*Visit/date | Screening | Enrolment | Visit 1.0 | Visit 2.0 | Visit 3.0 | Visit 3.1† | Visit 4.0 |
---|---|---|---|---|---|---|---|
Body mass index | 23.7 | 23.7 | 23.7 | 24.1 | 25.0 | N/A | 26.3 |
Waist circumference (cm) | 79 | 79 | 79 | 79 | 79 | N/A | 82 |
Urine pregnancy test results | Negative | Negative | Negative | Negative | Negative | N/A | Negative |
Gels dispensed | N/A | 10 | 20 | 20 | 20 | 20 | Product held |
Gels returned used | N/A | N/A | 10 | 20 | 20 | 20 | 20 |
Contraception | DMPA given | N/A | N/A | N/A | DMPA given | N/A | N/A |
*Physical and pelvic examinations are symptom directed and not mandated by the protocol at the monthly follow-up visits.
†Interim visit: participant returned to request additional gel as she was going on holiday with her partner.
CAPRISA, Centre for the AIDS Programme of Research in South Africa; DMPA, depot medroxyprogesterone acetate.