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Taking people in MalawiNo phase

Tests support to keep people on HIV prevention medicine in Malawi

Tests extra support to help people keep taking HIV prevention medicine.

Plain-language title generated from the registry record
Registry title: PathToScale: The PERSIST Trial

Key facts

Where
Lilongwe, MalawiSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 15 or older in Malawi who are at higher risk of HIV and are starting injectable cabotegravir for HIV prevention (PrEP). It tests support to help them keep using PrEP.

Age
15 years or older (up to 110 years)
Sex
All sexes
Earlier treatment
People currently taking post-exposure prophylaxis or multi-drug resistant tuberculosis (MDR-TB) medicines cannot join. People with a known history of severe side effects to long-acting cabotegravir cannot join.
Biomarker or test result
People living with HIV-1, or with signs of possible acute HIV infection, cannot join.

Main reasons for not taking part

  • Living with HIV-1 or signs of possible acute HIV infection
  • A prior Hepatitis B diagnosis
  • A known history of severe side effects to long-acting cabotegravir
  • Unwilling or unable to return for 3-monthly HIV testing or 2-monthly counseling and safety visits
  • Currently taking MDR-TB medicines or post-exposure prophylaxis

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 15 and 110 years old?

Source: NCT07221747, who can take part

Where in Malawi

  • Community Health Science UnitLilongwe, MalawiTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Georgetown University
Trial code
NCT07221747
Record updated
4 March 2026
Original description
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.Read full original descriptionShow less

ACCELERATING THE PATH TO SCALE FOR INJECTABLE HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) in MALAWI: THE PERSIST TRIAL

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.

Inclusion: •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; Female sex workers (FSW) OR; Men who have sex with men (MSM) OR; Transgender individuals (TG) OR; Women and adolescent girls and young women (AGYW) presenting at STI services and/or family planning and/or HIV testing services OR; Breastfeeding women (BFW) OR; 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: 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.

ClinicalTrials.gov NCT07221747