This is a continuing activity from FY 2007. No narrative required.

This is a continuing activity from FY 2007.

Columbia began providing basic palliative care to 28,000 PLHIV at 46 sites. Palliative care services in FY

2008 will continue including clinical staging and baseline CD4 count for all patients, follow-up CD4 every six

months, management of OIs and other HIV-related illnesses, including OI diagnosis and treatment, and

routine provision of CTX prophylaxis for eligible adults, children and exposed infants based on national

guidelines, basic nutritional counseling and support, positive living and risk reduction counseling, pain and

symptom management, and end-of-life care. In addition, Columbia will continue to provide psychosocial

counseling including counseling and referrals for HIV-infected female victims of domestic violence. To

ensure comprehensive services across a continuum, Columbia, through the partnership with CHAMP and

other community services providers, refers patients enrolled in care to community-based palliative care

services based on their individual need, including adherence counseling, spiritual support, stigma reducing

activities, OVC support, IGA activities, and HBC services for end-of-life care. Through SCMS, Columbia will

provide diagnostic kits, CD4 tests, and other exams for clinical monitoring, and will work with SCMS for the

appropriate storage, stock management, and reporting of all OI-related commodities.

In FY 2008, Columbia will expand its services to provide palliative care for 28,000 existing patients and add

an additional 4,646 new patients at 46 existing sites and 10 new sites, including 46 ART sites and 10

TC/PMTCT sites. Expanded services will emphasize on quality of care, continuum of care through

operational partnerships, and sustainability of services through PBF. Strengthened nutritional services

through training and provision of nutritional care will include counseling, nutritional assessments using

anthropometric indicators, and management of malnutrition through provision of micronutrient and

multivitamin supplements, and links to Title II food support for clinically eligible PLHIV and children in line

national nutrition guidelines. Columbia will also support referrals for all PLHIV and their families for malaria

prevention services, including for the provision of LLITNs, in collaboration with CHAMP, GFATM and PMI;

and referral of PLHIV and their families to CHAMP CBOs and other community-service providers for

distribution of water purification kits and health education on hygiene. In addition family planning education,

counseling and methods will be provided to PLHIV and their spouses. This service will be located within the

counseling unit of the site to reduce need for referrals.

Strengthened psychological and spiritual support services for PLHIV at clinic and community levels will be

done through expanded TRAC training in psychological support for all Columbia-supported health facilities

and community-based providers, including GBV counseling, positive living, and counseling on Prevention

for Positives.

In addition the Ministry of Health will implement a new community health policy in FY 2008. The policy calls

for the election of male and female leaders for every 100 households to lead community health activities,

organize other community volunteers into associations and supervise their activities. Columbia will support

56 facilities to train, equip, and supervise 20 community health leads per health facility, in addition to other

health care workers, reaching a total of 1,254 health workers trained. These community health workers will

organize periodic meetings to ensure quality and coverage of community-based HIV services and linkages

between community and facilities. The facility-based case managers, community health leads and

community based services providers constitute an effective system that ensures continuum, coverage and

quality of palliative care.

In order to ensure continuum of HIV care, Columbia in collaboration with CHAMP, will recruit case

managers at each of the supported sites. These case managers, with training in HIV patient follow-up, will

ensure referrals to care services for pediatric patients identified through PMTCT programs, PLHIV

associations, malnutrition centers, and OVC programs. To do this, the case managers will have planning

sessions with facilities and community-based service providers and OVC services providers for more

efficient use of patient referrals slips to ensure timely enrollment in care and treatment for children

diagnosed with HIV/AIDS. Columbia -supported sites will assess individual PLHIV needs, organize monthly

clinic-wide case management meetings to minimize follow-up losses of patients, and provide direct

oversight of community volunteers. The community volunteers will be organized in associations motivated

through community PBF based on the number of patients they assist and quality of services provided.

Columbia will work with CHAMP to develop effective referral systems between clinical care providers and

psycho-social and livelihood support services, through the use of patient routing slips for referrals and

counter referrals from community to facilities and vice versa. Depending on the needs of individuals and

families, health facilities will refer PLHIV to community-based HBC services, adherence counseling, spiritual

support through church-based programs, stigma reducing activities, CHAMP-funded OVC support, IGA

activities (particularly for PLHIV female and child-headed households), legal support services, and

community-based pain management and end-of-life care in line with national palliative care guidelines.

Increasing pediatric patient enrollment is a major priority for all EP clinical partners in FY 2008. To expand

quality pediatric care, Rwanda's few available pediatricians will train other clinical providers, using the

innovative model developed in FY 2006 and continuing in FY 2007 and FY 2008. Columbia will support

health facilities to refer HIV-infected children to OVC programming for access to education, medical, social

and legal services. Columbia will also support sites to identify and support women who may be vulnerable

when disclosing their status to their partner, and include in counseling the role of alcohol in contributing to

high-risk behaviors. Case managers will conduct regular case reviews with other partners included in the

referral system to review the effectiveness of the system, identify challenges and design common strategies

to overcome any barrier to pediatric patients routing between services. In addition, adult patients enrolled in

care will be encouraged to have their children tested and infected ones taken to HIV care and treatment

sites.

PBF is a major component of the Rwanda EP strategy for ensuring long-term sustainability and maximizing

performance and quality of services. In coordination with the HIV PBF project, Columbia will shift some of

their support from input to output financing based on sites' performance in improving key national HIV

performance and quality indicators. Full or partially reduced payment of palliative care and other indicators

is contingent upon the quality of general health services as measured by the score obtained using the

standardized national Quality Supervision tool.

In the context of decentralization, DHTs now play a critical role in the oversight and management of clinical

and community service delivery. Columbia will strengthen the capacity of four DHTs to coordinate an

effective network of palliative care and other HIV/AIDS services. The basic package of financial and

Activity Narrative: technical support includes staff for oversight and implementation, transportation, communication, training of

providers, and other support to carry out key responsibilities.

This activity addresses the key legislative areas of gender, wrap around for food, microfinance and other

activities, and stigma and discrimination through increased community participation in care and support of

PLHIV.

In FY 2007, Columbia began implementing the national TB/HIV policy and guidelines at their 46 supported

sites including two state prisons. The program's achievements include an improvement in the percentage of

TB patients tested for HIV from less than 70% to 90% and improving HIV-infected TB patient's access to

HIV care and treatment (increased proportion of patients accessing cotrimoxazole and ART).

In FY 2008, the goal is to ensure at least 95% of all TB patients are HIV tested, and 100% of co-infected

patients receive cotrimoxazole, and 100% of those eligible will receive ART. At 10 MCAP-supported PMTCT

and HIV care and treatment sites, 95% of 40,800 patients enrolled in HIV care will be routinely screened for

TB. However, lower than expected numbers of PLHIV in care and treatment are diagnosed and treated for

TB. The priority in FY 2008 will be to expand implementation of regular TB screening and for all PLHIV, and

for those with suspect TB, ensuring adequate diagnosis and complete treatment with DOTS.

In FY 2007 Columbia supported training in routine recording and reporting for the national TB/HIV

programmatic indicators. Initial uptake and quality of services has been variable at different sites. In FY

2008, Columbia will support individual sites to both collect quality data, and to report and review these data

in order to understand and improve their program and support integration of TB and HIV services at the

patient and facility level, per national guidelines. Additionally, in FY 2007 two staff from each of the seven

supported district underwent initial respiratory infection control training and have begun drafting infection

control plans and one is being implemented at a district hospital.

HIV services are not yet available at all facilities in Rwanda. In order to ensure effective integration of TB

and HIV, Columbia is supporting integrated planning and TB/HIV training to both HIV services providers and

TB services providers. It also plans to increase support to integrate diagnostic services, including

coordinating specimen transport for both programs and patient transport for appropriate diagnostic services

(such as chest radiography and diagnostics required for extra pulmonary TB) to referral centers and

appropriate follow-up.

In FY 2008, Columbia will continue to support 46 existing sites and add 10 new sites for the implementation

of the TB/HIV component of the clinical package of HIV care. This activity reflects the ideas presented in the

EP five-year strategy and the Rwandan National Prevention Plan by advancing the integration of TB/HIV

services through the operationalization of policies and increased coordination of prevention, counseling and

testing and care and treatment services. Lessons learned from integrating TB and HIV will serve in

integrating HIV into the primary healthcare.

This activity is continuning from FY 2007. No new narrative is required.

Noted April 24, 2008: This activity has been abandonned.

With these funds Columbia MCAP in collaboration with CDC, TRAC and clinical partners will conduct a

targeted evaluation of the causes of deaths of a representative sample of patients enrolled in HIV care at

selected health facilities in Rwanda.

Title of study: A descriptive analysis of the causes of death in patients enrolled in HIV care in Rwanda

Time and money summary: $200,000 for a total duration of 12 months

Local Co-investigator: The study will be conducted by Columbia University and TRAC in collaboration with

CDC, and clinical partners providing HIV services in Rwanda.

Project description: In both resource rich and poor settings, access to ART significantly increases the

survival of HIV-infected patients, prevents OIs, and delays the onset of AIDS stages 1-6. However, high risk

of mortality has been observed among ART patients in resource-poor settings, especially during the first few

months after ART initiation, compared to those in resource-rich settings. The risk of death increases during

the first 6 months after starting ART, then it decreases continuously thereafter. About two-third of the early

deaths are observed during the first three months after starting ART. In a study among ART-naïve patients

enrolled in a community-based ART program in South Africa, the mortality rate (deaths per 100 person-

years) was 35.6 at 1 month before starting ART, and access to ART resulted in a significant decrease in the

mortality, to 17.5 at 4 weeks, 6.2 at 6 months, and 2.7 at 9 months, after ART initiation. Advanced HIV

disease at enrollment and the occurrence of OIs (e.g. mycobacterial infection/tuberculosis) were identified

as the causes for the increased risk of mortality during the first months after starting ART. The risk of death

was significantly associated with WHO clinical stage of disease and blood CD4 cell count at baseline.

While CD4 count, clinical stage and OIs like tuberculosis are predictive of increased risk of mortality among

patients on ART, routine data collection has found deaths both in patients on ART and pre ART. This raises

issues of medical follow-up, lack of adherence to treatment and family and community support and delay in

enrollment on ART.

The number of patients on ART in Rwanda has increased from 17,000 in December 2005 and reached

40,768 by the end of July 2007. It is expected that 64,226 patients will be on ART by December 2007.

National data shows a cumulative death rate of around 7% among patients on ART. But an analysis of the

ART outcomes, particularly in terms of survival and circumstances of death among HIV-infected patients on

ART (which is currently being conducted) would be substantially enhanced by inclusion of controls (ART

patients who do not die) as a comparison group.

Evaluation question:

Hypothesis: When compared with PLHIV in care and ART who are alive (controls), PLHIV in care and on

antiretroviral therapy (ART patients) who died within the 12 months of enrollment (cases) are less likely to:

1. Live closer to ART site

2. Have CD4 count testing at regular intervals

3. Have antiretroviral drug (ARV) regimen changes

4. Have home visits and adhere to treatment

5. Receive social support services in family and through PLHIV associations

6. Receive care from a health facility that offers a comprehensive package of care

7. Have diagnosed and timely treated concurrent TB respiratory infections

Research question(s):

1. When does death occur in pre-ART and ART patients?

2. What factors are associated with mortality among ART patients?

3. What factors are associated with mortality among pre-ART patients enrolled into care?

4. Is there a significant difference in mortality and the causes thereof between pre-ART and ART patients?

5. What is the association between CD4 cell count testing at regular intervals, ARV regimen changes,

distance from clinic, support from family, communities and PLHIV support group, home visits, and mortality

among ART patients?

Programmatic importance/anticipated outcomes:

This evaluation will utilize routinely collected data from Rwandan HIV care and treatment sites on patients

who are enrolled into care and treatment. The result of the data analysis will be used by HIV program

implementers and the Ministry of Health's Treatment and Research AIDS Center (MOH/TRAC) for program

evaluation and improvement. It will provide expedient and essential data to the MOH/TRAC and other

partners regarding the performance of the national HIV care and treatment program and facilitate

prioritization of limited resources for program improvement. Knowing mortality predictors will guide the

design of interventions that decrease mortality rates among PLWA receiving care and treatment.

Methods:

A retrospective chart abstraction will be used. Additional information will be collected at home to understand

the circumstances of death, adherence issues, etc. A case-control methodology will be utilized for analysis

of the data. One case will be selected for three controls in ART patients and six controls in the pre-ART

patients respectively. A statistically representative sample of ART-naive PLHIV who initiated ART between

October 1, 2004 and at least one month prior to the date of data abstraction, and who are known to have

died within the first 12 months of enrollment will be considered cases. A statistically representative sample

of ART naive PLHIV who initiated ART in the same month as cases and who have similar baseline WHO

clinical stage as cases and were not known by the health care facility to have died, and who initiated ART

between October 1, 2004 and at least one month prior to the date of data abstraction will be included as

controls.

A statistically representative sample of pre-ART PLHIV who enrolled into care between October 1, 2004 and

at least three months prior to the date of data abstraction, and who are known to have died will be

considered cases. A statistically representative sample of pre-ART PLHIV who have similar baseline WHO

clinical stage as cases, were enrolled in the same month and were not known to have died by the health

care facility, and who enrolled into care between October 1, 2004 and at least three months prior to the date

Activity Narrative: of data abstraction will be included as controls.

For any single case, the controls will be selected from patients with similar WHO clinical stage who initiated

ART (in the case of ART controls), or enrolled into care (in case of the pre-ART patients) two months before

or after the corresponding date for the case.

Study Population: HIV patients enrolled into care or on ART who die and their controls who did not die.

Sample size calculation:

A representative sample will be calculated considering a power of 80%, 95% confidence interval, and

considering a relative risk of death at 2 and alpha value at .05.

Inclusion criteria:

For the ART patients:

1) Cases: ART naive PLHIV who initiated ART between October 1, 2004 and at least one month prior to the

date of data abstraction, and who are known to have died by the health care facility or after home visits

during the first 12 months after ART initiation.

2) Controls: ART naive PLHIV who have similar baseline WHO clinical stage of disease as cases, were not

known to have died by the health care facility, and who initiated ART between October 1, 2004 and at least

one month prior to the date of data abstraction.

3) Matching criteria: There will be three controls per case. Cases and controls will be matched by 60 days

before or after date of ART initiation and on WHO clinical stage of disease.

For the pre-ART patients

4) Cases: Pre-ART PLHIV who enrolled into care between October 1, 2004 and at least three months prior

to the date of data abstraction, and who are known to have died by the health care facility or after home

visits during the first 12 months after enrollment into HIV care.

5) Controls: Pre-ART PLHIV who have similar baseline WHO clinical stage of disease as cases, were

enrolled the same month, were not known to have died by the health care facility, and who were enrolled

between October 1, 2004 and at least one month prior to the date of data abstraction.

6) Matching criteria: There will be six controls per case. Cases and controls will be matched by 60 days

before or after date of enrollment and on WHO clinical stage of disease.

Exclusion criteria: the exclusion criteria include one or more of the following conditions:

1) Non-enrollment into the care and treatment program.

2) Starting ART before October 1, 2004 or less than one month before the date of data abstraction in case

of the ART cases and controls; or enrollment into care before October 1, 2004 or less than three months

before the date of data abstraction in the case of pre-ART patients.

Site selection:

Sites selected will have been offering HIV care and treatment services by July 1, 2008. Also sites with a

large number of patients enrolled into care and in ART by the July 1, 2008. Sites will be stratified to account

for rural-urban distribution.

Information Dissemination Plan:

The results from this study will be disseminated to Ministry TRAC, TB program and reference laboratory, the

clinical partners and districts health teams. The results will inform planning and quality improvement

interventions for HIV care.

Budget justification

This will be finalized.

This is a continuing activity from FY 2007. No narrative required.

This is a continuing activity from FY 2007.

In FY 2008, Columbia will continue its TA and capacity building activities at NRL by supporting technical

activities as well as strengthening the institutional infrastructure and management capacity critical to sustain

the national network of laboratories for the Rwandan HIV care and treatment program. Direct TA will

continue to be provided through long-term advisors and periodic short-term consultants as needed. Two

long-term technical advisors positions will be continued in FY 2008. The first provides support for HIV-

related quality laboratory services, including evaluations of new technologies, technician trainings, and

guidance on technical and policy issues. The second advisor, a local-hire senior lab technician, will remain

responsible for development and implementation of national standards, QA systems, and training. These

two technical advisors will continue to transfer skills, knowledge and capacity, ensuring a sustained impact.

In FY 2008, Columbia will continue to improve NRL's laboratory management through support of an

international-hire management advisor. The laboratory management advisor will help develop management

systems for finances, logistics, program data, transport and commodities and will mentor the new NRL

Director and Finance position funded under the CDC cooperative agreement. The management advisor

position continues to be critical in strengthening NRL's capacity to effectively manage multiple projects and

multiple streams of funding, including substantial EP resources. Columbia will continue through these

technical and financial positions to support the decentralization of NRL supervision and QA within the

national laboratory network. This decentralization will include continued strengthening of the five regional

district laboratories. PCR for Early Infant Diagnosis and viral load determination will continue to be

supported at NRL and CHUB via equipment maintenance and staff training.

TB services at NRL continue to require strengthening to meet the EP priority of providing reliable AFB

microscopy at the health facility level. Columbia will continue to support laboratory TA to the NRL and

CHUB TB laboratories to ensure high quality smear microscopy, liquid culture and drug sensitivity testing

capability. These TB diagnostic and treatment capabilities are essential in order to provide PLHIV adequate

access to comprehensive quality TB-related services. These capabilities are also essential for the support

of patients with MDR TB. Extrapulmonary TB diagnostics will be available through continued support to

CHUB and CHUK anatomopathology laboratories.

ACM (Atelier central de maintenance) and NRL maintenance units for laboratory equipment will continue to

be strengthened with training and staffing to guarantee the quality of results within the national laboratory

network. Also, small laboratory renovation/rehabilitation will be performed to assure building sustainability

inside the national laboratory network.

Columbia will also continue to strengthen and integrate QA/QC/QI into all HIV-related laboratory areas:

serology, chemistry, hematology, CD4, TB, and malaria. New QA/QC approaches will continue to be

explored in those HIV specific areas. National specimen transportation systems will continue to be

strengthened. Specific laboratory target evaluations on new technical alternatives and new technologies will

be supported to improve the accessibility and reliability of care and treatment programs. For example, new

alternatives technologies will focus on specific HIV areas like, CD4 (dipsticks, micro-chips etc) or TB infants

diagnostics. Protocols and/or indicators should be designed to evaluate laboratory performance impacts on

care and treatment programs.

Columbia will continue to support laboratory staff skills development through local (KHI), regional and

international training programs, with an emphasis on integration of all HIV-related laboratory activities and

total quality management as part of the laboratory accreditation process. In collaboration with CDC,

Columbia will continue to maintain and improve the laboratory information system for NRL and will continue

to support the LIS extension at district hospitals. The laboratory information system will manage financial

record keeping, as well as specimen tracking, inventory control, and programmatic indicators.

All of these activities are consistent with Rwanda's EP five-year strategic goals of strengthening NRL's

capacity to manage a national network of laboratories, standardize technical approaches, and support QA

of HIV-related services throughout the national laboratory network.