| NCT ID | NCT07221747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Georgetown University |
| Condition | Oral Pre-exposure Prophylaxis (PrEP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 9,900 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9,900 participants in total. It began in 2026-02-16 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high priority groups.
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.
Contact & Investigator
Charles Holmes, MD, MPH
PRINCIPAL INVESTIGATOR
Georgetown University
Frequently Asked Questions
Who can join the NCT07221747 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 110 Years, studying Oral Pre-exposure Prophylaxis (PrEP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07221747 currently recruiting?
Yes, NCT07221747 is actively recruiting participants. Contact the research team at charles.holmes@georgetown.edu for enrollment information.
Where is the NCT07221747 trial being conducted?
This trial is being conducted at Lilongwe, Malawi.
Who is sponsoring the NCT07221747 clinical trial?
NCT07221747 is sponsored by Georgetown University. The principal investigator is Charles Holmes, MD, MPH at Georgetown University. The trial plans to enroll 9,900 participants.