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. Author manuscript; available in PMC: 2012 Apr 24.
Published in final edited form as: AIDS. 2011 Apr 24;25(7):957–966. doi: 10.1097/QAD.0b013e32834541d9

Table 3.

Retention, gel and condom use, and HIV incidence rates for each site in the HPTN 035 trial.

Malawi Malawi South Africa South Africa United States Zambia Zimbabwe Zimbabwe All sites
Blantyre Lilongwe Durban Hlabisa Philadelphia Kamwala Chitungwiza Harare
N 441 596 702 346 200 319 260 223 3087
Retention rate (%) 95.0 92.4 93.3 96.8 94.5 94.4 89.6 92.4 93.6
% condom use in last sex act* 71.8 62.9 74.8 74.6 72.8 67.1 76.7 79.6 71.7
% gel use in last sex act* 82.6 75.4 79.0 79.2 76.7 82.5 93.5 91.0 81.1
% gel use in sex acts with no condoms* 64.8 68.7 63.5 61.7 56.0 81.6 89.9 78.1 69.1
Person-years of follow-up 708.75 1128.25 1239.25 637.50 416.25 439.25 367.75 321.25 5258.25
Number of HIV seroconversions 26 16 57 58 2 18 9 8 194
HIV incidence rates [95% Confidence Interval]
Overall 3.67 [2.4 – 5.4] 1.42 [0.8 – 2.3] 4.60 [3.5 – 6.0] 9.10 [6.9 – 11.8] 0.48 [0.1 – 1.7] 4.10 [2.4 – 6.5] 2.45 [1.1, 4.6] 2.49 [1.1 – 4.9] 3.69 [3.2 – 4.2]
0.5% PRO2000 Gel 1.09 [0.1 – 3.9] 0.70 [0.1 – 2.5] 5.43 [3.2 – 8.7] 6.18 [3.0 – 11.4] 0.00 [0.0 – 3.5] 3.73 [1.0 – 9.5] 0.00 [0.0 – 4.0] 1.20 [0.0 – 6.7] 2.70 [1.9 – 3.7]
BufferGel 3.45 [1.3 – 7.5] 2.10 [0.8 – 4.6] 4.23 [2.3 – 7.2] 11.24 [6.5 – 18.0] 0.00 [0.0 – 3.7] 4.60 [1.5 – 10.7] 3.17 [0.7, 9.3] 4.89 [1.3 – 12.5] 4.14 [3.1 – 5.4]
Placebo Gel 5.31 [2.4 –10.1] 1.09 [0.2 – 3.2] 4.92 [2.8 – 8.1] 7.74 [4.1 – 13.2] 1.92 [0.2 – 6.9] 4.49 [1.5 – 10.5] 3.33 [0.7, 9.7] 1.21 [0.0 – 6.8] 3.91 [2.9 – 5.1]
No Gel 4.97 [2.3 – 9.4] 1.78 [0.6 – 4.2] 3.82 [2.0 – 6.7] 11.50 [6.8 – 18.2] 0.00 [0.0 – 3.4] 3.57 [1.0 – 9.1] 3.29 [0.7, 9.6] 2.71 [0.3 – 9.8] 4.02 [3.0 – 5.3]
Hazard Ratios [95% Confidence Interval]
PRO2000 vs No Gel 0.22 [0.05 – 1.00] 0.39 [0.08 –2.02] 1.43 [0.68 – 3.00] 0.53 [0.25 – 1.17] - - 1.06 [0.26 – 4.27] 0.00 [0.0 – ∞] 0.45 [0.04 – 4.93] 0.67 [0.44 – 1.02]
PRO2000 vs Placebo 0.21 [0.04 – 0.96] 0.63 [0.11 –3.77] 1.11 [0.55 – 2.22] 0.81 [0.35 – 1.86] 0.00 [0.0 - ∞] 0.83 [0.22 – 3.11] 0.00 [0.0 – ∞] 0.96 [0.06 – 15.62] 0.70 [0.46 – 1.08]
BufferGel vs No Gel 0.69 [0.25 – 1.96] 1.18 [0.36 –3.88] 1.10 [0.50 – 2.43] 1.04 [0.53 – 2.05] - - 1.30 [0.35 – 4.88] 0.95 [0.19, 4.75] 1.82 [0.33 – 10.02] 1.05 [0.72 – 1.55]
BufferGel vs Placebo 0.65 [0.23 – 1.84] 1.91 [0.48 –7.66] 0.86 [0.41 – 1.81] 1.57 [0.74 – 3.31] 0.00 [0.0 - ∞] 1.02 [0.29 – 3.55] 0.95 [0.19, 4.75] 4.00 [0.45 – 35.91] 1.10 [0.75 – 1.62]
*

Calculated for the three gel arms only