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AIDSTAR-One | CASE STUDY SERIES                                                                                           ...
AIDSTAR-One | CASE STUDY SERIESTABLE 1. WHO RAPID ADVICE KEY RECOMMENDATIONS (WHO 2009)1.    Start ART in all patients wit...
AIDSTAR-One | CASE STUDY SERIESSince 2006, the National AIDS Programme in                 HIV and AIDS, Government of Guya...
AIDSTAR-One | CASE STUDY SERIESBy the end of 2009, a total of 2,832 persons were                                  protocol...
AIDSTAR-One | CASE STUDY SERIESemphasized that the national program would be              United States through in-person ...
AIDSTAR-One | CASE STUDY SERIESdepending on the circumstances, so that some              Initiation thresholds for antiret...
AIDSTAR-One | CASE STUDY SERIESand advocated for a more patient-friendly first-line            enabled the implementation ...
AIDSTAR-One | CASE STUDY SERIESHIV services. Guyana was receiving substantially          sick because they sought services...
AIDSTAR-One | CASE STUDY SERIESStrong global partnerships: Guyana’s HIV                       Patient concerns about switc...
AIDSTAR-One | CASE STUDY SERIEScontinued implementing this program and has             Georgetown with the support of the ...
AIDSTAR-One | CASE STUDY SERIES  LESSONS LEARNED FROM GUIDELINE REVISION PROCESS IN GUYANA  •	 Ensure top MOH policymakers...
AIDSTAR-One | CASE STUDY SERIESguidelines through a process similar to the one used         WHO. 2010. Antiretroviral Ther...
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AIDSTAR-One HIV Treatment Guidelines in Guyana - The Fast Track to Diagnosis and Treatment

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This case study details Guyana's process for revision of their national HIV treatment guidelines, based on WHO's 2010 revised recommendations . While many countries are still working to revise their national guidelines in response to WHO's latest guidance, the National AIDS Programme in Guyana has been implementing elements of WHO's 2010 recommendations since 2006.

www.aidstar-one.com/focus_areas/treatment/resources/case_study/guyana_treatment_guidelines

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AIDSTAR-One HIV Treatment Guidelines in Guyana - The Fast Track to Diagnosis and Treatment

  1. 1. AIDSTAR-One | CASE STUDY SERIES April 2011HIV Treatment Guidelinesin GuyanaThe Fast Track to Diagnosis and Treatment I n 2002, the World Health Organization (WHO) first published guidelines for a public health approach to scaling up antiretroviral therapy (ART) in resource-limited settings. These guidelines were simplified in 2003 and revised in 2006. In October Photo courtesy of JSI staff 2009, WHO led a multidisciplinary committee of HIV treatment experts to further revise the guidelines. Their recommendations were packaged as Rapid Advice: Antiretroviral Therapy for HIV Infection in Adults and Adolescents and were disseminated in late November 2009 (WHO 2009).National AIDS ProgrammeSecretariat, Georgetown, Guyana,April 2010. The key messages that emerged from these recommendations are earlier initiation of ART, the use of less toxic treatment regimens, and an expanded role for laboratory monitoring, including both CD4 testing and viral load (VL) monitoring (WHO 2010). Table 1 lists eight key Rapid Advice recommendations. The full revised guidelines, Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach, were released in July 2010 (WHO 2010). The WHO committee of experts that developed the recommendations agreed on a set of guiding principles for countries developing or revising their national HIV treatment guidelines. Principal consideration was given to the need for public health interventions that “secure the greatest likelihood of survival and quality of life forBy Victoria Rossi and the greatest numbers of people living with HIV” (WHO 2009, 4). TheBisola Ojikutu guidelines also specify that “the individual rights of people livingAIDSTAR-OneJohn Snow, Inc.1616 North Ft. Myer Drive, 11th Floor This publication was produced by the AIDS Support and Technical Assistance ResourcesArlington, VA 22209 USA (AIDSTAR-One) Project, Sector 1, Task Order 1.Tel.: +1 703-528-7474 USAID Contract # GHH-I-00-07-00059-00, funded January 31, 2008.Fax: +1 703-528-7480 Disclaimer: The author’s views expressed in this publication do not necessarily reflect the views of the United Stateswww.aidstar-one.com Agency for International Development or the United States Government.
  2. 2. AIDSTAR-One | CASE STUDY SERIESTABLE 1. WHO RAPID ADVICE KEY RECOMMENDATIONS (WHO 2009)1. Start ART in all patients with HIV who have a CD4 count of less than 350 cells/mm3, irrespective of clinical symptoms.2. • Start one of the following regimens in ART-naïve individuals eligible for treatment. • Zidovudine (AZT) + lamivudine (3TC) + efavirenz (EFV) • AZT + 3TC + nevirapine (NVP) • Tenofovir (TDF) + 3TC or emtricitabine (FTC) + EFV • TDF + 3TC or FTC + NVP3. Start ART in all individuals living with HIV with active tuberculosis, irrespective of CD4 cell count.4. Start ART in all individuals living with both HIV and hepatitis B virus (HBV) who require treatment for their HBV infection, irrespective of CD4 cell count or WHO clinical stage.5. Start ART in all pregnant women with HIV and a CD4 count of less than 350 cells/mm3, irrespective of clinical symptoms.6. Where available, use VL to confirm treatment failure. • Where routinely available, use VL every six months to detect viral replication. • A persistent VL above 5,000 copies/mL confirms treatment failure. • When VL is not available, use immunological criteria to confirm clinical failure.7. A boosted protease inhibitor (PI/r) plus two nucleoside analogues are recommended for second-line ART. • For second-line ART, atazanavir/ritonavir (ATV/r) and lopinavir/ritonavir (LPV/r) are preferred.8. National programs should develop policies for third-line therapy that consider funding, sustainability, and equitable access to ART.with HIV should not be forfeited in the course of providing continued, life-long access to ART fora public health approach” (WHO 2009, 4). The those in need.four guiding principles for countries revising theirtreatment guidelines are as follows: Many countries plan to revise their national guidelines to reflect the recent WHO• Do no harm: When introducing changes, recommendations. Côte d’Ivoire, Malawi, Nigeria, preserve access for the sickest and most in need. Tanzania, and Zambia have undertaken feasibility• Ensure access and equity: All clinically eligible studies, including cost analyses, to assess people should be able to enter treatment services the impact of adopting such recommendations (including ART) with fair and equitable distribution (PlusNews 2010). These studies have of treatment services. demonstrated that many countries face significant challenges as they move to incorporate the• Promote quality and efficiency: Ensure delivery recommendations into their national treatment of the highest standards of care within a public protocols, including ensuring the availability of health approach so as to achieve the greatest resources to support increased patient loads, health impact with the optimal use of available improving supply chain management capacity, human and financial resources. ensuring sufficient human resources, and building• Ensure sustainability: Understand the long- in-country consensus around protocol changes. term consequences of change with the vision of2 AIDSTAR-One | April 2011
  3. 3. AIDSTAR-One | CASE STUDY SERIESSince 2006, the National AIDS Programme in HIV and AIDS, Government of Guyana 2009). ByGuyana has been implementing WHO’s 2010 mid-2001, despite a flourishing epidemic, there wasrecommendations of a CD4 threshold of 350 still no public access to ART in Guyana because ofcells/mm3 for initiation of ART and a TDF-based the prohibitive cost of antiretrovirals (ARVs) in thefirst-line treatment regimen. Strong political global market.will and leadership from the government,collaborative partnerships between local and In 2001, Cipla Ltd., the generic pharmaceuticalinternational agencies, low patient loads, manufacturer, began marketing a generic fixed-effective supply chain management, and resource dose combination (FDC) of stavudine (d4T)/3TC/availability are key factors contributing to NVP to Guyana. After negotiating with Cipla inGuyana’s successful implementation of WHO’s 2001, the MOH was able to secure significant pricenew recommendations. reductions in the cost of first-line ART to U.S.$250 per patient per year. Additionally, both Cipla and Ranbaxy, another leading generic pharmaceuticalThe Response to HIV company, offered technical assistance to build the capacity of a local pharmaceutical company,in Guyana Georgetown Pharmaceutical Corporation (GPC), to manufacture ARVs in-country. Through theseGuyana is a small, English-speaking Caribbean capacity-building efforts, by the end of 2001,country located on the northeast coast of South GPC was able to produce first-line FDCs at aAmerica, with a population of 748,486 (Central price of U.S.$140 per patient per year, allowingIntelligence Agency 2009). According to 2008 the government to announce its support of HIVnational HIV estimates, HIV prevalence in Guyana treatment through the public health care system. Inis 1.9 percent and the country’s estimated December 2001, the distribution of first-line therapypopulation of adults living with HIV (over 15 years began free of charge at the national sexuallyof age) is 16,900, disaggregated into 8,900 males transmitted infection referral center, then calledand 8,000 females (Presidential Commission on the Genitourinary Medicine Clinic, in Georgetown,HIV and AIDS, Government of Guyana 2009). The Guyana’s capital.first case of AIDS in Guyana arose in 1987 withinthe men who have sex with men community. Since With additional support from the U.S. President’sthen, the number of reported cases has increased Emergency Fund for AIDS Relief (PEPFAR) andsteadily, and the epidemic is considered to be the Global Fund for AIDS, Tuberculosis and Malariageneralized (Presidential Commission on HIV and (GFATM), treatment services expanded to 16 sitesAIDS, Government of Guyana 2009). by 2008. Second-line treatment was made available free of charge through the public system in 2006.In response to the burgeoning HIV epidemic, the Local capacity for CD4 testing was establishedGovernment of Guyana established the National in 2003 and VL capacity in 2010 (PresidentialAIDS Programme (NAP) under the Ministry of Commission on HIV and AIDS, GovernmentHealth (MOH) in 1989. In 1992, the National AIDS of Guyana 2009). Currently, ART services areProgramme Secretariat (NAPS) was formed and available in all regions, and all medical care offeredcharged with coordination of the national response by the public system, including HIV care andto the HIV epidemic (Presidential Commission on treatment, is free of charge. HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment 3
  4. 4. AIDSTAR-One | CASE STUDY SERIESBy the end of 2009, a total of 2,832 persons were protocols. In 2003, WHO guidelines recommendedactively receiving ART through the NAP. Of those a minimum CD4 cell count initiation threshold ofpersons receiving treatment in 2009, 178 were 200 cells/mm3, irrespective of clinical disease stage,children. Females made up 55.6 percent of all while guidelines in the United States and Europepersons on treatment in 2009. In 2008, patients on were changing to reflect earlier ART initiation, upsecond-line treatment accounted for 6.8 percent to CD4 cell counts of 350 cells/mm3. The Ministerof all persons on treatment. At 12 months, average of Health, the Honorable Dr. Leslie Ramsammy,survival on treatment was 72 percent (Presidential aware of the treatment protocols being followedCommission on HIV and AIDS, Government of in the United States and Europe, has stronglyGuyana 2009). advocated for guidelines aligned with the treatment protocols in resource-rich settings because he does not believe in setting a different standard for the2004 and 2006 Guideline developing world.Revision Processes I believe that the restrictive protocol of using CD4 cut-offs for eligibility for ARVDeveloping initial HIV treatment treatment is a backward protocol and anguidelines: Following the Government of immoral one and we should pursue earlierGuyana’s announcement at the end of 2001 that treatment with ARVs. It is still my wishthere would be universal access to HIV treatment, to place persons who are HIV-positivepractitioners received a two-page brief that offered on ARV treatment as early as possible…very limited guidance on prescribing. By 2003, Treating people even though we don’tGuyana had developed the capacity to conduct know their CD4 is better than them dying.in-country CD4 testing, which prompted robust –The Honorable Dr. Leslie Ramsammy,discussion among stakeholders about clinical Minister of Health, Guyana The Minister argues that, as with other diseases, clinicians should be given the discretion to manage their patients based on their best clinical judgment. He believes “HIV diagnosis [is] good enough” to start treatment and “they [health care providers] should not wait for somebody to get sick” before providing treatment. He wants patients to get early treatment to maintain their health, but also because he views widespread early treatment Photo courtesy of JSI staff as an important component of an effective HIV prevention strategy. After negotiations within the Government of Guyana and with other international organizations, theNational Care and Treatment Centre, Georgetown, MOH launched the treatment access programGuyana, April 2010. with an initiation threshold of 200 cells/mm3, but4 AIDSTAR-One | April 2011
  5. 5. AIDSTAR-One | CASE STUDY SERIESemphasized that the national program would be United States through in-person meetings,working toward a threshold of 350 cells/mm3. conference calls, and emails. When the draftFormal guidelines recommending a CD4 initiation guidelines were complete, WHO and the Jointthreshold of 200 cells/mm3 and a first-line regimen U.N. Programme on HIV/AIDS also reviewed theof d4T/3TC/NVP were finalized and disseminated document and provided comments. FXB-USA andin 2004. As the NAP expanded, the Minister IHV, both implementing partners under PEPFAR,mandated and approved membership of a Technical conducted a full external review of the guidelinesWorking Group (TWG) for HIV Care and Treatment prior to their finalization.to be chaired by NAPS with participation from keytechnical partners. The TWG was to serve as an Both global scientific research and localadvisory board to NAPS and meet on a quarterly anecdotal evidence were considered by thebasis to discuss emerging issues facing the NAP, guideline revision committee during theirwith the goal of strengthening Guyana’s national discussions, a process detailed later in this caseHIV response. study (see “Evidence Considered”). Following technical approval of the 2006 revised guidelines,Developing the 2006 HIV treatment some time passed before they were officiallyguidelines revision: Supported by local endorsed as policy and disseminated by theclinicians and key international partners, when government. Meanwhile, to foster adoption ofthe WHO released its revised 2006 guidelines the revised guidelines as quickly as possible,advocating more strongly for a CD4 initiation NAPS “piggybacked” on already planned nationalthreshold of 350 cells/mm3, the Minister of Health and regional training efforts, such as thosemandated a revision of Guyana’s national HIV on prevention of mother-to-child transmission,treatment guidelines. The TWG identified additional by adding brief, informal training on the newtechnical experts to join the group and invited treatment guidelines to the agenda.them to become members of the guideline revisioncommittee. The committee was composed of: staff Implementation and roll-out: Once thefrom various departments of the MOH, including revised guidelines were formally endorsed andNAPS, disease control, maternal and child health, disseminated, NAPS conducted official trainingand tuberculosis; local public and private sector led by MOH staff and partners, which was rolledclinicians; and partners including the François- out nationally to all 360 health facilities. TheyXavier Bagnoud Center (FXB)-USA and FXB- employed a combination of training approachesGuyana (University of Medicine and Dentistry ofNew Jersey), the Canadian Society for InternationalHealth, the Centers for Disease Control and To foster adoption of thePrevention (CDC), the AIDS Relief Consortium revised guidelines as(Institute for Human Virology [IHV], Universityof Maryland), Dartmouth Medical School, and quickly as possible, NAPSthe Guyana HIV/AIDS Reduction and Prevention “piggybacked” on alreadyProgram (MOH 2006). planned national and regionalTechnical consultations funded by international training efforts.partners were conducted with experts in the HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment 5
  6. 6. AIDSTAR-One | CASE STUDY SERIESdepending on the circumstances, so that some Initiation thresholds for antiretroviraltraining sessions for health workers from different therapy: Clinicians from the National Careregions took place in Georgetown, while others and Treatment Centre (NCTC), the center ofwere conducted in the regions with support from excellence for management of HIV and sexuallythe regional health offices. Implementers and transmitted infections in Guyana, were membershealth workers from the field were invited to the of the guideline revision committee. They, alongquarterly TWG meetings on an ongoing basis with other private and public sector clinicians,and were asked to give feedback on the progress were concerned about how sick and weakand challenges facing implementation of the new their patients were by the time their CD4 countguidelines. The MOH maintained and cultivated reached 200 cells/mm3. They completed informalthe TWG as a forum for troubleshooting. assessments via patient chart reviews in which patient CD4 levels were plotted against theirThe newly revised 2006 guidelines were health outcomes, beginning at ART initiationdisseminated to all ART sites in different formats. and continuing over time, to show the changeNAPS made packages for distribution at the TWG in CD4 levels and how those changes affectedmeetings, sent packages to regional health offices overall health. From these informal assessmentswith instructions to distribute the guideline materials and their clinical observations, they reportedthroughout the region, and distributed packages at increased morbidity, opportunistic infections, andquarterly immunization meetings. NAPS followed longer recuperation periods in those patients whoup with each of the ART sites through the regional started treatment when their CD4 count was at orhealth offices to ensure they had received and were below 200 cells/mm3.implementing the new guidelines. Citing the findings of their informal assessmentsAdditionally, the new guidelines were announced and clinical observation, these local cliniciansat the Minister’s News Conference, a regularly began advocating strongly for earlier initiation ofscheduled meeting between the media and the ART. There were varying views within the revisionMinister of Health, which was covered by both print committee about the sustainability of increasingand television news outlets. The total timeframe the initiation threshold to 350 cells/mm3, with somefor the 2006 revision process was approximately members advocating for maintaining 200 cells/one year, beginning with the Minister’s mandate mm3 and others supporting a more temperedto update the guidelines to the government’s increase to 300 cells/mm3. PEPFAR-supportedendorsement of the final revised guidelines. local treatment partners FXB and IHV wereHowever, it took an additional year before all especially supportive of revising the guidelinesof the health workers were trained and actively to initiate patients at less than 350 cells/mm3,implementing the guidelines. based on cohort data in the United States and Europe showing improved clinical outcomes with earlier ART initiation. Both organizations providedEvidence Considered remote technical assistance from the United States through a combination of in-person meetings,The guideline revision committee considered both conference calls, and emails.global scientific research and local anecdotalevidence as they deliberated on the updates to Tenofovir-based first-line regimen: Themake. The evidence they considered regarding local clinicians on the TWG also provided anecdotaleach of the key 2006 revisions is summarized next. evidence of d4T-related neuropathy and lipodystrophy6 AIDSTAR-One | April 2011
  7. 7. AIDSTAR-One | CASE STUDY SERIESand advocated for a more patient-friendly first-line enabled the implementation of the 2006 revisedregimen. There was extensive debate about which guidelines.nucleoside reverse transcriptase inhibitors (NRTIs)to use. Data supporting the superiority of TDF-FTC Supply chain management: With the adventNRTI backbones in virologic suppression and CD4 of the SCMS Project in Guyana in 2006, the supplyresponse were released in 2006 (Gallant et al. 2006). chain in Guyana was significantly strengthened,In addition, fewer side effects, such as nausea and enabling it to effectively support the national HIVanemia, were noted with TDF than with regimens program. A satellite MOH Materials Managementincluding AZT. In the face of mounting concerns about Unit Farm Annex Warehouse was establishedincluding d4T in the first-line regimen, the revision to provide suitable storage conditions for ARVscommittee agreed to alter the first-line regimen. procured by major HIV donors, including PEPFAR and GFATM. A fleet of two trucks delivered ARVsTo help determine which drugs should be included directly to 13 of the 15 fixed ART sites, with the twoin the first line, NAPS asked the PEPFAR-supported main private sector sites managing their own pick-upSupply Chain Management System (SCMS) Project (SCMS Project-Guyana 2008).in Guyana to complete a cost analysis comparingthe old d4T-based first-line regimen to regimens SCMS-Guyana supported NAPS to complete acontaining TDF. SCMS-Guyana studied actual forecasting and quantification of ARV requirementsinvoices, made assumptions about annual ART according to the new treatment guidelines usingpatient targets, and used the new treatment initiation the software package Quantimed, which was thethreshold of 350 cells/mm3 to determine the cost standard quantification tool for the country. Usingof first-line therapy, including branded TDF/FTC. Quantimed, CDC-Guyana and NAPS worked withAlthough the TDF/FTC-based regimen proved SCMS-Guyana to forecast and quantify CD4 testingmore costly, the MOH believed that this regimen supplies to support earlier initiation of ART throughwas superior to the other options considered. After routine CD4 testing. Finally, NAPS used the ARVexhaustive discussion, the revision committee came and laboratory forecasts in the software packageto a consensus that a TDF-based first-line regimen PipeLine to develop a procurement and supply planwas the best option for patients and would be to help manage the supply chain of ARVs accordingcost-effective in the long-term. While cost was an to the new treatment guidelines.important factor in all of the discussions, the efficacy Registration and importation of the new ARVsand quality of the treatment regimen were the were significantly expedited by the fact thatpriorities. All new patients initiating ART began TDF/ in 2001 the government established a policyFTC in combination with a non-NRTI, specifically allowing the Food and Drug Department (FDD)NVP or EFV. Guidance for the management to issue registration waivers for new ARVs uponof existing patients on d4T-based therapy request from the MOH’s Chief Medical Officer. Arecommended an immediate switch to a TDF-based registration waiver was requested by the Chiefregimen in the absence of contraindications. Medical Officer for the new ARVs and promptly issued by FDD, allowing for importation of ARVsFactors Supporting recommended by the new guidelines.Successful Implementation Resources available: In 2006, Guyana’s NAP was in the enviable and relatively uniqueImportant supply chain management factors in position of having multiple donors supporting theGuyana along with financial resource availability MOH in covering the costs of all its public sector HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment 7
  8. 8. AIDSTAR-One | CASE STUDY SERIESHIV services. Guyana was receiving substantially sick because they sought services sooner andgreater money per patient than any other PEPFAR- treatment was initiated earlier. Decentralization ofsupported country at that time. GFATM was services to primary health centers further fosteredproviding funds for procurement of ARVs to cover all access to treatment, with the potential to lessen thefirst-line adult patients, post-exposure prophylaxis, stigma around HIV infection.and prevention of mother-to-child HIV transmission.PEPFAR procured ARVs for all adult second-line and The Minister of Health believes that the sense ofpediatric patients through the end of 2006, at which hopelessness in Guyana prior to universal treatmentpoint the Clinton Health Access Initiative (CHAI) took access lifted as patients initiated ART earlier andover coverage for all pediatric patients. Since 2007, were able to live healthier, longer lives. He feels this,GFATM has provided all first-line ARVs. Currently, in turn, gave confidence to health workers becausePEPFAR covers second-line ARVs and CHAI they were better able to serve their patients, and thusprovides pediatric treatment. However, CHAI funding improved overall morale at the health centers.will be entirely phased out by 2011. Fortunately,Guyana has recently secured a Rolling Continuation No formal study of the clinical outcomes of theChannel under GFATM Round 9, which secures 2006 guideline revision or Guyana’s national HIVfunding for all first-line and pediatric treatment from program in general has been completed to date.2010 through 2015. Given this funding landscape, However, NAPS has plans to conduct an outcomesthe availability of resources to support more patient- study in collaboration with CDC-Guyana in thefriendly regimens and earlier initiation of ART was near future and is currently developing a databasenot a major concern of the 2006 revision committee. to analyze cohort data to determine clinical outcomes. An HIV drug resistance study is also planned to begin in early 2011.ResultsFollowing implementation of the 2006 revised What Worked Wellguidelines, all patients had access to ART oncethey entered the national program and were The key factors that contributed to the successfuldeemed eligible for treatment. With strong donor revision of Guyana’s treatment guidelinesand ministry support, funding for HIV treatment was included strong political will and leadershipable to match scale-up plans, so an ART waiting from the government, collaborative partnershipslist never developed. Anecdotal reports from local between local and international agencies, and lowclinicians showed that patients were generally less patient loads. The importance of political will: Dating back to the early days of the emergence of Anecdotal reports from local HIV in Guyana, there was very strong political clinicians showed that patients commitment from the government to the fight were generally less sick against the epidemic. Ministry officials, including because they sought services the Minister of Health, remained aware of the latest global research around HIV treatment, care, sooner and treatment was and support, and the public health community initiated earlier. in Guyana remained receptive to changes and advances in the field.8 AIDSTAR-One | April 2011
  9. 9. AIDSTAR-One | CASE STUDY SERIESStrong global partnerships: Guyana’s HIV Patient concerns about switchingprogram has also benefited enormously from a regimens: Initial reports from implementersstrong, collaborative partnership between local and health workers revealed that patients wereand international agencies. The Pan American concerned about moving from the simple dosing ofHealth Organization, WHO, the U.N. Children’s one pill with the d4T-based FDCs in the old regimenFund, and U.S. Government partners have been to the more complicated dosing of two differentimportant allies that worked closely with the MOH pills in the new TDF-based regimens. The TWGto understand and support its goals. Although there discussed the issue with the implementers and, whilewere varying opinions on technical issues at certain a multidisciplinary approach to treatment counselingpoints throughout the revision process, the revision is the norm, everyone agreed to focus on the role ofcommittee generally agreed that long-term cost the social workers at the health centers to assuageeffectiveness and a higher quality of patient care patient fears. Social workers were mentored bywere the proper direction for the NAP. MOH staff and encouraged to work very closely with ART patients to increase their understanding ofConsistent leadership from the MOH: the benefits of the new regimen and the reasoningDifferent international partners bring different behind the switch. Patients were told that the newperspectives to the development of guidelines; drugs reduced their risk of treatment failure andtherefore, molding the guidelines into a uniquely adverse side effects and therefore increased theGuyanese approach required strong national quality of care they received.leadership. The Minister of Health provided thatleadership at all stages of the development of the Fostering patient adherence to newnational guidelines, resulting in a strategy that guidelines: Patient adherence to treatment wasprovides highly effective treatment for all eligible an ongoing challenge faced by the NAP that waspatients living with HIV. exacerbated by the new treatment guidelines. The NCTC, located in Georgetown, developedThe availability of funding to cover a Group Discussion Program to address thisnational treatment needs: Low patient load challenge. Before a patient was initiated onand funding availability in Guyana undoubtedly treatment at the NCTC, he or she was requiredfacilitated consensus around the 2006 guideline to attend three compulsory treatment-relatedrevisions. Although concerns about longer term counseling sessions. The patient was asked tofunding were discussed by the revision committee, select and bring a “support buddy” to at leastthe extent of these concerns was less than it would one of the three counseling sessions. Once ahave been in the African treatment context of limited patient successfully attended the three counselingfunding for hundreds of thousands of patients. sessions and selected a support buddy, he or she began ART and was asked to attend the focus group discussions, which were held biweekly atChallenges the NCTC. The focus groups consisted of five members of the NCTC staff, including a doctor,The key challenges that Guyana faced during pharmacist, nurse, social worker, and home-basedthe 2006 guideline revision process were patient care person, and all of the ART patients with theirunderstanding, adherence, human resource support buddies. The objective of the focus groupshortages, and supply chain management discussions was for adherent HIV patients toconstraints related to the timing for dissemination of talk about their successes and for non-adherentthe new guidelines. patients to share their struggles. The NCTC has HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment 9
  10. 10. AIDSTAR-One | CASE STUDY SERIEScontinued implementing this program and has Georgetown with the support of the Ministries ofmade a formal recommendation to NAPS that Health and of Amerindian Affairs.the program be rolled out to ART sites nationally.Many clinics have begun implementing similar Anticipating supply chain difficulties:support activities but with variations based on When the 2006 revised guidelines were formallyclinic size and staffing levels. endorsed and disseminated to health facilities, the MOH had a national overstock of ARVs for theDealing with personnel shortages: An old, d4T-based first-line therapy. They were notadditional challenge for the NAP was a shortage of comfortable allowing all the old ARVs to expire, sohuman resources to manage the increased patient they were forced to delay distribution of the ARVsload. Early in the epidemic’s history, Guyana worked for the new TDF/FTC-based first-line therapy untilto prevent the establishment of a parallel HIV more of the old ARVs had been consumed. Thisservice delivery system and leverage existing human resulted in some confusion among health workersresources by integrating HIV services into the public who had been trained to use the new guidelineshealth infrastructure. Task-shifting ART away from because the corresponding ARVs were notthe physicians to lower cadres of health care workers available to them at the health facilities. To addresswas also considered as a potential solution to the this challenge, ongoing updates were provided tohuman resource challenge, especially in the remote the clinicians at the treatment sites regarding stock-hinterland areas. The NAPS decided to recruit 11 on-hand of the old ARVs and ordering new ARVS.doctors from the U.N. Volunteer Program to provideadditional support to the ART sites. While keepingART initiation under the purview of physicians, RecommendationsNAPS did undertake some measures to betterdistribute the workload of clinicians and nurses who National health leaders must buildwere managing the country’s HIV patients. NAPS consensus: The success of Guyana’s 2006introduced a new position, the lay counselor, to guideline revision was due in large part to strongprovide HIV counseling in the larger clinics and thus leadership from the MOH and collaborativealleviate the bottleneck presented by long lines of partnership with both local and internationalpatients waiting for counseling sessions with nurses. agencies. A country’s MOH must work to build consensus among the various players while at theReaching remote communities: While HIV same time clearly articulating its vision and guidingprevalence in remote areas of Guyana is relatively the revision committee to develop guidelines that willlow, there was some concern that mining and logging most effectively achieve their vision.activities, coupled with limited access to treatmentfacilities, could worsen the epidemic among those Keep the committee small and flexible:communities. As a result, NAPS has begun to Countries should closely review the latestprovide HIV services through mobile ART clinics HIV research with a small group of technicallyvisiting remote areas quarterly. Mobile clinicians competent stakeholders who are open to new ideasinitiate patients on ART according to the new and approaches. A smaller revision committeeinitiation criteria, and local medics monitor them on will keep the process focused and efficient. Oncean ongoing basis. The mobile clinicians remain on consensus has been reached within the revisioncall by radio and telephone communication to advise committee and the updated guidelines have beenthe local medics as needed. If an emergency arises, drafted, the guidelines can then be circulated forarrangements are made for the patient to travel to comments to a larger group of stakeholders. To10 AIDSTAR-One | April 2011
  11. 11. AIDSTAR-One | CASE STUDY SERIES LESSONS LEARNED FROM GUIDELINE REVISION PROCESS IN GUYANA • Ensure top MOH policymakers remain abreast of HIV global research, WHO recommendations, and emerging local evidence so that ongoing revisions are made to the national HIV treatment guidelines as appropriate. • Issue a mandate from the MOH to revise national HIV treatment guidelines when deemed necessary. • Establish a small, technically competent guideline revision committee, led by the MOH, which has clear terms of reference through which consensus can be achieved. • Garner financial and technical support from strong local and international partners and arrange for an external third party review of the draft revised guidelines. • Assess supply chain management implications of guideline revisions including drug forecasting and quantification, procurement, storage and distribution, importation requirements, etc. • Assess resource availability to support guideline revisions including robust cost analyses. • Consider the impact of guideline revisions on patient loads and implement locally appropriate human resource interventions including rollout of lay counselors, phlebotomists, and/or task-shifting. • Review ARV supply and procurement plans before rolling out revised guidelines so that drugs from a previous protocol are consumed before the guidelines are fully rolled out. • Officially endorse the revised guidelines as policy by having MOH leadership hold a public press conference announcing them. • Collaborate with the local health offices to train health care workers nationally and distribute hard copies of the revised guidelines. • Establish a feedback mechanism, such as quarterly implementer meetings, for local health officers and health care workers to relay any challenges with implementation of the revised guidelines back to the central level so that appropriate interventions can be developed.successfully adapt WHO recommendations to thelocal context of a specific country so that quality Future Plansand sustainability of HIV treatment are effectively Recently, Guyana has gone through another processbalanced, members of the revision committee will of revising its national HIV treatment guidelines.need to be open, flexible, and free-thinking. In 2009, the Minister of Health convened a similar revision committee to plan for the addition of VLPlan around current ARV supply: It is monitoring, potential initiation of ART for all patientsrecommended that countries look carefully at their diagnosed with HIV irrespective of CD4 level,ARV supply and procurement plans before rolling revision of the pediatric ART regimens to includeout new guidelines. Ongoing updates should be abacavir (ABC) in first-line therapy, and furtherprovided to the clinicians at the treatment sites guidance on ART initiation in tuberculosis/HIV co-regarding stock-on-hand of old ARVs and ordering infection. Currently, the 2009 guidelines remain innew ARVS. Timing of the roll-out should be draft form and are being reviewed by various localmanaged so that drugs from a previous protocol are and international partners. In addition, an in-depthconsumed before the revised guidelines are fully costing of the new guidelines is underway to explorerolled out. Proper timing will foster rapid uptake of the resource implications for different guidelinethe new guidelines by ensuring that health workers scenarios. Following incorporation of the commentsand patients receive clear messages and immediate resulting from these reviews, the MOH plans todistribution of the new ARVs is possible. officially endorse and disseminate the revised HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis and Treatment 11
  12. 12. AIDSTAR-One | CASE STUDY SERIESguidelines through a process similar to the one used WHO. 2010. Antiretroviral Therapy for HIV Infection infor rollout of the 2006 guidelines. n Adults and Adolescents. Recommendations for a Public Health Approach (2010 Version). Available at www.who.int/ hiv/pub/arv/adult2010/en/index.html (accessed July 2010)REFERENCESCentral Intelligence Agency. 2009. The World Factbook ACKNOWLEDGMENTS2009. Washington, D.C.: Central Intelligence Agency.Gallant, J. E., E. DeJesus, J. R. Arribas, et al. 2006. AIDSTAR-One would like to thank the following partnersTenofovir DF, Emtricitabine, and Efavirenz vs. Zidovudine, for providing input and guidance in the developmentLamivudine, and Efavirenz for HIV. New England Journal of this case study: the Ministry of Health, Guyana andof Medicine 354(3):251–260. several of its programs and departments, including the National AIDS Programme Secretariat, the NationalMinistry of Health (MOH), Guyana. 2006. National Care and Treatment Centre, the National TuberculosisGuidelines for Management of HIV-Infected and HIV- Programme, and the Maternal and Child HealthExposed Adults and Children. August 2006 revision. Department; the Food and Drug Department, Guyana;Georgetown, Guyana: Ministry of Health. U.S. Agency for International Development (USAID)/ Washington and USAID/Guyana; the Supply ChainPlusNews, “Malawi: Malawi Moves to Adopt WHO Management Systems Project and Management SciencesGuidelines,” Integrated Regional Information Networks for Health; Centers for Disease Control and Prevention-(IRIN), May 27, 2010. Available at www.irinnews.org/ Guyana, Global AIDS Program; and François-Xavierreport.aspx?Reportid=89266 (accessed June 2010) Bagnoud Center (FXB)-Guyana and FXB-USA, University of Medicine and Dentistry of New Jersey. We would alsoPresidential Commission on HIV and AIDS, Government of like to thank the following members of the AIDSTAR-Guyana. 2009. UNGASS Country Progress Report: Republic One Treatment Technical Working Group: Robert Ferrisof Guyana. Reporting Period: January 2008 - December (USAID) and Tom Minior (USAID).2009. Georgetown, Guyana: Government of Guyana.Supply Chain Management Systems (SCMS) Project-Guyana. 2008. Supply Chain Management Systems RECOMMENDED CITATIONGuyana – Its Evolution & Current. Georgetown, Guyana:SCMS Project. Rossi, Victoria, and Bisola Ojikutu. 2011. HIV Treatment Guidelines in Guyana: The Fast Track to Diagnosis andWHO. 2009. Rapid Advice: Antiretroviral Therapy for HIV Treatment. Case Study Series. Arlington, VA: USAID’sInfection in Adolescents and Adults. Available at www.who. AIDS Support and Technical Assistance Resources,int/hiv/pub/arv/advice/en/index.html (accessed March 2010) AIDSTAR-One, Task Order 1. AIDSTAR-One’s Case Studies provide insight into innovative HIV programs and approaches around the world. These engaging case studies are designed for HIV program planners and implementers, documenting the steps from idea to intervention and from research to practice. Please sign up at www.AIDSTAR-One.com to receive notification of HIV-related resources, including additional case studies focused on emerging issues in HIV prevention, treatment, testing and counseling, care and support, gender integration and more.12 AIDSTAR-One | April 2011

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