Evaluating the implementation of long-acting injectable cabotegravir and oral PrEP for HIV prevention
Official title: Accelerating the Path To Scale for Injectable PrEP in Malawi: An Implementation Evaluation
Run by Georgetown University · NCT06319105 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
|---|---|
| Ages | 15 Years to 110 Years |
| Sex | All |
| Enrollment | 9900 (estimated) |
| Sponsor | Georgetown University Academic / other |
| Locations | 1 site (Lilongwe) |
| Trial ID | NCT06319105 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success with similar approaches to implementing PrEP, indicating a promising avenue for HIV prevention.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Community Health Science Unit
Lilongwe, Malawi Recruiting
Study contacts
- Principal investigator: Charles Holmes, MD, MPH — Georgetown University
- Study coordinator: Charles Holmes, MD, MPH
- Email: charles.holmes@georgetown.edu
- Phone: +1 (202) 662-9000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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BetterInfo on Women’s PrEP Choices and Outcomes in Malawi
This study tests how women in Blantyre, Malawi decide between injectable and oral PrEP and how tracing former PrEP users affects re-engagement and retention.
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PathToScale PERSIST: helping people stay on injectable and oral PrEP
This project will test whether a bundle of clinic and provider support strategies helps people in high-priority groups stay on long‑acting injectable cabotegravir or oral PrEP.
-
Long-acting HIV PrEP and contraception PK study in AGYW
This study tests how long-acting cabotegravir for PrEP interacts with hormonal contraception in young women.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.