Title of Study: To assess the impact of an HIV management (non-ART) training course for Reproductive and

Child Health (RCH) service providers on outcomes for HIV positive mothers and HIV-exposed children

Expected Timeframe of Study: 18 months

Development of protocols, sampling frame and standardized data collection tools: 3months

Baseline assessment, training intervention and data collection: 12 months

Data analysis and dissemination: 3 months

Local Co-investigator: Elizabeth Glazier Pediatric AIDS Foundation (EGPAF) TANZANIA

W.Schimana

I. Indile

E.Assenga

A. Nsheha

D. Tindyebwa

A. Giphart

Project Description: Reproductive and Child-health Nurses in Tanzania currently do not provide any

specialized care for HIV infected women and their children other than counseling and testing for PMTCT.

There are many missed opportunities for improved care of these patient groups at RCH (antenatal,

postnatal and child-health) clinics. HIV infected pregnant women or HIV-exposed children often fail to reach

Care and Treatment Centres (CTCs) from RCH clinics for several reasons including perhaps that RCH

nurses aren't knowledgeable facilitators of these referrals. This study aims to assess the impact of a newly

developed training course designed to improve the RCH nurses' skills in non-ART care and to improve

onward referral for patients needing ART.

Evaluation Question: Primary hypothesis: Training RCH service providers in clinical staging and non-ART-

care may lead to enhanced care for HIV positive pregnant women/mothers and their infants.

Primary objective:

1. To document the impact of a new training program for RCH cadres on providers' HIV knowledge and

practice and clinical activities for HIV positive mothers and HIV-exposed children

Secondary objective:

2. To document the impact of RCH Provider HIV training on referral of patients (pregnant women, HIV-

exposed children and HIV positive mothers) from RCH into CTCs and their retention in CTCs.

3. To document specific additional challenges for RCH providers at lower health facilities concerning non

ART care, and linkages to CTCs.

Methods: The Intervention: After development and field testing of a curriculum RCH-nurses will be trained in

non-ART care and clinical staging. The 4-day training has already been pre-tested and has 4 modules:

Introduction; natural causes and disease progression of HIV/ AIDS; common clinical manifestations of

HIV/AIDS and WHO staging of HIV-positive clients; basic principles of disease management; and treatment

counseling. The goal of the training is to improve knowledge and skills in RCH service providers in

managing HIV positive pregnant women, HIV positive mothers and HIV-exposed children and encourage

referral and ongoing attendance at CTCs where appropriate.

Study Design

The study will take 18 months. Ten districts will be selected from the current 35 EGPAF supported districts

and of these service providers in five will receive the intervention and the other five will form control districts.

The main outcome measures may include:

1. RCH service provider pre-and post-training knowledge and practice in HIV care

2. For pregnant women: clinical staging, CD4 measurement (in some clinics), appropriate referral to CTC,

registration at CTC, administration of cotrimoxazole, and reduction of early loss of follow-up after referral.

3. For children attending RCH clinics: HIV exposure identification rates (via PMTCT results on charts, and

new tests)

4. For HIV-exposed children identified: clinical staging, administration of cotrimoxazole, appropriate referral

to CTC, retention in RCH for follow-up to 18 months

5. HIV positive mothers of children attending RCH: enhanced knowledge on caring for an exposed child,

referral to CTC if not yet registered or not continuing to attend

Instruments used will include: training participant description forms; knowledge test (case based) and

interview guide; patient registers connoting clinical activities (e.g. clinical staging, cotrimoxazole

administration), and/or referral slips (if they don't exist), patient exit questionnaires.

The study, to be carried out by consultants in collaboration with EGPAF, will assess the outcomes of the

intervention by comparing intervention districts with comparison districts where no training has taken place.

Some outcomes will also be compared using retrospective data from the year prior to the intervention. Post

-training knowledge assessment will be done at 3 months and clinical data collection will cover 6-9 months

following the training.

Population of Interest: Intervention aims at RCH services in health centers and dispensaries as primary

contact points for mothers and their infants. Only districts which are comparable will be involved after

gaining consent from the local authorities. Sampling frame is yet to be decided depending upon ability to

match districts and also ability to provide training courses in random fashion. Sampling frame will be

explored early in the protocol development phase. Patient care will always follow the national guidelines.

Information Dissemination Plan: Results will be shared with the district authorities as well as with the

National AIDS Control program. Any results of wider interest will be submitted for presentation at national

and international meetings, as well as publishing in peer-reviewed journals.

Budget Justification for year one (US$): Salary/fringe benefits: 33400

Equipment: 100

Activity Narrative: Supplies: 1 000

Travel: 22,500

Participant Incentives: 15,000

Laboratory testing: None

Other: planning meetings, dissemination of results, training, miscellaneous: 38,000

Total: 110,000

TITLE EGPAF Facility-based Palliative Care

The Eliazabeth Glaser Pediatric AIDS Foundation (EGPAF) is the primary treatment partner in Arusha,

Kilimanjaro, Tabora, and Shinyanga. EGPAF provides palliative care to most of those registered in their

Care and Treatment clinics (CTCs). This includes both patients on Anti-Retroviral Therapy (ARTs) and not

yet eligible on ARTs. Patients receive WHO staging, provision of cotrimoxazole in accordance with national

guidelines, diagnosis and management of opportunistic infections, including tuberculosis screening and

referral and cryptococcal infection, nutritional assessments/counseling (and referrals), symptom and pain

management (for outpatients, pain management is currently restricted to non-opioid medicines such as

ibuprophen and paracetamol), and psychosocial support. General counseling addresses disclosure of HIV

status, adherence to care and treatment, behavior change counseling for prevention of HIV transmission,

and other individual specific issues, as appropriate. Pediatric formulations of cotrimoxazole are available for

children.

In FY 2008, after an assessment of nutritional supplement options are evaluated, an expanding number

may receive nutritional support. A growing number of people living with HIV/AIDS that can help to promote

adherence, provide psychosocial support, and to handle referrals for community services (e.g. income

generating activities and legal service).

An important linkage is between facility-based palliative care and community home-based care. This link is

critical as all palliative care cannot be done at the facility. There are two-way referrals from the CTC to the

community HBC program and from the community HBC program to the CTC. The program strives to have

100% of patients registered in Care and Treatment be referred to a community home-based care program.

Total palliative care targets are de-duplicated at the national program level for patients who receive facility-

based services from this partner and home-based services from other USG-supported partners.

TITLE: Scale up of TB /HIV services in Care and Treatment Clinics in four Regions

NEED and COMPARATIVE ADVANTAGE: Tanzania ranks 14th among the 22 highly burdened countries

with increased HIV/AIDS epidemic. According to the National Tuberculosis and Leprosy Program (NTLP),

TB -HIV dual infection contributes to 17.5 % of the total disease burden in Tanzania. Most health workers

have trouble finding up-to-date information with regard to TB control and don't intensify TB screening

among HIV patients. The TB/HIV activities have the objectives of creating the mechanism of collaboration

between tuberculosis and HIV/AIDS departments, reducing the burden of tuberculosis among PLWHA and

reducing the burden of HIV among TB patients, leading to more effective control of TB among HIV-infected

people.

ACCOMPLISHMENTS: From October 2006 to end of March 2007, all our supported sites monitored HIV

patients who where infected with TB. A total of 370 patients received TB treatment during that period. The

clinicians at the EGPAF supported sites use the clinical forms which have TB screening questions thus

ensuring the screening of all the patients. Linkage meetings between the TB and HIV clinics staff have been

promoted. Patients were referred from care and treatment clinics to TB clinics and vise versa using referral

forms.

ACTIVITIES: 1) All HIV infected patients receiving HIV care and treatment will be screened for TB routinely

and those suspected will access TB diagnostic services. Those found positive for TB will be immediately

referred to the TB clinic to initiate uninterrupted treatment using the Directly Observed Therapy (DOT)

method 1a) Support creating clinical forms with TB screening tool. 1b) Clinicians at each site will be trained

on TB/HIV collaborative activities including use of modified clinical forms to routinely identify underlying TB

signs and symptoms for all clients attending Counseling and Testing Centers (CTC). 1c) Develop a referral

system for access of HIV-infected TB suspects to laboratory diagnosis and treatment for TB.

2) TB infection control practices will be implemented in the care and treatment clinics to prevent

transmission of TB among PLWHA as well as health providers. 2a) CTC staff at each site will be trained on

TB infection control practices, and ensure ventilation in care and treatment clinics.

3) Strengthen existing laboratory services needed to implement TB/HIV program activities. 3a) Supplement

supply of X-ray films.

4) Support outreach ART services to remote TB clinic in the regions.

LINKAGES: With the new funding EGPAF will collaborate with the National TB and Leprosy Program

(NTLP) to increase more linkages between all the care and treatment sites and TB clinics. Referrals will be

strengthened by modifying current registers and ensuring all information regarding referral is accurately

recorded and reported. All the patients who are diagnosed to have TB at HIV care clinics will be referred

using referral forms to TB clinics and start anti-TB treatment promptly. Linkages with the community and

community based organizations (CBOs) will also be strengthened through regular meetings to reach TB

patients who should be screened for HIV.

CHECK BOXES: The areas of emphasis and target population have been selected following the planned

activities so that all male and female patients attending the CTC are adequately screened and treated for

TB, and TB prevention procedures at the CTC are strengthened.

M&E: EGPAF will collaborate with NTLP and The National AIDS Control Program (NACP) for the TB/HIV

M&E system for data collection and reporting. This will include the incorporation of the TB screening

questions into the clinical recording form, the modification of the TB clinic and the CTC registers to include

TB data. Referral of patients between the TB clinic and CTC will be done by a written referral form with a

detachable slip for returning to the referring unit. The site linkages person will be responsible for tracking

referrals between the CTC and other facility units including the TB clinic. TB/HIV data will be entered into

same CTC data by the site data entry clerk. Training, development of standard operating procedures

(SOPs) and supportive supervision will strengthen the quality and use of data. Data from primary health

facilities with both CTC and TB/HIV activities will be collected and reported by a designated site coordinator,

just like at the current CTC sites.

SUSTAINAIBLITY: EGPAF will support the Regional TB and Leprosy Coordinator in each region to initiate

and coordinate TB/HIV activities in each district hospital and health centre that has both a TB clinic and a

CTC. Within district and district designated hospitals EGPAF will assist in building linkages between the TB

and HIV clinics through a Multi Disciplinary Team approach. Management and contact persons in the CTC

and the TB clinics will be supported to plan for implementing an integrated program.

TITLE: Expanding comprehensive ART services in six regions and other under-served areas in Tanzania.

NEED and COMPARATIVE ADVANTAGE:

Approximately 2 million Tanzanians live with HIV and close to a cumulative 800,000 AIDS cases have been

reported. HIV prevalence is higher in urban areas (10.9%) than in rural areas (5.3%) and it varies in

different regions. In our current four regions, Kilimanjaro, Arusha, Tabora and Shinyanga, it is estimated that

100,823, 68.527, 123,689 and 182,363 people are infected respectively who will need care and ART

services at some point, whereas now, an estimated 7% of People Living with HIV/AIDS (PLHA) from these

regions have accessed care. The figure is lower in Mtwara and Lindi regions where EGPAF will extend

support in FY 2008. With a strong commitment and support from the government and local authorities,

EGPAF will play an important role to ensure accessible care and treatment services.

ACCOMPLISHMENTS:

As of March 2007, 20,026 patients have enrolled into HIV care and 9,477 initiated on ART including 1,090

(11.5%) children in 26 hospitals. However, 95,000 patients are estimated to need ART. About 300 health

care workers (HCWs) have been trained to provide comprehensive ART care including patient monitoring.

Quality of care has been improved in the facilities through integration with PMTCT, infrastructure

improvement and equipment and commodity supply.

ACTIVITIES:

EGPAF will use the additional funds to accomplish the original targets of rolling out HIV care and treatment

in 189 sites within six regions. Activities will include:

1) Provide support to four lower level health facilities per district in four regions 1a) Support planning,

training, mentorship and supervision by district teams. Ensure HIV is included in Comprehensive Council

Health Plans 1b) Improve referral system between facilities and facilitate transport for mentorship,

supervision, and specimen testing 1c) Minor renovations and equipment supply.

2) Provide continuum of care through integration and linkage between Care &Treatment and PMTCT and

TB services and community based services 2a) Strengthen referral mechanisms for HIV+ women from

PMTCT to care and treatment by promoting use of referral slips and/or physical escorting and registers to

countercheck 2b) Train PMTCT HCWs to carry out clinical staging of HIV+ mothers and partners and

provide basic care at RCH clinics till they are eligible for ART 2c) Support community liaison person at each

site to link enrolled patients to CBO's for non-medical care and support 2d) Support PLHA groups to provide

peer-led adherence counseling, defaulter tracking and strengthening prevention among positives. Condoms

and other contraceptives will be provided where religion is not a constraint.

3) Support and expand provider-initiated testing and counseling (PITC) to all health facilities 3a) Train

HCWs in PITC 3b) Provide HIV test kits when central supply is unavailable 3c) Conduct community

sensitization meetings to increase testing demand and uptake.

4) Increase the number and percentage of children enrolled in care and receiving ART. 4a) Train HCW on

routine testing, basic care and referral in RCH clinics and in-patient wards. 4b) Sensitize and disseminate

the revised child health cards with HIV exposure identification. 4c) Train HCW on early infant diagnosis

including use of dried blood spot for PCR testing. 4d) Mentor HCW on pediatric ART. 4e) Provide care and

treatment to HIV exposed and infected children through OVC programs; 15% of total patients on ART will

be children; 4f) Implement PITC at all points where children come in contact with the health care system,

including outpatient clinics, RCH clinics, and inpatient wards. EGPAF is part of the USG initiative to

increase identification of HIV exposed and infected children among those attending normal immunization

clinics. A demonstration project for integrating identification and referral of HIV exposed children within

immunization services is being implemented in 6 sites among 3 partners, with EGPAF providing overall

coordination.

5) Continue support for ART services in the current 38 health facilities. 5a) Provide back up team training

and focused pediatric training. 5b) Support activities for continuous quality improvement. 5c) Recruit a

laboratory technician to assist with quality assurance in collaboration with MOHSW. EGPAF will follow

MOHSW standard operating procedures for QA. 5d) Strengthen data collection, on-site utilization and

reporting.

6) Expand support for both PMTCT and ART to underserved areas in Lindi and Mtwara regions in close

collaboration with Clinton Foundation as requested by the Ministry of Health.

LINKAGES:

We will strengthen collaboration with NGOs that support programs for PLHA to ensure PLHA receive a

combination of clinical, psychological, spiritual, social, & preventive services to optimize quality of life. The

CTC community liaison person will coordinate with CBO's and PLHA groups in client follow-up and tracking.

The program will promote active participation of community resource persons and structures and will use

wrap-around programs for nutritional support (like WFP, World Vision) and the Emergency Hiring Plan for

human resource support. Continue partnership with Mkapa Fellows Foundation for placement of critically

needed human resource cadres in our supported facilities. Public-Private Partnerships: EGPAF currently

supports five private hospitals which are owned, staffed and run by private companies. The GoT provides

ARV drugs to these hospitals and EGPAF supplements the GOT's efforts with HIV-related supplies when

central supplies are not available. In addition, EGPAF supports 13 Faith Based Organization hospitals.

CHECK BOXES

Renovation will be conducted in an effort to improve health center capacity to provide care and treatment

services. Human capacity development activities revolve around in-service training of health care workers.

HIV testing and enrollment into treatment will focus on the general population

M&E:

EGPAF will collaborate with NACP/MOHSW to implement the National M&E system for care and treatment

in Arusha, Kilimanjaro, Shinyanga, Tabora, Mtwara and Lindi regions. Data will be collected using paper-

based systems and where possible entered into the National CTC2 database. District teams will be

supported to perform M&E supportive supervision to their respective sites. EGPAF will provide the required

Activity Narrative: National and PEPFAR reports. In order to promote data use culture, we shall provide regular feedback to

supported sites and promote data utilization at sites through the Quality Improvement program for better

patient management. Data Quality Assurance: District teams will be supported to perform M&E supportive

supervision to their respective sites. Scale-up of electronic database: Currently, 15 facilities have the CTC2

database. This number will increase to 38 by September 2008. At the EGPAF Semi-annual partners

meetings, partners will share best practices, motivation and recognition of top performing sites will occur

and operational practices will be standardized across all sites.

Evaluation to assess the impact of an HIV management (non-ART) training course for Reproductive and

Child Health (RCH) service providers on outcomes for HIV positive mothers and HIV-exposed children

Primary objectives:

1. Document the impact of a new RCH training program providers' HIV knowledge, practice, and clinical

activities for HIV+ mothers and HIV-exposed children

Secondary objective:

2. To document the impact of RCH Provider HIV training on patient referral and retention to CTCs.

3. To document specific additional challenges for RCH providers at lower health facilities concerning care

and linkages.

The pretested, 4 day training has 4 modules: Introduction; natural causes & disease progression of HIV/

AIDS; common clinical manifestations of HIV/AIDS & WHO staging of HIV-positive clients; basic principles

of disease management; and treatment counseling.

Evaluation Design

1. RCH service provider pre-and post-training knowledge and HIV care

2. For pregnant women: documented clinical staging, CD4 measurement (in some clinics), appropriate

referral to CTC, registration at CTC, administration of TMP-SMX, and reduction of early LTFU after referral.

3. For children: HIV exposure identification rates (via PMTCT results on charts and new tests).

4. For identified HIV-exposed children: documented clinical staging, administration of TMP-SMX,

appropriate referral to CTC, retention in RCH up to 18 months

5. HIV positive mothers of children attending RCH: enhanced knowledge on caring for an exposed child,

referral to CTC.

SUSTAINABILITY:

EGPAF Tanzania works closely with the Government in the implementation of activities to ensure that the

plans are aligned with the National strategy. Local capacity building is ensured by improving physical

infrastructure, training and mentoring local Tanzanian health workers and using local Tanzanian technical

officers in project implementation. Systems are developed that rely heavily on local inputs and personnel.

External TA will gradually decrease over time, and in the next year training from Baylor and UCSF will

concentrate on refresher training, training of trainers, and mentorship. District teams will be empowered to

do supportive supervision and provide TA to lower level facilities.

Title of Study: Validation Of The Clinical Criteria For "Presumptive Diagnosis" Of Severe HIV Disease In

Infants And Children Under 18 Months Requiring Art In Situations Where Virological Testing Is Not

Available (Multi-country study with African Network for Care of Children Affected by HIV/AIDS (ANECCA).

Expected Timeframe of Study (revised below):

Previous time frame

May-August 2007 Protocol development

September- October 2007 IRB approval

11.07- 11.2008 Study conducted

11.08-12.08 Data analysis

2009 Dissemination of results

New time frame

October - November 2007 Protocol development

December 2007 IRB approval

January 2008- February 2009 Study conducted

March 2009 - April 2009 Data analysis

June 2009 Dissemination of results

Funds: CDC funded

Local Co-investigators: EGPAF/KCMC

G. Kinabo 1,2

M.Swai 1,2

W. Schimana 1,2,3

D. Tindyebwa 3

1. Kilimanjaro Christian Medical Centre (KCMC), Moshi

2. Kilimanjaro Christian Medical College, Tumaini University, Moshi

3. Elizabeth Glaser Pediatric AIDS Foundation Tanzania

Project Description:

The study aims at validating the WHO clinical criteria for presumptive diagnosis of severe HIV disease in

infants and children under the age of 18 months in situations where virological testing is not available. The

design will be cross-sectional, correlating the presence of the WHO clinical criteria for presumptive

diagnosis of severe HIV disease requiring ART with the actual HIV-infection status (by polymerase chain

reaction (PCR) and ART eligibility by CD4 percentage, among the study subjects. This study aims to

determine whether this clinical algorithm should continue to be used and further scaled-up or whether it

requires modification.

Status of Study:

The second draft of the protocol has been developed and circulated among the investigators. This is a multi

-centre study with ANECCA with other centres in Malawi and Kenya. The ANECCA research advisory board

is currently reviewing the protocol. There have been some delays associated with protocol refinement and

multi-country co-ordination of approaches. The time frame has been rescheduled within a no-cost

extension.

Site selection is now under discussion.

The sites will be selected based on volume of patients seen, and availability of clinicians that can be trained

to uniformly examine children according to the protocol. Thus KCMC in Tanzania, Kisumu General Hospital

in Kenya and Lilongwe Hospital in Malawi are likely sites. A sample of 372 HIV positive children below the

age of 18 months need to be identified overall; 150 from KCMC in Tanzania. This sample is based on the

assumption that the sensitivity of clinical algorithms in predicting presence of advanced or severe HIV

disease in children under the age of 18 months is 70% . According to studies in Uganda suggesting HIV

prevalence rates of 15% in sick children, we estimate that 1000 sick children will require polymerase chain

reaction (PCR) screening to identify our sample of 150 HIV positive sick children.

Lessons Learned: Does not apply yet

Information Dissemination Plan:

Results will be disseminated locally and at national meetings. Within ANECCA the results will be reviewed

by the Technical Committee composed of child health and pediatric HIV care and programming experts

from the WHO (Afro and Geneva), CDC, UNICEF, USAID and ANECCA. Dissemination will be carried out

with assistance from members of this committee through publications, review of guidelines and issuing of

advocacy statements.

Planned FY 2008 Activities: data collection, data analysis, report writing and dissemination of results.

Budget Justification for FY 2008 Monies: no additional budgetary requirements.