Table 2.
Percentage of participants reporting primary outcomes, by study group and population
| Outcome | Standard of care | Oral-fluid + Blood-based HIVST1 | Oral-fluid HIVST1 | Blood-based HIVST1 | Overall |
|---|---|---|---|---|---|
| All participants | 166 | 329 | 163 | 166 | 495 |
|
| |||||
| Returned to clinic2 | 140 (84·3%) | 277 (84·2%) | 139 (85·3%) | 138 (83·1%) | 417 (84·2%) |
| Co-Primary: Tested for HIV* | 140 (84·3%) | 274 (83·3%) | 139 (85·3%) | 135 (81·3%) | 414 (83·6%) |
| Co-Primary: Refilled PrEP* | 134 (80·7%) | 257 (78·1%) | 130 (79·8%) | 127 (76·5%) | 391 (79·0%) |
| Co-Primary: Adherent (any TFV-DP detected)* | 95 (57·2%) | 200 (60·8%) | 94 (57·7%) | 106 (63·9%) | 295 (59·6%) |
| HIV serodifferent couples 3 | 99 | 196 | 97 | 99 | 295 |
|
| |||||
| Returned to clinic2 | 85 (85·9%) | 165 (84·2%) | 84 (86·6%) | 81 (81·8%) | 250 (84·8%) |
| Tested for HIV | 85 (85·9%) | 163 (83·2%) | 84 (86·6%) | 79 (79·8%) | 248 (84·1%) |
| Refilled PrEP | 79 (79·8%) | 154 (78·6%) | 78 (80·4%) | 76 (76·8%) | 233 (79·0%) |
| Adherent (any TFV-DP detected) | 74 (74·8%) | 132 (67·4%) | 65 (67·0%) | 67 (67·7%) | 206 (69·8%) |
| All women 3 | 111 | 219 | 109 | 110 | 330 |
|
| |||||
| Returned to clinic2 | 91 (82·0%) | 186 (84·9%) | 93 (85·3%) | 93 (84·6%) | 277 (83·9%) |
| Tested for HIV | 91 (82·0%) | 184 (84·0%) | 93 (85·3%) | 91 (82·7%) | 275 (83·3%) |
| Refilled PrEP | 88 (79·3%) | 173 (79·0%) | 87 (79·8%) | 86 (78·2%) | 261 (79·1%) |
| Adherent (any TFV-DP detected) | 50 (45·1%) | 125 (57·1%) | 57 (52·3%) | 68 (61·8%) | 175 (53·0%) |
| Women singly enrolled 3 | 67 | 133 | 66 | 67 | 200 |
|
| |||||
| Returned to clinic2 | 55 (82·1%) | 112 (84·2%) | 55 (83·3%) | 57 (85·1%) | 167 (83·5%) |
| Tested for HIV | 55 (82·1%) | 111 (83·5%) | 55 (83·3%) | 56 (83·6%) | 166 (83·0%) |
| Refilled PrEP | 55 (82·1%) | 103 (77·4%) | 52 (78·8%) | 51 (76·1%) | 158 (79·0%) |
| Adherent (any TFV-DP detected) | 21 (31·3%) | 68 (51·1%) | 29 (43·9%) | 39 (58·2%) | 89 (44·5%) |
Abbreviations:HIV self-testing (HIVST); pre-exposure prophylaxis (PrEP); tenofovir-diphosphate (TFP-DP).
Primary study outcomes were HIV testing (past six months), PrEP refilling (at six-month visit), and PrEP adherence (any TFV-DP detected) at six months among all participants, with the primary comparison being the pooled six-month PrEP dispensing + interim HIVST intervention arms vs. the standard-of-care PrEP dispensing arm.
Participants randomized to these intervention arms received six-month PrEP dispensing + interim HIVST (either oral-fluid or blood-based) with biannual clinic visits.
We included all follow-up visits assigned as six-month visits by study staff; the window for these visits closed 2 weeks prior to the next scheduled visit date, which as at nine months for participants randomized to the SOC group and 12 months for participants randomized to one of the intervention arms.
The sub-group HIV serodifferent couples included all men and women enrolled in HIV serodifferent couples (N=295). The sub-group all women included both women enrolled in HIV serodifferent couples and women singly enrolled (N=330). The sub-group women singly enrolled just included these women and not those enrolled in HIV serodifferent couples (N=200).