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PERSPECTIVES AND PRACTICE IN ANTIRETROVIRAL TREATMENT

World Health Organization

THE LIGHTHOUSEA centre for comprehensive

HIV/AIDS treatmentand care in Malawi

CASE STUDY

World Health OrganizationGeneva

2004

PERSPECTIVES AND PRACTICE IN ANTIRETROVIRAL TREATMENT

THE LIGHTHOUSEA centre for comprehensive

HIV/AIDS treatmentand care in Malawi

CASE STUDY

Sam Phiri, Ralf Weigel, Mina Housseinipour,Matt Boxshall, Florian Neuhann

WHO Library Cataloguing-in-Publication DataThe Lighthouse : a centre for comprehensive HIV/AIDS treatment and carein Malawi : case study / Sam Phiri ... [et al.].

(Perspectives and practice in antiretroviral treatment)

1.HIV infection – therapy 2.Acquired immunodeficiency syndrome -therapy 3.Community health centers 4.Case reports 5.Malawi I.Phiri, Sam. II.Series.

ISBN 92 4 159199 4 (NLM classification: WC 503.2)ISSN 1728-7375

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THE LIGHTHOUSE A centre for comprehensive HIV/AIDS treatment and care in Malawi 1

he Lighthouse Trust was established in 2001 toprovide a continuum of quality care and counselling as

well as to improve the quality of life of peopleinfected and affected by HIV/AIDS, including the terminallyill, in Lilongwe.

The Lighthouse evolved in response to the impact ofHIV/AIDS in the medical wards at the Lilongwe CentralHospital (LCH), which reflects the countrywide dimension ofthe epidemic. In September 1997, independent initiatives wereset up by staff members of the Medical Department, who sawthe need for HIV/AIDS care and support, in both hospitalpatients and in their own communities. In Lilongwe districtalone, there are over 90 000 HIV-infected individuals of whomabout 15% would be eligible for ARV therapy.

What is known today as the Lighthouse began in September1997. With an estimated national HIV prevalence rate of8.4%, Malawi is one of the most severely affected countries inthe world. The dilemma is further illustrated by the fact thatabout 15% of those aged 15–49 years are infected with thevirus causing AIDS, making it the leading cause of death in themost productive age group (20–49 years). The National AIDSCommission (NAC) estimated that in 2001 there were about1 million adults and children with HIV in Malawi, resultingin about 50 000 to 70 000 deaths annually. There is an urgentneed for quality HIV care and support, including palliativecare for people living with HIV/AIDS, to reduce individualsuffering and to dispel the fear, despair and hopelessness thatsurround HIV/AIDS in Malawi.

At the same time, Malawi’s poor health infrastructure is alreadyoverburdened and faces a severe human resource crisis withlack of trained personnel in various cadres. For example, theMinistry of Health and Population (MoHP) can currently fillless than 50% of established posts in some key cadres such asclinical officers and registered nurses. Positions that are filledare inequitably distributed and show a clear disadvantage forrural health facilities. Many health centres have one or even nonurse on staff. In addition, staff morale is often low andproductivity poor.

A study on patients suspected of smear negative tuberculosis

(TB) which included counselling and testing, demonstratedthat voluntary counselling and testing should be part of theservices the hospital provided. The research team also acknowl-edged the need for continuing care for study patients found tobe HIV-infected, and the element of clinical care graduallyevolved.

In 1998, the idea was conceived of integrating existing servic-es and initiatives into one centre, marking the inception of theLighthouse concept. This idea received strong backup throughthe Pro Test TB/HIV co-infection initiative. In that same year,a building that could potentially host the proposed centre wasidentified and the required funds for refurbishing a dilapidat-ed guardian shelter into a functional, friendly care centre wereawarded two years later.

Malawi's Vice President officially opened the LighthouseCentre on 26 July 2002, demonstrating political commitmentto the battle against HIV/AIDS. The provision of antiretrovi-ral therapy (ART), previously provided at cost at a specialist-paying clinic at LCH, was integrated into the Lighthouse serv-ices in the same year.

The Lighthouse was registered as a Trust to secure independ-ent funding and to function as an integral partner in Malawi'spublic health system. Today, the Lighthouse is the first spe-cialist centre in Malawi for the care and support of people liv-ing with HIV and AIDS, providing a comprehensive range ofservices for patients infected with HIV. This study describesLighthouse’s progress up to early 2004.

T

Perspectives and practice in antiretroviral treatment

Background

OBJECTIVEAs defined in its mission statement, “the Lighthouse exists toprovide a continuum of quality care and support to peopleinfected and affected by HIV/AIDS and to the terminally illin Lilongwe”.

The Lighthouse set out to achieve this mission by:

◗ bringing together innovative initiatives as anintegrated service within a single centre;

◗ complementing those services offered by the LilongweCentral Hospital; and

◗ integrating the main hospital’s services such as human resources, laboratory, radiology and pharmacy in orderto strengthen the Lighthouse.

With its strategy, the Lighthouse also aims to support theefforts of the MoHP to introduce ART while at the same timestrengthening the broader health sector.

DESCRIPTION OF THE PROGRAMME

Services provided:The Lighthouse offers the following key services to itspatients: Voluntary Counselling and Testing, clinical servicesincluding ART and palliative care, and community home-based care (Table 1).

2 THE LIGHTHOUSE A centre for comprehensive HIV/AIDS treatment and care in Malawi

Table 1. Services provided at the Lighthouse in 2003

Key elements of service and components Staff Number of patients per monthas of 3 November 2003

Voluntary confidential counselling and testing Team of trained > 700 ◗ Pre-test counselling counsellors◗ Testing using rapid-test◗ Post-test counselling including supportive

and risk-reduction strategies

Clinical care Potentially, 10 Malawian > 1800 patient reviews ◗ Quality care for opportunistic infections medical/clinical officers and about 750 patients ◗ Antiretroviral treatment to run the clinic; on ART◗ Palliative care Four clinicians are available◗ Paediatric treatment daily, with at least one

physician

◗ Day ward for stabilization of patients requiring Nurses manage the day admission or directed treatment care ward

Community home-based care (CHBC) Nurses and community About 150 clients/patients ◗ Care to the sick at their homes care supporters

Management:The Lighthouse exercises a participatory management style,which has its root in the self-organization of volunteers.However, the growing organization requires clear structuresand decision-making processes, which are defined in theorganizational chart (Figure 1).

Each position has a clear job description, including reportinglines to the respective line manager. Staff meetings are held ona regular basis. Recruitment procedures as well as terms andconditions for staff members are transparent and range fromannual performance reviews to regulations for grievances. Themanagement team makes important strategic decisions,which are endorsed by the board of trustees. Last year the firstmanagement retreat weekend for strategic planning tookplace, which proved very useful for team-building and plan-ning and hence will become a regular event.

Staffing at Lighthouse clinic:Over the last year improved funding and a growing demandenabled the Lighthouse to expand its staff tremendously.Whereas it mainly recruits its own administrative staff, coun-sellors and support staff, the HBC and Clinic teams rely pri-marily on MoHP staff.

The Lighthouse works with a team of 13 clinicians, but noneof them is assigned full time to clinical duties and half of themcome in only one day a week. Staffing has included three expa-triate clinicians (a paediatrician, a specialist in internal medicineand an infectious disease specialist/clinical researcher).Potentially, six Malawian medical officers, and four Malawianclinical officers are able to run the clinic (Table 1). Theseclinicians are drawn from the Lighthouse, LCH, University ofNorth Carolina (UNC) and the Malawi army.

Currently, the Lighthouse opens five days a week from 8:00until 16:00. However, the four clinic rooms are seldom alloperational at the same time because of the clinicians' otherduties. When seeing patients, each clinician reviews about 30patients a day.

The prescribing privilege has been limited to the team of cli-nicians in an effort to a) ensure that only well-trained indi-viduals are prescribing and b) to monitor the use of ARV pre-scriptions.

A receptionist and a team of five nurses complete the clinicteam. The nurses are available daily, and include one nurse ininformation, education and communication (IEC) activities,one for clinic and day-ward activities, two for taking vitalsigns, ART client management, and operational researchactivities, and one for palliative care and supervisory activities.The nurses are being trained in fast-track ART reviews, andwill assume increasing responsibility for reviewing and pro-viding repeat prescriptions to stable, adherent patients onantiretroviral drugs.

As a trust, the Lighthouse can access funds to recruit expatri-ate specialists to support this capacity-building role, workingalongside Malawian clinicians and nurses to share skills. It hasalso benefited greatly from the partnership with the UNC,several of whose clinical research staff put in time at theLighthouse, strengthening service delivery and contributingto the wider goals.




In light of the precarious human resources situation in theMalawian health sector, it is difficult to foresee whether thescale-up of ART will provide a satisfying response to thedemand for health care services. ART is a new and labour-intensive service, backed by strong advocacy and donorfunding, and services like those at the Lighthouse have thepotential to draw staff away from the periphery to centrallocations. Thus, primary health care and health services forthe rural poor may be further weakened. A key challenge isto leverage the support and funding flowing into Malawi tosupport ART so that it also strengthens the broader healthsector.

The Lighthouse's strategy is designed to support MoHP in itsefforts to meet this challenge. It is the Ministry's responsi-bility to allocate resources rationally to provide health careequitably for the people of Malawi. Through the health sec-tor-wide approach, the MoHP is developing the strategies itneeds to control and direct nongovernmental organizations(NGOs) and other providers, for example, by insisting onservice-level agreements that define and limit what servic-es NGOs should provide, and how and where they are pro-vided.

However, resource constraints make this difficult to achieve.The MoHP cannot hope to compete for staff with NGOs,research organizations, or the private sector, where salariesare higher and working conditions often better. Therefore,many NGOs still have carte blanche to recruit clinical staff onthe open market, which generally means from the Ministry.

However, to date, the Lighthouse has rejected the option ofrecruiting its own clinical staff directly. The Ministry allo-cates the majority of the local clinical staff and all the nurs-ing staff to the Lighthouse, through Lilongwe CentralHospital or Lilongwe District Health Office. In addition to itspolicy stance, this has practical advantages in its relationshipwith the Ministry and the Hospital. The Lighthouse relies onLCH not only for staff, but for drugs, most diagnostics andmany referrals. It functions as a department of the hospital.If the Lighthouse were to recruit its own clinical staff direct-ly, it would risk breaking that link, and finding itself withoutthe practical support and cooperation on which it relies.

On the downside, this makes scaling up services slow anddifficult. The Lighthouse must negotiate with the Ministryfor additional staff, and justify it against the demands of, forexample, rural district hospitals running with only a coupleof clinical officers.

Nevertheless, this rationale informs the wider Lighthousestrategy. It does not intend to scale up its services beyond itscurrent capacity, because to do so would inevitably meandrawing more staff into Lilongwe Central Hospital. Rather, byfocusing on developing a capacity-building role and imple-mentation of models at a district-hospital or health-centrelevel, the Lighthouse hopes to be part of the solution to thehuman resources crisis, instead part of the problem.

Box 1. Lighthouse and the Malawi health sector human resources

Facility:The Lighthouse is situated on the campus of the LilongweCentral Hospital, one of the major referral hospitals inMalawi serving the central region. When the Lighthousemoved into the new location close to the main hospital inMay 2002, the initial concern was that this easily identified“HIV/AIDS clinic” would prevent people from using thefacility. While this fear proved unfounded, the location's mostobvious disadvantage is its difficult access, particularly bypublic transport.

The building facilities at the Lighthouse include all the roomsnecessary to run the centre efficiently, including a small phar-macy and a store (Box 2). Given its rapid growth over the lasttwo years, there is already a need for more space, particularlyfor teaching purposes and an improved patient flow.

Box 2.Building facilities at the Lighthousew Counselling unit with four rooms for individual

counselling and testing

w Eight-bed stabilization day-care ward

w Four examining rooms

w Three suite offices for the home-based care

w Office space for reception, managementand administration

w Conference room

w Utility room

w Small pharmacy

w Store

Diagnostic services:For its routine operations the Lighthouse uses the centralhospital laboratory facilities, which on the one hand savesspace and staff, but on the other makes the Lighthouse vul-nerable to shortages or breakdown of equipment in the sameway as other hospital departments. Routine laboratory inves-tigations are kept to a minimum, and clinically indicated testsinclude:

w Full blood count

w Liver and kidney function tests

w Blood tests for malaria parasites

w Analysis of other body fluids, e.g. cerebrospinal fluid,1

ascites2 or pleural effusions.3

For patients being evaluated for ART, CD4+ cell count isavailable through the UNC Project on the LCH campus at acurrent cost of MWK 1500 (about US$ 15) to be paid by thepatient.

Other diagnostic procedures such as radiographic exams orultrasonography are also performed at the LCH facilities, withthe possibility of a wide range of referrals to specialists.Computer tomography is only available in Blantyre, which issome 300 kilometres from Lilongwe.

Drugs and consumables:Drugs and medical consumables are procured through thegovernment Central Medical Stores (CMS). Patients receivemost of their medications through the Lighthouse’s own smallpharmacy, which in turn takes an appropriate stock from thehospital’s main pharmacy. In order to secure uninterruptedsupply, an independently funded system of buffer stock-keep-ing has been introduced, e.g. for drugs in the treatment ofopportunistic infections or palliative care. Through theseefforts the Lighthouse also succeeded in introducing oral mor-phine solution into the government supply system.

Antiretroviral drugs have been purchased following a differ-ent mechanism (Box 3).

Funding:The Lighthouse started with almost nothing but the overtimecommitment of Malawian LCH staff members and some expa-triates. Personal initiative, strong performance and a widerrange of available funding sources have now helped theLighthouse to secure a better funding situation. Staff allocationby the MoHP/LCH and secondment of core staff members bydifferent donors were key in the establishment phase of theLighthouse. To date, various donors and partners supportdifferent areas, and some of these are illustrated in Table 2.



1 Clear watery fluid that surrounds the brain and spinal cord2 Accumulation of fluid in the abdominal cavity3 Fluid that has escaped from the membranes surrounding the lungs

Box 3. A revolving fund for procurementof ARV drugs to ensure uninterruptedsupplyMoney paid by patients for their ARVs goes directly intoa separate hospital account for the sole purposeof purchasing ARVs. The CMS buys these drugs throughthe local sales agent of a pharmaceutical company.

This mechanism has worked well with simple drugregimens (one fixed drug combination). With theintroduction of more complex treatment regimens,an additional backup system was required. Basedon this experience, the Lighthouse learned that anyscale-up strategy must give the issues of drug procure-ment, supply and distribution very careful consideration.


Table 2. Services provided at the Lighthouse

Area of support Donors / Partners

Staff secondment/ deployment ◗ MoHP Malawi◗ Centre for International Migration and Development (CIM), Germany◗ University of North Carolina, Lilongwe Project, United States of America

Testing and counselling ◗ Centers for Disease Control (CDC), United States of America◗ Catholic Agency for Overseas Development (CAFOD), United Kingdom

Community home-based care ◗ Family Health International (FHI), United States of America◗ Diana Princess of Wales Memorial Fund (DPWMF), United Kingdom

Clinic ◗ Deutsche Gesellschaft fuer Technische Zusammenarbeit,Backup Initiative, (GTZ), Germany

Institutional development ◗ Press Trust, Malawi◗ European Union◗ Heinz -Ansmann -Stiftung, Germany◗ Lions Club, Seesen, Germany◗ Umoyo Network, Malawi

Clinical research, laboratory and ◗ University of North Carolina project (UNC)personnel back-up & Backup system for ARV drug supply Benefits were observed for both the Lighthouse and UNC in working towards

the common goals of effective management and control of HIV/AIDS and Sexually Transmitted Diseases (STDs) as well as improving clinical services and infrastructure.

Qualitative research: attitudes ◗ Liverpool School of Tropical Medicine/TB Equity Programmetowards ART

Community involvement:One of the Lighthouse’s most valuable assets is its strong linkwith the community, especially in some of the poorer areas ofLilongwe. This link is best illustrated by the fact that some200 community volunteers—while not equally and continu-ally active—can be mobilized. Community volunteers canrefer patients directly to the Lighthouse Clinic, and there areregular meetings with the Lighthouse Community and home-based care (CHBC) nurses and the liaison, the “community-care supporter”. Annual get-togethers, exchange visits to oth-er programmes, token gifts like T-shirts, invitations to cele-brate the official opening of the Lighthouse or to commemo-rate World AIDS Day as well as refresher training courses inCHBC all help to create some kind of corporate identity whileincreasing or sustaining motivation. As of 2003, no specificcommunity involvement related to ARVs has been imple-mented.

Community volunteers



However, since Malawi has been awarded funds from theGlobal Fund to Fight Aids, Tuberculosis and Malaria(GFATM), community involvement has become a criticalcomponent in identifying patients for ART. As the proposalto the GFATM foresees treating 25 000 to 50 000 people—asmall proportion of those requiring treatment—the issues ofequity and access to antiretroviral therapy must be socially andculturally acceptable. In discussions with patients, duringclinics and IEC sessions as well as in letters to the Lighthouse’ssuggestion box, clients have already shown good understand-ing of this problem.

In addition, it is important that civic education addresses thefact that not all HIV-positive patients require treatment. Overtime, the Lighthouse will include this component of educa-tion in its services. The well-established home-based careoperations of the Lighthouse will provide a forum for that.The National AIDS Commission in collaboration with theHIV Unit at the MoHP is preparing a strategy on communitymobilization to address issues of equity and access to ART inMalawi in which the Lighthouse will participate.

ANTIRETROVIRAL TREATMENTFollowing an implementation phase the Lighthouse devel-oped a more systematic, programmatic approach to providingARV treatment, and many of the features were eventuallyintegrated into the national treatment guidelines. The newnational guidelines reflect a public health approach with stan-dardization for eligibility, treatment regimen and monitoringdelivered by certified providers (Box 4). They have been devel-oped in a wider consultative process using experienced clini-cians in HIV care, drawing on the experiences of theLighthouse and other providers of ART such as MédecinsSans Frontières (MSF) France and Luxembourg inChiradzulu and Thyolo, Southern Malawi, respectively.

The national guidelines incorporate the same medicationsthat have been used by the Lighthouse as well as additionalalternative options for failing patients or those intolerant torecommended first-line therapy. The first edition of theguidelines, which has benefited from contributions from theWorld Health Organization (WHO) and other internationalexperts, was completed in October 2003. As a result, a widerrange of treatment alternatives should be available soon.

The Lighthouse has not been independent in providing ARVdrugs and has observed the conditions and regulations,including drug prices, defined by the MoHP for this particu-lar treatment.

Clients served:Since the initiation of the antiretroviral programme, a grow-ing number of patients have sought testing and counsellingservices at the Lighthouse. While growing awareness andimproved services are in part responsible, access to ART andprimary care has likely been a contributing factor. Likewise,the number of clinic patients has dramatically increased on amonthly basis. Since the beginning of the dual therapy com-bination regimen in early 2000, some 1500 patients have beenevaluated for ARV therapy up to July 2003 (Figure 2).

Patients come from Lilongwe and its neighbouring townswithin the district. However, increasingly patients travel longdistances from the northern parts of the country to receivetreatment. This is not only inconvenient and expensive forthem but also increases the risk of poor adherence and com-promised results in follow-up, such as late discovery of adverseeffects. So far, little influx from patients from neighbouringcountries has been observed.

Box 4. Malawi’s national antiretroviraltreatment guidelines demonstrategovernment commitment to ARV delivery◗ Standardized combination ARV therapy to HIV-

seropositive eligible patients under proper casemanagement conditions with high levels of drugadherence

◗ Regular, secure and uninterrupted supply of ARVdrugs to units that are administering ARV treatment

◗ Monitoring system for supervision of ARV therapy,effective patient tracing and follow-up as wellas regular evaluation

Selection of people for therapy:The Lighthouse clinic, which has open access, works on afirst-come-first-served basis with no particular group targetedto benefit from the Lighthouse ART programme. However,since the cost of ARVs (direct, indirect and opportunity cost)is still a major obstacle to access, it is very likely that thewealthier, more educated, urban population of Lilongwe withgreater awareness of HIV, are the main beneficiaries.

Since the Lighthouse is committed to also providing the poorwith the best available primary care, half of the Lighthouseclinic’s capacity will be reserved for those patients lackingfinancial means for antiretroviral drugs.

However, the Lighthouse has limited the number of patientsit is accepting for treatment. This decision is based on anassessment of its capacity to provide an adequate level of qual-ity treatment and the aim to focus more on capacity-buildingat other sites rather than on a maximum intake at its own site.That being said, this has resulted in a waiting list of up toeight weeks for patients and frequent attempts to bypass thewaiting list using personal relationships.

The ratio between male and female patients receiving ARVs isbalanced, and their average age is around 39 years. The major-ity of them have advanced AIDS with a history of weight lossand various opportunistic infections, notably TB and oralcandidiasis. Based on retrospective data collection, the medi-an CD4+ count was as low as 70 cells, and more than 10% ofpatients also present with Kaposi’s sarcoma. However, thesedata need to be interpreted with caution.

A cohort of 30 children under the age of 13 years currentlyalso benefit from ARVs. Efforts are underway to improveHIV-related services, including drug delivery for this agegroup. Furthermore, the Lighthouse recently decided to deliv-er free ARVs to its employees and their spouses.

Eligibility for ART is determined by clinical and immuno-logical criteria as well as treatment readiness. Each week, 15to 20 patients are evaluated for treatment and given anappointment for a Thursday ART education session andblood test for CD4+ count (at cost). Five days later, based onthe lab results, a final decision is made on the enrolment inthe programme, and a starter pack of drugs for two weeks dis-pensed (Box 5).


Figure 2. The number of patients seekingservices at Lighthouse, Lilongwe CentralHospital, has increased significantly :

1200

1000

800

600

400

200

0

num

ber o

f pat

ient

s see

n

OPD clinic Monday,May 00 to Sept 01

OPD clinic Thursday,Oct 01 to June 02

Clinic July 02to June 03

62

452

1067

Reduction of ARV cost

Patients evaluated for ART since the introductionof this service

2000

1600

1200

800

400

0

patie

nts s

een

per m

onth

Patients seeking services Clinic patients

400

> 600 600

> 1800

Patients seeking services each month,July 2002 to July 2003

Jul-02

Jul-03

The Lighthouse has also made efforts to standardize eligibili-ty criteria: Patients meeting WHO AIDS Classification Stage3 and 4, regardless of CD4+ count, and all patients withCD4+ counts less than 200 cells/mm3 are eligible for therapy.For patients receiving anti-tuberculosis medication andtaking Rifampicin at that time, ART is deferred untilcompletion of the intensive TB treatment phase.

ARV regimens used:The choice of ART has largely been restricted by cost. Sincethe initiation of the ART component at the Lighthouse inMay 2000, a number of different drug combinations havebeen used (Table 3).

Once patients initiate therapy, they are seen monthly forrefills. Patients travelling from long distances and stable on

therapy are granted two-month prescriptions, if requested.For reasons of drug security, all prescriptions carry thepatient’s unique registration number. The refill procedurecomprises a short clinical review, questions on adverse effects,occurring infections and adherence.



Box 5. Key elements of ARV treatmentat the Lighthouse ◗ HIV counselling and testing

◗ Patient registration with a unique number

◗ Comprehensive clinical review

◗ Evaluation of patient for ARV:- Advanced WHO stage 3 disease or WHO stage 4 (regardless of CD4+ count)- WHO stage 2 with CD4+ count <200 or TLC <1200- Exclusion of medical contra-indications- Evaluation of ability to continuously pay for treatment- Readiness- Guardian support

◗ Compulsory group education session on HIV/AIDS and ART

◗ Individual counselling as required

◗ Induction of treatment- 14 days D4T/3TC/NVP in the morning and D4T/3TC in the evening- After 2 weeks: review for early toxicity

◗ Continuation therapy: D4T/3TC/NVP

◗ Monthly checklist-based review for toxicity, illness, adherence, or other problems

◗ Supportive treatment for adverse effects/ alternative first-line treatment

◗ Switch to bi-monthly review if stable

◗ CD4+ count every 6 months, if possible

◗ Evaluation for immunological or clinical failure/ second line treatment

Note: D4T = stavudine; 3TC = lamivudine; NVP = nevirapine

Table 3. Drugs used in the Lighthouse ART programme

Date Drug combinations

May 2000 ZDV/3TC (brand-name), fixed-dose combination

End 2000 ZDV/3TC (generic, fixed dose combination) at reduced cost

October 2001 D4T/3TC/NVP (generic), triple therapy fixed-dose combination

January 2003 “Starter Pack”: one tablet D4T/3TC/NVP in the morning and one tablet D4T/3TC in the evening of (Cipla)

Due to arrangements with the local supplier for the pharmaceutical company,the UNC project and the Lighthouse pharmacy buy medications so that the Starter Pack could be made available to all patients.

July 2003 ZDV (donation from pharmaceutical company), 3TC and NVP, alternative first-lineregimen for patients with D4T-associated neuropathy

Currently D4T/3TC/ NVPFixed combination for first-line treatment

D4T/3TCInduction phase

ZDV/3TC and NVPAlternative first-line treatment in the case of d4T neuropathy

ZDV/3TCPost Exposure Prophylaxis

NVPPrevention of maternal to child transmission of HIV


Note: ZDV= zidovudine

Adherence support strategies:Long-term adherence is crucial for the success of an ARTprogramme. That is why the Lighthouse emphasizes theimportance of patients' understanding of the treatment impli-cations. The Lighthouse developed its IEC programme basedon experience with other chronic diseases that require thepatient's self-management, e.g. diabetes, and with regard forthe patient's personal dignity and responsibility.

The overall aim of this programme is to inform, encourageand empower people infected and affected by HIV/AIDS tocope with the disease and related problems and to live posi-tively. Strategies currently used include daily group discus-sion, individual counselling, leaflets and a suggestion box.

With respect to ART, the Lighthouse uses the principles ofempowerment of patients and the reinforcement of key mes-sages. Patients are asked to identify a guardian or relative tosupport them in following treatment. This may or may notinclude directly observed therapy. This approach is nowtermed “guardian supported treatment” or “empowered rein-forced therapy”.



Prior to the initiation of treatment, all patients and guardiansare required to attend an education session on antiretroviraltherapy. This session touches on the natural history of HIVand AIDS, including opportunistic infections, the role ofCD4+ and its estimation, the treatment process at theLighthouse, messages on healthy, positive living, includingpartner notification/disclosure, and finally ARVs, their modeof action and potential toxic/adverse effects. The group ses-

sion is well accepted by patients and guardians, and there areclear indications that this contributes to decreased stigma andincreased understanding.

In the early part of the programme, there was no formal assess-ment of adherence but a considerable dropout rate was notedamong clinic attendees (Box 6).

As the programme continued, follow-up visits included ques-tions related to the number of missed doses per month andthe number of tablets remaining in the bottle as well as rea-sons for missing doses. In a recent survey among 122 ARTpatients, over 92% reported greater than 95% adherence tothe medications, after an average of seven months on treat-ment. The most common reason for missing doses was insuf-ficient funds to purchase medication.

In response to adherence issues, the Lighthouse collaboratedon the Equi-TB Knowledge Programme with the LiverpoolSchool of Tropical Medicine. The study used focus groups dis-cussions and in-depth interviews to explore patient under-standing of and adherence to antiretroviral therapy. Resultsare pending and shall be integrated into the patient commu-nication strategy used at the Lighthouse. Early analysis con-firms the important role that lacking funds plays in discon-tinuing treatment.

Treatment adherence: a nurse with a client

Box 6 . Lighthouse clinic patients evaluated for ART from 1 July 2002to 31 December 2002, including further evaluation until 30 June 2003:a follow upA survey of 482 patients evaluated at the Lighthouse for ART between July and December 2002found that approximately 80% of patients started treatment and more than half of themremained in treatment and responded well to drugs. Among these, the vast majority ofpatients achieved an adherence of at least 95%. The remaining 20% of those being evaluatedfor treatment did not start it due to a lack of financial resources, death, an intensive phase ofTB treatment or a CD4+ count > 200 cells.

However, the study confirmed that overall retention in the programme had been low.If patients did not attend the clinic for more than 90 days, they were counted as “lost to follow-up”. This was the case in about 40% of patients who initiated treatment, and in the majority ofthese cases the reasons remain unknown. However, there are indications that lack of funds anddeath may have prevented patients from adhering to therapy. Most of the loss to follow-upoccurred within the first month of treatment; hence patients received only one prescription.

Clinical outcomes:Within the same survey that is discussed in Box 6, 215patients received at least six months of antiretroviral therapy.Tests were obtained when clinical symptoms suggested thatpossible toxicity and routine monitoring was needed. Ingeneral, very positive clinical outcomes were observed andinclude a robust and considerable increase in body weight, lessor no subjective symptoms like fatigue, loss of appetite, as wellas a reduced number of fever episodes. Many of the patientsare back to work or pursue their usual tasks.

Adverse effects:◗ Neuropathy was by far the most common, with

some 40% of the patients experiencing some degreeof symptoms suggesting neuropathy. The Lighthouse since has developed an algorithm for managingdrug-induced neuropathy.

◗ Hepatitis, diagnosed with jaundice and elevated liver function tests, occurred in around 1% of patients.

◗ Pancreatitis and a suspected case of lactic acidosis occurred in only very few patients

◗ Rash, to some extent, is a more frequent problem, leading to discontinuation of treatment in around 12% of all patients with a rash.

CD4+ counts:CD4+ counts are recommended every six months. However,due to the cost of the test, in general less than 10% of thepatients receive follow-up CD4+ counts. Although the lownumber of patients receiving repeat CD4+ counts (approxi-mately 25% among the survey patients) makes assessment ofimmunologic response extremely limited, a mean increase of120 cells was observed in this group of patients. However,these data need to be seen in the light of non-systematic ret-rospective data collection and therefore should be interpretedwith caution.


Box 6 .

Patients evaluated for ART482

Started ART384 (80%)

Did not start ART 98 (20%)

Lost 168 (44%):Confirmed deaths: 28

Transfers to other units: 9Unknown: 131

Retained in Care 215 (56%)

Lost73 (74%)

Retained in care25 (26%)

Confirmed deaths:3

Adherenceof > = 95% 194 (90%)

“Each time I come into the commercial bank and getteller services from one of my patients, I feel thatproviding ARV to patients is one of the most rewardingtherapies that I have delivered. This Lighthouse patient,a single mother with one child, had suffered within aneight-month period from TB and PCP, complicated bya pneumothorax. She had then developed Cryptococcalmeningitis but could not afford ARV treatment.Then she came down with CMV retinitis but eventuallymanaged to get support to buy the drugs. Althoughshe is blind in one eye now, she is back at work. Notonly has a life been saved, but a mother avoids leavingbehind an orphan!”

A Lighthouse clinician



Currently, the Lighthouse and University of North CarolinaProject collaborate on a safety and efficacy study (SAFEST) todetermine patients’ immunologic and virologic response tothe recommended first-line treatment. Results are pendingand more robust data can be expected soon.

Added improvements:At the outset of the programme, no national guidelines for themonitoring of ART existed. Despite personal efforts to guar-antee a minimum of standardized data collection, the overalldocumentation has been relatively poor. Nevertheless, moni-toring and evaluation has been acknowledged as a crucial partof a successful programme. The University of North CarolinaProject facilitated the development of a standardized dataextraction form to collect key information from the records ofpatients seen to date. Subsequently, new patients have beenadded to the database as they present for evaluation. Forpatients presenting for follow-up visits, records have beenupdated for attendance, clinical outcomes, adverse events, andnew laboratory results. Periodic reviews of the database yieldkey information such as the number of monthly visits for newpatients and follow-up, retention rates and toxicity data.

Modification of the database occurs in response to changes inclinical practices or anticipating national reporting require-ments. Such information has been invaluable in guiding thedevelopment of the national antiretroviral treatment guidelines.

Since April 2003 all follow-up visits of patients on ART areuniformly documented using a check list of questions forsymptoms as well as for indicators of adherence and conse-quent action by the reviewing nurse or clinician. Currently,the University of North Carolina Project has managed data-base development and modification, data entry and statisticalanalysis. However, such intensive database management withmanual data entry requires a fair amount of human resources.One full-time data manager and one part-time data clerk areneeded to maintain timely records and ensure data quality.

Added improvements:Electronic patient registration system (EPRS): In collaborationwith the Baobab Health Partnership which is a HealthManagement Information System Project at LCH’s paediatricdepartment achieved together with the University ofPittsburgh, the Lighthouse works on providing a computer-ized system utilizing touch-pad entry in the clinic rooms andregistration area. Apart from patient registration, paper docu-mentation (reports and lab requests) can be generated as well.The same system has been in operation in the paediatrics in-

patient department of LCH since 2000 and has been wellaccepted in this setting. It is expected that this new efficiencywill promote better documentation and consequently carewhile reducing the workload related to monitoring andevaluation of patient care, in particular of the antiretroviralprogramme. The system will incorporate the requirements ofthe national guidelines for antiretroviral treatment and isexpected to be operational in mid-2004.

Fast track review: While maintaining quality care, theincreased workload in patient care has required changes indocumentation procedures. In light of the staff shortages andthe long waiting hours, patients stable on ARV therapy maynot require clinician assessment for refills. Therefore, stan-dardized forms were designed to assist the care provider inevaluating patients on ART. Trained nurses may well be theappropriate cadre to perform a “fast track” review and referpatients for a clinician’s review in the event of special indica-tions. These indications for referral have been defined usingan algorithm, which was developed in conjunction with thereview forms. Following a pilot-run with clinicians, theseforms have been tested with a nurse acting as the provider.Non-clinician providers will likely be needed for bringingART to national scale in Malawi and standardized assessmentsare likely to facilitate this effort.

The fast-track review will be accompanied by a simplifiedprocess of drug dispensing in which the role of new technol-ogy like smart cards needs to be explored. The fast-trackreview forms at the Lighthouse will be integrated into theEPRS and, within a newly developed operational framework,it is expected to improve the documentation while maintain-ing the standard of care.


Scaling up:Through its successful proposal to the Global Fund to FightAIDS, Tuberculosis, and Malaria Malawi has clearly demon-strated its commitment to scaling up efforts, including accessto ART. The Lighthouse plays an important role within thisprocess and the Lighthouse Trust strategy has been aligned tosupport the MoHP's efforts to meet the challenge of bringingARV treatment and care to the people of Malawi.

The strategy includes activities geared toward:◗ bringing the Lighthouse services to full capacity:

identifying funding and recruiting staff to achievethe defined organizational structure;

◗ making the Lighthouse services systematic: definingprocedures and protocols;

◗ establishing the Lighthouse as a model that can inform the development of similar interventionselsewhere; and

◗ establishing the Lighthouse as a training institution for capacity-building to deliver care and supportfor HIV/AIDS in Malawi.

The Lighthouse has a maximum capacity of 2000 visits permonth of which less than 1000 are new ARV patients. Sincethis capacity will be reached in the coming months, the insti-tution will soon have to cap the number of patients seen.Increasingly, patient reviews will have to be performed atperiphery health centres, making the Lighthouse centre moreof a referral centre for complicated cases.

Thus the future activities of the Lighthouse will focus onpreparing other sites to implement clinic activities. Currently,an in-service training module for clinicians is being developedthat foresees a six-week attachment of clinicians to theLighthouse. Furthermore, to prepare institutions prior to aclinician’s attachment to the Lighthouse, an ART implemen-tation framework is being drafted in collaboration with theHIV unit of the MoHP and other potential partners.

Lessons learned:◗ The Lighthouse, as an integral part of the health-

sector response to HIV/AIDS in Malawi, facesfamiliar challenges. They include the urgent needfor scaling up in response to the demand dictatedby the epidemic, while at the same time pavingthe way towards an equitable access to a qualitystandard of care (quantity vs. quality). This is evena greater challenge in light of the precariousinfrastructure and human resource constraintsof the Malawian health care system.

◗ This challenge also needs to be consideredin the Lighthouse’s rapid development overthe last 18 months. Because of an imminent riskof overestimating its own capacity, phases of rapid expansion need to be followed by the time ofconsolidation in order to ensure the programme’ssustainability.

◗ The Lighthouse has taken innovative paths in its closecooperation with MoHP, while being organizedas an independent trust. The Trust has been verysuccessful in acquiring funds from various donors. The funds were awarded because of already existing activities and high personal commitment. The wide array of funding sources helps to reduce donor dependency, e.g. in the case of policy changes butat the same time creates more reporting and political obligations.

Demonstration of the rapid test protocol



◗ The participatory process of development andthe finalization of the National Treatment Guideline for AIDS in Malawi, to which the Lighthouse and many others have provided considerable contribu-tions, must be regarded as a very significant milestone and prerequisite for further expansion of the ART programme. The Lighthouse is prepared to continue its creative role in the scaling-up process in closecooperation with other stakeholders.

◗ Provision of ART under circumstances like thosein Malawi is necessary, feasible, rewarding andchallenging. The initial steps of the Lighthouse have been difficult, but the subsequent steps will be even more demanding, since, for example, most ofthe second-line treatment regimen will be morecomplicated to deliver, not only for the individualbut also for the system as a whole.

◗ Despite patient willingness, the current paying system for ART has led to high numbers of patients lostto follow-up and carries the risk of promoting inequity and reduced adherence to treatment, which in turn will fuel the development of viral resistance. Parallel systems of paying and non-paying accessto ART may make control and follow-up verydifficult.

◗ The scaling-up process is a work in progress, with little pre-existing experience. It requires critical evaluation

of all steps being undertaken both within the individualinstitution and the health care system. The Lighthousehas already gone a long way together with its partners,the University of North Carolina in particular,to develop internal policies and quality standardsthat need vigorous implementation and follow-up. There is no one correct way of delivering ART in Malawi, but all should follow the framework laidout in the national treatment guidelines. There isthe opportunity that large-scale provision of ARTmay boost the health care system in general, but there is also the threat that this might draw resources and contribute to further decline of primary health care.

◗ Empowerment of patients, community involvement and participation of institutions in civil society willbe key to a successful scaling-up strategy. At the level of the Lighthouse this means continuing the developmentof the IEC strategy by integrating the results ofthe study on patients’ understanding of and attitudes towards ART.

◗ Keeping staff skilled and motivated requiresa favourable work environment, opportunitiesfor continuous professional training and development,and a sense of ownership within the institution.The transparent and participatory managementof the Lighthouse with clear decision-makingstructures has, to date, been successful.

For further information, contact :Sam PhiriClinical DirectorLighthouse TrustP.O. Box 106LilongweMalawiTel: + 265 1 758 705E-mail: [email protected]



Figure 1. Organization chart of the Lighthouse

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For further information, contact :WORLD HEALTH ORGANIZATIONDepartment of HIV/AIDS20, avenue Appia – CH-1211 Geneva 27 – SWITZERLANDE-mail: [email protected] – http://www.who.int/hiv/en

ISBN 92 4 159199 4

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