TABLE 2.
Preliminary, Domain-Adjusted Models Predicting Self-Reported Adherent Use of Assigned Study Products
| Characteristic | Arm Type | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
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| Gel-Diaphragm (n = 364 Visits) n and % Adherent |
Gel-Only (n = 381 Visits) n and % Adherent |
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| n | % | RR | 95% CI | P | n | % | RR | 95% CI | P | |
| Model 1: Trial and demographic factors* | ||||||||||
| Arm | ||||||||||
| Diaphragm plus Acidform | 78 | 45.1 | 0.68 | 0.51, 0.91 | <0.01 | — | — | — | — | |
| Diaphragm plus HEC (referent) | 124 | 64.9 | 1. | — | — | — | — | — | ||
| AcidformTM alone | — | — | — | — | 69 | 36.5 | 1.35 | 0.94, 1.92 | 0.10 | |
| HEC alone (referent) | — | — | — | — | 50 | 26.0 | 1. | — | ||
| Visit | ||||||||||
| Week 1 (referent) | 39 | 43.3 | 1. | — | 27 | 28.4 | 1. | — | ||
| Week 2 | 45 | 48.9 | 1.15 | 0.92, 1.44 | 0.22 | 19 | 20.2 | 0.75 | 0.49, 1.13 | 0.17 |
| Week 3 | 57 | 62.6 | 1.43 | 1.13, 1.82 | <0.01 | 30 | 31.3 | 1.11 | 0.76, 1.64 | 0.59 |
| Week 4 | 61 | 67.0 | 1.57 | 1.23, 1.99 | <0.01 | 43 | 44.8 | 1.66 | 1.16, 2.38 | <0.01 |
| Site | ||||||||||
| Mahajanga | 49 | 54.4 | 0.93 | 0.64, 1.35 | 0.70 | 28 | 29.5 | 1.16 | 0.69, 1.94 | 0.58 |
| Tamatave | 49 | 51.6 | 0.90 | 0.61, 1.32 | 0.59 | 36 | 37.5 | 1.63 | 1.00, 2.65 | 0.05 |
| Toamasina | 45 | 54.2 | 1.00 | 0.60, 1.66 | 0.99 | 30 | 31.6 | 1.46 | 0.84, 2.55 | 0.18 |
| Antananarivo (referent) | 59 | 61.5 | 1. | — | 25 | 26.3 | 1. | — | ||
| Age | ||||||||||
| 16–24 yr (referent) | 60 | 52.2 | 1. | — | 23 | 24.5 | 1. | — | ||
| 25–30 yr | 67 | 59.8 | 1.19 | 0.87, 1.63 | 0.27 | 36 | 36.0 | 1.38 | 0.79, 2.44 | 0.26 |
| 31–35 yr | 19 | 43.2 | 0.83 | 0.50, 1.39 | 0.48 | 19 | 21.6 | 0.87 | 0.44, 1.70 | 0.68 |
| 36+ yrs | 56 | 60.2 | 1.20 | 0.84, 1.71 | 0.31 | 41 | 41.4 | 1.62 | 0.94, 2.81 | 0.08 |
| Education | ||||||||||
| ≤5 yr | 107 | 58.8 | 1.16 | 0.83, 1.63 | 0.39 | 60 | 31.6 | 1.20 | 0.81, 1.77 | 0.37 |
| >5 yr (referent) | 95 | 52.2 | 1. | — | 59 | 30.9 | 1. | — | ||
| Share bedroom with ≥2 people | ||||||||||
| Yes | 96 | 60.8 | 1.15 | 0.86, 1.54 | 0.36 | 48 | 35.8 | 1.26 | 0.85, 1.86 | 0.25 |
| No (referent) | 106 | 51.5 | 1. | — | 71 | 28.7 | 1. | — | ||
| Participated in STI or pregnancy prevention study | ||||||||||
| Yes (referent) | 56 | 53.9 | 1. | — | 37 | 30.1 | 1. | — | ||
| No | 145 | 56.6 | 0.96 | 0.72, 1.28 | 0.79 | 82 | 31.8 | 0.91 | 0.62, 1.33 | 0.62 |
| Model 2: Sexual and reproductive factors* | ||||||||||
| Ever unwanted pregnancy | ||||||||||
| Yes | 71 | 44.9 | 0.73 | 0.57, 0.95 | 0.02 | 74 | 33.3 | 1.00 | 0.69, 1.47 | 0.98 |
| No (referent) | 131 | 63.6 | 1. | — | 45 | 28.3 | 1. | — | ||
| No. sex acts in previous week | ||||||||||
| 1–9 acts | 47 | 61.0 | 1.11 | 0.85, 1.45 | 0.46 | 40 | 40.8 | 2.01 | 1.25, 3.23 | <0.01 |
| 10–18 acts | 98 | 59.8 | 1.02 | 0.80, 1.31 | 0.88 | 59 | 31.9 | 1.32 | 0.90, 1.96 | 0.16 |
| ≥19 acts (referent) | 57 | 46.3 | 1. | — | 20 | 20.4 | 1. | — | ||
| Baseline condom use with casual partners | ||||||||||
| Never/rarely | 30 | 62.5 | 1.24 | 0.88, 1.76 | 0.22 | 6 | 37.5 | 1.09 | 0.63, 1.49 | 0.63 |
| Sometimes | 93 | 57.4 | 1.06 | 0.82, 1.37 | 0.64 | 52 | 31.7 | 1.29 | 0.52, 3.17 | 0.58 |
| Always/almost always (referent) | 79 | 51.3 | 1. | — | 61 | 30.4 | 1. | — | ||
| Ever female condoms for HIV prevention | ||||||||||
| Yes | 47 | 73.4 | 1.42 | 1.12, 1.80 | <0.01 | 22 | 36.7 | 1.45 | 0.94, 2.22 | 0.09 |
| No (referent) | 155 | 51.7 | 1. | — | 97 | 30.2 | 1. | — | ||
| Used any birth control method ever | ||||||||||
| Yes | 191 | 40.7 | 1.32 | 0.65, 2.68 | 0.43 | 112 | 32.4 | 1.84 | 0.77, 4.41 | 0.17 |
| No (referent) | 11 | 56.7 | 1. | — | 7 | 20.0 | 1. | — | ||
| Frequency of internal vaginal cleaning | ||||||||||
| Once a day or less often | 23 | 53.5 | 1.18 | 0.80, 1.74 | 0.40 | 18 | 35.3 | 1.18 | 0.69, 2.02 | 0.54 |
| More than once a day (referent) | 179 | 55.8 | 1. | — | 101 | 30.6 | 1. | — | ||
| Had sex with husband/boyfriend in last week | ||||||||||
| No | 162 | 61.1 | 1.35 | 1.00, 1.81 | 0.05 | 94 | 36.9 | 1.73 | 1.17, 2.56 | <0.01 |
| Yes (referent) | 40 | 40.8 | 1. | — | 25 | 19.8 | 1. | — | ||
| Model 3: Product-related and power/control factors* | ||||||||||
| Ease of concealing products from casual partners | ||||||||||
| Very/somewhat easy | 206 | 61.7 | 3.17 | 0.92, 10.90 | 0.07 | 105 | 35.7 | 1.62 | 0.90, 2.93 | 0.11 |
| Did not conceal | 7 | 43.8 | 4.42 | 1.23, 15.91 | 0.02 | 7 | 18.9 | 2.26 | 0.82, 6.25 | 0.12 |
| Very/somewhat hard (referent) | 2 | 14.3 | 1. | — | 7 | 15.6 | 1. | — | ||
| Importance of casual partners not knowing about products | ||||||||||
| Very important | 97 | 59.5 | 1.01 | 0.81, 1.25 | 0.96 | 98 | 34.8 | 1.55 | 0.71, 3.39 | 0.28 |
| Moderately important | 16 | 35.6 | 0.73 | 0.52, 1.01 | 0.06 | 10 | 25.0 | 1.17 | 0.59, 2.30 | 0.65 |
| Not important (referent) | 87 | 58.0 | 1. | — | 11 | 20.8 | 1. | — | ||
| How often casual partners aware of product use? | ||||||||||
| Never | 163 | 62.0 | 2.00 | 1.03, 3.88 | 0.04 | 93 | 35.0 | 1.79 | 0.66, 4.84 | 0.25 |
| Sometimes | 32 | 42.7 | 1.74 | 0.91, 3.33 | 0.09 | 22 | 28.2 | 2.00 | 0.75, 5.36 | 0.17 |
| Always (referent) | 6 | 31.6 | 1. | — | 4 | 15.4 | 1. | — | ||
| Experienced problems with products in previous week | ||||||||||
| No | 192 | 58.9 | 1.48 | 0.96, 2.28 | 0.07 | 110 | 32.9 | 1.21 | 0.60, 2.44 | 0.60 |
| Yes (referent) | 10 | 30.3 | 1. | — | 9 | 22.0 | 1. | — | ||
| How much control over condoms with casual partners | ||||||||||
| None/a little bit | 81 | 50.3 | 0.95 | 0.74, 1.21 | 0.68 | 49 | 34.3 | 1.28 | 0.90, 1.81 | 0.17 |
| A lot/complete (referent) | 121 | 59.6 | 1. | — | 70 | 29.4 | 1. | — | ||
| Any casual partner ever violent because asked to use condom | ||||||||||
| Yes | 44 | 78.6 | 1.43 | 1.14, 1.80 | <0.01 | 36 | 35.3 | 1.14 | 0.80, 1.62 | 0.47 |
| No (referent) | 158 | 51.3 | 1. | — | 83 | 29.8 | 1. | — | ||
*
Each model adjusts for all domain-specific variables; presented estimates controls for all other variables in that domain. All models are also adjusted for randomization arm, age, study visit and number of sex acts in previous week.