Table 1.
Participants’ demographic characteristics at baseline, by study arm
| Characteristic | Standard-of-care | Oral-fluid HIVST1 | Blood-based HIVST1 | Overall |
|---|---|---|---|---|
| N | 166 | 163 | 166 | 495 |
| Study Population | ||||
| Men, in HIV serodifferent couple | 55 (33·1%) | 54 (33·1%) | 56 (33·7%) | 165 (33·3%) |
| Women, in HIV serodifferent couple | 44 (26·5%) | 43 (26·4%) | 43 (25·9%) | 130 (26·3%) |
| Women, singly enrolled | 67 (40·4%) | 66 (40·5%) | 67 (40·4%) | 200 (40·4%) |
| Age, median (IQR) | 33 (28–40) | 33 (28–40) | 32 (27–39) | 33 (27–40) |
| Age categories | ||||
| 18–24 years | 27 (16·3%) | 23 (14·1%) | 26 (15·7%) | 76 (15·4%) |
| 25–29 years | 25 (15·1%) | 31 (19·0%) | 31 (18·7%) | 87 (17·6%) |
| 30–34 years | 38 (22·9%) | 40 (24·5%) | 42 (25·3%) | 120 (24·2%) |
| ≥35 years | 76 (45·8%) | 69 (42·3%) | 67 (40·4%) | 212 (42·8%) |
| Travel time to clinic | ||||
| <30 minutes | 7 (4·2%) | 4 (2·5%) | 4 (2·4%) | 15 (3·0%) |
| 30–<60 minutes | 42 (25·3%) | 45 (27·6%) | 40 (24·1%) | 127 (25·7%) |
| 1–<2 hours | 36 (21·7%) | 34 (20·9%) | 37 (22·3%) | 107 (21·6%) |
| >2 hours | 80 (48·2%) | 80 (49·1%) | 85 (51·2%) | 245 (49·5%) |
| Years of education, median (IQR) | 10 (8–12) | 10 (8–12) | 8 (8–12) | 9 (8–12) |
| Age of sexual debut, median (IQR) | 18 (15–19) | 18 (16–20) | 17 (15–19) | 17 (16–19) |
| Married | 126 (75·9%) | 129 (79·1%) | 127 (76·5%) | 382 (77·2%) |
| Currently pregnant2,3 | 6 (5·4%) | 7 (6·4%) | 7 (6·4%) | 20 (6·1%) |
| Using modern method of contraception2,4 | 59 (53·2%) | 49 (45·0%) | 53 (48·2%) | 161 (48·8%) |
| Fully circumcised5 | 50 (90·9%) | 51 (94·4%) | 51 (91·1%) | 152 (92·1%) |
| Sexual Behaviors | ||||
| No. sex partners (past month), median (IQR) | 1 (1–1) | 1 (1–1) | 1 (1–1) | 1 (1–1) |
| Frequency of sex (past month), median (IQR) | 8 (4–12) | 8 (4–12) | 8 (4–13) | 8 (4–12) |
| Inconsistent condom use (past month)6 | 144 (86·7%) | 139 (85·3%) | 122 (73·5%) | 405 (81·8%) |
| Exchanged sex for goods/money (past month)7,8 | 20 (12·0%) | 18 (11·0%) | 11 (6·6%) | 49 (9·9%) |
| PrEP disclosure to ≥1 person9 | 28 (16·9%) | 35 (21·5%) | 27 (16·3%) | 90 (18·2%) |
| Self-efficacy score, median (IQR)10,11 | 37 (29–40) | 38 (30–40) | 38 (30–40) | 37·5 (30–40) |
| Severity of depressive symptoms, median (IQR)11,12 | 1 (0–4) | 1 (0–4) | 1 (0–5) | 1 (0–4) |
| Any social harm, past 3 months13 | 10 (6·0%) | 12 (7·4%) | 18 (10·8%) | 40 (8·1%) |
Abbreviations:interquartile range (IQR)
Participants randomized to these intervention arms received six-month PrEP dispensing + interim HIVST (either oral-fluid or blood-based) with biannual clinic visits.
Outcome reported only among female participants (n=330).
Missing data on baseline pregnancy status for 19 participants.
Modern methods of contraception include oral, injectable, implants, and intrauterine devices (IUDs).
Outcome reported only among male participants (n=165); missing data for 10 participants.
Condom use categorized as inconsistent if condoms not used during every sex act in the past month; missing data for 28 participants.
Missing data for 24 participants.
Among females singly enrolled, 24% (n=48) reported exchanging sex for money/goods in past month.
Social harm includes any verbal, physical, or emotional abuse by a sexual partner.
Reported PrEP disclosure to at least one other person besides one’s main sexual partner in serodifferent couples.
Self-efficacy score calculated using the General Self-Efficacy Scale
Missing data for one participant.
Severity of depressive symptoms calculated using the Patient Health Questionnaire 9-item (PHQ-9) depression scale
Social harm includes any verbal, physical, or emotional abuse by a sexual partner.