| Study
(Active Product)
|
Population
|
Sample Size
|
Country
|
Overall Adherence Levels and Method of Measurement
|
Efficacy Results
Point Estimate; 95% CIs; and P-Value |
| CAPRISA 004[33]
(Tenofovir 1% gel)
|
Heterosexual women
|
N= 889
|
South Africa
|
70% by monthly count of product application divided by number of reported sex acts |
39% (6-60); P=0.017
|
| iPrEx [34]
(FTC/TDF)
|
MSM and transgender women who have sex with men
|
N=2499
|
Peru, Equator, South Africa, Brazil, Thailand, USA
|
95% by self-report; 89-95% by pill count; 54% by drug concentrations/PBMC
|
44% (15-63); P=0.005
|
| TDF2 Study[37]
(FTC/TDF) |
Heterosexual men and women |
N=1200
|
Botswana
|
84%; Monthly pill count
|
62% (20-82); P=0.026
|
| Partners for PrEP[38]
(TDF or FTC/TDF) |
Heterosexual couples
|
N=4758
|
Uganda, Kenya
|
95%; Monthly self-report, pill count and drug concentrations |
67% (29-85); P=0.01 TDF alone
55% (4-79); P=0.001 FTC/TDF |
| FEM-PrEP[35]
|
Heterosexual women
|
N=2120
|
Kenya, South Africa, Tanzania
|
95% by self-report; 85% by pill count; 40% and 30% by drug concentration in the overall population and among those who received the active drug, respectively |
Stopped for futility
|
| MTN-003[36] (VOICE) |
Heterosexual women |
N=5029 |
Uganda, Zimbabwe, South Africa |
Adherence levels by monthly self-report, pill count and drug concentration not available |
Stopped for futility for TDF and TDF gel; Ongoing for FTC/TDF |
