Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women

Summary

An Open Label randomized control study. To explore the safety of Truvada when used as PrEP during pregnancy and lactation. Pregnant women considered at risk for HIV infection and willing to participate in this randomized control study will be randomized to commencing PrEP in pregnancy and continued use throughout breastfeeding or deferred PrEP until breastfeeding cessation. All women will receive the standard of care for prevention of HIV and other sexually transmitted infections. Arm A: (Intervention): Standard HIV Prevention strategy plus a once daily dose of Truvada (FTC 200mg/TDF 300mg tablet) initiated in pregnancy, continuing until cessation of breastfeeding or 18 months postdelivery whichever is earliest and thereafter the option to continue PrEP post breastfeeding cessation. Arm B: (Control): Standard HIV Prevention strategy throughout pregnancy until cessation of breastfeeding plus the offer to initiate PrEP post breastfeeding cessation. Standard HIV prevention strategy includes risk reduction counselling, sexually transmitted infection (STI) screening and treatment, condom promotion and inviting the sexual partner to receive HIV counselling and testing (HCT) and referral for antiretroviral therapy (ART) if he tests positive. Main Outcome Measure: Renal function, pregnancy outcomes, bone health and infant growth. Other Outcome Measure: Incident HIV infections, adherence to PrEP, drug resistance and mother-to-child transmission of HIV.

Timeline

Start

2017-09-28

Primary completion

2021-12-30

Completion

2021-12-30

Publications

• Kistan G, Esterhuizen T, Naidoo M, Desmond AC, Sebitloane M, Moodley D. Renal function in African women receiving tenofovir disoproxil fumarate as pre-exposure prophylaxis for HIV during pregnancy and postpartum: A postpartum safety analysis in the CAP016 randomized control trial. HIV Med. 2026 May 15. doi: 10.1111/hiv.70258. Online ahead of print.
• Khoza N, Desmond AC, Moodley D. Adherence to Oral HIV Pre-exposure Prophylaxis During Pregnancy and the Post-partum Period: Lessons Learned in an Open-Labelled Clinical Trial. AIDS Behav. 2026 Apr;30(4):1097-1108. doi: 10.1007/s10461-025-04952-z. Epub 2025 Nov 15.
• Moodley D, Lombard C, Govender V, Naidoo M, Desmond AC, Naidoo K, Mhlongo O, Sebitloane M, Newell ML, Clark R, Rooney JF, Gray G; CAP016 Team. Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial. Lancet HIV. 2023 Mar;10(3):e154-e163. doi: 10.1016/S2352-3018(22)00369-1. Epub 2023 Feb 3.

Drugs

Indications