Inclusion and exclusion criteria for South Africa (SA) and Zimbabwe (Zim)
| Criteria | SA | Zim |
| Inclusion criteria | ||
| Age 16–40 years old (inclusive) at screening, verified per site-specific SOPs. | X | |
| Age 16–24 years old (inclusive) at screening, verified per site-specific SOPs. | X | |
| Able and willing to provide informed consent per site SOPs. (If under the legal age of consent (18 years old) be able to provide informed assent and obtain parental or guardian consent, to be screened for and to enrol in the study.) | X | X |
| Fluent in spoken Zulu and/or English. | X | |
| Fluent in spoken Shona and/or English. | X | |
| Able and willing to provide adequate locator information, as defined in site SOPs. | X | X |
| Able and willing to comply with all study procedures, including being comfortable taking the study products as evident by nurse/clinician-observed swallowing at Screening of a large vitamin capsule that is of similar size to the study products. | X | X |
| Postmenarche, per participant report at screening. | X | X |
| Sexually active, defined as having had penile-vaginal sex with a male within the 3 months before screening (per self-report). | X | X |
| At moderate to high risk of HIV infection based on clinician assessment. | X | X |
| Considers herself to be at moderate to high risk of HIV acquisition based on self-assessment. | X | X |
| Has been using COCs for contraception for at least 3 months prior to screening as confirmed by contraceptive card and intends to continue using COCs for at least 12 months. | X | |
| Currently using COCs for contraception and has been using them for at least 3 months prior to screening. | X | |
| HIV-negative per rapid test at screening and enrolment per site-specific SOP. | X | X |
| Negative pregnancy test at screening and enrolment. | X | X |
| Negative for chlamydia, gonorrhoea, trichomoniasis and syphilis at screening; women who test positive at screening may be treated and enrolled. | X | X |
| Hepatitis B surface antigen negative per blood test at screening. | X | |
| Hepatitis B surface antigen and hepatitis C negative per blood test at screening. | X | |
| Normal estimated creatinine clearance ≥60 mL/min per blood test at screening. | X | X |
| Exclusion criteria | ||
| Currently using emtricitabine or tenofovir (TDF) at screening (per self-report). | X | |
| Intends to become pregnant within the next 12 months. | X | X |
| Intolerance, adverse reaction or laboratory abnormality associated with PrEP use in the past. | X | X |
| Use of PEP within 3 months of Screening (per self-report). | X | X |
| Breastfeeding <6 months postpartum (per self-report). | X | X |
| Less than 6 weeks (≤42 days) post partum and not breast feeding (per self-report). | X | X |
| For women 35 and older, currently smoke cigarettes (self-report). | X | |
| History of deep vein thrombosis/pulmonary embolism (self-report) or history of thrombophlebitis or thromboembolic disorders at screening (per self-report or medical records). | X | X |
| Prolonged immobilisation (self-report). | X | X |
| Known thrombogenic mutation/complicated valvular disease (per self-report). | X | X |
| History of cerebrovascular or coronary artery disease reported at screening. | X | |
| Ischaemic heart disease (per self-report). | X | X |
| Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies (per self-report). | X | X |
| Migraines with aura. | X | X |
| For women over 35 years old, migraines without aura (per self-report). | X | |
| History of undiagnosed abnormal genital bleeding reported at screening. | X | |
| Current breast cancer or within 5 years of past breast cancer (per self-report) or history of carcinoma of the breast or other oestrogen-dependent neoplasia reported at screening. | X | X |
| Diabetes with nephropathy, retinopathy or neuropathy (per self-report). | X | X |
| Diabetes for >20 years (per self-report). | X | X |
| Symptomatic gall bladder disease (per self-report). | X | X |
| Severe cirrhosis (per self-report). | X | X |
| Liver tumour (per self-report). | X | X |
| Any other condition the clinician feels would jeopardise the health and well-being of the participant. | X | X |
COC, combined oral contraceptive; PrEP, pre-exposure prophylaxis; TDF, tenofovir disoproxil fumarate.