THE CARE AND TREATMENT PLAN

• PART OFTHE FIRST STEPS TOWARDS PLANNING SCALE UP OF ART AT TREATMENT FACILITY.

• IT IS DEVELOPED DURING SITE PREPARATION.

• It is part of the components of the sequence that eventually empower a facility to provide care and treatment for clients. partnership commences.

• The Care and Treatment Plan will also help you design services in line with the goal, objectives and guiding principles of the Project .

• The facility should design a plan that is appropriate for it’s capacity and patient population.

• Developing this plan will assist you to write a budget, identify areas for capacity-building, make quality improvements to your program throughout the year, and coordinate activities.

• Who completes the Care and Treatment plan ?.

• Development of the Care and Treatment Plan requires a collaborative effort of personnel from many sectors of your treatment facility.

• Thus, it may be useful for the site to have a leader or key representative from the following areas as appropriate:

• (1) clinical; (2) laboratory; (3) counseling and/or adherence support; (4) community-based health programs; (5) pharmacy; (6) medical records; and (7) finance and administration.

• IHVN Members of staff are available to provide technical and programmatic input during the process.

• The C and T plan consists of 8(eight parts) as listed on the next slides

• Part 1: Project Overview: Structure and Management of Care

• 1.1 Treatment delivery model

• 1.2 Human Resource Management

• 1.3 Identifying target populations for ART

• 1.4 Patient Enrollment Projections

• 1.5 Continuity of Care

• Part 2: Medical Care under the ART Program• Part 3: Strengthening your adherence

program• Part 4: Community Mobilization and Support

for ART• Part 5: Preparing your Laboratory for ART• Part 6: Preparing your Pharmacy for ART• Part 7: Strategic Information planning• Part 8: Financial systems preparation

• How to complete ?:• While some sections of the Care and

Treatment plan are crucial for planning the site annual budget, other sections can be developed on an on-going basis throughout implementation.

• It is recommended that a team of key personnel discuss part 1 in detail before completing the budget

• Then, the key personnel should familiarize themselves with the section that pertains to their specialty (e.g. laboratory), identifying essential activities that will impact the site budget

• Key personnel can continue leading on-going discussions with other relevant staff to complete the Care and Treatment Plan over time.

• Resources: The following documents may assist you in planning:

• Existing site policies and procedures

• National and international ART guidelines and strategy documents

• IGT (the site assessment tool)

• Part 1: Project Overview: Structure and Management of Care– Treatment Delivery Model

we recognize that no single ART delivery model has been validated as optimal for universal use in resource-constrained countries Therefore, the project supports treatment delivery modalities and solutions identified by the site that integrate into existing health care infrastructure, operate within national/international guidelines, and can achieve long-term programmatic success

Examples of treatment delivery models used include:

• Hospital-based services provided through the out-patient department.

• Home-based care centers.• Mobile VCT programs. Throughout the duration of the project,

measured program success of individual approaches will be linked to prioritization for program replication, expansion, and broader scale.

• Planning questions:• Identify your Treatment Delivery Model: • Please discuss with your team the treatment

delivery model that your site plans to implement and write a brief description. We also recommend drawing a framework (e.g. with boxes and arrows) of your program to illustrate how the components will integrate into the existing health care infrastructure. Please include entry points to care as well as community support services in the description and framework.

• 1.2 Human Resources Management:• Human resource capacity is a major constraint to scaling

up comprehensive HIV/AIDS care and treatment. An ARV treatment plan that calls for significant additions in physician or nursing staff to expand the healthcare system capacity in order to provide quality care and treatment to PLWHA by definition will not be scalable.

• It will be especially challenging to ensure that the necessary HIV/AIDS clinic workers are found without weakening the healthcare structure for other diseases by pulling workers out of existing programs.

• Therefore, to strengthen the ART program, local community members will need to be recruited and trained in the details of adherence to antiretroviral and recognition of medication side effects. Once adequately trained, these new ancillary healthcare workers from local communities can dramatically increase the potential of a single physician or clinical officer to deliver ARV to their surrounding communities

• Planning questions:• 1.Identifying the ART Team: • Please describe the structure of the ART team

in full detail, defining the roles and responsibilities of each member.IHVN encourages the site to make an organizational chart.

*Please refer to the programmatic budget guidance for additional information regarding staff structures.

• Members of the team• Name of the person who will be coordinating

activities Responsibilities with regards to ART• Project Coordinator• Medical Officers and/or Clinical Officers. • Nurse.• Adherence counselors/Treatment Support Specialists• Community Volunteers• Pharmacy Staff.• Strategic Information staff (M&E, data entry staff, etc)

• Laboratory staff

• Finance

• 2 Human Resource Management: • Describe the LPTF plan for hiring, retaining, and

training site and community staff.• How will you recruit new staff?

– Advertise and call for interviews not at present but as the programme expands.

– How will you retain existing staff? • Integration into hospital scheme

– What is your plan for training current and new staff, including community volunteers?

• E.g. Capacity building from donors• E.g. In-house training by hospital

– Step down training from those who have benefited. *Please refer to the programmatic budget guidance on training for information about the types of training that IHVN will provide.

• 1.3 Identifying target populations for ART-

Planning question:

1.Target population:

Please list the sub-groups of the population targeted by the site for ART care and Treatment.

• Sub-groups of population that ART program will targetExample:HIV positive children,Youths,Pregnant Women, People Living with HIV / Support Group.

• Inclusion Criteria :

• Please discuss with your team the medical and non-medical inclusion criteria that your site plans to implement . Please ensure that your criteria operate within the National HIV/AIDS guidelines and strategy for Nigeria.

• Items to consider for medical criteria: clinical criteria, immune staging criteria, asymptomatic pregnant women, etc.

• Items to consider for non-medical criteria: demonstrated motivation to enter care, disclosure status, substance abuse, family support, geographic criteria, socio-economic criteria, etc.

3.Patients on waiting lists for ART

• If your site has a waiting list of patients eligible for ART, what determines the order that patients are moved off the waiting list and placed on ART (assuming that all patients cannot be started on ART at once)?

• 1.4 Patient Enrollment Projections• Please complete a table for patient

enrollment per month for the next year.• To achieve and maintain these outcomes,

consider the human resource capacity at the site, the number of ART clinic days, the number of outreach days, and the community capacity for follow-up and adherence monitoring.

• Months

• Number of adult patients initiated on ART per month of the year.

• Number of pediatric patients initiated on ART per month of the year.

• Eg,10 for jan,15 for feb,25 for march etc

• 1.5 Continuity of Care • Antiretroviral therapy for AIDS has the ability to

transform AIDS from a fatal acute infection to a long-term chronic condition. This transformation requires a programmatic shift from provision of acute care to a model of chronic care at many sites. Several components of the treatment model will directly support continuity of care, such as integrating the ART program into holistic HIV/AIDS approach, strengthening health care networks, expanding community mobilization.

• Regular ART team meetings• Sites are strongly encouraged to hold regular (e.g. twice

monthly) coordination meetings with key ART staff involved in patient care, including clinical officers, treatment support specialists, pharmacists, home-based care coordinators, etc.

• At the meeting, the team discusses patient cases one by one in order to coordinate care plans specific to each patient. Due to time constraints, the team may decide to discuss only certain patients, such as patients in a specific catchment area, patients with adherence problems, patients preparing to start or to re-start ART, etc.

• For each patient, the staff makes a clear follow-up plan based on the following:

• What are the causes of any adherence problem that this patient is experiencing?

• how can the team help this patient succeed on ART?• Is the problem serious enough to consider either

changing the patient’s regimen or stopping the ARVs altogether until the problem is resolved?

• What follow up actions are necessary? Who is responsible? By when?

• The team also provides oversight of equitable access to care, including selection of patients who will commence ART according to criteria and specific target groups

• 1.5.1 Patient flow: Monitoring patients on ARVs• Please describe all of the steps that will be followed in

the first year to support a patient on ARV therapy to ensure continuity of care by making a flowchart illustrating the care of one patient over the course of a year.

• Include the following details in the patient flow:• Entry of the person into care (what departments or

organizations refer patients to AIDS care and treatment services—e.g. VCT, PMTCT, TB clinic, etc)

• Initial clinical evaluation (where and by whom) • Eg:next slide

• VCT, PMTCT, TB Clinics

• Medical Officer’s evaluation

• CD4 Test

• Medical Officer’s evaluation criteria for ART

• Treatment preparations (A/O, Counsellors)

• 1.5.2. Coordination of patient care and communication flow

• Please plan how staff will communicate patient appointments and follow up. Consider the protocol to be followed in specific situations, such as four examples outlined below:.

A clinician decides to switch a patient’s regimen. How will this decision be communicated to the rest of the ART team, in particular to the adherence counselors (treatment support specialists)? Who will inform the community volunteer that supports the patient?

a. How will the ART team track what patients have missed appointments? How will the team follow up patients who have missed medical or adherence appointments? Please give a specific answer (e.g. who, when, how).

b. The ART team at the site discovers that a patient has adherence problems and needs more support. How and when will the ART team inform a community volunteer to follow-up with this patient?

a. A community volunteer discovers that a patient has adherence problems. How and when will the community volunteer inform the site staff about the problems faced by this patient? Who on the ART team will the community volunteer inform?

• Part 2: Medical Care under the ART Program

• Please follow your country’s National ART Guidelines when completing this section. IHVN clinical technical officers will work with the site to complete this section.

• 2.1 Treatment Regimens• How do you determine if someone is

clinically eligible.eg CD4<350.• Regimens : 1st line regimen. Alternate 1st line. regimen for pregnant women. regimen for TB patients.

• 2.2 Safety Monitoring:• Please describe how the program will

monitor for toxicity in patients who recently initiated ART. e.g. weekly appointments for the first two weeks.

• How often will patients be monitored for toxicity in the short term?

e.g. weekly appointment for the first 2 weeks.

• How often will patients be monitored for toxicity over the long term?.

• Who will monitor the patient for toxicity? E,g pharmacist.

• Please describe how the program will monitor and address side effects of specific drugs, including nevirapine, d4T (stavudine), Alluvia, and efavirenz

• 2.3 Laboratory Monitoring• Detail a proposed schedule for immunological and

other laboratory tests required for enrollment and monitoring.

• Refer to programmatic budget guidelines for information about what kinds of laboratory tests should be included in your site budget. Viral load testing is not readily available in many sites.IHVN will conduct viral load measurements to validate programmatic success and to determine some individual patient response to therapy.

2.4 Linking ART to PMTCT

• Many sites are currently providing PMTCT services, which are natural starting points for initiating ART to women in the 3rd trimester of pregnancy, to newborns, and to their families. Plan with members of your site team how the ART program will coordinate care of women and families between the PMTCT and ART programs.

• Questions to discuss include the following:• How will the site screen and enroll pregnant

women into the ART program?• How will care be coordinated for pregnant

women participating in both the PMTCT and ART programs?

• How will staff communicate with one another about patient care? (e.g. Will the patient medical record contain information from both services?)

• How will the mother receive follow-up care after delivery (where, how often, who follows up?)

• How will the child receive follow-up care after delivery? (where, how often, who follows up?)

• Part 3: Strengthening your Adherence program (preamble)

• Giving the patients the best chance to achieve success on their first line regimen is critically important, especially in light of limited viral load monitoring and limited second line treatments. In order to achieve and maintain durable viral suppression, patients must take their ARV regimen greater than 95% of the time.

• Several psychological, social, and physical factors can influence patient adherence behavior. To address these factors, the site can strengthen specific components of the adherence program that have been shown to impact patient adherence :next slide

• implementing on-going patient treatment preparation and adherence education

• increasing the technical competence of ART program staff regarding adherence monitoring

• promoting positive interpersonal relations between the patient and the ART program staff

• integrating adherence support services into other services

• ensuring continuity of care • expanding community participation in adherence

support activities.

• Multiple strategies to support adherence can be utilized depending on each site’s and community’s needs. Developing human resources as “adherence specialists” can be accomplished through the training of community members, hospital staff, or even patients’ family members or guardians. Once adequately trained, these new ancillary health workers can dramatically increase the potential of a single physician or clinical officer to deliver ARVs to their surrounding communities.

• Site Planning Questions• 3.1 Treatment Preparation• Please outline the treatment preparation

plan, listing specific steps that a patient will need to fulfill before starting ARVs. The treatment preparation plan should prepare the patient to adhere to ARVs and should allow the staff to determine if the patient is able to be adherent to ARVs.

• Specifically address how the following activities will be conducted and by whom:

• Patient education about ART, adherence, and resistance

• Patient education about side effects and toxicity

• Identification of treatment supporters

• Adherence “trials” with non-ART medication (e.g. OI prophylaxis, vitamins, etc)

• Discussion of the patient’s daily schedule and identification of a dosing schedule

-Find out about occupation, social life and find out any limiting factor

• 3.2 Monitoring adherence of patients on ARVs

• Who will be responsible for monitoring patient adherence ?

• What methods will be used to monitor adherence levels of patients?

• What materials or tools will be used to record patient adherence?

• 3.3Patient Education:

• Please identify how your site can establish or strengthen existing patient and community education opportunities.

eg support group,TSS,Pharmacist.

• Part 4: Community Mobilization and Support for ART (preamble)

• By integrating ART services into treatment networks and community activities on the continuum of HIV/AIDS prevention, care, and treatment, sites are positioned to take a holistic approach to addressing HIV/AIDS.

• To obtain buy-in from the community, the site should consider holding meetings with general community members, People Living with HIV/AIDS, and community leaders to plan the community component together. Facilities may form a Community Advisory Board, which provides important feedback to the

site from the community regarding implementation and planning of programs.

• Site Planning Questions

• 4.1 Community responsibilities:

How aware is the community about the AIDS services at your site, including ART?

What role does the community see themselves filling to support the ART program?

How will your site support the community in their responsibilities? (e.g. resources, education, training, incentives, recognition, etc)

What other roles does the site hope to build within the community in supporting the ART program, specifically the adherence support component?

4.2 Community mobilization and stigma reduction

• Please outline the steps that your site will take this year to achieve the Crosscutting issue of:

“Community mobilization promotes an increased awareness of

accessible and affordable programs and reduces stigma”

• 4.3 Monitoring your community program :

• Please discuss how you will monitor and evaluate the following :Quality of adherence counseling and follow-up by community volunteers

Quality and impact of community mobilization activities,eg by doing comm. surveys to assess stigma etc.

4.4Creation of treatment networks:

• Please outline the steps that your site will take to achieve the objective :

“Health care treatment networks are created and strengthened to support capacity building within country and communities.”

e.g. hiring of network coordinators.

• Part 5: Preparing your Laboratory for ART

• Where will ART-related lab tests be conducted?:

• on-site

• off-site laboratory not located at the facility.

• For site conducting labs on-site at the facility:

• Have guidelines for infection control and waste management been implemented at your site? Establish sop for waste management.

• Have you identified a referral or back-up lab for CD4 and other tests? Establish one

• Do you have a forecasting and procurement plan for obtaining the necessary reagents? (Help site with forecasting tool and attach to C and T plan.)

• Have you implemented a quality assurance protocol for laboratory procedures and testing? IHVN lab to support this.

• Are there any physical resource needs identified during site assessment that need to be addressed (e.g. electricity, space, etc)? If there are,establish a mechanism to address this.

• * Quality assurance protocol for laboratory protocol and testing should include an equipment maintenance plan for laboratory equipment, quality control procedures/proficiency testing for staff, quality control procedures/routine maintenance for laboratory tests, and specimen tracking and accountability plan(IHVN lab to assist)

• Part 6: Preparing your Pharmacy for ART :

• Where will patients refill their AIDS medications:

• on-site at the facility

• off-site pharmacy not located at the facility.

• Pharmacy capacity-building activities:

• If applicable, have you made formal linkages to referral pharmacies off-site ?

• Are key staff working in the site pharmacy trained in ARV supply chain management ?

• Are there Standard Operating Procedures for drug procurement? If No link up with IHVN pharm. To develop one.

• Is there system for drug forecasting and supply chain management? If no IHVN pharm to assist.

• Is there a system for tracking drugs dispensed to patients enrolled in the ART program ? Dispensing tool.

• Is there a system for monitoring and reporting adverse drug reactions(pharmacovigillance).

• Does the site need to strengthen key Standard Operating Procedures (SOPs)? .If yes, link up with IHVN for support.

• Please list any skills-building topics required from IHVN to help your pharmacy staff .

• Part 7: Strategic Information Planning (preamble)

• The monitoring and evaluation component of an ART program provides accurate and timely data to measure the effectiveness of the ART program in producing optimal patient outcomes, to measure the site’s contribution to the national ART response, and to measure IHVN project’s contribution to the goals of the President’s Initiative.

• The general requirements of an HMIS system are the following:

• The system captures the data needed to provide monitoring reports to the various stakeholders, including the Ministry of Health and PEPFAR reports required by the donor representative and the Office of the Global AIDS Coordinator (OGAC).

• The system can be easily re-programmed to accommodate any changes in these donor reporting requirements

• The system can capture, or be programmed to capture, the clinical data needed byIHVN for quality assurance/quality improvement purposes

• Site Planning Questions:

• What kind of HMIS system does your site prefer to use?

Paper-based system

Computer-based system

Other (specify) --------------

• What paper forms will the site use? Does your site plan to use any of the IHVN paper M&E forms? (The IHVN clinical encounter forms are encouraged, but not required. If other forms are used, they must be able to fulfill reporting requirements. )

• How will patient (paper) files be stored to ensure confidentiality? Do you have enough storage capacity to accommodate patient (paper) files.

• Please outline the plan for harmonization of the forms to capture information required for:

• monitoring reports to the various stakeholders

• clinical data needed by IHVN for quality assurance/quality improvement purposes

• Please discuss plans for an automated patient management system, if available or supported through IHVN. In answering this question, please consider the issues below if applicable:

• Plans to obtain administrative or political buy-in

• Plans to hire data manager or administrator

• Plans to train data entry staff to use electronic patient management system;

• Computers designated for M&E with hardware specifications ;

• Other IT Capacity, Policies, and Procedures

• Local IT vendor service

• Part 8: Financial systems preparation• Have corrective actions been taken in

response to findings from the last audit of the site? (Audit should have occurred within the last 12-18 months.)

• Does the site have a method for separately tracking funds from different donors? (e.g. has specific donor codes and/or separate bank accounts)

• Have the site finance and administrative staff been trained on the reporting requirements and accounting procedures of the project?

• Does the site have an accounting system that allows it to track/aggregate expenses based on type of expense?

• Does the site have a chart of accounts that enables the tracking of specific project cost categories used for the ART project (ie. Lab supplies, CD4 tests, specific lab equipment, HIV tests, training).

• Does the site have a system that enables the tracking of staff effort based on activity/project( use of time sheet)

• Does the site have an accounting system that enables the tracking of interest income (interest earned on funds when they are in the bank)?

• Does the site have an accounting system that allows it to track fees for service (program income) directly related to the ART project?

• Does the site have a system to track/ manage inventory, including medical inventory such as drugs and lab equipment as well as other equipment and supplies such as computers?

• Does the site have a written procurement policy that ensures competitive bidding, adequate support documentation, and appropriate approval/oversight?