Program: NA
Organizational Type: Host Country Government Agency
Funding Agency: HHS/CDC
Total Funding: $1,050,000

Funding for Testing: HIV Testing and Counseling (HVCT): $400,000

The Uganda Virus Research Institute (UVRI) is a department within the Ugandan Ministry of Health (MOH),

and has been dedicated to conducting research on viral diseases since 1936. In the area of HIV/AIDS,

UVRI conducts research on the isolation and characterization of HIV strains, the epidemiology and

molecular epidemiology of HIV before and after the introduction of ART, comparing modalities of delivering

ART, HIV vaccines and microbicides, and PMTCT. UVRI also assists in the implementation of national sero-

behavioural surveys, and provides the MOH with HIV surveillance data from ante-natal clinic (ANC) and STI

clinics. UVRI is mandated by MOH to perform Quality Assurance/Quality Control (QA/QC) of all HIV

serological testing sites, both public and private. With USG funding assistance, the HIV Reference and

Quality Assurance Laboratory at UVRI has established a national laboratory QA program focused

specifically on HIV-related testing. This activity focuses on ensuring that the lay and the community health

workers in addition to counselors and lab staff that obtain samples for testing are providing quality service to

the client, obtain and provide quality samples following biosafety guidelines. These three cadres of staff

after proper training in rapid HIV testing nationwide will provide high quality results to inform prevention,

care, and treatment of HIV/AIDS.

Of the targeted 93 staff, 78 (Regional Laboratory Coordinator-RLC and District Laboratory Focal Persons

(DLFPs) were trained in QA/QC, because 15 were not available. In-service training in QA/QC was provided

only to 98 staff due to unreliable transport. Five SOPs for laboratory safety, sample processing, rapid HIV

laboratory testing, Elisa HIV testing, rapid syphilis testing and proficiency panel preparations for HIV were

reviewed, updated and distributed. Unfortunately there was no input from other stakeholders. Prepared and

distributed 700 proficiency testing panels to 216 testing sites. Unreliable transport was a limiting factor.135

internal controls were prepared and 15 test runs performed where they have been incorporated. Re-testing

was carried out on 1,435 samples from 34 sites including National Referral Hospitals, Regional Referral

Hospitals, and District Hospitals, Health Center IV, Health Center III and private facilities. Results have

been returned within 6 weeks. Concordance positive rates have ranged from 50% to 100%, while negative

rates have ranged from 82.4% to 100%. PT results at all these sites were 100%. Obtaining quality samples

for re-testing proved difficult. However, 36 discordant tests were resolved and results returned within 6

weeks. Compiled an inventory of 216 sites, held 216 sensitization meetings with the staff at the sites

regarding quality assurance, 700 distributed Proficiency Testing (PT) panels, collected 216 PT results and

provided corrective action when required, provided 17 out 216 support supervision visits in collaboration

with RLCs and DLFPs, distributed 1085 SOPs and other information tools, provided 216 formal reports

disseminating the findings of support supervision to 216 testing sites. The UVRI cold room has been

equipped to handle additional samples. Adherence to SOPs was assessed at these sites and revealed

availability of 77.8%, accessibility of 86.7%; two thirds displayed the SOPs, 79.2% understood them, and

80.6% of the sites followed them. 203 out of 216(94%) testing sites implemented the National Testing

Algorithms. Sites were further assessed for compliance with good clinical laboratory practice, waste

disposal and availability of requirements to conduct HIV testing. There is however a high demand for

counseling and testing as from the unmet need for HCT (UDHS 2006). Strategies include both client and

provider initiated HIV counseling and testing services and Ministry of Health [MOH] intends to scale up HIV

counseling and testing to all Health Center III by year 2010. There is need to further scale up through

training of service providers and ensuring quality control for HIV testing.

In FY 2006, MOH developed an HIV prevention strategy which places special emphasis on HIV testing

especially for the epidemic drivers (fishermen, commercial sex workers, discordant couples, those with

multiple sexual partners, transactional sexual relationships, etc). This calls for increased testing at health

facilities, home and through outreach/mobile clinics. UVRI shall ensure quality HIV testing is offered to

individuals through training, support supervision and continuous assessment of laboratories for QA/QC in all

laboratories testing for HIV, TB, STI and Malaria. It has been estimated that 1/3 of clients that seek HIV

testing are dually infected with TB. Thus all HIV testing sites are encouraged to offer TB diagnostics

especially to those clients with productive coughs. Through these means we shall support the TB, and

malaria strategic plans. The GFATM round three, phase one, targeted to test 2,200,000 people by the end

of June 2008, and, an additional 58,000 started on ART. Extra effort is required in counseling and testing to

achieve this target and more but ensuring high quality of the results. To achieve this, there is need to task

shift by training lay and community health workers in quality HIV testing throughout the country. By

maintaining and developing strong linkages with key service providers and trainers, UVRI shall support

integrated training especially in the diagnostics of HIV, malaria, syphilis and tuberculosis thus maximizing

benefits out of the available resources. The training provided to this cadre of personnel will ensure provision

of high quality support supervision.

UVRI shall maintain and develop new partnerships with PEPFAR funded partners e.g. CPHL/MOH,

AMREF, NUMAT, MJAP, JCRC, NMS, MUWRP, RHSP, RTI and other stakeholders in laboratory services

and CT to ensure sustainability of internal and external quality assurance at regional and district levels

using Regional Laboratory Coordinators (RLCs) and DFLPs as change agents. In collaboration with these

stakeholders and others especially Ministry of Health Quality Assurance Unit and Community Service

Organizations, UVRI shall identify suitable candidates for training in QA/QC. During support supervision

visits to the testing sites in collaboration with CPHL/MOH, Malaria Control Program, National Leprosy and

Tuberculosis Program and other stakeholders, UVRI shall identify needs in infrastructure, staffing,

laboratory management, commodity availability, storage capacity, recording keeping, availability and

implementation of SOPs, M&E tools and customer service satisfaction. UVRI will provide QC/QA of HIV

serology to TB sites that offer HIV testing. Supply chain management of HIV commodities, will be

addressed to avoid duplication. UVRI will draw up a consumption plan of HCT commodities and work with

NMS to ensure their availability. Buffer stock will be budgeted for to avoid any disruption of services. Due to

the scarcity of trained laboratory staff and the need to get millions of people counseled and HIV tested,

MOH has decided to provide quality training to non-laboratory staff including PHAs to conduct HIV rapid

testing. Despite this approach only 12% of the entire population knows their HIV status. UVRI in

collaboration with CPHL will continue to train lay and community health workers in quality HIV testing

through support supervision to ensure they provide quality results. In collaboration with RLCs and DLFPs,

UVRI shall develop a strategy to achieve this and shall emphasize during training the need for these groups

providing complementary services to coordinate their activities. The UVRI clinic shall continue providing

apprenticeship to both counselors and laboratory trainees. Training sessions for personnel at CT sites will

Activity Narrative: emphasize the need for QA/QC in whatever service they render. The SOP for counseling and testing will be

integrated for the benefit of the counselors, phlebotomists, and laboratory staff. UVRI shall prepare and

distribute Dried Tube Serum (DTS) to all testing sites for proficiency testing and obtain the results later by

means yet to be agreed upon. QA/QC testing will be conducted on samples obtained from CT and PMTCT

sites. Samples yielding discordant results in the field retested at UVRI and the results returned within six

weeks. These outcomes will be used to measure the effect of pre-analytical and analytical QA/QC training

on the quality of results provided to clients. Medical waste generated at UVRI will be disposed of using

disinfectants, incineration and sharps containers as appropriate. Hospitals will be requested to support other

testing centers in their area of jurisdiction for incineration of medical waste. These issues will be

emphasized during training and support supervisory visits. The funding in this programme area will increase

gender equity by ensuring that both male and female staff are equally represented in the various activities,

and courses promote females who are currently fewer in the counseling and testing profession in the

country.

New/Continuing Activity: Continuing Activity

Continuing Activity: 13322

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

13322 12494.08 HHS/Centers for Uganda Virus 6443 3440.08 Laboratory $400,000

Disease Control & Research Institute Quality

Prevention Assurance-

Cooperative

Agreement

12494 12494.07 HHS/Centers for Uganda Virus 4816 3440.07 Laboratory $350,000

Disease Control & Research Institute Quality

Prevention Assurance-

Cooperative

Agreement

Emphasis Areas

Gender

* Increasing gender equity in HIV/AIDS programs

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $130,000

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.14:

Funding for Laboratory Infrastructure (HLAB): $550,000

UVRI is a department within Ministry of Health (MOH), & has been dedicated to conducting research on

viral diseases since 1936. It conducts research on the isolation & characterization of HIV strains, & on the

epidemiology & molecular epidemiology of HIV before & after the introduction of ART; evaluates HIV

vaccines & microbicides; & compares modalities of delivering ART & PMTCT programs. UVRI also helps

implement national sero-behavioural surveys, & provides the MOH with HIV surveillance data from ANC &

STI clinics. UVRI is mandated by MOH to provide QA to all public & private HIV serological testing sites.

With USG funding, the HIV Reference & QA Lab at UVRI has established a national lab QA program for HIV

serologic testing. This activity focuses on ensuring that the lay, community health workers, counselors & lab

staff that obtain samples for testing are providing quality services, obtain & provide quality samples

following biosafety guidelines.

The UVRI cold room has been equipped; 78 of 93 staff (RLC & DLFPs) were trained in QA/QC because 15

were not available. 5 SOPs for lab safety, sample processing, rapid HIV lab testing, Elisa HIV testing, rapid

syphilis testing & PT panel preparations for HIV were reviewed, updated & distributed. 700 PT panels were

prepared & distributed to 216 USG & non USG supported testing sites. 135 internal controls were prepared

& 15 test runs performed where they have been incorporated. Re-testing was carried out on 1,435 samples

from 34 sites ranging from national, regional, district hospitals to HC IVs & III & private facilities; results

were returned in 6 weeks. We compiled an HIV testing inventory, distributed PT panels, collected PT

results & provided corrective action, provided support supervision with RLCs & DLFPs, distributed other

information tools, provided formal dissemination on support supervision to 216 testing sites. Sites were

further assessed for compliance with GCLP, waste disposal & availability of requirements to conduct HIV

testing. Strategies to increase HCT include both client & provider initiated HIV CT & MOH plans to scale up

HIV CT to all HC IIIs by 2010. There is need to further scale up training of service providers & ensuring

quality control for HIV testing.

While the existing M&E plan will guide implementation of activities, partnerships will be established with

government structures at district level through the health facility hierarchy including NGOs & uniformed

services. This will entail combined training of both lab & non lab including lay & community health workers,

support supervision visits, provision of DTS as PT panels & continuous assessment of labs for QA/QC

services in labs testing for HIV, TB, STI & malaria, thus supporting the TB & malaria National Strategic

Plans. MOH in collaboration with UAC has launched new preventive strategies to drive the HIV prevalence

below 6.4% & prevent an increase in new infections. There is now an urgent need to have high-quality HIV

serological testing in all labs across the country, including UNHCR sites, funded by WHO. Working with

MOH, particularly the QA Unit, the training coordination unit at CPHL & lab supervisors, we shall continue to

identify labs currently conducting HIV serological testing & the tests/algorithms used, at HCT, ANC &

PMTCT programs, in the private & public sector. Based on the inventory of HIV-testing labs, we shall

develop a QA plan that takes advantage of supervisory visits conducted by CPHL, NTLP, QA Unit of MOH,

Area Supervision Teams & other stakeholders to distribute DTS PT panels, & to meet reporting

requirements. Labs failing to meet QA criteria will be visited & remedial action taken. Testing algorithms for

use in the field & for QC at UVRI will be continuously monitored & new algorithms evaluated. With the

expanded LIMS & linked to databases at CPHL & MOH sharing of information, logistics management &

training needs will be easily coordinated, in line with the Uganda National Quality System Guidelines.

Activities include the preparation & distribution of PT panels, resolving discordant results & evaluation of

new HIV testing kits & algorithms. We shall work with the MOES to include quality assurance of HIV testing

in the curriculum of lab training institutions. Apprenticeships will be provided to both counselors & lab

trainees at the UVRI clinic. We shall work with the DFLPs to ensure that their activities are incorporated in

the annual district plan. Medical waste at UVRI will be disposed of using disinfectants, incineration & sharps

containers as appropriate. In collaboration with MOH & CPHL sites will be requested to support other

testing centers in their area of jurisdiction for incineration of medical waste. These issues will be

emphasized during training & support supervisory visits. UVRI shall work with MOH & HSC to recruit project

staff into Public Service thus allowing long term sustainability of QA/QC for the country; other efforts include

training provided to RLCs & DLFPs, supervisory visits, training in preparation & characterization of DTS PT

panels, their distribution & interpretation of the results. We shall coordinate activities with CPHL for training

in rapid HIV testing, EID & support supervision; & with NMS to ensure the availability of supplies. Regular

communication will be provided to labs in Uganda to highlight the role of the National HIV QA Lab, share

lessons learned, identify problems/issues for which assistance is required, & allow for dialogue about recent

news & innovations in HIV lab services. Working together with national regulatory authorities especially

NDA, we shall expedite the approval of new HIV rapid tests, including saliva-based tests. We shall procure

new HIV serologic assays & related instruments, evaluate their performance, & disseminate the findings.

This funding will increase gender equity by ensuring that both male & female lab staff are equally

represented in the various activities, & courses promote females who are currently fewer in the lab

profession in the country.

The development of HIV drug-resistance (HIVDR) is recognized as a serious threat to the efficacy of current

ART, & will compromise PEPFAR efforts to provide long-term treatment in sub-Saharan countries. Drug

resistance (DR) is likely to have a greater influence on the long term success of ART programs than any

other single factor. Emergence of resistance to one or more ARV drugs is a reason for therapeutic failure in

the treatment of HIV. In addition, resistance to one ARV drug sometimes confers a reduction in or a loss of

susceptibility to other or all drugs of the same class. Patients with HIVDR must switch treatment regimens,

reducing treatment options & significantly raising medication costs. Resistance is usually the result of sub-

optimal regimens, or inconsistent use resulting from poor adherence &/or interrupted drug supply. The

optimum time for minimizing the emergence & transmission of resistance is when treatment initiatives are

still in the early stages & first-line regimens are widely used. Prevention, surveillance & monitoring of drug

resistance are critical to the success of clinical & public health HIV/AIDS programs. WHO has developed

standardized strategies, protocols, & guidelines for the prevention of HIVDR in resource-limited settings that

are designed to be implemented alongside treatment programs. As part of this strategy, many African

countries including Uganda have set up National HIVDR prevention, surveillance & monitoring programs in

collaboration with WHO-AFRO. The major principles of containment of HIVDR include: appropriate ARV

drug access, proper prescribing & usage, drug adherence, reduction of HIV transmission, & appropriate

programmatic response based on the results of monitoring & surveillance. The WHO plan also includes

periodic evaluations of early warning indicators (EWI) which have been shown to correlate with early

emergence of DR. EWIs include poor drug supply continuity, inappropriate prescribing practices, & poor

adherence among clients among others. A consensus workshop on the prevention of DR was held in

Activity Narrative: Kampala in January 2007. A National HIVDR Monitoring Plan, developed with support from WHO, has been

endorsed by MOH & UAC. Under the plan, UVRI, working closely with the MOH-ACP & other partners, was

mandated to coordinate these activities, which include: 1) creation of a National HIVDR Data Center in

collaboration with MOH Resource Center; 2) establishing a National Drug Resistance Reference Lab 3)

program management, data coordination, & administration; 4) establishing a National HIVDR Working

Group (HIVDR WG) within the MOH & as part of the National ART Committee. The plan addresses key

areas within the National Strategic Plan for HIV/AIDS, 2007/8-2011/12, & is relevant to PEPFAR goals. The

national HIVDR WG is comprised of MOH, CDC, MRC, WHO, UVRI & PEPFAR-supported treatment

partners including JCRC, IDI, CRS, TASO & MJAP. With funding from WHO, the HIVDR WG conducted a

pilot survey in 2007 to collect EWI at 41 treatment sites. The sites were selected from different geographical

regions, represented different levels & modes of ART service delivery, & were supported by a range of

funders. The indicators evaluated included prescribing practices, proportion of patients lost to follow-up,

number of patients on first line ART, appointment keeping, adherence, & drug supply continuity. The results

of this pilot were presented at the Uganda National AIDS Conference the WHO-AFRO HIV DR meeting in

Namibia, & to various key partners, including the PEPFAR country team. UVRI, through support from WHO

& MRC, conducted a study in Entebbe to determine whether resistant viruses were transmitted to recently

infected individuals. No resistant viruses were identified. These results were published & presented at

various meetings including UAC & the International AIDS Society meeting in Sydney, 2008. The HIVDR WG

recommended that this activity be repeated in 2008. Plans exist for these threshold surveys to be conducted

among teenage pregnant females in Kampala & funding is being sought from PharmAccess. With funding

from MRC & GFATM, UVRI established the National HIV Drug Resistance Reference Lab which was

accredited by WHO. This is one of few accredited labs in Africa, & plans are underway to make it a regional

reference lab. With support from WHO, MRC, & the European Developing Countries Partnership (EDCTP),

the facilities & equipment have been upgraded, including the purchase of an additional Beckman Coulter

capillary sequencer & DNA/RNA extractor, & an ABI sequencer. The UVRI lab has provided training in drug

resistance testing for other technicians & scientists, including one from Zambia, & has also provided testing

of samples from other sub-Saharan African countries.

The DR WG continues to make efforts to secure funding from other sources to support HIVDR lab services,

& for expansion of EWI & acquired resistance surveys. One of the major challenges to implementation of

the national plan has been the absence of a dedicated HIVDR secretariat or center that can develop,

implement, & coordinate efforts, & a lack of adequate funding to perform EWI surveys & DR monitoring.

This funding will support dedicated staff & provide resources to coordinate national activities & enable drug

resistance prevention & monitoring. The proposed activities include: coordinating HIVDR prevention,

monitoring & surveillance at both national & institutional levels, supporting the national HIVDR Working

Group, monitoring emerging & transmitted HIVDR, & supporting the National HIVDR Reference Lab & other

labs to perform HIVDR testing, surveillance & monitoring. A Coordinating Center for HIVDR Prevention,

Monitoring & Surveillance shall be established at UVRI in close collaboration with the MOH-ACP. The terms

of reference of the HIVDR WG include: 1)to coordinate & implement of the National HIV Drug Resistance

(HIVDR) Prevention, Surveillance & Monitoring Plan; 2) to collect & analyze HIVDR EWIs; 3) to develop &

coordinate implementation of the country protocol for monitoring HIVDR in representative sentinel ART

sites; 4) to regularly perform HIVDR threshold surveys to evaluate transmitted resistance in specific

geographic areas; 5) to continue building capacity for genotyping & other activities to support HIV DR

surveillance & monitoring within the country; 6) to provide to other countries an example of implementation

of a national HIVDR strategy, including elements recommended by WHO; 7) to develop & collect

information on activities & programs which will contribute to minimizing HIVDR; 8) to collect & disseminate

information on, & help coordinate all HIVDR public health & research activities in the country; 9) to ensure

all activities follow country & international ethical standards designed to promote the well-being & health of

individuals & communities; 10) to prepare & disseminate annual HIVDR reports & recommendations. An

important component of the WHO & National Plan is the sentinel monitoring of HIVDR emerging during

treatment, & the relationship of resistance to ART program factors. We plan to follow WHO protocol

guidelines by evaluating adult cohorts from time of initiation of ART up to 12 months later, or at viral failure

or switch to a second line regimen. An assessment of routinely collected adherence measures will be made.

In FY2009, we will perform monitoring at 3-5 pilot sites, with possible expansion in subsequent years

subject to availability of funds. According to WHO protocols, 100 individuals newly initiating ART at each

site will be followed. Site selection will be made by the HIVDR working group based on geographic region,

type or level of clinical service, & funder (PEPFAR, GFATM, MOH, other). A protocol will be developed

following WHO guidelines, & reviewed by relevant IRB's. DR survey results will be used to develop

recommendations for improvement of outcomes & program planning, to help inform recommendations for

optimal first & second line regimens, & develop criteria for drug switching. This funding will support the

National HIVDR reference lab through continued participation in testing proficiency panels, QA/QC,

provision of supplies, training of lab staff & preparation for accreditation in genotypic testing using DBS. The

lab will develop SOPs for training, specimen collection, handling, shipment & storage; ensure observance of

GCLP, & assist in accreditation of other labs. The lab team will create a National Data base for resistance

marker sequencing, by working with WHO HIVResnet. Initially, viral loads will be determined in the labs of

the different partners at UVRI with the aim of establishing viral load measurements within the National

HIVDR Reference Lab.

New/Continuing Activity: Continuing Activity

Continuing Activity: 13323

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

13323 4709.08 HHS/Centers for Uganda Virus 6443 3440.08 Laboratory $325,000

Disease Control & Research Institute Quality

Prevention Assurance-

Cooperative

Agreement

8367 4709.07 HHS/Centers for Uganda Virus 4816 3440.07 Laboratory $325,000

Disease Control & Research Institute Quality

Prevention Assurance-

Cooperative

Agreement

4709 4709.06 HHS/Centers for Uganda Virus 3440 3440.06 Laboratory $170,000

Disease Control & Research Institute Quality

Prevention Assurance-

Cooperative

Agreement

Emphasis Areas

Gender

* Increasing gender equity in HIV/AIDS programs

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development $210,743

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.16:

Funding for Strategic Information (HVSI): $100,000

The Uganda Virus Research Institute (UVRI) is a department within the Ugandan Ministry of Health (MOH),

and has been dedicated to conducting research on viral diseases since 1936. In the area of HIV/AIDS,

UVRI conducts research on the isolation and characterization of HIV strains, the epidemiology and

molecular epidemiology of HIV before and after the introduction of ART, comparing modalities of delivering

ART, HIV vaccines and microbicides, and PMTCT. UVRI also assists in the implementation of national sero-

behavioural surveys, and provides the MOH with HIV surveillance data from ante-natal clinic (ANC) and STI

clinics. UVRI is mandated by MOH to perform Quality Assurance/Quality Control (QA/QC) of all HIV

serological testing sites, both public and private. With USG funding assistance, the HIV Reference and

Quality Assurance Laboratory at UVRI has established a national laboratory QA program focused

specifically on HIV-related testing.

The development of HIV drug-resistance (HIVDR) has been recognized as a serious threat to the efficacy of

current antiretroviral therapy (ART), and will compromise the efforts of PEPFAR to provide long term

treatment, not only in Uganda but also in other sub-Saharan countries. Drug resistance is likely to have a

greater influence on the long term success of ART programs than any other single factor. The emergence of

resistance to one or more antiretroviral drugs is one of the more common reasons for therapeutic failure in

the treatment of HIV. In addition, the emergence of resistance to one antiretroviral drug sometimes confers

a reduction in or a loss of susceptibility to other or all drugs of the same class. Patients with drug resistance

must switch treatment regimens, reducing treatment options and significantly raising medication costs,

assuming appropriate 2nd line drugs are available at all. Resistance is most often the result of sub-optimal

regimens, or inconsistent use due to poor adherence and/or interrupted drug supply. The optimum time for

minimizing the emergence and transmission of resistance is when treatment initiatives are still in the early

stages and first-line regimens are widely used (WHO,2003). Therefore, prevention, surveillance and

monitoring of drug resistance are critical to the success of clinical and public health HIV/AIDS programs.

WHO has developed a standardized strategy and protocols for the prevention of HIVDR in resource limited

settings, designed to be implemented alongside treatment programs. As part of this strategy and in

accordance with WHO guidelines, many African countries including Uganda have set up National HIVDR

prevention, surveillance and monitoring programs in collaboration with WHO-AFRO. The major principles of

containment of HIVDR include: appropriate ARV drug access, proper prescribing and usage, drug

adherence, reduction of HIV transmission, and appropriate programmatic response based on the results of

monitoring and surveillance. The WHO and Uganda HIV DR Monitoring Plan includes periodic evaluations

of early warning indicators (EWI) which have been shown to correlate with early emergence of drug

resistance. EWI include poor drug supply continuity, inappropriate prescribing practices, poor adherence

among clients, among others.

Prevention of ART resistance is most important in countries such as Uganda where first and second line

treatment options are limited. A consensus workshop on prevention of DR was held in Kampala in January

2007. A National HIVDR Monitoring Plan was developed with support from WHO, and has been endorsed

by the MOH and Uganda AIDS Commission. Under the plan, the Uganda Virus Research Institute (UVRI),

working closely with the MOH-ACP and other partners, was identified to coordinate these activities

including: 1) the creation of a National HIV drug resistance Data Center in collaboration with the MOH

Resource Center; 2) the establishment of a national drug resistance reference laboratory; 3) the

coordination of all activities (program management, data coordination, and administration); 4) the

establishment of a National HIVDR working group (HIVDR WG) within the MOH and as part of the National

ART Committee. The plan addresses key areas of care and treatment within the National Strategic Plan for

HIV/AIDS, 2007/8-2011/12, and is relevant to PEPFAR goals. The national HIVDR WG is comprised of

individuals with different expertise and from different organizations including the MOH, CDC, Medical

Research Council, WHO, UVRI and PEPFAR-supported treatment partners including JCRC, IDI, Catholic

Relief Services, TASO and MJAP. With some funding from WHO, the HIVDR WG conducted a pilot survey

in 2007 at 41 treatment sites to collect EWI. The sites were selected from different geographical regions,

represented different levels and modes of ART service delivery, and were supported by a range of funders.

The indicators included prescribing practices, percentage of patients lost to follow up, patients on first line

ART, appointment keeping, adherence, and drug supply continuity. The preliminary findings of this study

indicated that 71% of sites started all patients on appropriate first line drugs, 85% of sites had less than

20% loss to follow up during the first year, and 71% retained more than 70% clients on first line ART during

the first year. Most worrying, however, was the observation that only 19 sites reported no drug stock outs in

any quarter in the previous year. The results of this pilot were presented at the Uganda AIDS Conference

(UAC), the WHO-AFRO HIV DR meeting in Namibia, to various key partners, and to the PEPFAR country

team. UVRI, through support from WHO and MRC, conducted a study in Entebbe to determine whether

resistant viruses were transmitted to recently infected individuals. No resistant viruses were identified.

These results were recently published (Ndembi et al. AIDS Research & Human Retroviruses 2008; 24

(6):889-895), and presented at various meetings including the national UAC meeting and the International

AIDS Society meeting in Sydney, 2008. The HIVDR WG recommended that this activity be repeated in

2008. Plans exist for these threshold surveys to be conducted among teenage pregnant women in

Kampala. Funding for this activity is being sought from PharmAccess. With funding from MRC and the

Global Fund, UVRI established the National HIV drug resistance reference laboratory and was accredited

by WHO; this is one of few laboratories in Africa that are accredited. The UVRI laboratory has provided

training in drug resistance testing for other technicians and scientists, including one from Zambia, and has

also provided testing for samples from other sub-Saharan African countries. The DR WG is making efforts

to secure additional funding from other sources to implement the National plan.

In FY 2009, The USG country team will support the implementation and evaluation of Early Warning

Indicators, as part of the National HIVDR prevention activities and as part of the HIV DR working group

activities. An assessment of EWI will support ART program practices and country planning to minimize the

unnecessary emergence of HIV drug resistance. This evaluation will help determine the degree to which

ART programs are functioning to minimize emergence of HIVDR emergence.

This activity will include the following:

•develop a list of EWIs that can be/should be regularly collected at all sites

•determine methods of data abstraction of EWI from different current systems

•identify sites for collecting EWI

Activity Narrative: •strengthen the ART information management systems by integrating EWI into routine ART monitoring and

reporting

•monitor whether ART programs are functioning to optimize prevention of HIV drug resistance

•identify and implement mechanisms to provide support supervision to improve EWI and ART delivery

The HIVDR WG will work with USG partners and the MOH to determine which of the listed EWI can be

captured from current ART medical records systems or ART cards. WHO recommends that countries collect

EWI that are readily available and that are most useful for program assessment. Countries need not collect

all indicators. The following are the primary indicators suggested for use in Uganda:

1) Prescribing Practices: the proportion of individuals starting ART during a selected quarter who are

prescribed a standard regimen, or a regimen considered appropriate according to national guidelines and

the HIV DR WG. The recommended target is 100%.

2) Percentage of patients Lost to Follow-up: the proportion of ART clients lost to follow up during the first 12

months following initiation of ART, not including those who are dead, transferred out or stopped ART. The

recommended target is <20%

3) Patient retention on first-line ART: the proportion of clients initiating first-line ART who are still on first-

line ART after 12 months. The recommended target is >70%

4) ART appointment-keeping: the proportion of clients who attended all scheduled appointments during a

year, excluding those who are lost to follow-up, dead, transferred out, or stopped ART. The recommended

target is 80%

5) Drug supply continuity: the number of quarters in the last year in which there were ARV drug stock-outs

for any of the standard ART regimens supplied by the site. The target is zero.

Although WHO recommends collecting information on pill count/adherence, this indicator could not be

assessed during the pilot study due to weaknesses in routine ART adherence assessment at most sites. In

addition, the suggested use of adherence for each individual drug was rarely collected, and will be left out

of future EWI evaluations. The recommended indicator for "On-time Drug Pick up", meaning the proportion

of persons who pick up all prescribed drugs within 3 scheduled days, could not be assessed because some

clinics provide more drugs to cover for delayed pick-up times. Therefore, this indicator will also be excluded.

.

The country team, particularly the SI working group, will work with partners, the MOH, and the HIV DR WG

to develop systems for routine integration of these EWI into data collection systems, and for partners and

other clinical sites to have the capacity to extract and evaluate this information routinely. This will also

require coordination not only with partners, but also with the SI TWG, the HIV DR WG and the MOH

Resource Center that supports the national HMIS system. We will perform training in the collection,

extraction, and programmatic utilization of EWIs. Specific evaluation of EWIs will be expanded to 80 sites in

FY2009, covering all regions, in order to strengthen the ART information management systems, to ensure

that EWI are integrated into routine ART reporting systems and to monitor whether ART programs are

functioning to optimize prevention of HIV drug resistance. Through training and consultations, we will

provide support supervision to improve on the indicators for better ART delivery.

New/Continuing Activity: New Activity

Continuing Activity:

Emphasis Areas

Gender

* Increasing gender equity in HIV/AIDS programs

Human Capacity Development

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.17:

Cross Cutting Budget Categories and Known Amounts Total: $340,743
Human Resources for Health $130,000
Human Resources for Health $210,743