The International Partnership for Microbicides

HIV incidence refers to the number or rate of new infections in a given period. For example, an annual HIV incidence rate of two percent means that two percent of the population was newly infected with HIV in a given year.

HIV prevalence refers to the total number or rate of infection currently in a population. For example, an HIV prevalence rate of 15 percent means that 15 percent of the population is living with HIV infection at the present time.

IPM is establishing sites for large-scale clinical efficacy trials in developing countries with high rates of HIV incidence. These clinical trials must include large numbers of women at risk of HIV infection in order to provide robust evidence that a microbicide is effectively stopping new infections. Currently, countries with the highest rates of new HIV infection are found in sub-Saharan Africa and Asia.

IPM’s Site Development Process

	Identifying Collaborators: IPM has identified potential research collaborators at numerous trial sites based in Rwanda, Uganda, Tanzania, Kenya, Nigeria and South Africa. Preliminary discussions with potential collaborators in India, Mozambique and other countries are also underway. Once identified, these collaborators will work closely with IPM to determine their capacity to participate in future large-scale efficacy trials.
	Gathering Data for Large-Scale Trials: At each potential efficacy trial location, data is gathered to determine the HIV incidence rate and to ensure that researchers will be able to recruit and follow large numbers of women for the duration of the study. With a known HIV incidence rate, researchers are able to compare HIV infection rates between trial volunteers who receive an experimental microbicide and those who receive an inactive placebo. At the end of the study, researchers can analyze the data to determine if the HIV incidence rate was lowered among women who used the microbicide candidate. >> View a complete list of IPM incidence studies and their status
	Preparing Potential Trial Sites: IPM provides a variety of resources and technical assistance to establish and build capacity at research sites. For example, existing research sites may require additional infrastructure and capacity development in order to conduct the large-scale efficacy trials necessary for microbicide licensure. Or, new research sites may need to be established to provide added capacity for large-scale clinical trials.
	Devoting Resources to Local Communities: At each trial site, IPM provides local communities with material and financial resources as well as technical assistance to ensure that: trial site infrastructure, including laboratory and clinical capacity, is sufficiently developed; on-site staff receive the training necessary to conduct high-quality research that meets strict ethical and regulatory requirements and which is in accordance with Good Clinical Practice (GCP) standards; and communities are supportive, aware of and actively involved with research activities.

IPM HIV Incidence Studies
(as of October 2008)


Study Protocol	Study Name & Location	Number of Volunteers	Status & Reports

KCMC	Cohort study Tanzania (Moshi)	800	Data analysis
ICRH	Cross-sectional study Kenya (Mombasa)	800	Data analysis
Protocol 002	Cohort study Kenya (Mombasa)	400	Data analysis
IPM 002A	Cross-sectional study Kenya (Nairobi)	4,000	Completed, 2006-07 (Study report available)
IPM 002B	Cross-sectional study Nigeria (Abuja)	900	Completed, 2006-07 (Study report available)
Projet Ubuzima	Cross-sectional & cohort studies Rwanda (Kigali)	800-xs, 400-co 1,250-xs	Ongoing, 2006-08
IPM 100	Cross-sectional & cohort studies South Africa (5 centres)	800-xs, (300-co) (per centre)	Ongoing, 2007-08
IPM 100.1	Cross-sectional & cohort studies Kenya, Zimbabwe, South Africa	800-xs, (300-co) (per centre)	Planned