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Hivdr prevention and Assessment Annual Country Report Outline


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IX. HIVDR database(s)


Describe databases used in country for WHO related HIVDR surveillance, monitoring, and EWI activities

State if country will contribute data elements to regional and/or global database for global analysis and quality assurance.



X. Review and Support of HIVDR Prevention Activities

A. Activities


List country activities not under the supervision of the HIVDR working group, but associated with HIVDR prevention. All the factors below may not be present in a country; countries may also list additional factors. Under each activity, describe its implementation, monitoring and evaluation systems if relevant, and needs if any for increased support

  • Standard prescribing practices (highly active ART regimens) and appropriate ART eligibility definitions in place (The prescribing of highly active ART (i.e. three active drugs from at least 2 different classes) is necessary to achieve viral suppression and is essential in the prevention of HIVDR. Having national standard first and second line regimens and national criteria for starting of ART support optimal program practice. Describe national standard guidelines for determining eligibility to initiate ART and list standard first and second-line regimens. Provide guidelines for ART substitution and switch.

  • Ongoing quality assurance for drugs (not only initial QA) (Use of consistently potent quality assured drug is essential for treatment of HIV and prevents HIVDR emergence. Describe if and how ART is initially quality assured in country and if this quality assurance program is ongoing or performed only at start of program (i.e. WHO pre-qualified drug). If different partners/funders use different sources of drug describe all sources and quality assurance measured in place for each source.

  • Adequate and continuous drug supplies; monitoring at site and regional levels of drug supply shortages (Describe ART drug procurement in county, supply chain, and measures in place to prevent drug shortages and stock-outs. If different ART partners/donors in country have different drug supply management strategies, please describe all.).

  • Standard ART patient records or minimum standard data recording (describe if there is a national record keeping system and if it exists at all sites or describe a minimal nationally agreed-upon dataset used in countries having multiple record keeping systems).

  • ART patient and cohort monitoring (Good program practice (i.e. well kept medical records, low lost to follow-up, etc) minimize the emergence of preventable and optimize patient care. In this section, describe clinical cohort ART monitoring being performed in county; summarize results and recommendations.

  • Support for and monitoring of adherence (optimal ART adherence minimizes HIVDR at the individual patient and population level. Describe measures to assess and support patient adherence as part of country ART program. If different sites/partners have different adherence support measures please describe all.

  • Removal of barriers to continuous access to care (in this section describe national initiatives designed to promote HIV diagnosis and treatment; stigma reduction)

  • Prevention programs to reduce HIV transmission from persons in treatment (In this section describe measures in place to prevent transmission of HIV from infected individuals in care to uninfected individuals).



B. Future plans for additional prevention activities or for increased support of these activities

Please describe


XI. Other HIVDR research in Country X

A. Other HIVDR Activities and Results


Important HIVDR research, both supported by other institutions and by the HIVDR working group should be described in this section and include a description of development of clinical applications of viral load and HIVDR testing in country, if applicable.

a. HIVDR operations research or special studies based on hypotheses generated by results of HIVDR EWI, HIVDR Sentinel ART site surveys, HIVDR-TS.

b. Other HIVDR research or studies [University researchers, NGOs, national institutions, others]

B. Future plans for additional HIVDR research


Please describe future plans for additional HIVDR research

a. HIVDR operations research or special studies planned based on hypotheses generated by results of HIVDR EWI, HIVDR Sentinel ART site surveys, HIVDR-TS.

b. Other HIVDR research or studies planed in country [University researchers, NGOs, national institutions, others]

XII. Discussion of HIVDR prevention, emergence, and transmission based on current information

In this section summarize the implications of the results of WHO suggested EWI, HIVDR-monitoring, and HIVDR-threshold surveillance performed in country. Additionally, briefly summarize other HIVDR research conducted in country and how, if it all, HIVDR related research in country augments results obtained from EWI, HIVDR-monitoring, and HIVDR-TS. Summarize areas of good ART program function and areas of needed improvement. Critically evaluate country guidelines for ART regimens, guidelines for clinical-making, programs to reduce transmission for infected individuals, and PMTCT programs in light of the overall relevance of any assessment or study performed in the country.


Discuss Hypotheses for operational research or special studies which have been generated by results from assessments and discussion of various methods that could be used to test the hypotheses and the resources required. Prioritize the need for each of the potential operational research or special studies.

XIII. Recommendations
Based on the total HIVDR evidence in country make evidence based recommendations:


  • To optimize ART programmatic function and effect positive programmatic changes to minimize the emergence of preventable HIVDR.

  • To optimize available first and second-line ART regimens and plans for future regimen selection (if applicable)

  • To optimize PMTCT and post exposure prophylaxis regimens (if applicable)

  • To clinical decision-making for HIV infected individuals

  • To recommend future operational research or special studies based on hypotheses generated by results


Appendix 1
WHO Suggested Generic Terms of Reference for National HIVDR Working Group


    • Implement the HIV Drug Resistance (HIVDR) Plan 2007-2011

    • Adapt the generic HIVDR monitoring protocol for sentinel sites within country; implement country-adapted protocol for monitoring HIVDR in sentinel treatment sites -- resistance patterns

    • Regularly perform HIVDR threshold surveys to evaluate transmitted resistance

    • Collect and analyze HIVDR Early Warning Indicators

    • Build capacity for genotyping to support HIV drug resistance surveillance and monitoring within the country including quality control

    • Support programs which will minimize HIVDR, prioritizing adherence support and ART follow-up programs,

    • Summarize all HIVDR research in the country

    • Analyze and report annually on the situation with regard to HIVDR in the country

    • Make evidence based recommendations to effect positive programmatic change to minimize the emergence of HIVDR and maximize the long-term efficacy and durability of available first- and second-line regimens

    • Disseminate information and public health action to be taken to country ART program and key stakeholders

    • Provide guidance on optimal ART regimens

    • Coordinate the country HIVDR prevention and assessment strategy with the WHO HIVResNet

    • Ensure all activities follow local and international ethical standards

Membership of the HIVDR working group:

Example:


  • National AIDS Program - Care and Treatment Unit

  • National AIDS Program – Surveillance, M&E Unit

  • Clinicians

  • Laboratory representatives

  • Epidemiologists

  • Universities?

  • Other government departments?

  • Non-governmental organizations

  • Community representatives

  • International Organizations: WHO, CDC, Other Agencies?

    • Chose Chair-person(s)

    • Specify roles of various partners

Appendix 2 Early Warning Indicators

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