A Crossover Acceptability Study Assessing a DPP Capsule for HIV and Pregnancy Prevention

Summary

The study design is a single-site, two-arm, randomized, open-label crossover trial in 30 AGYW aged 16-24 in Chitungwiza (Harare), Zimbabwe. The aim of the study is to assess the acceptability of, preference for, and adherence to a single DPP capsule containing one PrEP tablet and one COC tablet compared to two separate tablets (FTC/TDF and EE/LNG), each taken for three consecutive menstrual cycles for a total of 24 weeks among current COC users.

Timeline

Start

2022-12-07

Primary completion

2023-09-11

Completion

2023-09-11

Publications

• Mgodi NM, Burnett-Zieman JB, Murombedzi C, Dandadzi A, Gatsi V, Musara P, Matimbira S, Mavemwa G, Jambaya J, Chidemo T, Plagianos M, Haddad LB, Bruce IV, Mathur S, Friedland BA. A Dual Prevention Pill for HIV & Pregnancy Prevention: A Pilot Study Among Adolescent Girls and Young Women in Zimbabwe. AIDS Behav. 2026 Apr;30(4):1186-1201. doi: 10.1007/s10461-025-04909-2. Epub 2025 Nov 18.
• Friedland BA, Mgodi NM, Palanee-Phillips T, Mathur S, Plagianos MG, Bruce IV, Lansiaux M, Murombedzi C, Musara P, Dandadzi A, Reddy K, Ndlovu N, Zulu SK, Shale LR, Zieman B, Haddad LB. Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlled, cross-over studies in South Africa and Zimbabwe. BMJ Open. 2024 Mar 12;14(3):e075381. doi: 10.1136/bmjopen-2023-075381.

Drugs

Indications