National Organization

The franchise will be operated by a non-profit, non-governmental organization based in the United States . This ‘supra-franchise organization’ (referred to as Healthspot) will identify, recruit and support potential in-country National Franchise Organizations (NFO) through collaborating agencies. Where possible, more than one potential franchiser will be identified in each country, and the contract for country level management off the franchise will be awarded following a competitive bidding process. Where no potential franchisers exist, new non-profits will be created and registered.

Within each country, the organization of the franchise will follow traditional for-profit models, with the National Franchise Organization (NFO) contracting individual private providers, usually in one-person clinics, to operate under the brand of the franchise. The contracted exchange will normally provide sole rights to operate in a set geographic area to a franchisee. The franchise will work with private providers who are already operating in the target communities, thereby making use of existing investments in human resources, infrastructure, and existing clientele.

The franchiser will be a local or international non-governmental organization (NGO) with in-country experience at private sector mobilization for direct health service provision and proven capability in management and logistics. The franchiser may be selected through a bidding process, if multiple candidates are active in the target countries. If no appropriate existing NGOs are operating in a target country, Healthspot Franchise International (Healthspot) will collaborate with an international technical assistance organization, with experience in private provider mobilization, to open a new local NGO for the purpose of acting as NFO.

NFOs will be supported by the Healthspot through the provision of template clinical guidelines, training materials, and ongoing technical support. However, all national standards, guidelines, training, and quality supervision systems will be adapted through ongoing consultation between the NFO and the relevant national governmental implementation and regulatory programs. Specific NFO activities will include:

Standards

Enforcement of Healthspot standard operating and clinical operating procedures as set out in guidelines and manuals. These standards will detail requirements for client interaction, testing, treatment, facility equipment, signage, painting and cleanliness, drug sourcing, storage and pricing, and other aspects of clinic appearance and activity relevant to patient care.

Provider Selection

Identification and recruitment of providers in target area using Healthspot criteria of site selection (in non-adjoining low-income areas), provider training and skill levels, appropriate government registration, self-owned clinic, local reputation, interest, and ability to raise minimum initial joining fees.

Training

The NFO will be responsible for the training of the franchisees in accordance with Healthspot’s Human Resource Development (HRD) program, which will be a competency-based program. The NFO will first help conduct a needs assessment of the competency level of the private providers in a targeted area of the country. The NFO will work with Healthspot to use the results from this needs assessment to adapt the generic HRD program, which will be based on international and national standards. The NFO will also aid Healthspot in the initial field-testing of the adapted training materials.

The majority of training for new franchisee members will take place over the first 6 months. Initial training will include sessions on skills directly relevant to running the franchise. The franchisees will be trained to the required level of competence in the areas of franchise management, financial management and drug management. Within the first three months, the franchisee will complete training in Clinical TB and HIV (non ART) care. Training in ART delivery will occur once the franchisee is well established (an estimated 6 months after joining). All franchisees will complete a training module in working with the public health system and community. Upon completion of individual aspects of training, franchisees will be awarded Healthspot certification.

Continuing education and support will be a key responsibility of the NFO. Continuing education courses, developed by Healthspot and implemented by the NFO, will be offered through out the year. Refresher courses in TB, HIV and AIDS care will be offered as well as specialized session such as Information Management, Palliative Care in order to keep franchisee abreast of the most current developments. The NFO will provide support to the franchisee outside the training courses through a regular newsletter, on-site visits by physicians, a telephone network and regional meetings to promote learning and communication between franchisees.

Data collection

The franchiser will assure the validity of data on diagnosis, treatment for TB, on diagnosis and ongoing prophylaxis for TB/HIV patients, as well as collating data from all franchisee providers to add to national databases. With the start of ARV delivery, HIV anonymous testing numbers and results will be collected, as well as patient-level data to assure monthly accurate tracking of drugs allocated to specific patients.

Drug procurement and resale

All essential drugs approved for national provision will be sold through the NFO to franchisees. The NFO will purchase drugs in bulk, either on the open market, from local quality specialized wholesalers (e.g. MEDS, Crown Agents or the International Dispensary Association), from the UNICEF Procurement Services, or from the Global Drug Facility (GDF) in countries where TB drugs are not directly supplied by the government. Prices used in the budgets are best-verified available prices from these sources. Drugs other than TB and ARVs will be sold with a mark-up of 15% to franchisees. The mark-up is set to cover costs of purchase, storage, and transportation.

The franchiser will deliver all drugs directly to the providers during the pilot phase. When at scale, local secondary wholesalers may be contracted for this service.

TB drugs

Default treatment for first time TB infection is six months of observed treatment using a rifampicin-based combination therapy. In countries where national guidelines are still based upon two months of intensive rifampicin-based treatment followed by six months of continuation therapy, the use of six or eight month regimens will be negotiated with the national TB program (NTP). Multi Drug Resistant TB (MDR-TB) drugs will not be used, and cases of suspected or diagnosed MDR-TB will be referred to the NTP.

Where agreed with national governments, TB drugs will be supplied by NTP to the NFO, and given free-of-charge to franchisees, on the condition that clients receive drugs at no cost, paying only for consultations. A holdback fund, sufficient to purchase six months of supply for estimated TB drugs, will be retained for direct purchase on local or international markets (from the Global TB Drug Facility) should there be a breakdown in NTP supply for any reason.

Quality enforcement

The NFO will be responsible for ensuring that franchisees do not sell drugs other than those purchased from the NFO, or to charge more than the posted fee rate for consultations of any kind. To make this acceptable to franchisees, the NFO will guarantee to match or beat prices for equivalent drugs, and free ranges will be negotiated with the franchisees. Following agreement on pricing, enforcement will be strict, with infractions leading ultimately to expulsion from the franchise. The NFO will ensure that all prices, for drugs and services, will be prominently posted in all clinics at all times.

Enforcement of other standards noted above will also carry financial and membership-linked penalties and be checked by scheduled and unscheduled visits, as well as by mystery client visits through externally hired auditors.

TB Testing

The NFO will organize and oversee TB testing. The NFO will contract out testing to laboratories certified by the national TB program. Testing will use one of two systems: 1) referrals of patients to certified laboratories, or 2) provider collected samples that will be stored and transported to certified laboratories by NFO vehicles on a weekly schedule. The proximity, facility equipment, laboratory staff, and management capacity of the testing facilities available nearby each franchisee site will determine which of the two testing systems is used.

Voluntary Counseling and Testing for HIV (VCT)

In order to increase accessibility (critical to increasing use and lowering costs – Forsythe et al. 2002) tests and limited counseling will be provided by franchisees as soon as ART is available. If VCT services are locally provided through existing community organizations, ART will be offered at franchisee sites, but testing and counseling will not be offered, and instead referral systems to the existing VCT programs will be developed. Testing with limited post-test counseling, in a clinic setting, is currently accepted as an interim protocol in areas where full VCT is unavailable.

Anti-Retroviral Therapy (ART)

ART requires the same programmatic abilities as those needed for TB and non-ART HIV care: close and easy access to care in a well managed environment that assures ease of use, provides a framework for support during treatment, and tracks compliance. Healthspot will base its guidelines on WHO’s Guidelines for Scaling Up Antiretroviral Therapy in Resource-Limited Settings: Treatment Guidelines for a Public Health Approach (WHO, 2004).

The NFO will be responsible for the adaptation of Healthspot’s ART guidelines to the national setting in collaboration with the National AIDS Committee (NAC), Ministry of Health (MOH), and other local and international NGOs involved in delivery of ART. Where the Healthspot (and/or WHO) guidelines for ART conflict with national guidelines or drug selection, national guidelines will take precedence.

The NFO will aid in an ART delivery model with two phases. Phase one will introduce ART to population not reached by government or NGO clinics. It will have contracted doctors visit the franchisees’ clinics on a weekly or bi-weekly basis to initiate ART and discuss each client’s treatment regimen. Phase two will expand ART to a level beyond the doctor based initiation model. In this phase, clinical officers and nurses will initiate ART, where allowed by national guidelines. In both phases, counselors will be contracted by the NFO to provide counseling support to the clients. The NFO will ensure that the franchisees employ proper drug management. Where national guidelines dictate, the NFO may use pharmacy technicians, overseen by a central NFO pharmacist, for prescribing drugs. Please see the ART plan for more details. The details of ART delivery remains developed only at a high level because ongoing changes in the testing and drug supply for HIV/AIDS are expected to create significant changes before final implementation begins approximately 18 months after Healthspot’s funding is secured.

Marketing and Branding

The NFO will be responsible for developing overall awareness of the franchise. Furthermore, the NFO will ensure that the standard stipulated in the standard operating guidelines and manuals for brand placement are adhered to by the franchisees. Branding will be positioned to highlight general quality healthcare at affordable prices, underscoring linkages to international quality control programs.

Data collection and reporting to funders

The NFO will both collect data in-house and collaborate with Healthspot to assure objective external evaluations to communicate at regular intervals the status and effectiveness of the pilot. Measures will include diagnosis and entry to treatment rates, changes in nearby NTP rates of the same, treatment completion (cure) rates for TB, and equivalent measures for care of opportunistic infections in HIV/AIDS patients. Ongoing tracking of likely OI incidence will occur, as well as client-based record keeping for confirmed HIV patients. Patients on ART will have client-records at the franchisee site with regular copies transferred to the NFO and drug regimen tracking incorporated into national and international MIS systems.

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