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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