new ARV-based prevention tools how the research is happening how we need to be involved Anna Forbes, MSS Consultant, HIV and women’s health HIV Research Catalyst Forum 21 May 2010

differences between treatment trials and prevention trials HIV treatment trials: enroll those who need treatment & may get immediate benefit may help prevent disease progression only benefits those with the disease HIV prevention trials: enrolling healthy people – no immediate benefit to person may help prevent disease transmission benefits society; everyone at risk of HIV

PrEP Clean injecting equipment Cervical barriers: vaginal diaphragms PMTCT Vaccines Voluntary counselling and testing HIV Prevention Microbicides Male and female condoms Male circumcision PEP

what do we need to know? Is the product safe? For whom?  Adolescents? Women – pregnant? breast-feeding?  HIV-negative only? Or HIV-positive also?  Topical products -- vaginal application only? rectal only? Is it effective? For whom?  e.g. circumcision: lowers men’s risk, not women’s Usable with condoms/other barriers?

early-stage concepts preclinical testing human safety trials 3 in large-scale efficacy trials the product pipeline Source: Alliance for Microbicide Development

expected trial results -- effectiveness PrEP Men who have sex with men PrEP Heterosexual men/women PrEP Serodiscordant couples PrEP Injection drug users Treatment Serodiscordant couples PrEP Men who have sex with men PrEP Women First ARV-based Microbicide Women PrEP/Microbicid es Women

what else do we need to know? Does the community see the as ethical?  What roles do they play in set up, implementation, results distribution? Is the test product acceptable?  Do trial participants use it?  Would people use it in real life, after the trial?

going through informed consent Recruitment Participant gets information about the trial in her own language Screening Visit 1: Hears more about trial, gets screened for HIV, STI and pregnancy. Baseline data are collected Screening Visit 2: Gets test results, STI treatment if needed, counselling, info. on trial reinforced Randomization: Participant is assigned by chance to a group Family Planning INFORMED CONSENT to be SCREENED Inform ed conse nt to enrol Condoms + placebo Condoms + experimental gel INFORMED CONSENT to be ENROLLED

who says when research is ethical? Researchers and sponsors Community and advocates Ethics committees Ethical research

the challenge of adherence Prevention technology trials measure both tool + behavior addHow well tool works + How consistently people use it = How well it prevents transmission Effectiveness rate =

educating communities is vital People use a new product when: It is affordable and accessible It works the way they think it will (realistic expectations) Their peers like it and/or use it Its benefit seems worth the effort/cost