Evaluating the implementation of long-acting injectable cabotegravir and oral PrEP for HIV prevention

Accelerating the Path To Scale for Injectable PrEP in Malawi: An Implementation Evaluation

This study is testing how well long-acting injectable cabotegravir and oral PrEP for HIV prevention work in real life for people at higher risk.

Quick facts

• Study type: Observational
• Enrollment: 9900 (estimated)
• Ages: 15 Years to 110 Years
• Sex: All
• Sponsor: Georgetown University (other)
• Locations: 1 site (Lilongwe)
• Trial ID: NCT06319105 on ClinicalTrials.gov

What this trial studies

This study evaluates how well long-acting injectable cabotegravir and oral pre-exposure prophylaxis (PrEP) are implemented in real-world settings, focusing on high-priority populations. It assesses client uptake, equitable access, and continuation of PrEP services across various delivery channels. The study also examines the readiness for implementing long-acting injectable cabotegravir and gathers perspectives from both providers and clients. Additionally, it includes clinical surveillance of outcomes related to long-acting injectable cabotegravir, such as pregnancy and HIV resistance.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 15 and older who belong to high-priority groups such as female sex workers, men who have sex with men, transgender individuals, and others at high risk for HIV.

Not a fit: Patients who do not fall into the specified high-priority groups or are under 15 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accessibility and effectiveness of HIV prevention strategies for at-risk populations.

How similar studies have performed: Other studies have shown success with similar approaches to implementing PrEP, indicating a promising avenue for HIV prevention.

Eligibility criteria

Inclusion Criteria:

* Inclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis will be applied per Ministry of Health guidelines. Per Ministry of Health guidelines, the following populations will be prioritized for long-acting injectable cabotegravir for pre-exposure prophylaxis distribution, following individual risk assessment:

Individuals who are 15+ years old AND either

1. Female sex workers (FSW) OR
2. Men who have sex with men (MSM) OR
3. Transgender individuals (TG) OR
4. Women and adolescent girls and young women (AGYW) presenting at STI services and/or family planning and/or HIV testing services OR
5. Breastfeeding women (BFW) OR
6. Male partners of female sex workers and/or Men at high risk for HIV and/or men presenting with a syndromic or lab-confirmed sexually transmitted infections. All individuals initiated on long-acting injectable cabotegravir for pre-exposure prophylaxis 15 years or above will be included in the passively enrolled sample.

Exclusion Criteria:

* Per Ministry of Health guidelines, exclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis includes:

Those living with HIV-1 or evidence of possible acute HIV infection OR Those with a prior Hepatitis B diagnosis OR Those with a known history of severe side effects to Cabotegravir Long Acting OR Those unwilling or unable to return for 3-monthly HIV testing or 2-monthly counseling and safety monitoring visits OR Clients currently on multi-drug resistance tuberculosis (MDR-TB) medications OR Clients currently taking post-exposure prophylaxis.

Where this trial is running

Lilongwe

• Community Health Science Unit — Lilongwe, Malawi (RECRUITING)

Study contacts

• Principal investigator: Charles Holmes, MD, MPH — Georgetown University
• Study coordinator: Charles Holmes, MD, MPH

Conditions: Oral Pre-exposure Prophylaxis, Long-acting Injectable Cabotegravir for PrEP, HIV, pre-exposure prophylaxis, Implementation Science, Long-acting injectable cabotegravir for PrEP, Oral pre-exposure prophylaxis