Franchisee

Healthspot franchisees will be nurses and clinical officers operating their own private practice. Specialists will not be accepted, and MBBS doctors, while allowed to join, will be discouraged (4). There are two reasons for the focus on mid-level providers:

• the income from franchised services will be more important to mid-level providers giving the franchiser greater leverage over their behavior.

• mid-level providers are more likely to work in slums and rural areas which are the target populations for this intervention.

All activities undertaken by franchisees will be considered ‘branded services’ and fall under the quality assurance purview of the Healthspot Franchise International (Healthspot) and National Franchise Organization (NFO). Emphasis will be on diagnosis and care of Tuberculosis (TB) and common opportunistic infections, however, all areas of care will be included in the continuing education program, and Integrated Management of Adolescent and Adult Illness (IMAI) guidelines for first level facility health workers used as a basis for general care activities ( See Human Resource Development section).

Franchisee activities will include:

Testing

Following procedures stipulated in the training manuals, the franchisee will collect sputum samples for TB and, after the introduction of anti-retroviral treatment (ART), conduct quick-tests for HIV. A government-certified laboratory technician will analyze TB sputum samples in all cases. In all cases, the technician will be certified annually by the national TB program in accordance with Directly Observed Treatment Short-course (DOTS) criteria, and by the national AIDS committee (NAC) and/or national laboratory certification board.

Patients testing positive for pulmonary TB will be informed about available treatment from the national TB program and also offered treatment within the franchise. Symptomatic patients with negative smears will be retested. Symptomatic patients with a second negative sputum smear will be referred to the government DOTS program for an X-ray.

Patients testing positive for HIV will be given on-site counseling and, in conjunction with a supervising physician, evaluated for initiation of Cotrimoxazole Preventive Therapy (CPT) and Isoniazid Preventative Therapy (IPT), together with mother-to-child prevention and/or ART as appropriate.

Referrals

All patients will receive documentation and counseling regarding the availability of free diagnosis and treatment for TB and for HIV from the government and Non-Governmental Organizations (NGO), DOTS or Prevention of Mother To Child Transmission (PMTCT) programs.

Where Voluntary Counseling and Treatment (VCT) services are available, they will be advertised in franchisee clinics, and franchisees will not offer HIV testing. Where VCT services do not exist, the differences between VCT services and franchisee testing will be described, both verbally and in printed materials.

TB treatment

Pending agreement by the national TB Program (NTP) in each country, treatment for TB will use the World Health Organization (WHO)-recommended six-month regimen for first-time TB patients and an eight-month regimen for relapse patients. Simplified treatment using blister packed, combined dosages will be used where possible, decreasing the incentive to withdraw from treatment prematurely.

All drugs for TB will be free to patients. Patients will pay a one-time charge up-front for all consultations that will be needed during the course of treatment. No additional payments by patients for TB care will be required. Client surveys will be conducted regularly to identify problem providers, and to evaluate the overall efficacy of permitting extra-treatment payments during the six-month cure period. This policy will be reviewed annually. Pre-payment for all counseling will cost patients approximately $4.

Providers, or staff working for the providers, will deliver drugs on a weekly basis to the patient or an identified family member providing direct observation, as per the application of DOTS in sub-Saharan Africa . Relapse patients will be required to comply with direct observation as a condition of treatment.

In a second stage, links with local community groups for support and direct observation will be integrated to the franchise where such groups exist or community interest to create them is high. This is seen as particularly likely where franchisees are located in urban slums.

Record keeping will follow the structure of the national DOTS program, and will be a requirement of franchise membership. Paper-based records will be entered into the national Management Information System (MIS) through duplicate entry, scanning, or manual copying as set out in the design of the MIS.

Upon completion of the full six or eight-month course of treatment, verification of cure will be made at the expense of the franchiser by a contracted DOTS-registered laboratory. Clients will be paid $4 upon documented completion of treatment. Member provider will be paid a bonus of $15 for each cure. Verification processes will be developed to assure patient identity and both spot checks and overlap among verification supervisors will be used to minimize corruption.

HIV/AIDS prevention of opportunistic infections

The franchise will provide HIV testing, described above, and treatment of opportunistic infections with an emphasis on prophylaxis using IPT and CPT, both according to standard regimens as set forth by WHO (5) (6). As with TB treatment, IPT and CPT will use the simplest drug combinations, in pre-mixed blister packs where available. Emphasis will be on ease of compliance, rather than cost minimization.

Drugs for IPT and CPT will be sold at profit-making rates. However, due to bulk purchasing and fixed mark-up rates, the franchise set prices will be lower than any available in the private sector, while quality assurance relating to treatment regimen and drug sourcing and potency will be assured. Sources for drugs will vary, but have been priced in our estimates according to the lowest available verified bulk rates, either Free on Board (FOB) or delivered in Kenya , depending on the drug.

HIV Opportunistic Infections

Franchisees will provide diagnosis and treatment of opportunistic infections (OIs) associated with WHO Stage 2 and Stage 3 HIV. In sub-Saharan Africa approximately 60% of those with HIV/AIDS are in Stages 2 or 3 (7). A draft list of opportunistic infections and treatment regiments to be used in the franchise is listed at the end of this section. Guidelines for treatment of integrated OIs in private clinics are currently being developed for franchise private providers, and will be based upon the 2004 WHO guidelines for management of HIV opportunistic infections. As with other guidelines, these will be adapted to meet country protocols through a collaborative review undertaken with the NFO, NAC and MOH. A more detailed description of the OI management guidelines and clinical manuals can be found in the Clinical Guidelines and Manuals section.

Anti-Retroviral Therapy

Delivery of ART will use the same market-based approach to assure supervision and quality controls, integrating the DOT-ART attributes recommended by Farmer et al. (2002) into the franchise network.

The system for delivery of ART by franchisees is described above. ART will be delivered by franchisees only following diagnosis and initiation of treatment by a contracted physician. In second phase, ART initiation will be conducted by the franchisee, where permitted by the national guidelines.

ART medications will be free, but consultation charges of $0.50 will be levied, either paid directly by clients out of pocket, or paid by clients using vouchers delivered to them by the initiating physicians as described below.

Other infections – Diagnosis and treatment

Providers will be permitted to conduct diagnosis and treatment for illnesses commensurate with their level of training, and to charge fees for this. A fee schedule must be printed and visible in the waiting room of each clinic, and fees charged cannot be higher than those listed, although partial or total fee waivers may be given according the providers’ judgment. Fee schedules will be set for all pharmaceutical products, but may list a range, rather than a single rate, for consultations.

Other infections – Drugs

All drugs stocked and sold by franchisees must be purchased directly from the franchise. Weekly or bi-weekly delivery will be made, generic or lowest-cost prices will be assured. Control over drugs stocked by members is the only effective way to assure drug quality in countries where fake pharmaceuticals are common. Drugs sold by franchisees will be those on the WHO or appropriate national Essential Drug List (EDL), and prices will be set by the franchiser and listed publicly in all franchise sites. Markup rates will vary so as to assure that cost to client of drugs are at or close to the lowest available private sector prices, except for drugs used in the treatment of TB and AIDS, which will be free to clients. Prices in all franchisee clinics will be fixed, and equal within each country.

Marketing/Pricing Model

Branding will be general, linked to quality of care, and have a secondary focus on respiratory illnesses. Because evidence from franchises in peri-urban and rural areas makes clear that word of mouth is the most important factor in provider selection, widespread advertising will occur only during the initial three years in order to build brand recognition. Experience and site-specific investments in signage and facility improvements will be the principal means of marketing individual clinics.

Pricing will be targeted at low-income clients, but high enough so as to clearly distinguish the franchise from the public sector for most services. Prices for diagnosis will be set very low to encourage testing, equal or lower than median transportation (bicycle taxi) costs to access government care ($0.50). We assume that free services will continue to be available at government facilities, for both TB and HIV/AIDS. Drug prices will be at or below market rate and within the capacity of the target low-income populations to afford, but high enough to increase the gains to the providers – thereby assuring their motivation to join the franchise and compliance with the franchise policies and standards; and generate income for the franchisee and franchiser, which will reduce the subsidies needed to bring this model to scale, and assure that the subsidy per client remains significantly lower than public sector provision of similar services.

All drugs to treat TB and AIDS will be free, but consultation charges will be required. Vouchers will be developed for use by consulting physicians in order to allow free treatment for AIDS (providers will accept the voucher from the client and be reimbursed after the fact by the NFO) of up to 10% of clients at any one franchise site. This system and the percentage allowable ‘free clients’ will be reviewed on an ongoing basis.

For TB, providers will be allowed to treat free of charge up to 5% of their clients for which they will be reimbursed by the franchise. No vouchers will be used for these clients, and these clients will still be eligible for the $4 ‘bonus payment’ upon completion of treatment.

End Notes:

(4) Depending on country conditions and interest by Mission hospitals and clinics, Mission facilities may be enrolled as franchise referral centers for higher-level care.

(5) At the time of writing IPT is not official policy for WHO, but is included in the draft Interim Policy on TB-HIV Collaborative Activities on the basis of a number of published studies Bell, J., D. Rose, et al. (1999). "Tuberculosis preventive therapy for HIV infected people in Sub-Saharan Africa is cost effective." AIDS13: 1549-1556.

UNAIDS, W. a. (1999). "Policy Statement on preventive therapy against tuberculosis in people living with HIV." Weekly Epdemio Rec74: 385-400.

Wilkinson, D. (2000). "Drugs for preventing TB in HIV infected persons." Cochrane Database Syst Rev.(CD000171).

LoBue, P. and K. Moser (2003). "Use of isonizide for latent tuberculosis infection in a public health clinic." Am J Respir Crit Care Med168: 443-447.

The draft report notes, however, that cost effectiveness has been challenged in resource constrained settings. Desormeaux, J., M. Johnson, et al. (1996). "Widespread HIV counselling and testing linked to a community based TB control programme in high risk population." Bull Pan A Health Organ30: 1-8.

Price reductions in the recent past have reduced the importance of this issue, and pending the ratification of the draft Interim Policy we intend to add IPT.

(6) CPT is recommended by WHO and UNAIDS for the prevention of several secondary bacterial and aparasitic infections in eligible adults and children living with HIV/AIDS in Africa. Tuberculosis patients are one of the eligible groups for CPT. This policy builds on the WHO/UNAIDS provisional recommendations.

(7) Based on findings in Uganda (AIDS. 2002 May 3;16(7):1031-8) 71% of HIV+ population was in stage 2 or 3; however this study used an older definition of AIDS that likely included some people who would now be considered Stage 4 in their definition of Stage 3. As a result we have reduced this to a conservative estimate of 60%.

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