HIV Infections Clinical Trial
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.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 24 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Academic Model Providing Access to Healthcare (AMPATH) Moi Teaching And Referral Hospital (MTRH) | Eldoret |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Indiana University, Moi Teaching and Referral Hospital, National Institute of Allergy and Infectious Diseases (NIAID), University of Nebraska |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 or 24 weeks after DMPA or implant initiation, respectively | |
Primary | 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. | 48 weeks after study enrollment | |
Secondary | 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. | 3, 6, and 12 months after method initiation | |
Secondary | 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. | 3, 6, and 12 months after method initiation | |
Secondary | 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. | 3, 6, and 12 months after method initiation |
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