. 2022 Jan 6;12(1):e052880. doi: 10.1136/bmjopen-2021-052880

Table 1.

Eligibility criteria

Inclusion criteria	Exclusion criteria
Female sex at birth. 18–40 years of age (Group 4 participants age criterion is 18–30 years). Able and willing to provide written informed consent. Able and willing to provide adequate locator information for study retention purposes. HIV-negative on testing performed by study staff. Negative pregnancy test performed by study staff. Agree to use a reliable non-barrier form of contraception during the study and for at least 14 days before enrolment and until 30 days after implant removal (even if not currently sexually active). Must be in general good health based on clinical assessment Group 1, 2 and 3 participants must be deemed to be at low risk of HIV infection on completion of an HIV risk assessment tool (eg, no current STIs, no concurrent sex partners and other criteria linked to HIV risk) which will be assessed by the investigators when confirming eligibility to enrol.	Pregnant or currently breastfeeding, or intends to become pregnant and/or breast feed during the study. Intends relocation from current residential area in the next 12 months. Haemoglobin <95 g/L. Alanine aminotransferase (ALT) >the upper limit of normal (ULN). Aspartate aminotransferase (AST)>ULN. Creatinine clearance <60 mL/min (Cockcroft and Gault estimation). Hepatitis B surface antigen (HBsAg) positive. LDL or triglycerides or total cholesterol >ULN from a random sample. Past (<6 months ago) or current participation in any other research study which may interfere with this study. Currently on tenofovir-containing oral PrEP drugs. Currently has a contraceptive implant but only if this would make it difficult to insert the study implant. Has a tattoo or other dermatological condition overlying the inner arm which in the opinion of the principal investigator or designee, may interfere with interpretation of insertion site reactions. Bleeding abnormality or on anticoagulants. Active or planned use of prohibited medications as described in the study specific procedures manual. Has any other condition that, based on the opinion of the principal investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Inclusion criteria

Exclusion criteria

Female sex at birth.
18–40 years of age (Group 4 participants age criterion is 18–30 years).
Able and willing to provide written informed consent.
Able and willing to provide adequate locator information for study retention purposes.
HIV-negative on testing performed by study staff.
Negative pregnancy test performed by study staff.
Agree to use a reliable non-barrier form of contraception during the study and for at least 14 days before enrolment and until 30 days after implant removal (even if not currently sexually active).
Must be in general good health based on clinical assessment
Group 1, 2 and 3 participants must be deemed to be at low risk of HIV infection on completion of an HIV risk assessment tool (eg, no current STIs, no concurrent sex partners and other criteria linked to HIV risk) which will be assessed by the investigators when confirming eligibility to enrol.

Pregnant or currently breastfeeding, or intends to become pregnant and/or breast feed during the study.
Intends relocation from current residential area in the next 12 months.
Haemoglobin <95 g/L.
Alanine aminotransferase (ALT) >the upper limit of normal (ULN).
Aspartate aminotransferase (AST)>ULN.
Creatinine clearance <60 mL/min (Cockcroft and Gault estimation).
Hepatitis B surface antigen (HBsAg) positive.
LDL or triglycerides or total cholesterol >ULN from a random sample.
Past (<6 months ago) or current participation in any other research study which may interfere with this study.
Currently on tenofovir-containing oral PrEP drugs.
Currently has a contraceptive implant but only if this would make it difficult to insert the study implant.
Has a tattoo or other dermatological condition overlying the inner arm which in the opinion of the principal investigator or designee, may interfere with interpretation of insertion site reactions.
Bleeding abnormality or on anticoagulants.
Active or planned use of prohibited medications as described in the study specific procedures manual.
Has any other condition that, based on the opinion of the principal investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

LDL, low-density lipoprotein; PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection.