Table 2.
Parameter | Preferred criteria | Minimally acceptable criteria |
---|---|---|
Indications | HIV + contraception (high emphasis for sub-Saharan African markets) (high emphasis for sub-Saharan African markets) |
HIV + HSV (high emphasis for non-LDC markets) contraception + STI (high emphasis for Indian and Chinese markets) BV, HPV, and TV (moderate emphasis) GC + syphilis (minimal emphasis) |
Route of administration | Vaginal rings | Oral pills, injectables |
Dosage form and schedule | Sustained release (1–12 months) Pericoital Fast-acting Topical (vaginal) |
Daily Oral |
Efficacy: | ||
(i) HIV | 80% | 40%–70% |
(ii) Contraception | >Current levels per contraceptive of >90% | Current levels with recommended use |
(iii) STI | >80% | 40% |
Storage conditions | >40°C/75% RH | 15–30°C/65% RH for topical/pills Refrigeration at 4°C for injectables |
Shelf life | >36 months | 24 months |
Yearly product cost/user | <US$ 50 | <US$ 100 |
Disposal/waste | Concealable, biodegradable user disposal | Controlled disposal (to include all associated materials (implant, injectables)) |
Adherence | >80% of users follow prescribed regimen | >60% of users follow prescribed regimen |
Time to licensure | 5 years | 8–12 years (by 2020) |
Reversibility | 0–24 hours for oral, topical, sustained-release methods 14 days for implants, injectables |
14–30 days for oral, topical, sustained-release methods 90 days for implants, injectables |