Long-acting injectable treatment for HIV in young women
Official title: Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives
Run by University of Alabama at Birmingham · NCT05044962 · Data updated 2026-11-12
This study is testing a long-acting injectable treatment for HIV in young women to see if it works better than standard pills and helps improve their health and prevent unintended pregnancies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years to 24 Years |
| Sex | Women only |
| Enrollment | 700 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Eldoret, Kenya) |
| Status | Recruiting |
| Started | November 26, 2021 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT05044962 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are HIV-positive adolescent girls and young women aged 15-24 who are virally suppressed and willing to participate in the study.
✕Probably not a fit
Patients who are not HIV-positive or those who are already on incompatible ART regimens may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of long-acting injectable cabotegravir/rilpivirine compared to standard oral antiretroviral therapy in adolescent girls and young women living with HIV in Kenya. It includes foundational pharmacokinetic and qualitative studies to understand the implications of co-delivery of long-acting antiretroviral therapy and contraceptives. Participants will be randomized to receive either the injectable treatment or continue with their current oral regimen, with the aim of improving adherence and reducing unintended pregnancies. The study also seeks to gather insights from healthcare providers and stakeholders to enhance health system readiness for broader implementation.
Why it matters
Potential benefit: If successful, this study could significantly improve treatment adherence and reproductive health outcomes for young women living with HIV.
How similar studies have gone: Other studies have shown promise with long-acting antiretroviral therapies, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria (PK study): * 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, * 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 Exclusion Criteria (PK study): * 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), * 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. Inclusion Criteria Aim 1b (qualitative PK study): * 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 Inclusion Criteria (Hybrid trial): * 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 Exclusion Criteria (Hybrid trial): * 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. Inclusion Criteria Aim 2b (qualitative study): * 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
Where it's running
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Academic Model Providing Access to Healthcare (AMPATH) Moi Teaching And Referral Hospital (MTRH)
Eldoret, Kenya, Kenya Recruiting
Study contacts
- Principal investigator: Rena Patel, MD, MPH, MPhil — University of Alabama at Birmingham
- Study coordinator: Rena Patel, MD, MPH
- Email: renapatel@uabmc.edu
- Phone: 205.934.8145
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.