Background
Methods
Study design and population
Sample size determination
Screening and eligibility criteria
Randomization
Laboratory testing
Statistical analysis
Ethics and consent
Results
Baseline characteristics of the study population
Screened | Enrolled | |||||
---|---|---|---|---|---|---|
Enrolled No. (%) | Not enrolled No. (%) | P value | Phone Arm No. (%) | Physical Arm | P value | |
All Participants | 661 (75.2) | 218 (24.8) | 330 (49.9) | 331 (50.1) | ||
Socio-demographics | ||||||
Sex | ||||||
Male | 403 (78.7) | 109 (21.3) | 199 (49.4) | 204 (50.6) | ||
Female | 258 (70.3) | 109 (29.7) | 0.004 | 131 (50.8) | 127 (49.2) | 0.726 |
Age at enrolment (years) | ||||||
15–19 | 49 (75.4) | 16 (24.6) | 26 (53.1) | 23 (46.9) | ||
20–24 | 175 (77.8) | 50 (22.2) | 88 (50.3) | 87 (49.7) | ||
25–34 | 320 (74.8) | 108 (25.2) | 159 (49.7) | 161 (50.3) | ||
35–49 | 117 (73.1) | 43 (26.9) | 0.749 | 57 (48.7) | 60 (51.3) | 0.964 |
Highest education level | ||||||
None | 34 (69.4) | 15 (30.6) | 21 (61.8) | 13 (38.2) | ||
Primary | 379 (74.5) | 130 (25.5) | 187 (49.3) | 192 (50.7) | ||
Secondary | 230 (77.2) | 68 (22.8) | 117 (50.9) | 113 (49.1) | ||
Post-secondary | 18 (78.3) | 5 (21.7) | 0.619 | 5 (27.8) | 13 (72.2) | 0.134 |
Religion | ||||||
Catholic | 256 (71.5) | 102 (28.5) | 120 (46.9) | 136 (53.1) | ||
Protestant/Anglican | 170 (74.6) | 58 (25.4) | 78 (45.9) | 92 (54.1) | ||
Muslim | 146 (82.9) | 130 (17.1) | 81 (55.5) | 65 (44.5) | ||
Pentecostal/Adventist | 89 (76.1) | 28 (23.9) | 0.035 | 51 (57.3) | 38 (42.7) | 0.122 |
Ethnicity/tribe | ||||||
Baganda | 325 (75.4) | 105 (24.6) | 167 (51.4) | 158 (48.6) | ||
Non-Baganda | 336 (75.0) | 112 (25.0) | 0.938 | 163 (48.5) | 173 (51.5) | 0.460 |
Occupation | ||||||
Fishing/Fishing relateda | 270 (75.0) | 90 (25.0) | 139 (51.5) | 131 (48.5) | ||
Shop/Market | 46 (71.2) | 18 (28.1) | 19 (41.3) | 27 (58.7) | ||
Bar/Lodge/Restaurant | 70 (72.2) | 27 (27.8) | 25 (35.7) | 45 (64.3) | ||
Farming | 73 (78.5) | 20 (21.5) | 39 (53.4) | 34 (46.6) | ||
Housewife | 66 (82.5) | 14 (17.5) | 42 (63.6) | 24 (36.4) | ||
Othersb | 136 (73.5) | 49 (26.5) | 0.553 | 66 (48.5) | 70 (51.5) | 0.026 |
Community location | ||||||
Mainland | 353 (73.1) | 130 (26.9) | 179 (50.7) | 174 (49.3) | ||
Island | 308 (77.8) | 88 (22.2) | 0.109 | 151 (49.0) | 157 (51.0) | 0.666 |
Duration in community at enrolment (years) | ||||||
Less than 2 | 85 (72.7) | 32 (27.3) | 39 (45.9) | 46 (54.1) | ||
2–4 | 259 (76.6) | 79 (23.4) | 129 (49.8) | 130 (50.2) | ||
5–10 | 192 (74.1) | 67 (25.9) | 101 (52.6) | 91 (47.4) | ||
More than 10 | 125 (75.8) | 41 (24.2) | 0.810 | 61 (48.8) | 64 (51.2) | 0.760 |
Marital status | ||||||
Not married | 209 (69.7) | 91 (30.3) | 103 (49.3) | 106 (50.7) | ||
Married monogamous | 325 (78.1) | 91 (21.9) | 161 (49.5) | 164 (50.5) | ||
Married polygamous | 127 (77.9) | 36 (22.1) | 0.024 | 66 (52.0) | 61 (48.0) | 0.875 |
Retention
Characteristics | Intensive Early Phase | Later Phase | ||||
---|---|---|---|---|---|---|
4/4 n (%) | < 4/4 n (%) | P value | 2/2 n (%) | < 2/2 n (%) | P value | |
All Participants | 425 (64.3) | 236 (35.7) | 497 (75.2) | 164 (24.8) | ||
Study Arm | ||||||
Phone tracing | 215 (65.2) | 115 (34.8) | 232 (70.3) | 98 (29.7) | ||
Physical contact tracing | 210 (63.4) | 121 (36.6) | 0.647 | 265 (80.1) | 66 (19.9) | 0.004 |
Sex | ||||||
Female | 171 (66.3) | 87 (33.6) | 198 (76.7) | 60 (23.3) | ||
Male | 254 (63.0) | 149 (37.0) | 0.395 | 299 (74.2) | 104 (25.8) | 0.459 |
Age group | ||||||
15–19 | 25 (51.0) | 24 (49.0) | 130 (74.3) | 45 (25.7) | ||
20–24 | 121 (69.1) | 54 (30.9) | 35 (71.4) | 14 (28.6) | ||
25–34 | 201 (62.8) | 119 (27.2) | 235 (73.4) | 85 (26.6) | ||
35–49 | 78 (66.7) | 39 (33.3) | 0.105 | 97 (82.9) | 20 (17.1) | 0.194 |
Location of Community | ||||||
Mainland | 202 (57.2) | 151 (42.8) | 274 (77.6) | 79 (22.1) | ||
Island | 223 (72.4) | 85 (27.6) | < 0.0001 | 223 (72.4) | 85 (27.6) | 0.121 |
Occupation | ||||||
Fishing/Fishing related† | 175 (64.8) | 95 (35.2) | 199 (73.7) | 71 (26.3) | ||
Shop/Market | 34 (73.9) | 12 (26.1) | 36 (78.3) | 10 (21.7) | ||
Bar/Lodge/Hotel | 42 (60.0) | 28 (40.0) | 50 (71.4) | 20 (28.6) | ||
Farming | 52 (71.2) | 21 (28.8) | 56 (76.7) | 17 (23.3) | ||
Housewife | 40 (60.6) | 26 (39.4) | 52 (78.8) | 14 (21.2) | ||
Others†† | 82 (60.3) | 54 (39.7) | 0.378 | 104 (76.5) | 32 (23.5) | 0.882 |
Marital status | ||||||
Not married | 129 (61.7) | 80 (38.3) | 144 (68.9) | 65 (31.1) | ||
Married monogamous | 208 (64.0) | 117 (36.0) | 250 (76.9) | 75 (23.1) | ||
Married polygamous | 88 (69.3) | 39 (30.7) | 0.369 | 103 (81.1) | 24 (18.9) | 0.026 |
Education | ||||||
None | 16 (47.1) | 18 (52.9) | 27 (79.4) | 7 | ||
Primary | 245 (64.6) | 134 (35.4) | 286 (75.5) | 93 | ||
Secondary or beyond | 164 (66.1) | 84 (33.9) | 0.091 | 184 (74.2) | 64 | 0.790 |
Religion | ||||||
Catholic | 163 (63.7) | 93 (36.3) | 198 (77.3) | 58 (22.7) | ||
Protestant/Anglican | 107 (62.9) | 63 (37.1) | 130 (76.5) | 40 (23.5) | ||
Muslim | 96 (65.8) | 50 (34.2) | 107 (73.3) | 39 (26.7) | ||
Pentecostal/Adventist | 59 (66.3) | 30 (33.7) | 0.926 | 62 (69.7) | 27 (30.3) | 0.470 |
Ethnicity/Tribe | ||||||
Baganda | 217 (66.8) | 108 (33.2) | 254 (78.2) | 71 (21.8) | ||
Others | 208 (61.9) | 128 (28.1) | 0.192 | 243 (72.3) | 93 (27.7) | 0.083 |
Duration in community at enrolment (years) | ||||||
Less than 2 | 46 (54.1) | 39 (45.9) | 49 (57.7) | 36 (42.3) | ||
2–4 | 159 (61.4) | 100 (38.6) | 182 (70.3) | 77 (29.7) | ||
5–10 | 129 (67.2) | 63 (32.8) | 160 (83.3) | 32 (16.7) | ||
More than 10 | 91 (72.8) | 34 (27.2) | 0.024 | 106 (84.8) | 19 (15.2) | < 0.0001 |
All follow up visits | ||||
---|---|---|---|---|
Good retention (5/6 of 6 visits) n (%) | Odd Ratios (95% CI) | |||
Yes | No | Unadjusted | Adjusted | |
All participants | 495 (74.9) | 166 (25.1) | – | – |
Study arm | ||||
Phone tracing | 235 (71.2) | 95 (28.8) | 1 (reference) | 1 |
Physical tracing | 260 (78.5) | 71 (21.4)¶ | 1.48 (1.04–2.11)¶ | 1.56 (1.08–2.26)¶ |
Sex | ||||
Male | 295 (73.2) | 108 (26.8) | 1 | 1 |
Female | 200 (77.5) | 58 (22.5) | 1.26 (0.87–1.82) | 1.70 (0.99–2.91)ϕ |
Age (years) | ||||
15–19 | 31 (63.3) | 18 (36.7) | 1 | 1 |
20–24 | 134 (76.6) | 41 (23.4) | 1.90 (0.96–3.74) | 1.99 (0.98–4.04)ϕ |
25–34 | 238 (74.4) | 82 (25.6) | 1.68 (0.89–3.17) | 1.54 (0.78–3.04) |
35–49 | 92 (78.6) | 25 (21.4) | 2.14 (1.03–4.43)¶ | 1.67 (0.76–3.67) |
Education | ||||
None | 25 (73.5) | 9 (26.5) | 1 | 1 |
Primary | 284 (74.9) | 95 (25.1) | 1.08 (0.48–2.39) | 1.19 (0.52–2.75) |
Secondary and beyond | 173 (75.2) | 57 (24.8) | 1.08 (0.48–2.44) | 1.31 (0.55–3.10) |
Occupation | ||||
Fishing/Fishing relateda | 204 (75.6) | 66 (24.4) | 1 | 1 |
Shop/Market | 35 (76.1) | 11 (23.9) | 1.03 (0.49–2.14) | 0.75 (0.32–1.75) |
Bar/Lodge/Hotel | 49 (70.0) | 21 (30.0) | 0.75 (0.42–1.35) | 0.60 (0.28–1.27) |
Farming | 61 (83.6) | 21 (16.4) | 1.64 (0.83–3.24) | 1.29 (0.63–2.66) |
Housewife | 50 (75.8) | 16 (14.2) | 1.01 (0.54–1.89) | 0.76 (0.33–1.72) |
Othersb | 96 (70.6) | 40 (29.4) | 0.78 (0.49–1.23) | 0.76 (0.47–1.24) |
Community location | ||||
Mainland | 251 (71.1) | 102 (28.9) | 1 | 1 |
Island | 244 (79.2) | 64 (20.8)¶ | 1.55 (1.08–2.22)¶ | 1.62 (1.08–2.43)¶ |
Duration of stay (years) | ||||
Less than 1 | 51 (60.0) | 34 (40.0) | 1 | 1 |
– 4 | 188 (72.6) | 71 (27.4) | 1.76 (1.06–2.95)¶ | 1.70 (0.99–2.92)ϕ |
– 10 | 155 (80.7) | 37 (19.3) | 2.79 (1.59–4.90)¶ | 2.88 (1.58–5.28)¶ |
More than 10 | 101 (80.8) | 24 (19.2) | 2.80 (1.51–5.22)¶ | 3.46 (1.78–6.73)¶ |
Marital status | ||||
Not married | 152 (72.7) | 57 (27.3) | 1 | 1 |
Married monogamous | 246 (75.7) | 79 (24.3) | 1.17 (0.78–1.73) | 0.93 (0.59–1.44) |
Married polygamous | 97 (76.4) | 30 (23.6) | 1.21 (0.73–2.02) | 0.88 (0.49–1.55) |