Long-acting injectable treatment for HIV in young women
Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 15 Years to 24 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Eldoret, Kenya) |
| Trial ID | NCT05044962 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are not HIV-positive or those who are already on incompatible ART regimens may not benefit from this study.
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 performed: Other studies have shown promise with long-acting antiretroviral therapies, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Eldoret, Kenya
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.