Skip to main content

Table 1 Feasibility Study data.

From: Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention

 

South Africa

  

Zambia

Tanzania

Uganda

 

Durban

Joburg

Africa Centre sites

Mazabuka

Mwanza+

Masaka*

Populations

Health clinics and associated communities

 

Recreational facilities

Sero-discordant couples

Start date

Aug 02

Oct 02

Jul 03

Mar03

Mar 03

Oct 03

N screened

1263

1088

882

1974

1573

1370

% HIV +ve at screen

47%

20%

50%

30%

25%

7%

% pregnant at screen

1%

4%

1%

4%

10%

-

N enrolled

608

757

453

590

1573

50

% of enrolled seen at FU or later†

      

3 m

94%

84%

63%

87%

83%

90%

6 m

88%

79%

56%

79%

79%

84%

9 m

82%

83%

56%

70%

70%

86%

12 m

67%

87%

58%

63%

71%

86%

Recruitment period (months)

14

15

12

18

14

2

Person years FU

499.2

531.4

158.1

356.4

717.4

31.2

Sero-conversions

37

21

20

13

25

4

HIV incidence

7.4

3.9

12.6

3.6

3.5

12.6

95%CI

5.4, 10.2

2.6, 6.1

8.2, 19.6

2.1, 6.3

2.4, 5.2

4.8, 34.1

  1. †follow-up rates based on % of 3 month attendees who returned subsequently; +All 1573 women were enrolled in Mwanza but the HIV incidence calculation was based on those who were HIV negative at enrolment;*sero-discordant couples enrolled