Novel Study Evaluates Implementation of Long-Acting Injectable PReP In Sexual, Gender Minorities

Investigators are conducting the first study to evaluate long-acting injectable cabotegravir (CAB-LA), a form of preexposure prophylaxis (PrEP) for HIV, in young sexual and gender minorities (SGMs) in Latin America, according to an article published in JMIR Public Health Surveillance. Investigators predict that acceptability of this modality will be high because previous surveys have suggested injectable PrEP is preferred in Brazil.

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“Our study will also contribute to the expansion of the knowledge on the best HIV testing algorithm to be implemented in low- and middle-income countries when using CAB-LA for PrEP, which is a major need,” the study authors wrote in the article.

Some forms of daily HIV PrEP, including oral tenofovir disoproxil fumarate (TDF), are free in Brazil through the national public health system. Although it dramatically reduced population-level incidence of HIV, use continues to be low.

Additionally, discontinuation rates are common, especially among gay men, bisexual men, and other men who have sex with men (MSM) and transgender women (TGW) in Brazil. This lack of adherence particularly impacts HIV incidence among SGM populations who are young, racial, and ethnic minorities, or TGW.

Long-acting CAB-LA is an effective form of PrEP, but it needs to be studied in a real-world setting for susceptible SGMs, according to the study authors. Investigators in Brazil are conducting the ImPrEP CAB Brazil type-2 hybrid implementation-efficacy study to evaluate the acceptability, choice, efficacy, implementation, and feasibility of adding CAB-LA to existing public health system oral PrEP services for SGMs.

The study will also evaluate a mobile health (mHealth) and digital intervention tool as a way to optimize decision-making on the best PrEP regimen for PrEP users.

They will evaluate the efficacy of adding the CAB-LA PrEP package to PrEP services in Latin America in 4 clinical steps:

1. Participants who are HIV-negative will be informed about oral and injectable PrEP, then receive standard of care (SOC) counseling or the mHealth support intervention.
2. Patients who were interested in injectable CAB-LA who have undetectable HIV viral load will get same-day CAB-LA injection. They will be randomized to receive digital appointment reminders or SOC and have scheduled CAB-LA injections (every month or every 2 months) for the next 25 months.
3. Patients who changed to oral PrEP or discontinued CAB-LA will have a 1-year follow-up.
4. Patients who are diagnosed with HIV will receive follow-up, evaluation, and antiretroviral therapy, and will then be monitored for treatment efficacy or resistance.

Investigators will compare incidence of HIV among patients on CAB-LA or traditional oral PrEP to better understand whether CAB-LA will be an effective addition to the national health system’s PrEP services. They anticipate follow-up at 1.5 years and 75% retention for each year of the study. The team was cleared for the study late last year and will enroll patients in quarter 2 of 2023.

“[CAB-LA] will…contribute to maximizing the impact of a public health approach to reducing HIV incidence among SGMs in Brazil and other countries in the Global South,” the study authors wrote in the article.

Reference

Grinsztejn B, Torres T, Hoagland B, et al. Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study. JMIR Public Health Surveill 2023. Doi: 10.2196/44961