Annex 3: draft list of potential PICO questions on care packages for PLHIV

Transcription

1 Annex 3: draft list of potential PICO questions on care packages for PLHIV 1. Frequency of clinic visits Comments What is the most effective and acceptable frequency of clinic visit for adults, adolescents and children living with HIV? Population Intervention Comparator Outcome(s) Sub-analyses PLHIV 6-12 monthly clinic visits 3-monthly follow up clinic visit Mortality, morbidity, viral suppression, treatment By patient category (stable on ART, late presenters, failing 1 st line ART, early presenters) 2. Frequency of pharmacy delivery of HIV medication What is the most effective and acceptable frequency of pharmacy visit for medication pick up/refills for adults, adolescents and children living with HIV? Question already existing in 2015 core list of PICO questions (but listed in this meeting as a priority for stable and treatment failure care packages - see F.1.1). More details in terms of interventions and sub-analysis is needed. New question listed in this meeting as priority for stable and treatment failure care packages. More details in terms of sub-analysis need to be discussed by core group This question can be potentially merged with questions 3 and 13 (ref CTX and INH pick up) Intervention 3-6 monthly medication pick-up/refills at pharmacies Comparator Monthly medication pick up/refills at pharmacies Sub-analyses By patient category (stable on ART, late presenters, failing 1st line ART, early presenters) 3. Frequency of community delivery of HIV medication New question listed in What is the most effective and acceptable frequency of community delivery of HIV medicines for adults, adolescents and children living with HIV? Population Intervention Comparator Outcome(s) Sub-analyses PLHIV 3-6 monthly medication pick-up/refills at community level Monthly pharmacy pick-ups or refills at community level Mortality, morbidity, viral suppression, treatment By patient category (stable on ART, late presenters, failing 1st line ART, early presenters) this meeting as priority for stable and treatment failure care packages. More details in terms of sub-analysis need to be discussed by core group This question can be potentially merged with questions 2 and 13 (ref CTX and INH pick up)

2 4. Frequency of viral load monitoring for PLHIV stable on treatment What is the optimal timing for viral load testing for PLHIV stable on ART? Intervention 6 monthly Comparator 12 monthly Sub-analyses Adults Children Pregnant/breastfeeding women 5. Frequency of viral load monitoring in PLHIV with treatment failure What is the optimal timing for viral load testing for adults, adolescents and children living with HIV for PLHIV with treatment failure? Intervention 3-6 monthly Comparator 12 monthly Sub-analyses Adults Children Pregnant/breastfeeding women 6. Frequency of viral load monitoring in PLHIV at risk of treatment failure What is the optimal timing for viral load monitoring in PLHIV at risk of treatment failure? Intervention 3-6 monthly Comparator 12 monthly Outcome(s) Treatment failure, mortality, morbidity, viral suppression, retention, patient acceptability Sub-analyses PLHIV with viral load >400 and <1000copies/mL PLHIV in mobile populations PLHIV with low baseline CD4 PLHIV who are non-adherent Adults Children Pregnant/breastfeeding women Already existing in questions (but listed in this meeting as a priority for stable and packages - See C.3.4) Can be potentially merged with questions 5 and 6 and focused on VL frequency by specific patient care groups (stable, at risk of failure and failing) Already existing in questions (but listed in this meeting as a priority in stable and packages - See C.3.4) Can be merged with questions 4 and 6 and focused on VL frequency by specific ART patient groups (stable, at risk of failure and failing) Already existing in questions (but listed in this meeting as a priority in stable and packages - See C.3.4) Can be merged with questions 4 and 5 and focused on VL frequency by specific ART patient groups (stable, at risk of failure and failing)

3 7. Enhanced adherence interventions for PLHIV at risk of treatment failure Do enhanced adherence interventions (counselling, peer support strategies, etc.) for those at risk of treatment failure reduce the risk of treatment failure? Already existing in questions (see F.2.3 and F.5.4) and listed in this meeting as a priority for early, stable and Intervention Enhanced interventions (adherence, counselling etc.) packages. Consider to better discriminate what Outcome(s) Treatment failure, mortality, morbidity, viral enhanced interventions suppression, retention, patient acceptability should be evaluated. Sub-analyses Adults Children Pregnant/breastfeeding women 8. Mental Health Services (including screening, treatment) New question listed as Do mental health services improve treatment outcomes? a priority in early and Intervention Mental health services packages. Should be included in the NCD PICO sub-package. Can potentially be Sub-analyses By patient category (stable on ART, late merged with question 9. presenters, failing 1st line ART, early presenters) Consider to better discriminate the interventions to be evaluated. 9. Combination of mental health, adherence and disclosure support New question listed as Does a combination of mental health services, adherence support and disclosure support improve treatment outcomes? a priority in early care package. Should be included in the NCD Intervention Combination of mental health services, adherence support and disclosure support PICO sub-package but can potentially be merged with question 10, adding peer review as one of the Sub-analyses By patient category (stable on ART, late interventions. presenters, failing 1st line ART, early presenters)

4 10. Combination of mental health, adherence and disclosure support by peers Does a combination of mental health services, adherence support and disclosure support provided by peers improve treatment outcomes? New question listed as a priority in early care package. Should be included in the NCD PICO sub-package but Intervention A combination of mental health services, adherence support and disclosure support provided by peers can be merged with question 9, adding peer support as one of the interventions Sub-analyses By patient category (stable on ART, late presenters, failing 1st line ART, early presenters) 11. Presumptive TB treatment New question and Is presumptive treatment for TB for late presenters equivalent or better than standard treatment/screening for TB? listed as priority in late presenters care presenting late for treatment packages. Intervention Presumptive treatment for TB Comparator Standard screening/diagnosis/treatment practices for TB, By prevalence of TB 12. Cotrimoxazole-Isoniazid Fixed dose combination New question and For HIV infected adults, adolescents, and children, does CTX/INH fixed dose combination result better or comparable treatment outcomes listed as priority in all care packages. However, the Intervention CTX-INH FDC formulation is not Comparator CTX-INH non-fdc available in the market Outcome(s) Mortality, morbidity, OIs & TB incidence, viral yet. Some studies has suppression, treatment adherence, retention, patient been planned in Africa. acceptability Formulation already included in WHO EoI. Probably best answer with case studies/best By prevalence of TB and malaria practices.

5 13. Frequency of isoniazid and co-trimoxazole prophylaxis pick up /refills Is 3-6 months equivalent to monthly pick-up/refills of isoniazid or cotrimoxazole? New question and listed as priority in all care packages. Consider to merge with PICO questions 2 and 3. Intervention 3-6 months pick-up/refills of isoniazid or cotrimoxazole Comparator Monthly pick up/refills of isoniazid or cotrimoxazole adherence, TB incidence, drug side effects, retention, patient acceptability, Setting (pharmacy and community levels) Prevalence of TB and malaria 14. Nutritional support New question (not Does nutritional support when patient is identified as deficient versus standard of care improve outcomes? listed as a priority). Maybe more focused on young children and Intervention Nutritional support (FBP-supplement, nutritional assessment, counselling) severe malnourished adults. Consider to check with Nutrition Department. 15. STI screening and treatment Already existing in Does STI screening and treatment in ART clinic versus none improve outcomes? questions (but listed as a priority for early and Intervention STI screening and treatment in ARV clinic stable care packages - Comparator No STI screening and treatment in ARV clinic see F.1.2). Consider to check with SHR Department. By key populations (MSM,, Sex workers, TG) 16. NCD assessment New question (listed as Does CVD assessment versus none improve outcomes? Intervention CVD screening (BP, cholesterol, glycaemia, BMI) Comparator No NCD screening Sub-analyses By age (over 50s, adults, adolescents) By gender a priority for early care package) to be included in the NCD subpackage. Consider to add more info on what interventions to be evaluated.

6 17. Community care linkages Already included in Community care with links to the healthcare facility versus community care with no links to the healthcare facility versus community care without any links improves outcomes? 2013 guidelines but focused only in ART maintenance. Listed as (not listed as a priority). Intervention Community care with links to the healthcare facility Consider to add more Comparator Community care with no links to the healthcare info on what facility interventions to be Community care with no links evaluated. Better evaluated as bets practices. By gender 18. ART initiation in HIV+ male partners of females on option B+ New question, listed as Does starting treatment for the male partners of women on option B+ improve adherence for women in the postpartum and retention? a priority in early and stable care packages. Population Females on option B+ and their HIV+ male partners Intervention Starting treatment for the male partner of women on option B+ Comparator Not starting treatment for the HIV+ male partners of women on option B+ Sub-analyses 19. Resistance testing Already existing in Does resistance testing for children and adolescents with treatment failure (second line and third line) improve outcomes compared with no resistance testing? questions(see C.3.7). Not listed as a priority Population Children and adolescents (less than 15) with treatment failure intervention. Intervention Resistance testing Comparator No resistance testing Sub-analyses Children Failure to second line Failure to third line

7 20. Linkage to Care using Community New question (listed Do linkage facilitators/community care contacts/health navigators improve linkage to HIV care better/more effectively than standard trained health care workers and professionals? as priority in early care package).can be merged with Population People living with HIV PICO question 22. Intervention Linkage facilitators /community care contacts/health navigators Better evaluated by best practices. Comparator Trained health care workers and health professionals Outcome(s) Primary outcomes (1) Patient literacy (2) Quality of care (3) Adverse event (stigma, discrimination, coercion, psycho-social, late presentation, loss-to-follow-up) (4) HIV positivity (5) Linkage to medical care after diagnosis (6) Initiation of ART Secondary outcomes (7) Feasibility/capacity building (training) (8) Values and preferences (health workers, clients) 21. Hormone therapy (high dose) and ARVs Already existing in What is the safety and effectiveness of ARVs and hormone therapy (high dose) in PLHIV 2013 guidelines, but not in the context of Population Adults and with HIV high dose. Can be Intervention High dose hormonal therapy and ARV (PIs) included in the Comparator High dose hormonal therapy and no PIs systematic reviews Outcome(s) Hormonal therapy effectiveness, ARV on drug interactions effectiveness, safety (ARV pharmacokinetics, of the 2015 hormone therapy pharmacokinetics and adverse guidelines review. effects) Sub-analyses PLHIV in key populations (transgender) 22. Treatment and care education New question and Does continued treatment and care education for adults, adolescents and children (i.e. their care providers) living with HIV result in improved outcomes? listed as priority in early, stable and treatment failure care packages. Can Intervention Treatment and care education be merged with Comparator No treatment and care education PICO question 20. Outcome(s) Treatment adherence, viral suppression, adverse Better evaluated as events, quality of life, mortality, patient best practices. acceptability and provider acceptability

8 Sub-analyses By patient category (stable on ART, late presenters, failing 1st line ART, early presenters)