Table 5:

Trials in progress and planned, and demonstration PrEP (oral and topical) projects in women and female sex workers

	Population	Design, product, and follow-up duration	Location	Timeline
Clinical trials
FACTS 001	2600 heterosexual women	Placebo RCT, 1% TDF gel, BAT 24	South Africa	Enrolling, 2015
ASPIRE	Heterosexual women	Placebo RCT, dapivirine vaginal ring	Zimbabawe, Malawi, Uganda, South Africa	Fully enrolled, 2015
RING study	Heterosexual women	Placebo RCT, dapivirine vaginal ring	South Africa	Enrolling, 2016
FACTS 002	100 young women (aged 16–17)	Safety and acceptability, 1% TDF vaginal gel, BAT 24	South Africa	Under review
CHAMPS-SA PLUSPILLS PrEP	150 young men and women (aged 15–19)	Open label TVD oral	South Africa	Under review
Follow-on and demonstration studies
Partners PrEP (post-placebo phase)	4747 heterosexual HIV serodiscordant couples	Randomised daily oral TDF vs TVD (unblended), follow-up 12 months	Kenya, Uganda	Fully enrolled
CDC 494/TDF2 open-label extension	1219 heterosexual men and women	Open label TVD, 12 months follow-up	Botswana	Enrolling, results 2014
Partners Demonstration Project	1000 HIV serodiscordant couples	Open label, daily TVD oral as bridge to treatment in infected partner, follow-up 24 months	Kenya, Uganda	Enrolling, results 2014–15
CAPRISA 008	··	Open label, 1% TDF vaginal gel, BAT 24	South Africa	Results 2015
SAPPH-Ire FSW RCT	2800 FSWs	Open label, oral daily TVD	Zimbabwe	Enrolling
TAPS: Expanded use of ART for treatment and prevention for female sex workers in South Africa	400 FSWs for PrEP, 300 FSWs for ART	Open label, PrEP for negative FSWs and immediate ART for FSWs living with HIV	South Africa	Enrolling

RCT=randomised controlled trial. TVD=emtricitabine and tenofovir (Truvada). TDF=tenofovir. PrEP=pre-exposure prophylaxis. BAT 24=one dose before sex, one dose after sex, but no more than two doses in 24 h. FSW=female sex worker.