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GRIPP– Herpes Simplex Virus Type-2 Treatment and HIV Infection: International Guidelines Formulation and the Case of Ghana Burris H1, Adu-Sarkodie Y2, Parkhurst J1, Baafuor KO2, Mayaud P1 1 London School of Hygiene & Tropical Medicine, London, UK 2 Kwame Nkrumah University of Sciences & Technology, Kumasi, Ghana
Study Aim & Design • To evaluate the process of incorporating evidence from international or national research into international or national policies/guidelines • Case study: • incorporating management of Herpes simplex virus (HSV) into genital ulcer disease (GUD) guidelines; • International level: WHO • National level: Ghana
C C C C C ommunication GRIPP: from an RPC perspective… International level Policy Research (multicentre trials, modelling, CE, reviews, meta-analysis) Policy National level Practice
C Research (trials, observational, CE) C Research (operational, health systems) C ommunication GRIPP: from an RPC perspective… International level Policy Policy National level C Practice C
Background: GUD & HSV • GUD proven cofactor of HIV acquisition or transmission (Cameron 1989; Hayes 1995; Gray 2001) • GUD aetiologies include syphilis, chancroid and herpes simplex virus (HSV) • Relative prevalence has changed over time, with HSV now dominant aetiology (>40%) (Mayaud 2004) • Syndromic approach to GUD management promoted by WHO: 1994 vs. 2003
1994 WHO GUD algorithm • Only treats for TP and HD
2003 WHO GUD algorithm • Treats for HSV-2 if ulcer has sign or symptom for HSV-2 (first arm) • Otherwise treat for TP or HD (second arm) • Includes prevalence threshold for treating everyone for HSV-2 in second arm
Herpes treatment often not provided because: • Self-limited disease (in HIV negatives) • Perceived to be ineffective (1-2 days gain in healing rates) • Does not prevent recurrences (unless provided daily) • Expensive (US$0.5 per day, but generics could be as cheap as US$0.07) • Access/availability (private sector, HIV clinics) • Lack of awareness (among planners, clinicians, patients, community…) • Lack of epidemiological data (GUD aetiology, seroprevalence) • Complicated algorithm?
HSV-HIV and International Policy Context • HSV-HIV synergies++ • WHO Consultation on HSV Research (London, 2001) • HSV-HIV trials (2002-09) (ANRS, CDC, Gates, NIH, WT) • Strategies: episodic (5d) vs. suppressive (daily) therapy • Populations: HIV+ and HIV-, men/women, Asia/SSA/LAC/US • Outcomes: HIV acquisition (in HIV-), HIV infectivity (genital shedding in HIV+), HIV transmission (serodiscordant couples), HIV disease progression • Global Strategy for the Prevention and Control of STI (2006-15) adopted at WHA (Geneva, June 2006) • Formation of International HSV-HIV Collaborative group (London, October 2007) • Acyclovir Access study planned with WHO (2007-08) • Revision of WHO GUD management guidelines + international HIV-HSV meeting (Montreux, April 2008)
Ghana • GUD management policy in Ghana • Based on WHO; last revision guidelines 2000 • ANRS1212 HSV-HIV trial (2002-2006): Ghana+CAR • Multicentre RCT of acyclovir (400mg x3 for 5d) in addition to synd. mx. for GUD episodes among women • Results: • 50% of GUD caused by HSV-2; 50% of patients HIV+ • small impact of acyclovir on ulcer healing, no impact on HIV genital shedding or plasma viral load • Impact on healing in subgroups: HIV+ with low CD4, primary herpes • Dissemination/Communication: • national w’shops in 2002 and 2006 (preceded by w’shop on interpretation of results with WHO STI and WHO Afro staff… but little “national” representation!)
“Black Stars To Receive Heroes’ Return” Communication with national stakeholdersworkshops, participation of national (+international) stakeholders, researchers, police & army, NGOs, etc, media, press release, RPC newsletter, editorials, ….publications) Daily Graphics, February 2002 C
Study Methods • In-depths interviews in Montreux (n=11) • Researchers, programme managers, WHO staff • In-depths interviews in Ghana (n=8) • High-level sexual health government officials, policy-makers, leaders in HIV and reproductive health non-profit community, prominent researchers, practitioners MSc student with supervision of two LSHTM staff; accompanied by senior researcher in Ghana for stakeholders interviews
Theoretical frameworks I (1) Evidence into Policy Linear/rationalist model: change as problem-solving Enlightenment model: change requires an accumulation of information (Weiss C, 1977) The “two-worlds” model: need “bridging the gap” RAPID Study: context, evidence, links, external influences (ODI) (2) International to National Policy Transfer “Looped” and “incremental” policy transfer (Cliff et al. 2004) HIV/AIDS as a policy window (Lush L, et al. 2003)
Theoretical frameworks II (3) Research to National Policy Development • Champions of the cause • Policy change follows practice (Meheus and syndromic management) (4) Accounting for context • Health policy triangle: accounting for a complexity of factors (Walt G & Gilson L, 1994) • Agenda setting: drivers of change (ODI) • “Three streams” model: creating a window of opportunity
Findings: international level Conscious attempt to incorporate evidence into guidelines: high-level quality research from multitude of formats (RCT, meta-analysis, biological experiments, health economics, modelling, policy); consensus building; grading of the evidence; commissioning of further research Despite inconclusive evidence, changes in guidelines were recommended: HSV treatment incorporated, and highlighted further research required Importance of “Intellectual Clubs” to get research onto agenda, then into guidelines Some disconnect between researchers and programmatic staff (“two worlds”)
Findings: national level Mechanisms of GRIPP in Ghana: Response to donor pressure (influenced by international research and WHO/International guidelines) Need a local “Champion” (at MOH/Govt level) Importance of “intellectual clubs” (communities of researchers, practitioners and Govt. officials) “Policy will follow practice” Commissioning Research HSV trial perceived as too international, no real local scientific ownership/champion Turnover of programme staff: discontinuity, lack of ownership More locally-relevant research would be operational in nature
Summary • Changes in international GUD guidelines best explained by the ‘Enlightenment framework’ • HIV-HSV synergies provided the policy window • Epistemic communities (Haas E, 1990) appear to be a primary internal driver of change in Ghana • Donors are a considerable force shaping national research agenda and set national priorities in Ghana • Importance of WHO Guidelines, particularly as they may tie in into funding/aid
C Research (trials, observational, CE) Research (multicentre trials, modelling, CE, reviews, meta-analysis) C C Research (operational, health systems) C C C C ommunication GRIPP: from an RPC perspective… International level Policy DONORS Policy National level Practice
Lessons learnt for RPC • International level: • importance of high quality and multiple forms of evidence • thematic coalitions with international researchers, WHO/UNAIDS, DFID and others (eg HSV, HPV, POC, microb.) • being responsive to needs or emerging agendas (eg MC) • exploit windows of opportunity • National level: • successful engagement for GRIPP in other contexts for HSV-HIV (South Africa, Malawi) • development of the maternal/congenital syphilis research agenda (Ghana) • Communication: • investment in multiple formats and channels of communication, reinforcing the same/incremental messages to different audiences