Long-acting HIV PrEP and contraception PK study in AGYW

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized PK study conducted in Botswana among five groups of adolescent girls and young women. Participants who are using or not using CAB-LA PrEP will be grouped by their hormonal contraception method or absence of contraception, with visits every 4–12 weeks for up to 24 weeks to measure drug and hormone levels and monitor safety and satisfaction. The goal is to see if CAB-LA affects hormone concentrations or if hormones affect CAB-LA levels, providing data to guide co-delivery of PrEP and contraception. The study builds on existing control groups and focuses on real-world implementation in a resource-limited setting.

Why it matters

Who can join: the full rules

Parent Tshireletso Study Inclusion Criteria:

1. Female 18 years of age or older and willing and able to provide an informed consent
2. \< 14 days after delivery (calendar day of birth = day 0)
3. Negative HIV screening test (conducted at the time of enrolment)
4. Female \<30 years old or has had \< 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)
5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months

Parent Tshireletso Study Exclusion Criteria

1. Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\>1 dose oral/IV), or St. John's wort
2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)
3. Previous hypersensitivity reaction to CAB or other INSTI
4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months
5. Plan for pediatric and post-partum care outside the government system (private clinics)
6. Inflammatory skin condition that compromises the safety of the intramuscular injection
7. Weight \<35kg

Parent Doris Duke Study Inclusion Criteria Post-partum females included;

1. if HIV-uninfected or unknown HIV status, willing to be tested for HIV
2. if HIV-infected, documented to be on DTG as part of an antiretroviral treatment regimen
3. maternal age \>18 years,
4. ability to speak English or Setswana
5. intend to be available for follow up in Molepolole, Gaborone or Mochudi for 18 months post-delivery
6. have access to a cell phone (including phone of friend or relative)

Parent Doris Duke Study Exclusion Criteria Post-partum females excluded if

1. did not attend antenatal care or were not included in Tsepamo surveillance
2. maternal age \<18,
3. females who do not speak English or Setswana,
4. unable or unwilling to give consent
5. will not be able to attend follow up at a study site
6. do not have access to any cell phone for follow up calls

Additional Inclusion Criteria for this PK Study

1. For DMPA and ETG implant groups, intends to initiate or continue use of DMPA or ETG implant for at least another three or six months, respectively,
2. For the CAB-LA groups, have received at least three consecutive CAB injections on time, including the one administered concurrently while starting a contraceptive method,
3. Willing to undergo phlebotomy every 4 weeks for the duration of the sub-study period Additional Exclusion Criteria for this PK Study

1\) Use or anticipated use of nicotine-containing products (e.g., cigarettes or hookahs) known to interact with CAB-LA for the duration of the sub-study period 2) Use within the previous 90 days, current use, or planned future concomitant use of other hormonal contraceptives, including oral contraceptive methods 3) BMI≥35 4) Has any of the following laboratory abnormalities within the last year:

1. Serum ALT\>5x ULN at the time of screening,
2. Serum creatinine \>2.5x ULN at the time of screening. 5) Has any other condition that, in the opinion of the sub-study PI/designee, would preclude informed consent, make study participation unsafe, or complicate interpretation of study outcome 6) HIV infected females on the Doris Duke parent study

Where it's running

• Princess Marina Hospital
  Bontleng, Gaborone, Botswana 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

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.