Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.
- Conditions
- Prevention
- Interventions
- Registration Number
- NCT06273943
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- Brief Summary
The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly increase the sustained PrEP use over time and the PrEP coverage of at-risk sexual risk behaviors.
- Detailed Description
Long-acting injectable cabotegravir (CAB-LA) is a promising agent to address the issue of uptake, adherence, and persistence among oral PrEP users who faced adherence challenges. However, the potential benefits of offering CAB-LA as an additional prevention option for MSM adherent to oral PrEP has yet to be demonstrated. We hypothesize that offering CAB-LA as an additional prevention option for MSM already using oral PrEP can mitigate PrEP fatigue over time, resulting in enhanced PrEP use and increased coverage of at-risk sexual intercourses.
This study is designed as a pragmatic, open-label, multicenter, parallel-group, randomized controlled clinical trial aiming to enroll MSM using PrEP for at least 6 months. Participants will be randomly assigned in a 1:1 ratio to remain on their current oral PrEP regimen with daily and/or on-demand TDF/FTC (Control arm) or to switch to a CAB-LA based PrEP (Intervention arm). Participants will be enrolled over 6 months and followed for two years. The trial will be conducted at 9 clinical sites in the Paris region. The primary objective of the study will be to compare the sustained PrEP use over time among participants randomized to CAB-LA vs. oral TDF/FTC based PrEP at Months 12 and 24. The main secondary objectives will aim to evaluate the PrEP coverage of at-risk sexual intercourses, the change from baseline in sexual risk behaviors, the safety of the drugs, and the HIV incidence.
The study protocol includes three ancillary studies:
* Social science: Focus groups will be conducted among study participants to investigate their perceptions of CAB-LA, motivations for using it, adherence and persistence, changes in HIV risk perception, and impact on sexual satisfaction. Additionally, this study will assess healthcare providers' perceptions, barriers, and facilitators regarding CAB-LA implementation for PrEP.
* Rectal tissue HIV-1 permissibility: This study aims to evaluate the protection from HIV-1 at different time points after oral and injectable CAB initiation using a model of Ex-vivo rectal tissue and PBMCs infection with HIV-1.
* Medico-economics analysis: The main objective of this study is to establish cost-effectiveness performance benchmarks for CAB-LA in HIV PrEP.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 322
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral PrEP with daily or on-demand TDF/FTC Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use Participants randomly assigned to the oral PrEP regimen will be instructed to take a single dose combination of TDF 300 mg + FTC 200 mg (TDF/FTC), either daily or on-demand, according to their preferences. Long-acting injectable PrEP with cabotegavir Cabotegravir Tablets, for oral use. Participants assigned to the cabotegravir group will initially take a 30mg oral tablet of cabotegravir daily for a four-week period. Following this initial phase, they will receive 13 intramuscular injections of 600mg (3mL) long-acting injectable cabotegravir (CAB-LA) administered every two months after an initial loading dose given one month after the last oral tablet. Oral PrEP with daily or on-demand TDF/FTC Rectal Biopsies Participants randomly assigned to the oral PrEP regimen will be instructed to take a single dose combination of TDF 300 mg + FTC 200 mg (TDF/FTC), either daily or on-demand, according to their preferences. Long-acting injectable PrEP with cabotegavir Cabotegravir Extended-Release Injectable Suspension, for intramuscular use. Participants assigned to the cabotegravir group will initially take a 30mg oral tablet of cabotegravir daily for a four-week period. Following this initial phase, they will receive 13 intramuscular injections of 600mg (3mL) long-acting injectable cabotegravir (CAB-LA) administered every two months after an initial loading dose given one month after the last oral tablet. Long-acting injectable PrEP with cabotegavir Rectal Biopsies Participants assigned to the cabotegravir group will initially take a 30mg oral tablet of cabotegravir daily for a four-week period. Following this initial phase, they will receive 13 intramuscular injections of 600mg (3mL) long-acting injectable cabotegravir (CAB-LA) administered every two months after an initial loading dose given one month after the last oral tablet.
- Primary Outcome Measures
Name Time Method Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. At Month 12
- Secondary Outcome Measures
Name Time Method Number of condomless anal sexual intercourse in the month prior to each study visit. At each study visits. Number of participants with Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study. From Day 1 up to end of study. Change from baseline in the insulin resistance index (HOMA-IR). At Months 12 and 24. HOMA-IR : \[fasting glucose (mmol/L) 脳 fasting insulin (渭mol/L)/22.5\]
Number and severity of injection site reaction. After 12 and 24 Months. Number of participants with missing follow-up visits, temporary PrEP discontinuation, permanent PrEP discontinuation, switching to another PrEP regimen, study discontinuation, lost to follow-up. At 12 and 24 Months. Number of sexual partners in the last 3 months. At baseline, 6, 12, 18 and 24 months Mean PrEP satisfaction score based on study arm. At baseline, 6, 12, 18 and 24 months. Change from baseline in lipids At Months 12 and 24. Fasting total Cholesterol (mmol/L), LDL cholesterol (mmol/L), HDL cholesterol (mmol/L).
Score of quality of life measured by the EuroQol-5D questionnaire At baseline, 6, 12, 18 and 24 months. The possible range of scores is 0 to 100%, with the higher scores indicating better outcome.
Number of participants whose last condomless anal sexual intercourse was not covered by PrEP. At each study visits. Cabotegravir concentration in plasma and tenofovir diphosphate and emtricitabine triphosphate concentration in dried blood spots. At baseline, 6, 12, 18 and 24 months. Number of participants with new HIV infection. From Day 1 up to end of study. Depression score assessed with the Center for Epidemiologic Studies Depression Scale (CES-D). At baseline,12, and 24 months. The possible range of scores is 0 to 60, with the higher scores indicating worse outcome.
Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. At Month 24 Number of participants with syphilis, chlamydiae, and/or gonorrhea infection. From Day 1 up to end of study. Change from baseline in body weight (kg). At Months 12 and 24. Number of participants who used psychoactive drugs in the last 3 months At baseline, 6, 12, 18 and 24 months. Number and nature of uses of community peer support and therapeutic patient education. At baseline, 6, 12, 18 and 24 months. Self-esteem score assessed with the Rosenberg scale. At baseline,12, and 24 months. The scale ranges from 0 to 30, with the higher score indicating a better outcome.
Trial Locations
- Locations (8)
H么pital Lariboisi猫re
馃嚝馃嚪Paris, Ile De France, France
H么pital Saint Louis
馃嚝馃嚪Paris, Ile De France, France
H么pital H么tel Dieu
馃嚝馃嚪Paris, Ile De France, France
H么pital Saint Antoine
馃嚝馃嚪Paris, Ile De France, France
H么pital Bichat
馃嚝馃嚪Paris, Ile De France, France
H么pital Tenon
馃嚝馃嚪Paris, Ile De France, France
H么pital La Piti茅 Salp锚tri猫re
馃嚝馃嚪Paris, Ile De France, France
H么pital Necker
馃嚝馃嚪Paris, Ile De France, France