NOTE: Although GHESKIO has not provided an activity narrative in PMTCT in previous COPs, this is not a

new activity for them, but rather a further refinement of Haiti's COP to more accurately reflect the activities

of our partners.

Integrated Activity: This activity links to Activity IDs 18948.08, 15465.08, 4601.08, 4341.08 and 9672.08.

SUMMARY: GHESKIO will provide field support to 11 public and private sites for the provision of a full

package of PMTCT services to both mother and infant These PMTCT activities will be conducted within the

"four pillars" model for implementing a comprehensive HIV program in the context of primary care: 1) HIV

prevention and care, including voluntary counseling and testing (VCT); 2) detection and treatment of

tuberculosis (TB) and other opportunistic infections; 3) detection and treatment of sexually transmitted

infections (STIs); and 4) women's health and prevention of mother-to-child transmission (PMTCT) of HIV

services. The primary emphasis areas for these PMTCT activities are human resources, and training. The

primary target populations for PMTCT activities are pregnant women, HIV positive pregnant women, and

HIV/AIDS-affected infants. Activities will be carried out at 9 sites in the Port-au-Prince metropolitan area,

which is the first for population density, Hôpital de Fermathe, Centre Bernard Mews, Hôpital de la

Communauté Haïtienne, IMIS, GHESKIO (Blvd Harry Truman, Centre Eliazar Germain, , Centre Fame

Pereo, Hôpital Adventiste de Diquini and Hôpital Ste Catherine Labouré (Cité Soleil). Field support will be

provided in addition at the island of La Gonave and the North-Western city of Bombardopolis through two

hospitals: Hôpital Wesleyen de la Gonâve and the Hôpital Évangélique de Bombardopolis. The primary

targets of this intervention are the 25,000 pregnant women, which on average attend services at these

facilities.

BACKGROUND: GHESKIO is one of the first and oldest institutions that worked in HIV/AIDS prevention,

care and treatment. Three years ago, the institution used mobile teams that helped implement PMTCT,

Palliative Care and Treatment services at the main public hospitals, located at the main cities of the health

departments. The program will address the structural barriers which hamper retention of women, and more

specifically put in place mechanism to: (i) motivate pregnant women to make follow up visits after their initial

visits, as in Haiti large proportion of pregnant women tend to drop out of follow up after their first ANC visit

(ii) create an environment conducive to the adoption by pregnant women of buddy companions

(accompagnateurs) to supervise the uptake of drugs at home, in the same way that has been used for the

ARV treatment program (iii) create more linkages with communities by allowing PMTCT sites to recruit more

community health agents or work closer with TBAs in order to monitor and track pregnant women. Health

agents will be helped with the World Concern/AERDO staff that will be deployed at community level for the

provision of Palliative Care staff at the western department, (iv) encourage women to deliver at the health

facilities not only by subsidizing delivery costs but also by offering incentives to TBAs, and (v) motivate

partners of positive pregnant women and provide them with CT and care.

ACTIVITIES AND EXPECTED RESULTS:

Activity 1. Field support to 11 VCT/PMTCT sites that will enable them to provide a full package of services

including: (i) Opt-out Counseling and testing to all pregnant women (ii) STI management using a syndromic

approach iii) Prophylaxis of opportunistic infections (OIs) (iv) Reproductive health services, including safe

obstetric practices and family planning counseling for HIV positive individuals and the promotion of

condoms; (v) Psychosocial support through individual and family counseling, mainly by social workers and

community health workers and through the setting up of support groups (vi) Case management of HIV

positive pregnant women including clinical and biological monitoring (vii) short-course ARV regimen for HIV-

positive women according to national guidelines (viii) education on best infant feeding practices.

Activity 2. The funding will support: (i) hiring of more qualified staff, (ii) hiring of dedicated social workers

and community health agents for PMTCT, (iii) acquisition of educational materials and support equipment to

facilitate educational activities (iv) support to some operational costs incurred by facilities

Activity 3: The creation of a retention package, which includes: (i) subsidies for the cost of follow-up visits

and hospital delivery (ii) maintenance of women support groups (iii) incentives to TBAs

Activity 4: Implementation of an integrated PMTCT (+) package model. This activity implies the

implementation of an integrated family-centered PMTCT (+) approach that will offer HIV/AIDS partner

referral services, couple counseling and referrals to IMIS and GHESKIO health centers for the provision of

pediatric care to chidren born from HIV+ mothers.

Targets: - September 2009:

- Number of service outlets providing the minimum package of PMTCT services according to Haitian and/or

international standards: 11

- Number of pregnant women who received HIV counseling and testing for PMTCT and

received their test results: 20,000

- Number of pregnant women provided with a complete course of antiretroviral

prophylaxis in a PMTCT setting: 490- Number of health workers trained in the provision of PMTCT services

according to

national and international standards: 33

NOTE: Although GHESKIO has not provided an activity narrative for Palliative Care: Basic Health Care and

Support in previous years' COPs, they have been providing such care routinely. Thus, this activity narrative

does not reflect a new activity, but rather further refinement of the Haiti PEPFAR program management.

Integrated Activity: This activity links to Activity IDs 17920.08, 15465.08, 4601.08, 4341.08 and 9672.08.

Summary: Activities are carried out to support the effort of sites enrolling patients to be placed on highly

active antiretroviral therapy (HAART). The primary emphases of these activities include training, human

resources and (doing what to the infrastructure? Strengthening it, perhaps?)infrastructure. Specific target

populations include adults and children infected with HIV and not yet placed on anti-retroviral therapy

(ART.) The activities will be carried out in the Ministry of Health /GHESKIO/ President's Emergency Plan for

AIDS Relief (PEPFAR)'s network of 14 sites and will be linked with counseling and testing (CT), preventing

mother to child transmission (PMTCT), tuberculosis (TB)/HIV, anti-retroviral (ARV) services, and human

capacity building that is being also supported through this network

BACKGROUND:

GHESKIO is one of the two lead non-governmental organizations (NGOs)—the other one is Partners in

Health (PIH)—that have launched an integrated model of HIV services in Haiti. With PEPFAR, the United

States Government (USG) decided to build on its success to expand HIV services throughout the country.

Through GHESKIO, 12 sites, including four major departmental hospitals, have been reinforced to offer

integrated CT, PMTCT, TB/HIV, ARV as well as palliative care services. provided in conjunction with the

Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM). GHESKIO has ensured that all HIV positive

patients detected through its CT network gain access to clinical, biological, nutritional, and psycho-social

assessments and services, as well as long term follow up to determine the optimal time for HAART. So far,

44,600 patients have been enrolled in palliative through the GHESKIO network. These activities are

essential to keeping active the cohort of HIV infected adults and children. Service providers will encourage

patients diagnosed with HIV to continue to attend regular clinic visits and maintain their link with the

community.

With Fiscal Year 2008 resources, GHESKIO will expand its network to 16 institutions and will continue to

strengthen palliative care services to reach about 10,000 additional patients with particular emphasis on

expanding nutrition services and building the capacity of nurses to play a greater role in the provision of

services.

ACTIVITES AND EXPECTED RESULTS:

GHESKIO will carry out four separate activities in this Program Area:

ACTIVITY 1: In integration with GFATM resources, GHESKIO will use PEPFAR funding to provide the non-

ART package of services including, diagnostic, treatment and prevention of opportunistic infections,

diagnostic and treatment of sexually transmitted infections, care of ART related illness (i.e., diabetes,

arterial hypertension), nutrition assessment and recuperation (if needed), psycho-social assessment and

support. All of the network's facilities will offer this package of care. Funding will support enhancement of

infrastructure, procurement of necessary drugs, diagnostic materials, hospital staff training in providing

specific care, and hospital supervisory staff training to ensure a minimum standard of quality of services.

ACTIVITY 2: Encourage building of support groups at each site and regrouping patients on ART and those

enrolled in palliative care. Meetings between these groups' members will serve as a forum for sharing

experiences and encouraging interactive communication between care providers and patients. Meetings will

be held once to twice a month depending on the number of patients enrolled at each site, Funding will be

used to provide patients with transportation fees, (I am not sure to whom these services are to be provided)

refreshing, collation, and education materials.

ACTIVITY 3: GHESKIO will increase the number of community health workers to accommodate scale-up at

each of its palliative care sites. The community workers will be in charge of tracking patients (including

pregnant women enrolled in PMTCT and infected and exposed children), provide at home adherence

support, health education on best health and nutrition practices, counseling for positive behavior,

distribution of care, and preventive commodities such as condom, ORS, symptom and pain medications

according to the guidelines. Resources will be used to pay their (whose? Patients or community health

workers?)transportation fees.

ACTIVITY 4: Strengthening interventions to maintain patient's adherence to ART treatment. Funding will

help sites provide patients fees for transportation, phone cards, and educational materials. Patients will be

referred to community based organizations to gain access to a broader package of social support services

such as school fees for children, nutrition support, etc.

EMPHASIS AREAS:

Development of Network/Linkages/Referral Systems

Community Mobilization/Participation

Training

TARGETS:

1.16 of GHESKIO's sites will offer palliative service care to PLWA.

2.57,000 new patients will be enrolled in palliative care

3.Number of individuals trained: 100.

TARGET POPULATIONS:

Persons living with AIDS

INTEGRATED ACTIVITY FLAG:

The activity described below relates to the provision of antiretroviral (ARV) treatment services and technical

assistance (TA) to the national laboratory's quality assurance/quality control (QA/QC) program in monitoring

and evaluating performance of healthcare providers. This activity is linked to other program areas funded by

the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM). This activity links to Activity IDs

17920.08, 8948.08, 15465.08, 4601.08 and 4341.08.

SUMMARY:

With Fiscal Year (FY) 2008 resources, GHESKIO will continue to integrate TB screening, prophylaxis, and

treatment in its network of HIV clinics and pursue the development of Sigueneau Hospital, a stand alone TB

center, to become a national center of excellence for TB/HIV. As a center of excellence, Sigueneau will

have the capacity to offer antiretroviral therapy (ART), provide care to patients with multidrug-resistant

tuberculosis (MDRTB), and train personnel to manage and care for patients co-infected with tuberculosis

and HIV, requiring ART. Siguenau Hospital will be the second site in Haiti capable of offering care to

patients with MDRTB. These activities will focus on community mobilization and participation, development

of network and referral centers, human resources, logistics, needs assessment, policy and guidelines,

supervision for quality assurance/quality control/quality improvement (QA/QC/QI), and training. The

program will target TB clients attending Siguenau Hospital and other patients with TB/HIV requiring highly

active antiretroviral treatment (HAART) and hospitalization. In addition, health professionals from different

TB and HIV networks will access TB/HIV training through Siguenau Hospital. The program will also

integrate these with other HIV related activities [antiretroviral treatment (ART), palliative care, counseling

and testing (CT), and prevention of Mother-to-Child Transmission (PMTCT)] supported by the President's

Emergency Plan for AIDS Relief (PEPFAR) and GFATM through GHESKIO and other key lead HIV and TB

partners.

BACKGROUND:

GHESKIO is one of the two lead non-governmental organizations (NGOs)—the other is Partners in Health

(PIH)—that has an integrated model of HIV services in Haiti. With existing resources, GHESKIO is

expanding its integrated model to 16 sites, including four major public departmental hospitals. Nine of these

sites offer also TB services (with support from the Global Fund and USAID). With few ressources, efforts

were made to integrate TB/HIV activities in GHESKIO network, focusing on TB screening, prophylaxis, and

treatment for HIV patients, on integrating counseling in TB wards and on establishing referrals between the

TB and HIV services at these sites to provide care to co-infected patients . As TB/HIV care for children and

protocols for infection control and monitoring of TB drug resistance has been integrated in the two main

GHESKIO centers in Port-au-Prince, they are yet to be implemented in the rest of the network.

Siguenau is a TB stand alone public hospital located in the West Department. One year ago, with support

from PEPFAR and GFATM it started offering CT services. This hospital is ideally located to serve as a

referral center for HIV infected patients with TB requiring HAART and for those with MDRTB. The treatment

of patients co-infected with HIV and TB is complicated and requires an experienced team. At present, there

is no standardized treatment for such patients. Studies done at GHESKIO centers show: 1) over one third of

persons receiving counseling and testing for HIV and have a cough have active TB, 2) up to 50% of TB

patients seen at the GHESKIO facility were HIV infected, and 3) in Port-au-Prince, up to 10% of HIV positive

patients who were never treated for TB may develop associated MDRTB. The West Department, where

Siguenau Hospital is located, is the most populated region in Haiti and has the highest prevalence of TB in

the country. At present, GHESKIO is the only facility in Haiti that offers a complete laboratory diagnosis for

TB including MDRTB. The PIH clinic in Cange is the only facility in Haiti that offers care for patients with

MDRTB. Because the PIH site in Cange is far from Port-au-Prince, most patients diagnosed at GHESKIO

with MDRTB do not want to travel so far to receive inpatient therapy for two years. Strategies to diagnose

and manage co-infection TB/HIV are an integral part of the National Strategic Plan.

ACTIVITES AND EXPECTED RESULTS:

ACTIVITY 1: GHESKIO will continue to reinforce its network of HIV sites to perform TB screening,

prophylaxis, and treatment for HIV positive individuals. GHESKIO will focus on HIV positive children as

pediatric care in being expanded through this network. TB infection control measures as well as TB drug

resistance monitoring will be implemented in this network according to national norms and protocols.

Resources will be used to build human capacity, reinforce infrastructure, and to ensure adequate provision

of purified protein derivative (PPD) test and related commodities and Isoniazid (INH) for prophylaxis (see

SCMS activity narrative). Based on needs assessment, the major hospitals will be reinforced with chest x-

ray capacity, including equipment and related materials, and commodities to improve TB screening. This will

complement sputum smear diagnosis capacity implemented at all TB sites through the TB/Directly

Observed Treatment Short-Course (DOTS) program financed by GFATM.

ACTIVITY 2: With FY 2008 funds, GHESKIO will reinforce Siguenau hospital with a multidisciplinary team

of doctors, nurses, pharmacists, social workers, laboratory technicians, and field workers to maintain and

expand ARV services to TB patients.

ACTIVITY 3: GHESKIO will continue to reinforce Siguenau Hospital to become a training center in the

management of TB/HIV co-infection, identification, and referral of MDRTB. Resources will be allocated to

provide training classrooms, equipment and materials as well as logistic costs for participants. GHESKIO

will coordinate this activity with other network TB and HIV clinics to allow healthcare providers from these

clinics to access this training.

ACTIVITY 4: GHESKIO will procure necessary reagents and supplies needed to diagnose MDRTB in

patients who fail conventional TB therapy. GHESKIO will assist in expanding Siguenau Hospital's capacity

so that it can become a specialized, national reference center providing care to patients with MDRTB.

GHESKIO will assign two of its clinicians, recently trained at the New York City Health Department in the

management of patients with MDRTB, to Siguenau Hospital.

ACTIVITY 5: GHESKIO‘s TB specialists will participate in the MOH effort to establish national guidelines for

the management of TB/HIV co-infection.

.

TARGETS:

Number of service outlets providing treatment for tuberculosis (TB) TO HIV-infected individuals (diagnosed

or presumed) in a palliative care setting (a subset of all palliative care oulets) : 10

Number of HIV-infected clients attending HIV care/treatment services that are receiving treatment for TB

disease (a subset of all served with palliative care): 520

Number of individuals trained to provide treatment for TB to HIV-infected individuals (diagnosed or

presumed). (A subset of all trained): 150

Activity Narrative: Number of HIV patients screened for TB: 7,500.

Number of HIV patients on INH prophylaxis: 3,000

Number of TB patients tested for TB drug resistance: 100

Number of TB patients treated for MDRTB: 12

SUMMARY:

Through activities listed in this project GHESKIO will contribute to the United States Government's (USG)

effort to provide treatment to people with HIV/AIDS (PLWHA) by maintaining and strengthening anti-

retroviral (ARV) services in a national network of public and private health facilities and by building human

capacity for the overall program. The major focus will be: 1) reinforcing technical, infrastructure, human and

administrative capacity of the 16 institutions in the GHESKIO network for the provision of ARV care; 2)

training providers; 3) supervising quality assurance (QA), quality control (QC) and quality improvement(QI)

of ARV services; 4) maintaining Immaculee Conception hospital, the South Regional Hospital as a Center of

Excellence; and 5) building capacity of St Michel Hospital, the South East Departmental Hospital to

become a center of excellence.

Areas of emphasis for these activities will include: community mobilization and participation; reinforcement

of existing network and referral systems; human resources; infrastructure development; development of

local organizations capacity; development of network/linkages/referral systems; information, education and

communication (IEC); linkage with other sectors and initiatives; development of guidelines; quality

assurance, quality improvement and supportive supervision; and strategic information and training.

Specific target population identified will be PLWA, HIV positive infants and adolescents from 0 to 14 years,

affected relatives, HIV positive pregnant women and different category of care providers.

BACKGROUND:

GHESKIO has been one of the two lead non-governmental organizations (NGO) that has an integrated

(integrated with STI, TB, CT, PMTCT) model of anti-retroviral (ARV) services and basic care. Over past last

three years, the USG has provided resources to GHESKIO to expand this integrated model in a network of

16 sites, including four of the largest departmental public hospitals and a large stand alone tuberculosis

(TB) facility. This program was built on previous efforts to implement CT, PMTCT and basic care services -

the entry point for enrolling patients on ARV—at the 16. All 16 sites have been reinforced with infrastructure,

laboratory equipment, and a multidisciplinary team of clinicians, nurses, counselors, pharmacists,

community and social workers as well as with medical equipment, electronic medical records, drug storage

capacity and SI tools to provide quality care. Based on the pilot experience of launching ARV pediatric care

in the main GHESKIO center in Port-au-Prince, efforts were since last year, to expand this program

throughout the network. Efforts are being made to strengthen one of the South's departmental hospitals,

Immaculee Conception Hospital, to become a center of excellence where training, supervision, and QA/QI

could be decentralized. Nearly 5000 patients have been placed on ARV through the GHESKIO network so

far.

The USG team has mandated GHESKIO to train healthcare providers nationwide for the ARV program and

to support the Minister of Health's (MOH) ARV certification process using national guidelines and updated

training. To date, GHESKIO has trained a total of 425 health professionals. As ARV services are expanded

and reinforced and because of a significant turnover of personnel, there is a continuous need to train and

provide refresher courses on ARV at GHESKIO. There is also a growing need to train nurses to play a

greater role in the provision of ARV services as well.

USG has also required GHESKIO to provide QA/QC/QI to 22 sites, some of which are outside of the

GHESKIO network. GHESKIO has formed three mobile multidisciplinary teams of clinicians, pharmacists,

and others to make regular supervision visits. There is a need to continue strengthening this activity to

implement a QA/QI system through which data could be generated and used to improve quality at the

patient, site, and program level.

With Fiscal Year 2008 funding GHESKIO will continue to strengthen its integrated model of ARV services in

its network of 16 sites, including its main site in Port-au-Prince, to continue enrolling new patients on ARV,

with the goal being to reach 10,000 patients by the end of September 2008 and 14,000 patients by the end

of September 2009. If obtained, these numbers will contribute to more than half of PEPFAR's targets for the

country. These sites will also focus on improving quality of care and adherence to treatment, and on

expanding pediatric treatment. GHESKIO will build the capacity at Hospital Saint Michel, the South East

departmental hospital to become a new center of excellence. GHESKIO will continue to train health care

professionals on ARV with an emphasis on training nurses. GHESKIO will work with MOH, CDC and other

stakeholders to improve the system of QA/QI with standardized indicators and with a focus on continuous

improvement of care for twenty-two (22) sites (14 in the MOH-GHESKIO network and eight in other

networks: Bethel, Gonaives, MARCH, Beraca, HAS, CBP, Grace Children's Hospital and Ouanaminthe).

This effort will be integrated with activities supported by the GFATM through GHESKIO.

ACTIVITES AND EXPECTED RESULTS:

ACTIVITY 1: Funding will be used to strengthen GHESKIO's headquarters to continue providing technical,

administrative, and accounting assistance to its network of 16 sites in integration with GFATM resources.

These sites are: GHESKIO-INLR, Les Cayes , Jeremie, Jacmel, Cap-Haitienne, Fame Pereo, IMIS,

Bombardopolis, Food for the Poor, Hopital de la Communaute Haitienne, Petit Goave, Hospital Bernard

Mews, La Gonave and Fermathe. GHESKIO's headquarters will provide oversight and monitoring of the

project.

Activity 2: GHESKIO will use funding to cover additional renovation, equipment, and personnel needed for

expansion of services at the 16 sites. Emphasis will be put next year on pediatric wards to ensure they have

adequate space, equipment, and personnel to enhance ARV pediatric services. Special attention will also

be given to improve laboratory services for ARV care to make available at all major sites automated

equipment for the dosage of CD4, hematology and blood chemistry (see laboratory narratives). Linkages

will be established with Supply Chain Management System to ensure adequate supply of drugs as well as

with CBOs and PLWA support group organization to provide community support to maintain patient

adherence to treatment.

Activity 3: GHESKIO will expand its training infrastructure, staff, and equipment to train and provide

refresher courses on ARV to close to 400 health professionals nationwide through all the networks. Funding

Activity Narrative: will be used to cover materials, per diem, and logistic costs for the trainees.

ACTIVITY 4: GHESKIO will maintain and expand supervision and on site training for ART services at 22

main sites supported by PEPFAR for QA/QC/QI using a national framework and tools that MOH, CDC, and

key stakeholders have started to develop. This will be supported through three mobile teams. The main

items covered by this funding will include: support for mobile teams, per diem, lodging, logistics for visits,

materials for supervision and training. A quality manager team will be created at GHESKIO to oversee the

QA/QI system.

ACTIVITY 5: Funding will be used to make St Michel Hospital, the South East departmental hospital a

center of excellence for the South East Department. This new activity is necessary to continue the

decentralization of ARV services and to serve as a model for extending services to peripheral sites. In this

capacity, St Michel Hospital will be a regional reference and training center, offering training sessions and

supervision for peripheral centers in their area of influence.

TARGETS:

1- Two (200) health providers from PEPFAR sites will be trained in ART management, and 100 others will

receive refresher courses.

2- Fourteen (14) health facilities from the MOH/GHESKIO network will offer ART to patients,

including children throughout a national network.

3- Supervision visits for QA/QC/QI will occur in twenty-two (22) PEPFAR funded sites.

4- Hospital St Michel of Jacmel will serve as the Center of Excellence for the South-East Department,

capable of offering training and supervision to peripheral sites.

5-The objective is to provide and maintain ART care to 14,050 patients including 3,564 new patients during

this period.

INTEGRATED ACTIVITY FLAG: This activity is also related to the following PEPFAR program areas

conducted by GHESKIO: Counseling and testing, HIV care and treatment (ARV drugs and services), and

palliative care for HIV/TB. PMTCT services are also supported by the Global Fund. This activity links to

Activity IDs 17920.08, 15465.08, 18948.08, 4341.08 and 9672.08.

SUMMARY: The goal of these activities is to strengthen National Public Health Laboratory (NPHL) capacity

by providing continuing technical assistance in the areas of Dried Plasma Spot (DPS) Quality Assurance

for HIV antibody testing, whole blood syphilis testing and early infant diagnosis through p24 testing.

GHESKIO will also support laboratories at PMTCT, VCT, ARV, and palliative care sites through training and

technical assistance in diagnostic tests used for diagnosis and follow up. The main emphasis for these

activities is continued training, technical assistance for quality assurance/quality control and equipment

maintenance for GHESKIO laboratories. These activities will involve NPHL, GHESKIO, and designated

sites. The specific target population includes public and private health care workers nationwide.

BACKGROUND: Many activities in 2008 are a follow up of activities conducted in 2007 as part of NPHL's

objective to develop and provide QA/QC services to sites providing HIV-related testing in Haiti. Through

these activities, GHESKIO will continue to build the NPHL's capacity by mastering and transferring to NPHL

the capacity for HIV screening using DPS (re-testing activity). These activities will improve the capacity of

NPHL to provide quality control of laboratory results in healthcare facilities nationwide.

ACTIVITIES AND EXPECTED RESULTS

ACTIVITY I: GHESKIO will conduct a training of trainers (TOT) for the use of whole blood syphilis rapid

testing for 10 NPHL staff and 6 GHESKIO mobile team technicians. These trainees will then assist the

NPHL to conduct syphilis whole blood rapid testing training for 150 health workers.

ACTIVITY II: This activity is to conduct a competency assessment twice a year for 150 healthcare workers

with the collaboration of NPHL on DPS processing and HIV whole blood testing. It will build on the previous

year's activity to assist NPHL in the implementation of the DPS HIV testing. Corrective action and retraining

based on the results will be provided. GHESKIO mobile team will only be in charge of the assessment of the

healthcare workers of GHESKIO network. NPHL will be responsible for the MOH network.

ACTIVITY III: GHESKIO will provide QA/QC assistance in whole blood rapid syphilis testing to NPHL and

the MOH lab network.

ACTIVITY IV: GHESKIO will prepare a 1-week refresher workshop for the 10 trainers of the NPHL trained

during the COP07 activities. These trainers had previously been trained in CD4 T-cell count determination

by flow cytometry, ELISA, Western Blot, and p24 antigen assay. During this refresher workshop, the skills of

these trainers will be assessed and new recommendations will be made to the NPHL based on the trainers'

performance.

ACTIVITY V: GHESKIO will train 8 national lab staff in diagnosis of opportunistic infections, TB culture, TB

drug resistance testing, bacteriology and parasitology testing (4 weeks) in collaboration with American

Society of Microbiology (ASM) and Association of Public Health Laboratories (APHL) who will provide on-

site technical assistance to the national lab for TB, bacteriology, and parasitology. This joint effort is aimed

to enable the national lab to function in these laboratory areas in a timely manner.

ACTIVITY VI: In collaboration with the USG team, NPHL, and Partners In Health (PIH), GHESKIO/IMIS will

develop the polymerase chain reaction (PCR) test for HIV in infants, using dried blood spot (DBS)

technology. GHESKIO anticipates testing 2,500 infants born to HIV-infected mothers. In order to perform

this new technique, three laboratory technicians will be hired and trained. Supplies and reagent will be

procured and provided by SCMS. Funds requested for this activity are for personnel to perform this

technique and transportation of specimens from sites to GHESKIO/IMIS

ACTIVITY VII: With the support of the CDC GAP International lab branch GHESKIO will participate in

performance evaluation of the three (3) laboratories (GHESKIO/IMIS, NPHL, and PIH) expected to be

trained during 2007 in DBS-PCR for early infant diagnosis of HIV. Corrective action and troubleshooting will

be conducted. GHESKIO, NPHL and PIH will participate in a proficiency testing program provided by WHO

and CDC.

ACTIVITY VIII: GHESKIO will develop drug resistance testing capacity to monitor HIV/AIDS patients

receiving ART by following the WHO/CDC criteria and monitoring treated patients. Based on preliminary

data at GHESKIO, we anticipate that 5% per year of the patients receiving antiretroviral therapy (ART) will

meet WHO eligibility criteria for ART failure. We will collect and freeze plasma specimens from an estimated

500 patients who meet WHO criteria for failure in order to perform HIV drug resistance testing. Two

laboratory technicians will be hired and trained by GHESKIO senior staff to perform this technique.

ACTIVITY IX: As part of patient care and in collaboration with the NPHL, GHESKIO will evaluate the p24

antigen test as a surrogate for viral load to monitor patients receiving ART. Monitoring HIV-infected patients

receiving ART and determining ART failure in the absence of viral load technology is becoming an

increasingly challenging task facing Haitian clinicians. Current viral load technologies are expensive and

require well-trained staff, running water and a reliable electrical supply that are not available in resource-

limited countries. The modified p24 assay offers a simpler alternative to viral load tests. GHESKIO has

already implemented and validated the assay for the diagnosis of HIV infection in infants (George et al. J

Clin Microbiol accepted for publication in October 2007). We plan to correlate the results of the p24 assay

established at GHESKIO with the results of viral load tests performed in 200 HIV-infected patients receiving

ART. Two NPHL staff will be trained by GHESKIO in the performance of the p24 assay.

ACTIVITY X: GHESKIO will provide laboratory support for four ART sites in its network. These sites are La

Gonâve, Hôpital Communauté Haïtienne, Eliazar Germain, and Fermathe. GHESKIO will play an active role

by improving laboratory infrastructure, upgrading the facility, and hiring additional lab staff to make

laboratories at these facilities ready for becoming ARV sites.

ACTIVITY XI: GHESKIO will hire 2 biomedical engineers assisted by 2 electricians. It is anticipated that this

staff will receive training supported by CDC/Haiti on maintenance, repair and troubleshooting of mechanical

Activity Narrative: and automated analyzers used in the network (Point Care, Sysmex, Reflotron).This staff will be available to

assist the national lab biomedical engineer unit providing services as deemed necessary.

ACTIVITY XII: GHESKIO will develop a protocol for maintenance of basic laboratory equipment

(refrigerator, freezer, microscope, pipette, timer, centrifuge, etc) including preparation of instrument records,

maintenance and troubleshooting log, daily-weekly-monthly maintenance schedule, instrument information

record, and temperature monitoring charts to be used by labs in the GHESKIO network. This protocol will be

shared with the NPHL and the rest of the national laboratory network in order to put this protocol in use

nationwide.

ACTIVITY XIII: GHESKIO will train 2 laboratory technicians per site in the network (total of 32 technicians)

to perform instrument check and preventive maintenance. GHESKIO will send its Biomedical engineering

staff to assist the national lab with the training of lab equipment maintenance at the national lab.

ACTIVITY XIV: NPHL will be in charge of equipment maintenance of the Ministry of Health (MOH) Network.

The GHESKIO maintenance staff will serve as a backup for the National Laboratory and will be responsible

for maintenance and service of equipment in the GHESKIO network.

Twice a year, GHESKIO staff will verify the equipment maintenance activities in the GHESKIO laboratory

network including equipment cleaning adjustment and replacement of parts, functional checks, temperature

recording, troubleshooting activities, calibration of equipment and record verification. GHESKIO and NPHL

maintenance staff will communicate regularly to share experiences, skills and knowledge in this area.

ACTIVITY XV: GHESKIO will acquire one additional blood chemistry instrument to increase the capacity of

the laboratory and for better follow up of patients receiving ART.

RESULTS: These results will contribute to the President Emergency Program for AIDS Relief (PEPFAR) "2-

7-10 goals" by improving and maintaining the capacity of the National Public Health Laboratory and the

national laboratory network to provide quality laboratory results in healthcare facilities nationwide.

PUBLIC HEALTH EVALUATION

PEPFAR Haiti, Laboratory Infrastructure Program

Title of Study (NEW): Evaluation of HIV p24 antigen assay as a surrogate for viral load to monitor patients

receiving antiretroviral therapy (ART) in Haiti

Time and money: Expected timeframe of study from protocol development to completion is two years (June

2008 - May 2009). Budget requested is approximately $147,000.

Local Co-investigator: Dr Bill Pape, GHESKIO, Haiti

Project overview: As part of patient care, GHESKIO will evaluate the p24 antigen test as a surrogate for

viral load to monitor patients receiving ART. Monitoring HIV-infected patients receiving ART and

determining ART failure in the absence of viral load technology is becoming an increasingly challenging

task facing Haitian clinicians. Current viral load technologies are based on molecular biological techniques

which are sophisticated, expensive and require well-trained staff, running water and a reliable electrical

supply, things frequently not available in resource-limited countries. The modified p24 antigen assay could

offer a simpler alternative to molecular-based viral load tests. GHESKIO has already implemented and

validated the assay for the diagnosis of HIV infection in infants (George et al. J Clin Microbiol accepted for

publication in October 2007). We plan to correlate the results of the p24 assay established at GHESKIO

with the results of viral load tests performed in ~200 HIV-infected patients receiving ART

Evaluation Question: Could HIV p24 antigen assay be used as an alternative method in resources-limited

countries to monitor the level of viral load in HIV-infected patients receiving ART?

Programmatic importance: This public health evaluation is of importance to the ARV services in the

PEPFAR program in relation to patient care. Traditional laboratory tests to measure viral load are molecular

biology - based techniques that require a sophisticated laboratory setting and equipment, are expensive

and need very well trained lab personnel. Thus it is costly to do so in resources-limited countries. Currently,

there are >12,000 HIV-infected patients receiving ART in Haiti. However, these patients do not receive viral

load testing to monitor the success of therapy due to the high cost of the test. The only laboratory testing

offered to such patients include CD4 counts, complete blood counts, and 2 blood chemistry tests (serum

alanine transferase and Creatinine) twice a year. The P24 antigen test, however, is an enzyme

immunoassay (ELISA-based) which is easier to perform, cheaper and does not required a complicated

laboratory setting If a simpler p24 antigen test could be used to monitor patients under ART, patients under

ART will be benefit from such test. Clinicians would know when to change regimens should there is a sign

of therapy failure. This PHE is of importance for clinical management of patients under ART.

Methods: This is a prospective study. Blood specimens will be collected in EDTA tubes from 200 patients

who will undergo ART at the baseline, 6 and 12 months after initiating the therapy. CD4 counts will be

performed with the blood samples as a routine procedure using Facscount. The leftover blood samples will

be used for the study. They will be centrifuged and plasma samples will be separated and stored in -70C for

further investigation. The stored plasma specimens will be measured for the level of viral load using an

EasyQ method. Another portion of the plasma specimen form the same patients will be quantified for the

level of HIV p24 antigen expressed in pico or nanograms. There will be no cost for equipment for both viral

load and p24 antigen tests as both tests are already established at GHESKIO laboratory. Results of the

p24 antigen test will be correlated with the viral load results and also with the CD4 count as well as the type

of ART the patients received

Population of Interest: People living with HIV/AIDS

Information Dissemination Plan: Results of this public Health Evaluation will be shared among the USG

team, and major stakeholders through meetings, and presentations, particularly during HIV Implementers

meeting.

Budget Justification for year 1 budget:

Evaluation of p24 Year 1

Staff

2 Laboratory Technicians (2X900X13) $ 23,400.00

fringe 15% $ 3,510.00

subtotal $ 26,910.00

200 patients at 3 times points (0, 6, and 12 months after ART)

Supplies and test kits

Lab supplies and reagents for p24, $15/test, 30% redo $ 11,700.00

Lab supplies and reagents for viral load, $100/test, 30% redo $ 78,000.00

subtotal $ 89,700.00

Travel $12,000

Gas and utilities $18,000

TOTAL $146,610.00

Staff: Two technicians are required to conduct the study, collecting specimens, filing and recording as well

as to perform viral load and p24 antigen tests.

Equipment: GHESKIO does not request budget to procure equipment since the two tests were already set

up at GHESKIO laboratory.

Supplies: GHESKIO, however requests support for the cost of lab supplies and test kits needed to conduct

the evaluation for 200 patients at three times points plus some percentage in case retesting is needed.

Travel: The partner requests some funding for $12,000 for travel to participate in scientific meetings or

Activity Narrative: training in order to share their results with other scientific communities.

Participant incentives: None

Laboratory testing: None

Other: The partner requests to get support for general utilities cost (gas and electricity for $1500/month).

This is a co-share cost for utilities, a fraction of the total cost not the real total amount of the utilities cost at

GHESKIO.

TOTAL BUDGET: round up to $147,000

INTEGRATED ACTIVITY FLAG: This activity is also related to the following PEPFAR program areas

conducted by GHESKIO: Counseling and testing, HIV care and treatment (ARV drugs and services), and

palliative care for HIV/TB. PMTCT services are also supported by the Global Fund. This activity links to

Activity IDs 17920.08, 18948.08, 4601.08, 4341.08 and 9672.08.

BACKGROUND AND SUMMARY:

GHESKIO has three laboratories:

1.GHESKIO/INLR (Service and research laboratories)

2.GHESKIO/IMIS (Training laboratories)

3.Service laboratory (to be completed in March 2008)

4.Biosafety Level 2 and 3 facilities at IMIS (Research laboratories to be completed in March 2008)

GHESKIO and NPHL will place its laboratory facilities at the service of private and public medical

technology schools for training to strengthen their curricula, improve the competence of their graduates, and

increase capacity in the medical technology field. These graduates will create a pool of well-prepared

laboratory technologists who can contribute to the attainment of the objectives of the Ministry of Health.

These two major activities will address the objectives of the GHESKIO-NPHL partnership:

1.GHESKIO propose in partnership with the National Laboratory of Public Health to fulfill the urgent needs

of qualified lab technicians in Haiti.

2.GHESKIO proposes an internship program to provide a critical mass of skilled lab technicians, available to

support the activity of the National Laboratory of Public Health and GHESKIO laboratory activities.

These activities will involve the National Public Health Laboratory (NPHL), GHESKIO/INLR,

GHESKIO/IMIS, and designated sites upon signature of a contract between GHESKIO Center and Center

for Disease Control (CDC). The specific target population includes public and private health care workers

nationwide.

ACTIVITIES AND EXPECTED RESULTS

ACTIVITY I:

In order to complete the ITECH program in collaboration with the National Schools of Technicians), the

GHESKIO propose in partnership with the National Laboratory of Public Health to fulfill the urgent needs of

qualified lab technicians in Haiti. We aim to provide one-year advanced training (practical and theoretical) in

well-equipped laboratories at GHESKIO/INLR, GHESKIO/IMIS, and NPHL. A pool of 50 to 60 technicians in

training at the best 3-4 Medical Technology Schools will be offered practical training in these laboratories.

At GHESKIO/INLR and GHESKIO/IMIS, training will include:

HIV ELISA and Western blot

Automated CD4 count (FACS count)

Diagnosis of opportunistic infections in bacteriology and parasitology

TB culture and susceptibility testing

Automated chemistry and hematology equipment

At the NPHL, training will include:

HIV and syphilis rapid testing

Complete blood count (CBC)

TB and malaria diagnosis by smear microscopy

Manual CD4 count

QA/QC in different diagnostic testing

Funds requested for this activity will also support the recruitment of staff for training at GHESKIO/IMIS.

GHESKIO/INLR and NPHL already have a well-qualified staff for training.

ACTIVITY II:

Another pool of 10-14 lab technicians recently graduated will be offered one year internship at

GHESKIO/INLR and GHESKIO/IMIS laboratories and at the NLPH with rotations in the different sections of

the laboratories (Microbiology, Serology, Immuno-hematology, Biochemistry, HIV molecular biology, and

QA/QC program). The aim is to provide a critical mass of skilled lab technicians, available to support the

activity of the National Laboratory of Public Health and GHESKIO laboratory activities.

RESULTS: These results will contribute to the President Emergency Program for AIDS Relief (PEPFAR) "2-

7-10 goals" by improving and maintaining the capacity of the National Public Health Laboratory and other

laboratories nationwide to provide quality laboratory results in healthcare facilities nationwide.

TARGETS:

50-60 medical technology students received hands-on training on HIV/TB/OI related testing at

GHESKIO/INLR, GHESKIO/IMIS, and NPHL.

14 laboratory technicians received one year internship at GHESKIO/INLR, GHESKIO/IMIS, and NPHL.