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.

NCT06807736 | Recruiting FDA Drug

• 1 other identifier: PrEPared to Choose
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infection; Sexual and Reproductive Health

Keywords

HIV prevention; Pre-exposure prophylaxis; Injectable PrEP; Adolescents and young people; South Africa; Cabotegravir long-acting; PrEP Choice

Outcome Measures

Primary Outcomes (2)

• Short-term persistence

  Persistence (return for PrEP product within a scheduled visit window) over the short-term (7 months) will be measured and reported as persistent vs non-persistent continuation on each specific PrEP product (oral, injectable, ring) and on PrEP overall (accounting for continuation after switching to a different PrEP product). Non-persistence will be defined as failure to return for PrEP within (a) 7 days of the scheduled visit and (b) 28 days of the scheduled visit.

  7 months

• Primary implementation aim.

  The combination of implementation strategies best achieve pre-exposure prophylaxis (PrEP) adoption, active implementation (initiation), and persistence (sustainment) outcomes over the short term (7 months) and the long term (18 months) will be collected and reported within a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. This will include implementation strategies that describe PrEP choice counselling, the integration of injectable PrEP into standard of care clinical practise, and the differentiating practises required for the effective delivery of PrEP from community based and healthcare facility based settings.

  7 months; 18 months

Secondary Outcomes (6)

• Durable persistence

  18 months

• Time on PrEP

  18 months

• Safety of PrEP products

  18 months

• Tolerability of PrEP products

  18 months

• Acceptability of PrEP products

  18 months

Other Outcomes (1)

• HIV incidence

  18 months

Study Arms (3)

Injectable PrEP User

Participants that select to use injectable PrEP (Cabotegravir long-acting) at baseline.

Drug: Cabotegravir long-acting

Oral PrEP user

Participants that select to use oral PrEP at baseline.

Drug: Tenofovir emtricitabine

Ring User

Participants that select to use vaginal ring PrEP (DapiRing) at baseline.

Drug: Dapivirine containing vaginal ring

Interventions

Cabotegravir long-acting DRUG

3ml intramuscular injection containing 600mg of Cabotegravir

Also known as: Apretude

Injectable PrEP User

Tenofovir emtricitabine DRUG

Oral tablet taken daily to PrEP HIV infection.

Oral PrEP user

Dapivirine containing vaginal ring DRUG

Intra-vaginal silicone ring containing slow-release Dapivirine, replaced every 28 days

Ring User

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the Klipfontein-Mitchells Plain Health sub-district (a peri-urban, high-density, low socio-economic setting) in Cape Town, South Africa. Participants can access the study through the mobile clinic (which rotates through the study area on a fixed schedule) or a local government primary healthcare facility. The target study population includes adolescent girls and young women (aged 15 -29 years) and their intimate male partners (\>15 years). Gender and sexually diverse populations, including men who have sex with men, transgender women, and transgender men, are eligible for study enrollment.

You may qualify if:

• All participants must be HIV negative at baseline
• All participants must have a body weight ¬\> 35kg at baseline
• All participants must be older than 15 years. Specific age criteria will be applied to certain population groups.
• All participants must be currently resident in the study area
• All participants must be able to provide written, informed voluntary consent to partake in the study and willing and able to receive an injectable pre-exposure prophylaxis (PrEP) product

You may not qualify if:

• Confirmed HIV-positive test result and/or signs and symptoms of an acute HIV infection
• Clinical conditions contraindicated for the chosen PrEP product as per SAHPRA regulations, including use of known contraindicated medications.
• Allergy to any of the study products
• Do not spend a reasonable amount of time in the study area as residents, for school, or work, or are otherwise unable to participate in clinical or study visits for geographical reasons, according to the site investigator
• Medical, social or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (e.g., provided by self-report, or found upon medical history and examination or in available medical records)
• Current enrolment in another HIV prevention clinical trial that in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (as verified by registration on the South African Medical Research Council biometric co-enrolment prevention system).

Sponsors & Collaborators

• Desmond Tutu HIV Foundation: lead
• Bill and Melinda Gates Foundation: collaborator
• ViiV Healthcare: collaborator

Study Sites (1)

Desmond Tutu Health Foundation

Cape Town, Western Province, 7925, South Africa

RECRUITING

Related Publications (1)

• Pike C, Rousseau E, Macdonald P, Mapukata P, Lebelo K, Joseph-Davey D, Little F, Bekker LG. PrEPared to choose: the protocol for an implementation study of the delivery of cabotegravir long-acting injectable pre-exposure prophylaxis (PrEP) as an HIV prevention product option within a real world PrEP choice context in cape town. BMC Public Health. 2025 Sep 24;25(1):3109. doi: 10.1186/s12889-025-24370-z.

  PMID: 40993613 DERIVED

MeSH Terms

Conditions

HIV Infections; Coitus

Interventions

cabotegravir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sexual Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: February 4, 2025
• Study Start: February 13, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

ZA (1)