Injectable HIV PrEP for Priority Populations in Malawi
The study aims to evaluate the effectiveness of an injectable medication in preventing HIV in high-risk populations in Malawi.
Standard of Care (SoC)
+ Enhanced continuation support package
Prevention Study
Summary
Study start date: November 1, 2025
Actual date on which the first participant was enrolled.This study aims to find the best ways to help people continue using a medication called cabotegravir (CAB LA) for preventing HIV. CAB LA is a long-acting injection that helps protect against HIV infection, and this study will focus on ensuring people keep using it consistently. It targets groups such as female sex workers, men who have sex with men, and transgender persons in Malawi, who often face higher risks of HIV. Finding effective methods to encourage continued use of CAB LA is important because it could significantly reduce HIV infections among these vulnerable populations. Participants in the study will receive either the usual care or an enhanced support package to help them stick with their treatment. The study will track participants' use of CAB LA over at least five months. Data will be collected using advanced technology to monitor how often people continue or switch their HIV prevention methods. The research will also include surveys and interviews with participants to gather in-depth insights into their experiences. This will help evaluate the effectiveness of different support strategies and improve future HIV prevention programs.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.9900 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 15 to 110 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location