Aids Fonds funding
for programmes to
prevent HIV drug
resistance
Call for proposals
July 2012
Aids Fonds
Keizersgracht 390
1016 GB Amsterdam
Date July 2012
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[email protected]
Documentnumber 20120719/JKA/RAP
Universal Access
‘Lifting barriers to universal access’ is an important multiyear strategic objective of
the Aids Fonds. Under this objective, the international policy for 2012 includes a
call for proposals, focussed on treatment as prevention and/or the prevention of
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HIV drug resistance.
At the 2011 High Level Meeting on AIDS, UN Member States adopted a Political
Declaration on AIDS, providing a roadmap towards achieving the vision of zero
new HIV infections, zero discrimination and zero AIDS-related deaths. Through
this declaration UN Member States promised to deliver antiretroviral therapy to 15
million people by 2015, eliminate new HIV infections in children, achieve a 50%
reduction in new HIV infections among adults, reduce transmission of HIV among
people who inject drugs by 50% and reduce TB deaths in people living with HIV
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also by half.
According to UNAIDS estimates, around 14 million people are in need of
antiretroviral treatment – based on CD4 counts below 350. At the end of 2011,
only 6.6 million people were receiving these life-saving medicines.
For every person placed on treatment, 2.5 people are still becoming infected every
year, amounting to approximately 2.7 million new infections in 2010. Scale-up of a
combination of effective prevention interventions therefore remains urgent, and
antiretroviral treatment will play a central role.
Unfortunately, the rapid scale up of antiretroviral treatment often results in a
compromised monitoring of the quality of these programs.
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Advise international funding 2011 and 2012, internal memo 20111198
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Aids Fonds
Keizersgracht 390
1016 GB Amsterdam
www.unaids.org
Date July 2012
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Increasing use of antiretrovirals
The number of people judged to be in need of antiretroviral therapy in 2011 will
almost double as a result of recent World Health Organization recommendations
on the use of antiretroviral drugs to prevent HIV transmission. These
recommendations follow on last year’s release of the results of the HPTN 052
study, which showed that early antiretroviral therapy for the HIV-positive partner
reduced the risk of HIV transmission by 96% in serodiscordant partnerships.
Similarly, evidence from KwaZulu-Natal demonstrates that, at the population level,
antiretroviral therapy is already having an impact. Every 1% increase in
antiretroviral coverage among adults in rural communities between 2004 and 2011
was associated with a 1.7% reduction in the risk of HIV acquisition. This means
that global HIV incidence could be reduced if greater progress towards universal
access to antiretroviral treatment can be achieved.
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The new WHO guidelines recommend that in couples who are serodiscordant—
where one partner is living with HIV and the other not—antiretroviral therapy is
offered to the person living with HIV to prevent his or her partner from becoming
infected with the virus. These guidelines are the newest example of a treatment as
prevention approach, a term used to describe HIV prevention methods that use
antiretroviral treatment to decrease the chance of HIV transmission.
Thirteen countries already make recommendations for serodiscordant couples on
the use of antiretrovirals for prevention of HIV transmission, including several
African countries with a high burden of HIV infection.
Together with recommendations for antiretroviral therapy for all TB patients
diagnosed with HIV, and all pregnant women irrespective of CD4 counts, the
impact of the new guidance is to add around six million people to the number in
need of antiretroviral treatment in low- and middle-income countries, adding up to
almost 13 million people.
In addition to this, antiretroviral treatment will increasingly be used by HIV
negative people after the iPrex, TDF2 and CAPRISA studies provided evidence
that pre-exposure prophylactic use of antiretrovirals (PrEP) can reduce the risk of
acquiring HIV.
So, more and more people who have never felt the consequences of HIV-related
diseases will start using antiretrovirals. Either because they are using those drugs
prophylactic, or because they start antiretroviral treatment shortly after infection.
This means that we may have to reconsider choices for medicines in first-line
regions and methods to improve adherence.
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Aids Fonds
Keizersgracht 390
1016 GB Amsterdam
http://www.who.int/hiv/pub/guidelines/9789241501972/en/index.html
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HIV drug resistance
HIV drug resistance refers to the ability of the virus to withstand the effects of a
given antiretroviral drug to prevent its replication. Drug resistant virus will continue
to replicate in the presence of the drug to which it has become resistant. As ART
continues to expand, the emergence of some drug resistance is inevitable. It is
related to the total number of people on treatment and to the number of years
antiretroviral treatment has been rolled out. Insufficient knowledge among patients
and health workers, insufficient health care infrastructure from which to deliver HIV
treatment , the cost of antiretrovirals and the complexities of supply chain
management, the lack of support required to optimize adherence and inadequate
patient monitoring mechanisms are among the many factors leading to treatment
failure and eventually drug resistance.
If patients develop HIV drug resistance to their first-line regimen, they stop
responding to it effectively. In order to stay healthy, they need to receive a
second-line regimen. In 2010, in low- and middle-income countries, second-line
treatment regimens were on average at least six times more expensive than firstline treatment. Keeping drug resistance at bay is therefore a key strategy to the
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success and sustainability of HIV treatment programmes.
HIV drug resistance will undermine the investments made in the global expansion
of HIV treatment programs in resource-limited settings, risking a reversal of the
gains made in the response to HIV.
To assess clinical and programmatic factors associated with HIV drug resistance,
the World Health Organization has developed a set of so called ‘early warning
indicators’. These indicators are currently monitored by over 50 countries by
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abstracting data routinely recorded in clinical records . The prevention of HIV drug
resistance is associated with:
• Patient care: appropriate prescribing and patient monitoring
• Patient behaviour: adherence
• Clinic/program management: efforts to reduce treatment interruptions, follow
up, retention on first-line ART, procurement and supply management of
antiretroviral drugs.
The LAASER program
The LAASER program, coordinated by Aids Fonds, set out in 2006 to strengthen
and improve the quality and durability of HIV/AIDS treatment in Africa and Asia.
The program has generated new evidence to better inform HIVDR programs in the
future. Numerous reports on LAASER program outcomes and affiliated projects
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are being published in scientific journals , showing that:
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http://www.who.int/hiv/facts/drug_resistance/en/index.html
5
Diane E. Bennett et al. HIV Drug Resistance Early Warning Indicators in Cohorts of Individuals
Starting Antiretroviral Therapy Between 2004 and 2009: World Health Organization Global Report
From 50 Countries Clin Infect Dis. (2012) 54 (suppl 4): S280-S289.
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Aids Fonds
Keizersgracht 390
1016 GB Amsterdam
LAASER brochure: HIV drug resistance in Africa and Asia, achievements of the LAASER program
2006 – 2011 www.aidsfonds.nl/uploads/laaser_achievements_brochure.pdf
Date July 2012
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•
•
•
•
6% of recently infected patients in Asia have evidence of HIV drug resistance
at the time they start ART, putting them at risk of early treatment failure.
Alarming numbers of African patients are on suboptimal first-line regimens
because 1 in 20 HIV-positive had clinically important resistance mutations
against minimally one of the prescribed drugs.
HIV drug resistance is on the rise, particularly in East Africa, with an overall
38% increase of relative risk for each additional year elapsing since ART rollout. Primary HIV drug resistance in Ugandan cities is now already 12%. This
is probably due to the earlier start of ART roll-out in Uganda.
Half of the African patients who switched to second-line treatment switched
unnecessarily, resulting in increased treatment costs and loss of drug options.
Additionally, late detection of treatment failure in other patients resulted in
more extensive HIV drug resistance, which will impair the effectiveness of
second-line regimens.
Based on these findings, the LAASER program has put forward a number of
recommendations for future programming.
The long-term success of treatment can be achieved through investment in
resistance monitoring today. A growing concern among HIV drug resistance
experts is the general absence of routine viral load monitoring in Africa. As a
consequence, either premature and inaccurate diagnoses of treatment failure, or
delayed diagnoses, leading to development of higher levels of HIVDR, may result.
Current HIV drug resistance testing is expensive and technically challenging,
making it unfeasible for many resource-limited settings. A more cost-effective
approach for the monitoring of HIV drug resistance is therefore required.
Communities of key populations, including people living with HIV, face many
challenges and it may be difficult to prioritize issues like resistance. HIV drug
resistance will become even less of an advocacy priority unless its importance is
constantly upheld by policy makers. Enhanced and more focused advocacy
work is needed to address the emergence and impact of HIV drug resistance.
Specific advocacy should be conducted to ensure that price reductions on secondline treatment for adults and children are continued and strengthened in order to
ensure access to these life-saving medicines.
National ART programs that were rapidly scaled-up in the context of relatively
weak health systems risk the development of HIV drug resistance due to
inadequate program retention and adherence support at the patient and clinic
levels. National ART programs should allocate ~0.5%-1% of budgets to monitor
HIV drug resistance prevention efforts and their outcomes.
Based on the LAASER recommendations we have formulated this call for
proposals, to prevent and adequately address HIV drug resistance. As a private
and non governmental organization Aids Fonds supports important but
underfunded niches. For this call, Aids Fonds seeks proposals on innovative
initiatives, especially activities that are linked to programs where antiretrovirals are
used to prevent transmission or acquisition of HIV. Activities should have a
leverage effect beyond the particular programme.
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Keizersgracht 390
1016 GB Amsterdam
Date July 2012
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Call for proposals on HIV drug
resistance
Scope
The scope of this call includes the full range of activities that can prevent and
adequately address HIV drug resistance for participating patients. All interventions
have to contribute to the quality of care of the patients involved.
This call is particularly meant for innovative approaches. Interventions could be,
but are not limited to, viral load monitoring, targeted resistance monitoring,
adherence counselling and support, focused advocacy on the importance of HIV
drug resistance or providing medicines with a lower risk of resistance.
Activities can be part of programs in which antiretrovirals are used to prevent the
transmission (earlier start of treatment) or acquisition (pre-exposure prophylaxis)
of HIV.
Aim and objectives
• To support programmes that implement activities to prevent and adequately
address HIV drug resistance in participating individuals.
o To support the introduction of improved regimens, avoidance of stockouts, and better procurement and supply management.
o To support better patient monitoring, including the use of viral load and
resistance testing.
o To support the understanding of treatment options, access and stay in
care, and adherence to treatment. Especially for people living with
HIV who are asymptomatic
• To generate results that can be transferred beyond the context in which the
programme takes place.
• To involve communities in creating a favourable environment for preventing
and addressing HIV drug resistance
Monitoring and Evaluation
Close monitoring of the quality of treatment programmes and gathering evidence
on how to prevent HIV drug resistance is hardly done. Therefore, each program
under this call should start with developing hypotheses on the proposed
interventions followed-up by close monitoring and evaluation during and after the
activities.
The format for the activity plan and budget includes indicators for outcome and
output (appendix).
If proposals are rewarded with a grant, the proposal will become the basis for
further monitoring, Annual financial statements and information on progress are
required. Aids Fonds explicitly values information with regard to the outcome of
the activities, which means that applicants commit to reporting about this after the
grant period has ended (since this is often the moment wherein outcome can be
observed). Projects that receive support as part of a specific call will be evaluated
in coherence with the other projects that receive a grant under the same call.
Eligibility criteria for proposals
1. Applications have to be submitted before the deadline of 1 September
2012, 9 am CET.
2. Programmes should take place in one of the following countries: South
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Date July 2012
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3.
4.
5.
6.
7.
Africa, Kenya, Zambia, Zimbabwe, Malawi, Thailand, Brazil, Botswana,
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Rwanda, Namibia or Lesotho
Programmes should focus on approaches to prevent and adequately
address HIV drug resistance
Programmes should be primarily aimed at improving the quality of care for
the target group
The activities are grounded in a context analysis.
Applicants should use the specific format provided in appendix I for their
application. The application should be in English and the form has to be
submitted in Microsoft Word to [email protected]
Applicants should use the specific format provided in appendix II to
describe objectives, outcomes, indicators, activities and the budget. The
framework has to be submitted in Microsoft Excel to [email protected]
Eligibility criteria for applicants
1. Funding will only be applied to registered organisations and not to
individuals.
2. Applicants must be non-profit and non-governmental organisations.
3. Organisations should provide their latest annual narrative and financial
report together with the application
4. Organisations must have strong management and the capacity to
formulate a proposal, to carry out the proposed activities and to effectively
manage award funds
Budget
For each programme a maximum budget of €240.000 is available for the duration
of three years (maximum of €80.000 per year). The total available budget is
€850.000. In the situation of a high number of proposals of excellent quality and
the availability of funds, additional budget can be added in January 2013.
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This selection is based on the WHO progress report 2011, page 98 and includes the low- and middle
income countries with the highest number of people receiving antiretroviral therapy and an estimated
Aids Fonds
Keizersgracht 390
1016 GB Amsterdam
antiretroviral therapy coverage of >50%.
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Procedures
Publication
NGO’s from the selected countries are asked to submit a proposal through this
call. NGO’s are reached via global networks and partners of Aids Fonds. The call
is published on the Aids Fonds website and will be actively distributed at the
International Aids Conference in Washington.
Language
All communication will be in English.
Quality review
Proposals that are submitted before the deadline of 1 September, 2012, will be
checked on the above mentioned eligibility criteria for proposals and applicants.
Proposals that fulfil these criteria will be reviewed by experts in the field. The
submitting organizations receive the anonymous reviews and are given the
opportunity to write a rebuttal. Based on the reviews and the rebuttals, an external
commission will give its advice to the Board of Aids Fonds. The Board will make a
final decision.
Evaluation criteria
The reviewers will assess all eligible proposals on the following evaluation criteria:
• Overall quality of the proposal
• Capacity to monitor outcome indicators
• Relevance of the programme and potential impact for the target group in the
specific context
• Potential of sharing (and implementing) the results with other stakeholders
• Feasibility of the programme and its positive impact on the general health
system, for example through partnerships
• Budget in comparison to the proposed activities
• Sustainability: links with other stakeholders and other sources of funding
• Innovativeness of the proposed activities
• Programmes where a broad range of interventions will be combined to
increase the potential impact will have an asset.
Apart from these criteria, Aids Fonds aims for a diverse portfolio which means
that programmes of comparable quality may be assessed differently in order
to cover different subjects, different target groups and different regions within
one call.
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Keizersgracht 390
1016 GB Amsterdam
Date July 2012
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Timeline
Aids Fonds
Keizersgracht 390
1016 GB Amsterdam
1 September 2012
09:00 am CET - Deadline for submitting proposals
26 September 2012
Proposals reviewed by experts, anonymous reviews sent
to submitting organization
3 October 2012
09:00 am CET - Deadline for rebuttal by submitting
organization
31 October 2012
Advice of the external advisory committee based on
reviews and rebuttals
1 December 2012
Decision by the board of Aids Fonds, acknowledgements
immediately afterwards
1 April 2013
Deadline for start of the programme (all programmes must
start within four months after the decision of the Board)
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Appendix I – application form
http://www.aidsfonds.nl/funding/possibilities
Appendix II – activity framework
and budget
http://www.aidsfonds.nl/funding/possibilities
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