HIV InfectionsNCT05044962
Kuwa Free! - Live Free!
A study testing Cabotegravir/ Rilpivirine, Etonogestrel (ETG) implant and Intramuscular depo-medroxyprogesterone acetate (IM DMPA) in people with HIV Infections and Contraception, run by University of Alabama at Birmingham at 1 site in Kenya.
Trial summary
The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation… Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Contraception, Drug-drug Interaction
- What is being tested?
- Cabotegravir/ Rilpivirine, Etonogestrel (ETG) implant and Intramuscular depo-medroxyprogesterone acetate (IM DMPA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteKenya
- Study dates
- 26 Nov 2021to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female sex,
- HIV-positive (for PK groups #1-4) or HIV-uninfected (for PK group #5 only),
- Age 15-24 years at the time of enrollment,
- Documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 6 months prior to study enrollment,
- Have been on the study oral drug for at least 4 weeks for the PK groups #1-4,
- Have initiated and intends to use DMPA or implant for at least another three or 6 months, respectively,
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- Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period
- Able to consent or assent (with parental consent) for study participation in English or Kiswahili
- Participating in PK study for study participants,
- Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,
- Able to consent for study participation in English or Kiswahili
- Female sex,
- HIV-positive,
- Age 15-24 years at the time of enrollment,
- Documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 6 months prior to study enrollment,
- Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period,
- Able to consent or assent (with parental consent) for study participation in English or Kiswahili
- Participating in hybrid trial study for study participants,
- Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,
- Able to consent for study participation in English or Kiswahili
Who cannot join
- Already be on ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir
- Currently pregnant or intends to become pregnant or breastfeeding within the next 12 or 24 weeks for DMPA or implant groups, respectively,
- Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,
- Use or anticipated use of drugs for the duration of the study period known to interact with hormonal implants or the study ART regimen,
- Current or planned concomitant use of other hormonal contraceptives,
- Be obese (BMI≥30),
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- Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded).
- Serum ALT>5x ULN at the time of screening,
- Serum creatinine >2.5x ULN at the time of screening.
- Already be on ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir
- Currently pregnant or intends to become pregnant or breastfeeding within the next one year,
- Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,
- Use or anticipated use of drugs for the duration of the study period known to interact with the study ART regimen,
- Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded).
- Serum ALT>5x ULN at the time of screening,
- Serum creatinine >2.5x ULN at the time of screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Academic Model Providing Access to Healthcare (AMPATH) Moi Teaching And Referral Hospital (MTRH)
Eldoret, Kenya
Eunice Kaguiri, pipscoordinatoreldoret@gmail.com
About this study
Official title: Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives
The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation trial randomizing individual AGYWLHIV to receive long-acting (LA) injectable cabotegravir/rilpivirine vs. standard of care within one of Kenya's largest HIV treatment programs. The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK and qualitative studies will largely be conducted with a sentinel cohort of AGYWLHIV. Learning from this early LA ART use, the investigators will refine the procedures in the LA ART hybrid trial.
Read the detailed description
Long-acting (LA) antiretroviral therapy (ART), such as injectable cabotegravir and rilpivirine, has been receiving global clinical approvals and has the potential to address barriers to ART and improve patient adherence and persistence to treatment. LA ART regimens can potentially also increase options for patients and providers to individualize treatment plans, provide a powerful treatment option for those experiencing adherence issues related oral treatment options, and may ease the burden of health systems in RLS. Another major threat to AGYW's health is unintended pregnancies and AGYWLHIV also face unique challenges in uptake and continuation of LA contraceptives. Use of LA ART may foster synergy in usage of LA contraceptives among AGYWLHIV.
This proposed research study has three main components: 1) 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 (Aim 1a); 2) a qualitative study that will conduct individual interviews with four different subgroups of AGYWLHIV from the sentinel cohort from the PK study, as well as focus group discussions with providers, policy makers, and other stakeholders for health systems readiness for wider scale-up (Aim 1b); and 3) an open-label, mixed methods, 48-week type I hybrid trial randomizing AGYW with viral suppression on their current ART regimen to switch to 1:1 cabotegravir/ rilpivirine (intervention arm) vs. continue their oral ART regimen (Aim 2a), with a component also evaluating implementation outcomes of acceptability, feasibility, and fidelity (Aim 2b). The proposed study will be conducted in HIV treatment facilities in western Kenya within the regional Moi Teaching and Referral Hospital (MTRH).
This study will provide foundational data for future studies and implementation plans related to addressing barriers and will critically inform follow-up studies of LA ART in other priority subpopulations. Providing an array of method options for both HIV treatment and pregnancy prevention has the potential to revolutionize personal decision-making and improve long-term outcomes for AGYWLHIV. Our real-world experiences of co-delivery will also inform future considerations for co-formulations of antiretrovirals and contraceptives for both HIV treatment and prevention.
Our central hypothesis is the following: 1) at the client level, the use of LA ART or contraceptives will foster long-term thinking for health, forging a convergence of the use of the two when applicable; and 2) at the program/provider level, leveraging existing LA contraceptive delivery platform will make LA ART highly acceptable, feasible, and deliverable with high fidelity.
Our overall objective in this study is to conduct the foundational PK and qualitative studies first as a lead in to the hybrid trial. Guided by Proctor et al.'s implementation outcomes framework, the hybrid trial will also focus on acceptability, feasibility, and fidelity. These implementation outcomes are proximal indicators of implementation processes and intermediate outcomes, which ultimately predict implementation success. Demonstrating successful implementation outcomes will then inform wider-scale implementation of LA ART, when service and client outcomes can be fully realized.
The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK (Aim 1a) and qualitative (Aim 1b) studies will largely be conducted with a sentinel cohort of AGYWLHIV in parallel to each other. Learning from this early LA ART use, the investigators will refine our procedures in the LA ART hybrid trial (Aim 2). For all possible outcomes/scenarios of Aim 1, the investigators still anticipate conducting a robust trial in Aim 2.
Thus, our specific aims are:
Aim 1: To collect foundational data to better inform design of an effectiveness-implementation trial.
Aim 1a: To determine if combined cabotegravir/rilpivirine injectable use has bidirectional drug-drug interactions with injectable (depot medroxyprogesterone acetate [DMPA]) or implantable (etonogestrel or levonorgestrel) contraceptives.
Aim 1b: To qualitatively explore points of convergence and divergence, preferences and values, and health systems readiness around wider-scale co-delivery of LA ART and contraceptives.
Aim 2: To evaluate the impact of clinic-provided, co-delivery of LA ART and contraceptives among AGYWLHIV.
Aim 2a: To evaluate the impact on effectiveness outcomes of HIV treatment (viral suppression and adherence/persistence) and contraception (uptake and continuation rates).
Aim 2b: To evaluate the impact on implementation outcomes of acceptability, feasibility, and fidelity.
- Conditions
- HIV Infections, Contraception, Drug-drug Interaction
- Being tested
- Cabotegravir/ Rilpivirine, Etonogestrel (ETG) implant, Intramuscular depo-medroxyprogesterone acetate (IM DMPA), Levonorgestrel, NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens
- Keywords
- Kenya, Adolescent girls and young women, HIV adherence, Long-acting antiretroviral therapy, Injectable cabotegravir, Injectable rilpivirine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir/ RilpivirineDrug
For initial injection participants will be given CABENUVA 600-mg/900-mg Kit: (single-dose vial of 600 mg/3 mL (200 mg/mL) cabotegravir , single-dose vial of 900 mg/3 mL (300 mg/mL) rilpivirin).
For subsequent injections participants will be given CABENUVA 400-mg/600-mg Kit: (single-dose vial of 400 mg/2 mL (200 mg/mL) cabotegravir, single-dose vial of 600 mg/2 mL (300 mg/mL) rilpivirine)
CABENUVA® is owned by or licensed to the ViiV Healthcare group of companies, GlaxoSmithKline Research Triangle Park, NC 27709
Etonogestrel (ETG) implantDrug
Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm
Intramuscular depo-medroxyprogesterone acetate (IM DMPA)Drug
DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide
LevonorgestrelDrug
Contraceptive estrogen implants are thin rods inserted under the skin of a woman's arm
NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimensDrug
ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir
| Study group | Role | What they receive |
|---|---|---|
| Aim 1a (PK study group 1) | Experimental | Initiating injectable cabotegravir/rilpivirine (LA ART) and DMPA Receives: Drug: Cabotegravir/ Rilpivirine; Drug: Intramuscular depo-medroxyprogesterone acetate (IM DMPA) |
| Aim 1a (PK study group 2) | Experimental | Initiating injectable cabotegravir/rilpivirine (LA ART) and and etonogestrel implant Receives: Drug: Cabotegravir/ Rilpivirine; Drug: Etonogestrel (ETG) implant |
| Aim 1a (PK study group 3) | Experimental | Initiating injectable cabotegravir/rilpivirine (LA ART) and levonorgestrel implant. Receives: Drug: Cabotegravir/ Rilpivirine; Drug: Levonorgestrel |
| Aim 1a (PK study group 4) | Active comparator | Receiving injectable cabotegravir/ rilpivirine (LA ART) and not using any hormonal contraceptive method (e.g. copper IUD) Receives: Drug: Cabotegravir/ Rilpivirine |
| Aim 1a (PK study group 5) | Active comparator | AGYW without HIV and not exposed to antiretrovirals (e.g., for PrEP) initiating DMPA Receives: Drug: Intramuscular depo-medroxyprogesterone acetate (IM DMPA) |
| Aim 2a (Hybrid trial intervention group) | Experimental | AGYW with viral suppression on their current ART regimen to switch to cabotegravir/ rilpivirine. Receives: Drug: Cabotegravir/ Rilpivirine |
| Aim 2a (Hybrid trial comparator group) | Active comparator | AGYW with viral suppression to continue their oral ART regimen. Receives: Drug: NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hormone concentrations with cabotegravir/rilpivirine use (Aim 1a)
To assess differences in hormone concentrations with cabotegravir/rilpivirine use, the investigators will first calculate the progestin geometric mean concentrations at 12 or 24 weeks after DMPA or implant initiation, respectively, for each group. These geometric means will be compared to HIV-negative groups recruited in this study (for the DMPA comparator) or from the PARVI study (for the implants comparator), using geometric mean ratios with 90% confidence intervals (a FDA standard) and the Wilcoxon rank sum test.
Measured: 12 or 24 weeks after DMPA or implant initiation, respectively
Number of participants with HIV viral suppression (Aim 2a)
Our primary analysis will compare the proportion of participants with viral suppression (via HIV viral load <40 copies/mL) 48 weeks after study enrollment (primary outcome) in the intervention vs. control arms (primary exposure) using logistic regression, adjusting for age group strata.
Measured: 48 weeks after study enrollment
Secondary outcomes (3)
Adherence to ART (Aim 2a)
For secondary outcome of adherence to ART, the investigators will use multivariate logistic regression to assess associations between study arm and adherence/ medication possession ratio (MPR=[# pills dispensed - # pills returned]/[avg. # doses required per day * # days of use]) ≥95% over the preceding month prior to the VL evaluation.
Measured: 3, 6, and 12 months after method initiation
Persistence to ART (Aim 2a)
For secondary outcome of persistence to ART, the investigators will use multivariate logistic regression to assess associations between study arm persistence/average MPR since study enrollment.
Measured: 3, 6, and 12 months after method initiation
Contraceptive outcome (Aim 2a)
Among participants who are not already using a LA contraceptive method at enrollment and wish to delay pregnancy, the investigators will use Cox proportional hazards models to compare time to LA contraceptive uptake, or incident use, between study arms.
Measured: 3, 6, and 12 months after method initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start26 Nov 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The hybrid trial will be a parallel, randomized design.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Moi Teaching and Referral Hospital, Indiana University, University of Nebraska, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Rena Patel, University of Alabama at Birmingham
- Investigators
- Rena Patel, MD, MPH, MPhil, Principal investigator, University of Alabama at BirminghamEdwin Were, Principal investigator, Moi Teaching and Referral HospitalEdith Apondi, Principal investigator, MTRH Adolescent Rafiki Clinic and Pediatric Program at AMPATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044962
- Sponsor's protocol ID
- STUDY00012640
- Other IDs
- R01AI155052
- Status last verified
- Apr 2026
- First submitted
- 26 Aug 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD that underlies the results reported in a publication will be provided. Data sharing will begin 9 months after article publication and will be available for up to 36 months. Data will be made available to qualified researchers whose proposed research has received IRB approval. The data will be provided through a data repository following the execution of a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives
- ClinicalTrials.gov ID
- NCT05044962
- Acronym / sponsor ID
- STUDY00012640
- Conditions
- HIV Infections, Contraception, Drug-drug Interaction
- Keywords
- Kenya, Adolescent girls and young women, HIV adherence, Long-acting antiretroviral therapy, Injectable cabotegravir, Injectable rilpivirine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Moi Teaching and Referral Hospital, Indiana University, University of Nebraska, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation trial randomizing individual AGYWLHIV to receive long-acting (LA) injectable cabotegravir/rilpivirine vs. standard of care within one of Kenya's largest HIV treatment programs. The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK and qualitative studies will largely be conducted with a sentinel cohort of AGYWLHIV. Learning from this early LA ART use, the investigators will refine the procedures in the LA ART hybrid trial.
Detailed description
Long-acting (LA) antiretroviral therapy (ART), such as injectable cabotegravir and rilpivirine, has been receiving global clinical approvals and has the potential to address barriers to ART and improve patient adherence and persistence to treatment. LA ART regimens can potentially also increase options for patients and providers to individualize treatment plans, provide a powerful treatment option for those experiencing adherence issues related oral treatment options, and may ease the burden of health systems in RLS. Another major threat to AGYW's health is unintended pregnancies and AGYWLHIV also face unique challenges in uptake and continuation of LA contraceptives. Use of LA ART may foster synergy in usage of LA contraceptives among AGYWLHIV.
This proposed research study has three main components: 1) 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 (Aim 1a); 2) a qualitative study that will conduct individual interviews with four different subgroups of AGYWLHIV from the sentinel cohort from the PK study, as well as focus group discussions with providers, policy makers, and other stakeholders for health systems readiness for wider scale-up (Aim 1b); and 3) an open-label, mixed methods, 48-week type I hybrid trial randomizing AGYW with viral suppression on their current ART regimen to switch to 1:1 cabotegravir/ rilpivirine (intervention arm) vs. continue their oral ART regimen (Aim 2a), with a component also evaluating implementation outcomes of acceptability, feasibility, and fidelity (Aim 2b). The proposed study will be conducted in HIV treatment facilities in western Kenya within the regional Moi Teaching and Referral Hospital (MTRH).
This study will provide foundational data for future studies and implementation plans related to addressing barriers and will critically inform follow-up studies of LA ART in other priority subpopulations. Providing an array of method options for both HIV treatment and pregnancy prevention has the potential to revolutionize personal decision-making and improve long-term outcomes for AGYWLHIV. Our real-world experiences of co-delivery will also inform future considerations for co-formulations of antiretrovirals and contraceptives for both HIV treatment and prevention.
Our central hypothesis is the following: 1) at the client level, the use of LA ART or contraceptives will foster long-term thinking for health, forging a convergence of the use of the two when applicable; and 2) at the program/provider level, leveraging existing LA contraceptive delivery platform will make LA ART highly acceptable, feasible, and deliverable with high fidelity.
Our overall objective in this study is to conduct the foundational PK and qualitative studies first as a lead in to the hybrid trial. Guided by Proctor et al.'s implementation outcomes framework, the hybrid trial will also focus on acceptability, feasibility, and fidelity. These implementation outcomes are proximal indicators of implementation processes and intermediate outcomes, which ultimately predict implementation success. Demonstrating successful implementation outcomes will then inform wider-scale implementation of LA ART, when service and client outcomes can be fully realized.
The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK (Aim 1a) and qualitative (Aim 1b) studies will largely be conducted with a sentinel cohort of AGYWLHIV in parallel to each other. Learning from this early LA ART use, the investigators will refine our procedures in the LA ART hybrid trial (Aim 2). For all possible outcomes/scenarios of Aim 1, the investigators still anticipate conducting a robust trial in Aim 2.
Thus, our specific aims are:
Aim 1: To collect foundational data to better inform design of an effectiveness-implementation trial.
Aim 1a: To determine if combined cabotegravir/rilpivirine injectable use has bidirectional drug-drug interactions with injectable (depot medroxyprogesterone acetate [DMPA]) or implantable (etonogestrel or levonorgestrel) contraceptives.
Aim 1b: To qualitatively explore points of convergence and divergence, preferences and values, and health systems readiness around wider-scale co-delivery of LA ART and contraceptives.
Aim 2: To evaluate the impact of clinic-provided, co-delivery of LA ART and contraceptives among AGYWLHIV.
Aim 2a: To evaluate the impact on effectiveness outcomes of HIV treatment (viral suppression and adherence/persistence) and contraception (uptake and continuation rates).
Aim 2b: To evaluate the impact on implementation outcomes of acceptability, feasibility, and fidelity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- The hybrid trial will be a parallel, randomized design.
| Arm | Type | Receives |
|---|---|---|
| Aim 1a (PK study group 1) | Experimental | Drug: Cabotegravir/ Rilpivirine, Drug: Intramuscular depo-medroxyprogesterone acetate (IM DMPA)Initiating injectable cabotegravir/rilpivirine (LA ART) and DMPA |
| Aim 1a (PK study group 2) | Experimental | Drug: Cabotegravir/ Rilpivirine, Drug: Etonogestrel (ETG) implantInitiating injectable cabotegravir/rilpivirine (LA ART) and and etonogestrel implant |
| Aim 1a (PK study group 3) | Experimental | Drug: Cabotegravir/ Rilpivirine, Drug: LevonorgestrelInitiating injectable cabotegravir/rilpivirine (LA ART) and levonorgestrel implant. |
| Aim 1a (PK study group 4) | Active comparator | Drug: Cabotegravir/ RilpivirineReceiving injectable cabotegravir/ rilpivirine (LA ART) and not using any hormonal contraceptive method (e.g. copper IUD) |
| Aim 1a (PK study group 5) | Active comparator | Drug: Intramuscular depo-medroxyprogesterone acetate (IM DMPA)AGYW without HIV and not exposed to antiretrovirals (e.g., for PrEP) initiating DMPA |
| Aim 2a (Hybrid trial intervention group) | Experimental | Drug: Cabotegravir/ RilpivirineAGYW with viral suppression on their current ART regimen to switch to cabotegravir/ rilpivirine. |
| Aim 2a (Hybrid trial comparator group) | Active comparator | Drug: NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimensAGYW with viral suppression to continue their oral ART regimen. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- Female sex,
- HIV-positive (for PK groups #1-4) or HIV-uninfected (for PK group #5 only),
- Age 15-24 years at the time of enrollment,
- Documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 6 months prior to study enrollment,
- Have been on the study oral drug for at least 4 weeks for the PK groups #1-4,
Key exclusion criteria (16 listed)
- Already be on ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir
- Currently pregnant or intends to become pregnant or breastfeeding within the next 12 or 24 weeks for DMPA or implant groups, respectively,
- Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,
- Use or anticipated use of drugs for the duration of the study period known to interact with hormonal implants or the study ART regimen,
- Current or planned concomitant use of other hormonal contraceptives,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabotegravir/ RilpivirineFor initial injection participants will be given CABENUVA 600-mg/900-mg Kit: (single-dose vial of 600 mg/3 mL (200 mg/mL) cabotegravir , single-dose vial of 900 mg/3 mL (300 mg/mL) rilpivirin). For subsequent injections participants will be given CABENUVA 400-mg/600-mg Kit: (single-dose vial of 400 mg/2 mL (200 mg/mL) cabotegravir, single-dose vial of 600 mg/2 mL (300 mg/mL) rilpivirine) CABENUVA® is owned by or licensed to the ViiV Healthcare group of companies, GlaxoSmithKline Research Triangle Park, NC 27709 | Drug | Aim 1a (PK study group 1), Aim 1a (PK study group 2), Aim 1a (PK study group 3), Aim 1a (PK study group 4), Aim 2a (Hybrid trial intervention group) |
| Etonogestrel (ETG) implantContraceptive progestin implants are thin rods inserted under the skin of a woman's arm | Drug | Aim 1a (PK study group 2) |
| Intramuscular depo-medroxyprogesterone acetate (IM DMPA)DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide | Drug | Aim 1a (PK study group 1), Aim 1a (PK study group 5) |
| LevonorgestrelContraceptive estrogen implants are thin rods inserted under the skin of a woman's arm | Drug | Aim 1a (PK study group 3) |
| NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimensART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir | Drug | Aim 2a (Hybrid trial comparator group) |
Primary outcome
Hormone concentrations with cabotegravir/rilpivirine use (Aim 1a)
Time frame: 12 or 24 weeks after DMPA or implant initiation, respectively
To assess differences in hormone concentrations with cabotegravir/rilpivirine use, the investigators will first calculate the progestin geometric mean concentrations at 12 or 24 weeks after DMPA or implant initiation, respectively, for each group. These geometric means will be compared to HIV-negative groups recruited in this study (for the DMPA comparator) or from the PARVI study (for the implants comparator), using geometric mean ratios with 90% confidence intervals (a FDA standard) and the Wilcoxon rank sum test.
Number of participants with HIV viral suppression (Aim 2a)
Time frame: 48 weeks after study enrollment
Our primary analysis will compare the proportion of participants with viral suppression (via HIV viral load <40 copies/mL) 48 weeks after study enrollment (primary outcome) in the intervention vs. control arms (primary exposure) using logistic regression, adjusting for age group strata.
3 secondary outcomes
Adherence to ART (Aim 2a)
Time frame: 3, 6, and 12 months after method initiation
Persistence to ART (Aim 2a)
Time frame: 3, 6, and 12 months after method initiation
Contraceptive outcome (Aim 2a)
Time frame: 3, 6, and 12 months after method initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD that underlies the results reported in a publication will be provided. Data sharing will begin 9 months after article publication and will be available for up to 36 months. Data will be made available to qualified researchers whose proposed research has received IRB approval. The data will be provided through a data repository following the execution of a data-sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rena Patel, MD, MPH, MPhil principal investigator
University of Alabama at Birmingham
Edwin Were principal investigator
Moi Teaching and Referral Hospital
Edith Apondi principal investigator
MTRH Adolescent Rafiki Clinic and Pediatric Program at AMPATH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cabotegravir/ Rilpivirine, Etonogestrel (ETG) implant and Intramuscular depo-medroxyprogesterone acetate (IM DMPA) in people with HIV Infections and Contraception, run by University of Alabama at Birmingham at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rena Patel, MD, MPH (205.934.8145, renapatel@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hormone concentrations with cabotegravir/rilpivirine use (Aim 1a) (time frame: 12 or 24 weeks after DMPA or implant initiation, respectively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.