SlideShare ist ein Scribd-Unternehmen logo
1 von 26
Downloaden Sie, um offline zu lesen
LOGO 
Condoms And Microbicides 
Presented by 
Dr Fredrick Stephen (P.G in Community Medicine)
Introduction 
•The term condom first appears in the early 18th century 
•Dr Condum recommended one for King Charles II 
•The first rubber condom was produced in 1855 
•Condoms have been used for at least 400 years 
•Since 19th century - one of the most popular methods of 
contraception in the world
Condoms & Microbicides
Types 
• Synthetic condoms - AT-10 resin and polyisoprene. 
• Natural Latex condoms- They can be stretched in excess of 800% 
before it is broken. 
• Spermicidal condoms – Manufactured by lubricating condoms 
with a small amount of nonoxynol-9, which is a spermicidal chemical. 
• Lambskin condoms – Produce more body warmth and tactile 
sensation than any other condoms.
Effectiveness of Condoms 
• In longitudinal studies among heterosexuals condoms have 
shown to decrease the decrease the risk of HIV by 80-97%* 
• Sero-conversions in discordant couples who used condoms 
Consistently = 0% per person-year (n=124) 
Inconsistently = 4.8% per person-year (n=121)** 
* - Weller S & Davis K, The Cochrane Library 2004 
** - N Engl J De Vincenzi Med 1994
Merits 
• Simple , safe and Cheap 
• No side effects 
• Protects against STD’s 
• Easily usable 
• Available without prescription 
• Easily Disposable
Female condom
Merits 
• Controlled by women 
• Prevents both pregnancy & STD’s 
• As effective as male condoms in preventing STIs 
• No apparent side effects 
• Generally used to complement male condoms 
• No allergy/ contraindications 
• Data support impermeability to HIV
Demerits 
• Are several times more expensive than male condoms 
• Issues related to reuse are not totally defined 
• Ignorance due to poor promotional drive 
• Hesitancy – for insertion 
• Yet to gain universal acceptability
Diaphargm
Rationale for Diaphragm 
• Female initiated and controlled 
• Worn inside the vagina- unobtrusive 
• Creates a physical barrier over the cervix site believed 
to be most vulnerable to HIV 
• If effective, could be combined with an effective 
Microbicide
Demerits 
• Failure rate is 10 to 20 per 100 women years of 
exposure (HWYE) 
• Insertion should be demonstrated by medical practitioner 
• Contra indications- Prolapse, cystocele, Too long/ short 
cervix 
• If left for long time may lead to TSS
Condoms & Microbicides
Demerits of Condoms 
• Consistent condom use is difficult to achieve 
• Even those who use condoms with “outside” partners, may be 
unwilling or unable to use them with a primary partner 
• In cultures where childbearing is linked to a person’s self 
worth, the prospect of childlessness often outweighs the risk 
of HIV infection 
• Prevention burnout 
• Violence within relationship makes it difficult for people to 
negotiate condom use
Microbicides
Microbicides 
• A microbicide is any substance that can substantially reduce 
transmission of sexually transmitted infections (STIs) when 
applied in the vagina or the rectum 
• A microbicide could be produced in many forms- Gels, 
creams, films, suppository, sponge, vaginal ring or vaginal 
wipe
Advantages 
• Could be used frequently without irritation 
• Some Would prevent pregnancy 
• Will be available over the counter 
• Are likely to be inexpensive 
• Will be effective against more than one STI 
• Could be used without the partner’s cooperation, or even awareness 
• Development of microbicides in liquid form 
 mouth rinse for protection during oral sex 
 potentially low-cost way of reducing perinatal transmission via vaginal 
washing prior to delivery
Microbicides benefits to HIV+ women 
• Help protect against re-infection with other HIV strains 
• Help them protect their partners -- bi-directional effect 
• Help protect against other STDs, chlamydia and bladder 
infections 
• May help them get pregnant safely and increase their 
chances of having HIV negative babies
Action of microbicides 
1. Preventing HIV and other pathogens from reaching the 
target cells by creating a physical barrier. 
2. Maintaining an acidic vaginal pH which enhances the 
natural defense mechanism 
3. Killing or disabling pathogens by disruption of the 
protective outer cover 
4. Preventing virus replication after it enters the cell.
Microbicide Clinical Trials 
• Pre-clinical: This includes laboratory and in-vivo animal studies 
• Phase I -- a few volunteers (usually 10-50) use product to see 
how they react to it 
• Phase II -- a slightly larger number (50-200) use the product to 
see if it is safe for most women to use 
• Phase 1/2 trials - Either a combination of Phase I and II designs, 
or designed for Phase I to merge with Phase II
Phase III -- a large number (500-5,000) are enrolled to 
confirm its effectiveness against HIV and other STIs & 
monitoring of side effects 
Acceptability studies: To determine acceptability of the 
microbicide in partners of the women using the candidate 
microbicide.
Method of Protection Product Examples 
Kills or immobilizes the pathogen Non-oxynol-9 (N-9) 
Savvy 
Sodium Docecyl Sulfate 
(SDS) 
Creates a barrier between the 
pathogen and the cell wall 
PRO 2000 
Carageenan 
“Invisible Condom” 
Prevent infection from taking hold 
once the virus enters the body 
Tenofovir 
Nevirapine 
Boost vaginal defense system BufferGel 
LB Suppositories 
Plantibodies
Field challenges 
• No validated surrogate endpoints exist, primary endpoint is HIV infection 
• Thousands of high risk women required for trials 
• Efficacy trials must measure the incremental effect of the potential 
microbicide over and above known effective methods-condom use and 
HIV treatment 
• If efficacy is less than condoms, it may be hard to show 
• Placebo gel may be protective through lubricating effects 
• Adherence of participants may be difficult to measure
Microbicide trials in India 
•No phase III trials in India because of less than expected HIV incidence 
to conduct such research 
•Phase 1 trials of Buffer gel and PRO 2005 have been completed in Pune 
•Tenofovir gel and Praneem Polyherbal vaginal tablets have completed 
Phase II trials. 
•Cellulose Sulfate - the Phase III study had to be stopped in 2007 
because more participants using the gel were becoming infected than 
those in the placebo group. 
•Similar experience was reported in studies pertaining to Carraguard gel 
conducted in other country sites
Future of Microbicides 
• Vital to raise awareness about the potential availability of a device such 
as a microbicide against HIV/AIDS in the community. 
• Involvement of Non-Governmental Organizations and community 
stakeholders along with political commitment is required to prioritize 
microbicide research 
• Phase III trials should be conducted with due attention to ethical 
concerns given the lesson learnt from Carraguard and Cellulose Sulfate 
trials. 
• Public health professionals to play a major role by sensitizing the 
community about microbicides and creating motivation to participate in 
clinical trials
Thank You

Weitere ähnliche Inhalte

Ähnlich wie Condoms & Microbicides

Methods of family limiting and spacing methods (1)
Methods of family limiting and spacing methods (1)Methods of family limiting and spacing methods (1)
Methods of family limiting and spacing methods (1)deepasrideepasri
 
CONTRACEPTION
CONTRACEPTIONCONTRACEPTION
CONTRACEPTIONShambhu N
 
Ppt on family panning methods
Ppt on family panning methodsPpt on family panning methods
Ppt on family panning methodsashokdhakad6
 
Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV PreventionDec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV PreventionJim Pickett
 
Microbicides background
Microbicides backgroundMicrobicides background
Microbicides backgroundsiphojanuary
 
Microbicides Dth Fbackground
Microbicides Dth FbackgroundMicrobicides Dth Fbackground
Microbicides Dth FbackgroundSipho January
 
Prevention of hiv transmission
Prevention of hiv transmissionPrevention of hiv transmission
Prevention of hiv transmissionanasabkry
 
family planning (1).pdf community health nursing
family planning (1).pdf community health nursingfamily planning (1).pdf community health nursing
family planning (1).pdf community health nursingKanchanDyal
 
Family welfare and contraceptive methods
Family welfare and contraceptive methodsFamily welfare and contraceptive methods
Family welfare and contraceptive methodsJavedSheikh20
 

Ähnlich wie Condoms & Microbicides (20)

Condoms & Microbicides
Condoms & MicrobicidesCondoms & Microbicides
Condoms & Microbicides
 
MICROBICIDES: Efficacy and Effectiveness
MICROBICIDES: Efficacy and EffectivenessMICROBICIDES: Efficacy and Effectiveness
MICROBICIDES: Efficacy and Effectiveness
 
Methods of family limiting and spacing methods (1)
Methods of family limiting and spacing methods (1)Methods of family limiting and spacing methods (1)
Methods of family limiting and spacing methods (1)
 
The female condom
The female condomThe female condom
The female condom
 
CONTRACEPTION
CONTRACEPTIONCONTRACEPTION
CONTRACEPTION
 
Contraception
ContraceptionContraception
Contraception
 
Ppt on family panning methods
Ppt on family panning methodsPpt on family panning methods
Ppt on family panning methods
 
Contraception
ContraceptionContraception
Contraception
 
Contraception
ContraceptionContraception
Contraception
 
Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV PreventionDec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
Dec 11, '14 WEBINAR - Lubes, Rings, Films, Fibers, and Shots 4 HIV Prevention
 
MICROBICIDES
MICROBICIDESMICROBICIDES
MICROBICIDES
 
Iucd seminar
Iucd seminarIucd seminar
Iucd seminar
 
Microbicides background
Microbicides backgroundMicrobicides background
Microbicides background
 
Microbicides Dth Fbackground
Microbicides Dth FbackgroundMicrobicides Dth Fbackground
Microbicides Dth Fbackground
 
Prevention of hiv transmission
Prevention of hiv transmissionPrevention of hiv transmission
Prevention of hiv transmission
 
family planning (1).pdf community health nursing
family planning (1).pdf community health nursingfamily planning (1).pdf community health nursing
family planning (1).pdf community health nursing
 
Chapter 9 lecture outline
Chapter 9 lecture outlineChapter 9 lecture outline
Chapter 9 lecture outline
 
Std 12 biology chapter 4
Std 12 biology chapter 4 Std 12 biology chapter 4
Std 12 biology chapter 4
 
Family welfare and contraceptive methods
Family welfare and contraceptive methodsFamily welfare and contraceptive methods
Family welfare and contraceptive methods
 
contraceptive.pptx
contraceptive.pptxcontraceptive.pptx
contraceptive.pptx
 

Mehr von fredrick_Stephen

Mehr von fredrick_Stephen (7)

Still birth
Still birth Still birth
Still birth
 
Overweight&breast cancer
Overweight&breast cancer Overweight&breast cancer
Overweight&breast cancer
 
Sst 13 8-13
Sst 13 8-13Sst 13 8-13
Sst 13 8-13
 
Motherhood method 12 9-13
Motherhood method 12 9-13Motherhood method 12 9-13
Motherhood method 12 9-13
 
Rashtriya Bal Swasthyia Karyakaram (RBSK)
Rashtriya Bal Swasthyia Karyakaram (RBSK)Rashtriya Bal Swasthyia Karyakaram (RBSK)
Rashtriya Bal Swasthyia Karyakaram (RBSK)
 
Cohort Study
Cohort StudyCohort Study
Cohort Study
 
Jannai Shishu Suraksha Karyakaram (JSSK)
Jannai Shishu Suraksha Karyakaram (JSSK)Jannai Shishu Suraksha Karyakaram (JSSK)
Jannai Shishu Suraksha Karyakaram (JSSK)
 

Kürzlich hochgeladen

High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)kishan singh tomar
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfMedicoseAcademics
 
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfCONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfDolisha Warbi
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondSujoy Dasgupta
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptxWINCY THIRUMURUGAN
 
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationPhysiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationMedicoseAcademics
 
Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024EwoutSteyerberg1
 
AORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectionAORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectiondrhanifmohdali
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyMedicoseAcademics
 
Using Data Visualization in Public Health Communications
Using Data Visualization in Public Health CommunicationsUsing Data Visualization in Public Health Communications
Using Data Visualization in Public Health Communicationskatiequigley33
 
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdfSGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdfHongBiThi1
 
ORAL HYPOGLYCAEMIC AGENTS - PART 2.pptx
ORAL HYPOGLYCAEMIC AGENTS  - PART 2.pptxORAL HYPOGLYCAEMIC AGENTS  - PART 2.pptx
ORAL HYPOGLYCAEMIC AGENTS - PART 2.pptxNIKITA BHUTE
 
power point presentation of Clinical evaluation of strabismus
power point presentation of Clinical evaluation  of strabismuspower point presentation of Clinical evaluation  of strabismus
power point presentation of Clinical evaluation of strabismusChandrasekar Reddy
 
Unit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptUnit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptPradnya Wadekar
 
Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisSujoy Dasgupta
 
CPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentCPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentsaileshpanda05
 
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdfSGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdfHongBiThi1
 
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptxDNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptxMAsifAhmad
 

Kürzlich hochgeladen (20)

High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)High-Performance Thin-Layer Chromatography (HPTLC)
High-Performance Thin-Layer Chromatography (HPTLC)
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdf
 
Biologic therapy ice breaking in rheumatology, Case based approach with appli...
Biologic therapy ice breaking in rheumatology, Case based approach with appli...Biologic therapy ice breaking in rheumatology, Case based approach with appli...
Biologic therapy ice breaking in rheumatology, Case based approach with appli...
 
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfCONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
 
Male Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and BeyondMale Infertility, Antioxidants and Beyond
Male Infertility, Antioxidants and Beyond
 
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptxANATOMICAL FAETURES OF BONES  FOR NURSING STUDENTS .pptx
ANATOMICAL FAETURES OF BONES FOR NURSING STUDENTS .pptx
 
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxationPhysiology of Smooth Muscles -Mechanics of contraction and relaxation
Physiology of Smooth Muscles -Mechanics of contraction and relaxation
 
Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024
 
AORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissectionAORTIC DISSECTION and management of aortic dissection
AORTIC DISSECTION and management of aortic dissection
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before Pregnancy
 
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
 
Using Data Visualization in Public Health Communications
Using Data Visualization in Public Health CommunicationsUsing Data Visualization in Public Health Communications
Using Data Visualization in Public Health Communications
 
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdfSGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
SGK RỐI LOẠN TOAN KIỀM ĐHYHN RẤT HAY VÀ ĐẶC SẮC.pdf
 
ORAL HYPOGLYCAEMIC AGENTS - PART 2.pptx
ORAL HYPOGLYCAEMIC AGENTS  - PART 2.pptxORAL HYPOGLYCAEMIC AGENTS  - PART 2.pptx
ORAL HYPOGLYCAEMIC AGENTS - PART 2.pptx
 
power point presentation of Clinical evaluation of strabismus
power point presentation of Clinical evaluation  of strabismuspower point presentation of Clinical evaluation  of strabismus
power point presentation of Clinical evaluation of strabismus
 
Unit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.pptUnit I herbs as raw materials, biodynamic agriculture.ppt
Unit I herbs as raw materials, biodynamic agriculture.ppt
 
Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosis
 
CPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing studentCPR.nursingoutlook.pdf , Bsc nursing student
CPR.nursingoutlook.pdf , Bsc nursing student
 
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdfSGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA    .pdf
SGK NGẠT NƯỚC ĐHYHN RẤT LÀ HAY NHA .pdf
 
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptxDNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
DNA nucleotides Blast in NCBI and Phylogeny using MEGA Xi.pptx
 

Condoms & Microbicides

  • 1. LOGO Condoms And Microbicides Presented by Dr Fredrick Stephen (P.G in Community Medicine)
  • 2. Introduction •The term condom first appears in the early 18th century •Dr Condum recommended one for King Charles II •The first rubber condom was produced in 1855 •Condoms have been used for at least 400 years •Since 19th century - one of the most popular methods of contraception in the world
  • 4. Types • Synthetic condoms - AT-10 resin and polyisoprene. • Natural Latex condoms- They can be stretched in excess of 800% before it is broken. • Spermicidal condoms – Manufactured by lubricating condoms with a small amount of nonoxynol-9, which is a spermicidal chemical. • Lambskin condoms – Produce more body warmth and tactile sensation than any other condoms.
  • 5. Effectiveness of Condoms • In longitudinal studies among heterosexuals condoms have shown to decrease the decrease the risk of HIV by 80-97%* • Sero-conversions in discordant couples who used condoms Consistently = 0% per person-year (n=124) Inconsistently = 4.8% per person-year (n=121)** * - Weller S & Davis K, The Cochrane Library 2004 ** - N Engl J De Vincenzi Med 1994
  • 6. Merits • Simple , safe and Cheap • No side effects • Protects against STD’s • Easily usable • Available without prescription • Easily Disposable
  • 8. Merits • Controlled by women • Prevents both pregnancy & STD’s • As effective as male condoms in preventing STIs • No apparent side effects • Generally used to complement male condoms • No allergy/ contraindications • Data support impermeability to HIV
  • 9. Demerits • Are several times more expensive than male condoms • Issues related to reuse are not totally defined • Ignorance due to poor promotional drive • Hesitancy – for insertion • Yet to gain universal acceptability
  • 11. Rationale for Diaphragm • Female initiated and controlled • Worn inside the vagina- unobtrusive • Creates a physical barrier over the cervix site believed to be most vulnerable to HIV • If effective, could be combined with an effective Microbicide
  • 12. Demerits • Failure rate is 10 to 20 per 100 women years of exposure (HWYE) • Insertion should be demonstrated by medical practitioner • Contra indications- Prolapse, cystocele, Too long/ short cervix • If left for long time may lead to TSS
  • 14. Demerits of Condoms • Consistent condom use is difficult to achieve • Even those who use condoms with “outside” partners, may be unwilling or unable to use them with a primary partner • In cultures where childbearing is linked to a person’s self worth, the prospect of childlessness often outweighs the risk of HIV infection • Prevention burnout • Violence within relationship makes it difficult for people to negotiate condom use
  • 16. Microbicides • A microbicide is any substance that can substantially reduce transmission of sexually transmitted infections (STIs) when applied in the vagina or the rectum • A microbicide could be produced in many forms- Gels, creams, films, suppository, sponge, vaginal ring or vaginal wipe
  • 17. Advantages • Could be used frequently without irritation • Some Would prevent pregnancy • Will be available over the counter • Are likely to be inexpensive • Will be effective against more than one STI • Could be used without the partner’s cooperation, or even awareness • Development of microbicides in liquid form  mouth rinse for protection during oral sex  potentially low-cost way of reducing perinatal transmission via vaginal washing prior to delivery
  • 18. Microbicides benefits to HIV+ women • Help protect against re-infection with other HIV strains • Help them protect their partners -- bi-directional effect • Help protect against other STDs, chlamydia and bladder infections • May help them get pregnant safely and increase their chances of having HIV negative babies
  • 19. Action of microbicides 1. Preventing HIV and other pathogens from reaching the target cells by creating a physical barrier. 2. Maintaining an acidic vaginal pH which enhances the natural defense mechanism 3. Killing or disabling pathogens by disruption of the protective outer cover 4. Preventing virus replication after it enters the cell.
  • 20. Microbicide Clinical Trials • Pre-clinical: This includes laboratory and in-vivo animal studies • Phase I -- a few volunteers (usually 10-50) use product to see how they react to it • Phase II -- a slightly larger number (50-200) use the product to see if it is safe for most women to use • Phase 1/2 trials - Either a combination of Phase I and II designs, or designed for Phase I to merge with Phase II
  • 21. Phase III -- a large number (500-5,000) are enrolled to confirm its effectiveness against HIV and other STIs & monitoring of side effects Acceptability studies: To determine acceptability of the microbicide in partners of the women using the candidate microbicide.
  • 22. Method of Protection Product Examples Kills or immobilizes the pathogen Non-oxynol-9 (N-9) Savvy Sodium Docecyl Sulfate (SDS) Creates a barrier between the pathogen and the cell wall PRO 2000 Carageenan “Invisible Condom” Prevent infection from taking hold once the virus enters the body Tenofovir Nevirapine Boost vaginal defense system BufferGel LB Suppositories Plantibodies
  • 23. Field challenges • No validated surrogate endpoints exist, primary endpoint is HIV infection • Thousands of high risk women required for trials • Efficacy trials must measure the incremental effect of the potential microbicide over and above known effective methods-condom use and HIV treatment • If efficacy is less than condoms, it may be hard to show • Placebo gel may be protective through lubricating effects • Adherence of participants may be difficult to measure
  • 24. Microbicide trials in India •No phase III trials in India because of less than expected HIV incidence to conduct such research •Phase 1 trials of Buffer gel and PRO 2005 have been completed in Pune •Tenofovir gel and Praneem Polyherbal vaginal tablets have completed Phase II trials. •Cellulose Sulfate - the Phase III study had to be stopped in 2007 because more participants using the gel were becoming infected than those in the placebo group. •Similar experience was reported in studies pertaining to Carraguard gel conducted in other country sites
  • 25. Future of Microbicides • Vital to raise awareness about the potential availability of a device such as a microbicide against HIV/AIDS in the community. • Involvement of Non-Governmental Organizations and community stakeholders along with political commitment is required to prioritize microbicide research • Phase III trials should be conducted with due attention to ethical concerns given the lesson learnt from Carraguard and Cellulose Sulfate trials. • Public health professionals to play a major role by sensitizing the community about microbicides and creating motivation to participate in clinical trials