HIV and AIDS Trial, Recruiting NCT05044962 Sponsor: University of Alabama at Birmingham Condition: HIV and AIDS
Back to Hiv Aids

HIV and AIDS Trial, Recruiting

NCT05044962
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are female
  • You are between 15 and 24 years old at the time of joining the study
  • You are living with HIV and your HIV viral load (the amount of virus in your blood) has been undetectable (fewer than 40 copies/mL) within the last 6 months — or, for one specific part of the study, you do not have HIV
  • You are willing to have blood drawn every 4 to 12 weeks throughout the study
  • You are able to give your agreement to participate in English or Kiswahili (younger participants may need a parent or guardian to also give consent)
  • For the medication drug-level (PK) part of the study: you have been taking the study HIV medication for at least 4 weeks, and you have started or plan to use a specific hormonal contraceptive (an injection called DMPA or a contraceptive implant) for at least the required time period
  • For the interview/qualitative parts of the study: healthcare providers, program staff, policymakers, or other relevant professionals aged 18 or older who can consent in English or Kiswahili may also be eligible to participate

Who may not be able to join:

  • You are currently taking a combination of HIV medications that includes certain specific drug types together — such as a non-nucleoside reverse transcriptase inhibitor (e.g., efavirenz) combined with a protease inhibitor (e.g., atazanavir/ritonavir or lopinavir/ritonavir) or an integrase inhibitor (e.g., raltegravir or dolutegravir) (confirm with trial site)
  • You are currently pregnant, plan to become pregnant, or are breastfeeding within the coming weeks or year (the exact timeframe depends on which part of the study you are joining)
  • You have had unprotected sex in the last two weeks, or a urine pregnancy test shows you may currently be pregnant
  • You are taking or plan to take any medications during the study that are known to interfere with the study HIV drugs or, in some parts of the study, with hormonal contraceptives
  • For the contraceptive (PK) part of the study: you are currently using or plan to use any other form of hormonal contraception at the same time
  • For the contraceptive (PK) part of the study: your body mass index (BMI) is 30 or above (a medical measure of body weight relative to height)
  • You have an active Hepatitis B virus (HBV) infection based on specific blood test results (confirm with trial site for details on exactly which test results would affect your eligibility, as some people with past Hepatitis B exposure may still be eligible)
  • Your liver enzyme levels (ALT) are more than 5 times the normal upper limit at the time of your screening blood test, which may suggest a liver problem
  • Your kidney function marker (creatinine) in your blood is more than 2.5 times the normal upper limit at the time of your screening blood test, which may suggest a kidney problem

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
26 November 2021
Est. completion
31 March 2027

Where this trial is recruiting

Kenya

Primary endpoints

Hormone concentrations with cabotegravir/rilpivirine use (Aim 1a); Number of participants with HIV viral suppression (Aim 2a)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov