New study checks if HIV prevention shots and contraceptives clash
NCT ID NCT07516548
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This study looks at how a long-acting injectable HIV prevention drug (CAB-LA) and hormonal birth control methods (like the shot or implant) affect each other in women. About 105 women who already use CAB-LA or no HIV prevention will join groups based on their contraceptive choice. Researchers will measure drug and hormone levels in blood over 12 to 24 weeks to check for interactions, side effects, and satisfaction.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult females aged 18 years or older who are HIV-seronegative
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Princess Marina Hospital
Bontleng, Gaborone, Botswana
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Other studies related to the condition(s) this trial covers.
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