NCT07516548

Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV

Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptive Options in HIV Prevention

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 105 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.

Detailed description

Long-acting (LA) HIV pre-exposure prophylaxis (PrEP), such as injectable cabotegravir (CAB-LA), is increasingly available and has the potential to address barriers to adherence seen with daily oral PrEP. LA PrEP regimens can expand options for women and providers to individualize prevention strategies, provide a powerful prevention tool for those facing adherence challenges with oral regimens, and reduce the burden on health systems in resource-limited settings. Another major threat to women's health is unintended pregnancies, and women at risk for HIV face unique challenges in uptake and continuation of long-acting contraceptives. Use of CAB-LA may create synergy with long-acting contraceptives, fostering more consistent uptake and improved health outcomes. This proposed research study is a prospective, non-randomized, parallel-group pharmacokinetic (PK) study among a sentinel cohort of five distinct groups of AGYW, and will leverage existing control groups. The study will be conducted in Botswana. This study will generate critical data to guide future implementation studies integrating CAB-LA PrEP and contraceptive services. Providing an array of prevention and reproductive health options has the potential to empower women to make informed decisions, improve adherence and continuation, and inform real-world considerations for co-delivery or future co-formulations of PrEP and contraceptives. Our central hypotheses are the following: * CAB-LA will not adversely influence hormonal contraceptive concentrations; * Hormonal contraceptive method use will not adversely modify CAB-LA concentrations below therapeutically relevant plasma concentrations. Primary Objectives: * To evaluate any associations between CAB-LA exposure and hormonal contraceptive use in the three groups of IM DMPA, ETG implant, and non-hormonal method users by generating geometric mean hormone concentrations throughout 12 weeks for IM DMPA or 24 weeks for ETG implant and no hormonal method groups (Aim 1a) * To evaluate any associations between hormonal contraceptive exposure and CAB-LA use by generating geometric mean trough CAB-LA concentrations measured immediately prior to dosing of next CAB-LA (Aim 1b) Exploratory Objectives * To assess safety, including side effects, satisfaction, and continuation rates of both LA ART/PrEP and hormonal contraceptive method (Aim 2a) * To qualitatively explore decision-making around PrEP and contraceptive method options, study experiences with use of/switch to CAB-LA and contraceptive method (Aim 2b)

Conditions

• HIV Infections
• Contraception
• Drug-drug Interaction
• PrEP
• Long-acting Injectable Cabotegravir for PrEP

Interventions

Type	Name	Description
DRUG	Long-acting injectable cabotegravir (CAB-LA)	Injectable cabotegravir 600 mg administered as long-acting HIV pre-exposure prophylaxis (PrEP).
OTHER	No PrEP	No HIV pre-exposure prophylaxis administered

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: Botswana