Manuel de Normes en Charge Clinique et Thérapeutique des Adultes et Adolescents Vivant avec le VIH/Sida

Objectives

Provide a national, standardised and context-appropriate framework for prevention, clinical management and long-term therapeutic care of adults and adolescents living with human immunodeficiency virus (HIV) in Haiti, with the wider aims of improving survival and quality of life, reducing transmission and opportunistic infections, achieving viral suppression, and reducing the epidemic’s impact.[1][2][3][4]The framework seeks universal access to care and antiretroviral medicines while continuing prevention and awareness activities.[2]

• Standardise clinical and therapeutic protocols for HIV, including HIV and tuberculosis co-infection, HIV and hepatitis B co-infection, opportunistic infections, treatment toxicity, treatment failure, occupational blood exposure and sexual violence.[3][4][5][6][7]
• Provide multidisciplinary clinical, therapeutic, psychosocial and preventive care tailored to clinical condition, laboratory findings, opportunistic infections and informed consent.[8]
• Expand eligibility for antiretroviral treatment, prioritising people with advanced World Health Organization clinical disease, active tuberculosis, treatment-requiring hepatitis B, pregnancy or breastfeeding, serodiscordant partnerships, HIV-associated nephropathy and older age, while using CD4 counts to guide treatment for other asymptomatic patients.[9][10]
• Prevent opportunistic infections and tuberculosis through lifelong cotrimoxazole prophylaxis, isoniazid with vitamin B6 or pyridoxine after exclusion of active tuberculosis, early case detection, timely treatment and integrated HIV and tuberculosis care.[11][7][12]
• Strengthen treatment pathways by using preferred first-line regimens, protease-inhibitor-based second-line regimens following failure, and nationally reviewed third-line salvage options where second-line treatment has failed.[13][14][15][16]
• Protect patients’ rights through confidentiality, coded records, informed consent, voluntary partner notification, counselling and non-coercive referral arrangements.[8][17]
• Address barriers to equitable care, including stigma, economic constraints, treatment access, adherence, medicine storage, co-infections and community preparedness.[18][9]

Implementation

Implement the guidance throughout a three-level national health system, linking community and primary services with departmental, specialised and university hospitals through referral, counter-referral, technical supervision and clinical coordination.[4][19][20][21]The Ministry of Public Health and Population, through its National Programme for the Fight against Sexually Transmitted Infections/HIV/AIDS, leads the response, supported by national technical and expert committees, healthcare providers, partner institutions, laboratories, pharmacies, community organisations and networks of people living with HIV.[2][14][15][22]

• Deliver primary-level prevention, testing, counselling, adherence support, family-planning advice, management of sexually transmitted infections, tuberculosis screening, supportive care, post-exposure management and referral; enable higher-level facilities to initiate and monitor antiretroviral treatment, manage opportunistic infections and tuberculosis, and address severe illness and treatment failure.[20][21]
• Use multidisciplinary teams including clinical and nursing staff, laboratory and pharmacy personnel, adherence counsellors, psychologists or social workers where available, and trained people living with HIV to provide psychological assessment, social support, counselling and treatment preparation.[23][24][22][25]
• Prepare patients for treatment through counselling before initiation, assess clinical and laboratory status, explain regimen duration, benefits, limitations and adverse effects, and continue adherence support at medicine collections and clinical visits.[17][26][22]
• Schedule clinical follow-up intensively after treatment initiation, then reduce visit frequency where adherence, tolerance and clinical progress are satisfactory; monitor weight, symptoms, opportunistic infections, adherence, adverse effects, CD4 counts, viral load where indicated, and relevant haematological, hepatic and renal measures.[18][27][28][29]
• Use viral load above 1,000 copies per millilitre as the principal criterion for virological treatment failure, alongside clinical and immunological assessment; require committee review of second-line and third-line transitions, supported by treatment history, adherence assessment and resistance testing where feasible.[30][16][31]
• Maintain referral documentation covering HIV status, comorbidities, treatment history, adherence, CD4 and viral-load results where available, recent opportunistic infections and clinician contacts; assess referral performance, map available services and document referral outcomes.[19][32]
• Ensure emergency management after occupational blood exposure or sexual assault through immediate decontamination, consent-based testing, counselling, prompt post-exposure prophylaxis, clinical follow-up and referral.[33][34][35][36]
• Manage essential inputs through approved procurement, pharmaceutical quality assurance, secure storage, three months of antiretroviral stock at each site, national distribution arrangements, consumption-based requisitions and site reports on medicine use.[25][37]
• Monitor service quality through clinical and laboratory follow-up, case-review forms, routine data responsibilities, technical supervision and quality indicators including HIVQUAL; revise protocols periodically in response to scientific evidence, treatment outcomes, patient analysis, new medicines and relevant legislation.[22][20][21]

Monitoring & Evaluation

The clinical manual establishes a predominantly patient-level monitoring system for HIV care in Haiti, combining scheduled clinical reviews, laboratory testing, referral documentation, treatment-failure assessment, toxicity surveillance and case-review committees. It includes some quality-improvement and medicine-utilisation reporting provisions, but does not set out a comprehensive programme-wide indicator framework, surveillance architecture or external accountability system.[20][21][25][37]

• Monitor people not yet receiving antiretroviral treatment through clinical assessment, weight trajectory, opportunistic-infection screening and CD4 testing at least every six months; schedule consultations every three months or more often where clinically indicated.[38][39]
• Review patients shortly after antiretroviral treatment initiation, then weekly or fortnightly during the intensive phase and generally monthly once adherence, tolerance and clinical progress are satisfactory. Assess adherence, adverse effects, immune reconstitution inflammatory syndrome, opportunistic infections, treatment failure and weight at scheduled reviews.[27][28][40]
• Use clinical staging, CD4 measurement, viral load and relevant biological tests to guide treatment decisions. A plasma viral load above 1,000 copies/ml is the principal criterion for virological failure, while second-line failure may also be assessed through CD4 decline, persistently low CD4 count and clinical criteria.[30][16][31]
• Require review of suspected second-line failure through viral-load and resistance testing where feasible, adherence assessment and reconstruction of treatment history. Submit documented cases through network technical committees to the national technical committee, which makes decisions on transition to empirical third-line treatment.[15][16]
• Conduct clinical review at every visit for people with HIV and tuberculosis co-infection, including assessment of opportunistic infections, associated illness, medicine reactions and progress. Apply laboratory and tuberculosis follow-up schedules, including sputum microscopy at months 0, 2, 5 and 6 for co-infected patients.[41][7]
• Monitor treatment toxicity through targeted laboratory testing, including renal assessment for tenofovir-containing treatment, liver monitoring for potentially hepatotoxic medicines, and blood counts where zidovudine-related anaemia or neutropenia is suspected. Use a four-grade toxicity classification and refer complex severe toxicity to higher-level care when needed.[42][43][44][29]
• Record and transmit clinical information during referrals, including CD4 results, adherence, opportunistic infections, comorbidities, treatment history, viral load where available and treating-clinician contacts. Assess referral and counter-referral arrangements, document outcomes and monitor whether patients obtain timely access.[19][32]
• Report medicine use at service sites, base requisitions on consumption, and apply Ministry of Public Health and Population pharmaceutical standards to storage, distribution, dispensing and quality assurance.[25][37]
• Assign personnel for daily and monthly data collection, with responsibility allocated by the centre manager. Define quality standards and periodic checks for reception, counselling, laboratory services, medicine expiry dates and testing.[22][45]
• Develop service-quality indicators, including through HIVQUAL, and review therapeutic protocols annually using technological developments and analysis of outcomes among patients receiving antiretroviral treatment.[20]
• Follow occupational blood-exposure and sexual-assault survivors through baseline, three-month and six-month HIV testing, with specified clinical and biological assessments. Require incident reporting for occupational exposures and formal notification of confirmed positive exposure cases within 24 hours.[34][46][35][47]

Costing & Financing

Financing information is limited. Historical external funding supported HIV prevention, access to antiretroviral medicines and expansion of care sites, while the manual identifies essential medicines, diagnostics, laboratory capacity, counselling, supply-chain systems and trained staff as resource requirements. It provides no overall budget, costed implementation plan, allocation, funding-gap estimate or resource-mobilisation strategy.[2][25][37]

• Recognise Global Fund financing from around 2001 as support for prevention strategies and improved access to antiretroviral medicines.[2]
• Recognise Presidential Emergency Plan for AIDS Relief funding from 2004 as support for expanding and strengthening clinical and therapeutic care sites.[2]
• Maintain required inputs including antiretroviral medicines, medicines for opportunistic infections, rapid tests, laboratory supplies, condoms, educational materials and data-collection forms; maintain three months of antiretroviral stock at each site.[25][37]
• Prefer lamivudine over emtricitabine where clinically appropriate because the manual identifies lamivudine as the lower-cost equivalent option.[13]
• Prefer atazanavir/ritonavir over lopinavir/ritonavir where appropriate because it is identified as less costly and requires fewer tablets per day.[48]
• Avoid excessive expenditure on diagnostic investigations that are inaccessible, too costly or unlikely to lead to an available treatment.[49]
• Provide anti-tuberculosis medicines and laboratory examinations free to patients, although the source does not specify how these services are financed.[50]
• Do not reduce treatment intensity, switch from triple to dual therapy, or alter treatment solely because of economic constraints.[47]
• Note that affordability and patients' economic circumstances can affect treatment access, while medicine availability, accessibility and storage are necessary operational conditions.[9]