RTI International is a trade name of Research Triangle Institute Overview of lessons learned from previous biomedical HIV prevention interventions in South Africa Presented by: Elizabeth T. Montgomery, Ph.D February 7,2012

Background The history of other biomedical HIV prevention methods introduced in South Africa may offer insights relevant to the introduction of oral PrEP and vaginal microbicides –Case studies to consider: PMTCT Male circumcision

Case Study 1: PMTCT, timeline HIVNET 012 results published in 1999 First SAG policy drafted in 2001 –Original Department of Health plan was to implement single dose Nevirapine (NVP) at 18 pilot sites (1 urban, 1 rural, per province) –July 2002: “lobby groups” won a case against the NDOH in the Constitutional Court. National expansion of PMTCT mandated August 2005: ~2525 sites offering PMTCT

PMTCT Timeline continued SAG published new PMTCT guidelines in 2008 to include provision of dual therapy –2008 PEPFAR estimates of ARV coverage for HIV+ pregnant women in South Africa just under 60% 2010 Updated Guidelines published 5/23/2015 4

PMTCT Programme Intervention 5/23/2015 5

h 5/23/2015 6

PMTCT Analysis – one perspective

PMTCT Programme in South Africa Strengths Policy drafted in 2001 New guidelines published in 2008 Wide consultation on policies and plans PLWHA and disability sector involved in the social mobilization plan for PMTCT Weaknesses Protocol does not fully match international best practice standards Men not sufficiently involved Adolescent mothers not included in PMTCT planning Inadequate human resources Poor quality counseling Infant formula supply problems Inaccurate M & E

PMTCT Programme – another perspective PMTCT: A Winnable Battle in South Africa National cross-sectional facility-based survey of infant-caregiver pairs attending the 1 st infant immunization visit Dried blood spot (DBS) specimens from 4-8 week old infants were tested for HIV antibodies –Exposed infants further tested using DNA PCR 5/23/2015 9

PMTCT Programme results 9610 enrolled infant-caregiver pairs, 2888 (30%) HIV- exposed infants were identified. National MTCT rate at 4-8 week postpartum was estimated to be 4.0% (95%CI 3.3%-4.8%). –Unplanned pregnancy (AOR=1.7; 95%CI ) associated with MTCT. –Exclusive breast-feeding (AOR=0.6; 95%CI ); and maternal triple antiretroviral treatment (AOR=0.4; 95%CI ) were protective factors. 5/23/

PMTCT – important lessons Civil society keeps up with research and will hold SAG accountable to all citizens, not just those in “pilot” areas –Early preparation needed More than just a pill –Prevention interventions complex and rely on a series of interventions and a holistic approach of how the pills fit in Importance of ongoing and evidence-based evaluation

Case Study 2: Male circumcision OVERVIEW Clinical trial results: ~60% reduction in HIV acquisition 2007 WHO/ UNAIDS recommendations issued South Africa identified as a priority country March 2011 South African National Implementation Guidelines for Medical Male Circumcision

National and multinational goals South African Guidelines goal: to make accessible, safe MMC services available to all South African men. The priority age group is young men aged between 15 and 49. WHO/ UNAIDS Strategic Framework seeks to achieve the following goal: By 2016 countries with generalized HIV epidemics and low prevalence of MC have: –a) VMMC prevalence of at least 80% among 15–49 year old males, and –b) Established a sustainable national programme that provides VMMC services to all infants up to 2 months old and at least 80% of male adolescents. 5/23/

VMMC Considerations Goal(s) Guiding principles, e.g. supportive leadership, safe and effective practice, human rights, gender sensitivity, socio-cultural sensitivity, comprehensive HIV prevention Implementation Activities –Management at different levels –Service Delivery –Clinical Guidelines –Communication –Leadership and partnerships –HR, Financing, Costing, Supplies, etc etc etc 5/23/

South Africa Estimates of VMMC 130,000 VMMC in South Africa by end of 2010 (UNAIDS) To date: Catey and Carlos? Successes and Weaknesses of VMMC programme 5/23/

Summary and Conclusions Issues of potential relevance to Oral PrEP/ Vaginal Microbicides –Political Leadership –Role of civil society –Costs of intervention/ opportunity costs –Degree of integration with other RH activities and HIV prevention efforts related impact on capacity of service delivery –Training and human resources –Supply/ commodity demands –Marketing and communications –Counseling needs, issue of partial efficacy –Need for ongoing monitoring and evaluation 5/23/

And finally What have we learned from implementation of other (non HIV- related) interventions that could be useful? 5/23/