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Microbicides Essentials
Microbicides Essentials
Getting Started
Getting started: Course interface
Getting started: Course navigation
Getting started: Pretest/Course test
Getting started: Course modules
Getting started: Content features
Getting started: Certification
Module 1: Sample Screen What forms would they take?
Module 2 Sample Screen: Physiology of the vagina
Module 3 Sample Screen: Why not just focus on condoms?
Module 4 Sample Screen: Preclinical testing
Module 5 Sample Screen: Access is critical
Rectal Microbicides Sample Screen: Who needs them?
Module 6 Sample Screen
Sample Animation from Module 2
Sample Vignette from Module 5
Pretest
Pretest
1. Introduction to Microbicides
Objectives
What are microbicides?
What forms would they take?
Learn more: Lactobacillus Bacteria
Multiple choices for multiple needs
Contraception
Today's HIV/AIDS pandemic
Learn more: Women's vulnerabilities
Learn more: Violence and HIV
Learn more: Worldwide impact of HIV/AIDS
Learn more: Global perspective on STIs
Need for new prevention options
Quiz 1
A full spectrum of options
Existing strategies
Strategies under investigation
Reducing risk
How will microbicides work?
How and where are microbicides tested?
Status of development
Quiz 2
When will microbicides be available?
Investment in research
Module test
Summary
Module resources
Talking Points: Introduction to Microbicides
2. Basic Science
Objectives
HIV transmission facts
Sexual transmission
Risk factors
Steps in transmission
Physiology of the vagina
Learn more: Adolescents' vulnerability to HIV
Learn more: Lactobacillus and other natural flora
Learn more: Douching and The Risk of HIV
Learn more: Other vaginal practices
Vagina: Points of vulnerability
Physiology of the penis
Physiology of the rectum
Prove it: Estimated risk by exposure route
Learn more: Challenges of developing rectal microbicides.
Quiz
Introduction to HIV
Timeline of HIV
Learn more: HIV viral load, infectiousness, and timing of treatment
Role of other STIs
Learn more: STIs - Bacterial and viral pathogens
Learn more: Focus on herpes
Learn more: Focus on gonorrhoea
Learn more: Links to Other Information
HIV at the cellular level
The HIV lifecycle
Replication
Systemic dissemination
Learn more: Bacterial vaginosis
Module test
Summary
Module resources
Talking Points: Basic Science
3. How Would Microbicides Work?
Objectives
Mechanisms of action
Overview
Key characteristics
Blocking agents
Blocking agents: Characteristics
Vaginal defence enhancers
Vaginal defence enhancers: Characteristics
Membrane disrupting agents
Membrane disrupting agents: Characteristics
Learn more: Nonoxynol 9
Learn more: The Col 1492 Trial
Learn more: The Col 1492 trial: Findings
Learn more: What has happened with N-9?
Learn more: How has microbicides research changed since the N-9 trial?
Entry inhibitors
Entry inhibitors: Characteristics
Replication inhibitors
Replication inhibitors: Characteristics
Quiz 1
Special issues
Future developments
Module test
Summary
Module resources
Talking Points: How would microbicides work?
4. Need, Use, and Impact
Objectives
Why microbicides?
Who might benefit most?
Where are infections occurring?
Why not just focus on condoms?
Prove it! Condom Protection
Learn more: The global condom gap
What do we know about condom use?
Could more condom promotion work?
Learn more: Sex workers, condoms, and microbicides
What does this mean for women?
Quiz 1
Will women use microbicides?
Learn more: Female condom acceptability and use
Research on use and acceptability
Exploring user preferences
Product characteristics
Prove it! Studies show women's interest in and need for microbcides
Learn More: Eliciting women's preferences - South Africa
Trust, risk, perception & use
Formulations & sexual pleasure
Prove it! Microbicides and sexual pleasure studies
Learn more: Microbicide acceptability and vaginal lubrication norms and practices
Learn more: WHO study on vaginal practices
Covert use
Male attitudes
Learn more: Acceptability studies involving men
Prove it! Male attitudes toward microbicides
Cultural appropriateness
Learn more: Marketing microbicides
Learn more: Lessons from condom marketing
Quiz 2
Focus on effectiveness and impact
Risk reduction as a prevention strategy
Learn more: Prevention versus protection versus reduction in risk
Efficacy & consistency of use
Learn more: Some prevention methods reduce risk more than others
Condom substitution
Prove it! More choices = more protection
Learn more: Using mathematical modelling to explore condom substitution
Potential public health impact
Module test
Summary
Module resources
Talking Points: Need, Use, and Impact
5. Development and Clinical Trials
Objectives
Overview
A good idea
Preclinical testing
Learn more: What kinds of tests happen in the lab?
Testing in animals
Clinical trials
Quiz 1
What's different in the phasing of microbicide trials?
Evaluating early safety
Learn more: Confusion over the term "safety"
Learn more: Microbicides made from antiretrovirals (ARVs)
Evaluating safety
Learn more: Challenges of colposcopy
Understanding effectiveness trials
Learn more: Microbicide study terminology
Learn More: Exercise in loaded language
Loaded language exercise
How do we know if it works?
Learn more: Testing microbicides in HIV-positive participants
Randomised controlled trials (RCTs)
Learn more: The different meanings of "significant"
What makes RCTs special?
Learn more: Communicating complicated concepts
Condom use during trials
Quiz 2
Participant safeguards
Learn more: Why might a trial be stopped before it is finished?
Learn more: Cellulose sulfate trials closure
Selecting a study location
Learn more: Incidence versus prevalence
Learn more: Cost of clinical trials
Study size
Overview of the clinical trial process
Learn more: Community issues and concerns
Site preparation and implementation
Participating in a trial
Learn more: Creative approaches to informed consent
Care for HIV-positive individuals
Community involvement
Learn more: Mechanisms for community involvement
Quiz 3
Special challenges
Challenge 1: Pregnancy in trials
Learn more: Evaluating product safety for pregnant women
Challenge 2: Anticipating incidence
Challenge 3: Tracking sexual behaviour
Challenge 4: Product adherence
Module test
Summary
Module Resources
Talking Points: Development and clinical trials
Learn More: Exercise in loaded language
6. Making Access a Reality
Objectives
Access is critical
Traditional access trajectory
Learn more: Investing in global health research and product delivery
Key considerations
Commitment to access
Cost and price
Preparing for access
Data analysis and stakeholder consensus
Quiz 1
Regulatory approval
Regulatory challenges
Quiz 2
Manufacturing
Learn more: Need, demand, and use
Licensing
Pre-introduction studies
Wide-scale introduction
Learn more: Supporting women to use the female condom
Marketing
Learn more: The Pleasure Project: Linking safer sex to pleasure
Procurement, supply, and distribution
Module test
Summary
Module resources
Talking Points: Making Access a Reality
7. The Microbicides Landscape
Objectives
History
Key players
Research institutions and collaborations
Product developers
Learn more: What is big pharma doing?
Clinical trial networks
Funders
Learn more: What is being spent on microbicides and who is investing?
Advocacy organisations
Quiz
What is advocacy?
Key advocacy objectives
Advocacy moving forward
Message 1: Development takes time
Message 2: Greater access to existing preventions
Message 3: New technologies are only part of the solution
Message 4: Multiple overlapping strategies
The changing prevention landscape
Module test
Summary
Module resources
Talking points: The Microbicides Landscape
Rectal Microbicides
What are rectal microbicides?
Who needs them?
How would they work?
Challenges in development
Scientific challenges
Research questions
Safety issues
Learn more: Lubricants and potential damage to rectal cells
Political, cultural, and funding barriers
Current status of research
Baseline studies
Distribution studies
Phase 1 clinical trial
Acceptability & behavioural studies
Summary
Module Resources
Talking points: Rectal Microbicides
Course Test
Course test
CE Evaluation
Course Evaluation
Glossary
Glossary
Course Resources
References/Sources
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Links
Educational Resources
Print Publications
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