Active — Not RecruitingPhase 3

Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa

South Africa200 participantsStarted 2023-11-01

Plain-language summary

This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting Pre-exposure Prophylaxis at private pharmacies, who will be offered either Cabotegravir Long-Acting Injectable, oral Pre-exposure Prophylaxis (TDF/FTC\[3TC\]), or Pre-exposure Prophylaxis deferment at each of their regular visits, with the option to switch between options for up to 15 months, with a final exit interview following the transition to standard-of-care. The number of study visits will vary, depending on participant Pre-exposure Prophylaxis choices. Those choosing oral Pre-exposure Prophylaxis will be seen 3 monthly from V2 onwards, but those choosing Cabotegravir Long-Acting Injectable will be seen 2 monthly from V2. A maximum of 9 visits is possible.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult male or female (≥18 and ≤ 35 years old)
. Is self-reported sexually active
. HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1)
. Body weight ≥ 35 kilograms.
. Creatinine clearance ≥ 60 mL/min.
. Willingness to sign informed consent.

Exclusion criteria

. Symptoms of HIV seroconversion (see Table 1).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.

Timeframe: 15 Months

To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.

Timeframe: 12 Months

Trial details

NCT IDNCT06138600

SponsorUniversity of Witwatersrand, South Africa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult male or female (≥18 and ≤ 35 years old)
. Is self-reported sexually active
. HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1)
. Body weight ≥ 35 kilograms.
. Creatinine clearance ≥ 60 mL/min.
. Willingness to sign informed consent.

Exclusion criteria

. Symptoms of HIV seroconversion (see Table 1).

What they're measuring

To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.

Timeframe: 15 Months

To describe acceptability of CAB-LA (Long-Acting Cabotegravir) PrEP, amongst different PrEP modalities, including PrEP deferment, in eligible men and women.

Timeframe: 12 Months