1. MULTIPURPOSE PREVENTION TECHNOLOGY (MPT) PRODUCT PIPELINE & THEIR POTENTIAL ACCEPTABILITY AMONG ADOLESCENT GIRLS & YOUNG WOMEN
Barbara Friedland, Population Council
Girls and HIV
AIDS2016 Satellite Session
Durban, South Africa
July 21, 2016

2. What Are MPTs?

3. MPT Delivery Options Examples of delivery options
SILCS is currently available as a marketed contraceptive to be used with a spermicide
All other products are still in development
Tenofovir GEL was the first product to show any effectiveness (CAPRISA 004);
2 Dapivirine IVR studies showed ring about 30% effective (reduced risk by 1/3); however, adherence issues in both trials – higher adherence, higher level of protection

4. What do we know? Low adherence among “young” women
FACTS: overall low adherence (18-30)
FEM-PrEP (Van Damme et al. 2012): overall low adherence (18-35)
VOICE (Marrazzo et al. 2015: <25 less adherent
ASPIRE (Baeten et al. 2016): ≤21 less adherent
Little data to explain why
Young women defined differently depending on the study
FEM-PrEP and FACTS essentially enrolled women to be considered “young and at risk” – and – adherence low overall
VOICE, ASPIRE and the Ring study enrolled a broader age group and compared younger women (21 and under) to women over 21

5. What about adolescents under 18?
Clinical trial data <18 extremely limited
Col-1492 trial (Van Damme et al. 2000)
MDP301 (McCormack et al. 2009)
Carraguard Phase 3 trial (Skoler-Karpoff et al )
Coitally-dependent vaginal gel in >6,000 women
16-17 year olds at all sites: Gugulethu (W Cape), Soshanguve (Gauteng), Isipingo (KZN)
No parental consent
2 IRBs from outset
3rd eliminated requirement during trial
The majority of the data we have to date is from trials of HIV-prevention products – mainly gels. Some trials of gels with diaphragm (e.g. MIRA). First trials to show any effect contain antiretrovirals – e.g. tenofovir gel and dapivirine IVR.
Carraguard was the only Phase 3 trial to enroll year old girls at all 3 clinical trial sites; Col-1492 (in the late 1990’s) and MDP 301 (of Pro-200 gel) enrolled adolescents at some sites
We wanted to explore if enrolling year olds put them at elevated risk of HIV or other outcomes and also to see if their enrollment had a negative impact on the trial. Because we had no external comparison group, we compared them to the year olds in the trial – the next oldest age group and the lowest age group in almost all other trials (18 and older).
No significant difference in BL characteristics – most single, coital frequency the same, contraception the same (about half of both groups using hormonal contraception); significantly MORE year olds than year olds reported condom at last sex with any type of partner (60% vs 50%)
20% of both groups missed at least visit; 38% withdrew early; adherence reports identical (98-99% reported using gel during last sex)

6. Data from Carraguard trial
Predictors of adherence (Friedland et al. 2015)
Coital frequency and site (not age)
Lowest adherence in year olds (vs and 30+)
Enrollment of year olds (Schenk et al )
No elevated risk of HIV, STI, adverse effects, or pregnancy in year olds (n=247) vs year olds (n=511)
No difference in operational outcomes (missed visits, loss to follow-up, adherence)
2 Secondary analyses – one on predictors of adherence; second one exploring impact of trial on adolescents and vice versa….

7. What do we need to learn?
Would women prefer an HIV/STI prevention method that also prevents pregnancy?
What characteristics are most important?
Duration of protection
Lubricating properties
Feasibility for rectal use
Dissolution rate for on-demand formulations
Which products are women most interested in trying?
Are specific geographic, demographic and/or behavioral characteristics associated with interest in specific products?
Why wouldn’t women be interested in using specific products?

8. How can we find out?
Sexually active girls should be included in trials to have access to products ASAP once approved
End User Internet Survey
Currently targets 18+
Working with colleagues to implement within DREAMS projects
The majority of the data we have to date is from trials of HIV-prevention products – mainly gels. Some trials of gels with diaphgragm (e.g. MIRA). First trials to show any effect contain antiretrovirals – e.g. tenofovir gel and dapivirine IVR.
Carraguard was the only Phase 3 trial to enroll year old girls at all 3 clinical trial sites; Col-1492 (in the late 1990’s) and MDP 301 (of Pro-200 gel) enrolled adolescents at some sites
We wanted to explore if enrolling year olds put them at elevated risk of HIV or other outcomes and also to see if their enrollment had a negative impact on the trial. Because we had no external comparison group, we compared them to the year olds in the trial – the next oldest age group and the lowest age group in almost all other trials (18 and older).
No significant difference in BL characteristics – most single, coital frequency the same, contraception the same (about half of both groups using hormonal contraception); significantly MORE year olds than year olds reported condom at last sex with any type of partner (60% vs 50%)
20% of both groups missed at least visit; 38% withdrew early; adherence reports identical (98-99% reported using gel during last sex)

9. Survey screen shot

10. Video of FDI insertion

11. Strategy for getting it out there- email to those with networks, facebook,/