NCT06807736

PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.

PrEPared to Choose (PtC): An Implementation Study of the Delivery of Cabotegravir Long-acting Injectable Pre-exposure Prophylaxis (PrEP) as an HIV Prevention Product Option Within a PrEP Choice Context in a Real World Setting in Cape Town.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,800 (estimated)
• Sponsor: Desmond Tutu HIV Foundation · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period. The study has both clinical and implementation primary aims. The primary clinical aim is short and long-term persistence on PrEP. Persistence is defined as the length of time that a participant shows continuous use of a PrEP product as intended, without stopping PrEP or switching to another PrEP product. The primary implementation aim involves the determination of factors that either enable or serve as a barrier to PrEP uptake and continuation. Participants will be offered a choice between three antiretroviral-containing PrEP products: (1) a Tenofovir-based oral tablet that needs to be taken daily; (2) a vaginal ring containing Dapivirine that provides HIV protection for up to one month; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point. The study will be offered from two study sites: the first is a mobile clinic that rotates on a fixed schedule across the study area and the second is a fixed-location government primary healthcare clinic. The study will be open to confirmed HIV-negative individuals, including adolescent girls and young women (aged 15-29 years), young gender and sexually diverse populations aged 15-29 years (including men who have sex with men, transgender people, and non-binary people), and their collective sexual partners (including heterosexual, cisgender men) of any age.

Detailed description

The PrEPared to Choose (PtC) study seeks to describe patterns of persistence on HIV pre-exposure prophylaxis (PrEP) products, individually and overall, amongst a cohort of South African adolescents and youth when offered a choice between PrEP products in real-world public health facility and mobile clinic settings. The study will further seek to understand implementation barriers and enablers in PrEP adoption (decision to use any PrEP product), initiation (first dose of any PrEP product), and persistence amongst both PrEP users (adolescents and youth) and PrEP providers (healthcare providers). This study will utilise a prospective cohort design that recruits 1800 adolescents and young people, specifically adolescent girls and young women, including pregnant and lacting women (15-29 years), young male key populations including men who have sex with men and male sex workers (15-29 years), and their collective intimate male partners (any age). Participants will be invited to choose to initiate on one of three types of PrEP (injectable, oral, or vaginal ring PrEP). Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point. Participants will be followed for 7 months to meet the primary outcome of short-term persistence and for a further 18 months to meet the secondary outcome of long-term persistence. Persistence will be defined as the continuous use of the selected product as intended with (a) \<7 day gap and (b) \<28 day gap in PrEP availability for daily dosing (oral PrEP), vaginal ring insertion, or subsequent injection. The 7-day window aligns with previous trial definitions of on-time dosing while the 28-day window aligns with pragmatic definitions of on-time dosing for PrEP in the South African context. The three products available will include: (1) a Tenofovir-based oral tablet that needs to be taken daily and is provided as a 30-day supply of oral tablets; (2) a intra-vaginal silicone ring containing slow-release Dapivirine that provides HIV protection for up to 28 days; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. The study will aim to recruit up to 900 participants that initiate on injectable PrEP, up to 600 participants that initiate on oral PrEP, and up to 300 participants that initiate on vaginal ring PrEP. PrEP choice counselling will be co-created with PrEP providers and young PrEP users (members of an existing PrEP-orientated youth reference group) and delivered by trained, adolescent-friendly HIV counsellors. PrEP will be administered by NIMART trained (Nurse Initiated Management of Anti-Retroviral Therapy) nurses at two clinical sites: a stationary government primary health care facility and a mobile clinic service that rotates on a fixed schedule through the study area. Participants will initiate at a single site but remain eligible to receive subsequent product refills/doses at the other site if desired.

Conditions

• HIV Infection
• Sexual and Reproductive Health

Interventions

Type	Name	Description
DRUG	Cabotegravir long-acting	3ml intramuscular injection containing 600mg of Cabotegravir
DRUG	Tenofovir emtricitabine	Oral tablet taken daily to PrEP HIV infection.
DRUG	Dapivirine containing vaginal ring	Intra-vaginal silicone ring containing slow-release Dapivirine, replaced every 28 days

Timeline

• Start date: 2024-02-13
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2025-02-04
• Last updated: 2025-02-04

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study