An observational study in HIV Infections, Contraception and Drug-drug Interaction, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in Botswana. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University of Alabama at Birmingham · Observational
This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.
Long-acting (LA) HIV pre-exposure prophylaxis (PrEP), such as injectable cabotegravir (CAB-LA), is increasingly available and has the potential to address barriers to adherence seen with daily oral PrEP. LA PrEP regimens can expand options for women and providers to individualize prevention strategies, provide a powerful prevention tool for those facing adherence challenges with oral regimens, and reduce the burden on health systems in resource-limited settings. Another major threat to women's health is unintended pregnancies, and women at risk for HIV face unique challenges in uptake and continuation of long-acting contraceptives. Use of CAB-LA may create synergy with long-acting contraceptives, fostering more consistent uptake and improved health outcomes.
This proposed research study is a prospective, non-randomized, parallel-group pharmacokinetic (PK) study among a sentinel cohort of five distinct groups of AGYW, and will leverage existing control groups. The study will be conducted in Botswana.
This study will generate critical data to guide future implementation studies integrating CAB-LA PrEP and contraceptive services. Providing an array of prevention and reproductive health options has the potential to empower women to make informed decisions, improve adherence and continuation, and inform real-world considerations for co-delivery or future co-formulations of PrEP and contraceptives.
Our central hypotheses are the following:
Primary Objectives:
Exploratory Objectives
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 105 is below the median of 200 across 781 observational studies indexed under HIV Infections.
Browse HIV Infections studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult females aged 18 years or older who are HIV-seronegative
Parent Tshireletso Study Inclusion Criteria:
Parent Tshireletso Study Exclusion Criteria
Parent Doris Duke Study Inclusion Criteria Post-partum females included;
Parent Doris Duke Study Exclusion Criteria Post-partum females excluded if
Additional Inclusion 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) ≥35 4) Has any of the following laboratory abnormalities within the last year:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Injectable cabotegravir 600mg + intramuscular depo-medroxyprogesterone acetate 150mg (IM DMPA)
Drug: Long-acting injectable cabotegravir (CAB-LA)
Injectable cabotegravir 600mg + etonogestrel (ETG) implant 68mg
Drug: Long-acting injectable cabotegravir (CAB-LA)
Injectable cabotegravir 600mg + no hormonal method
Drug: Long-acting injectable cabotegravir (CAB-LA)
No PrEP + intramuscular depot medroxyprogesterone acetate (IM DMPA) 150mg
Other: No PrEP
No PrEP + etonogestrel (ETG) implant 68mg
Other: No PrEP
Injectable cabotegravir 600 mg administered as long-acting HIV pre-exposure prophylaxis (PrEP).
No HIV pre-exposure prophylaxis administered
To evaluate any associations between CAB-LA exposure and hormonal contraceptive use in the three groups of IM DMPA, ETG implant, and non-hormonal method users by generating geometric mean hormone concentrations (Aim 1a)
Mean hormone concentrations starting at 0 week (when feasible), 4 weeks, 8 weeks, 12 weeks, and 24 weeks, as applicable to the three contraceptive groups, after contraceptive method initiation and at least after receiving 3rd dose of CAB-LA if in the CAB-LA groups.
Time frame: 0, 4, 8, 12 weeks for IM DMPA; 0, 4, 8, 12, 24 weeks for ETG implant and non-hormonal method users
To evaluate any associations between hormonal contraceptive exposure and CAB-LA use by generating geometric mean trough CAB-LA concentrations measured immediately prior to dosing of next CAB-LA (Aim 1b)
Mean trough CAB-LA concentrations prior to next dosing of CAB-LA
Time frame: Immediately prior to each scheduled CAB-LA injection
Incidence of adverse events associated with CAB-LA and hormonal contraceptive methods (Aim 2a1)
Number and proportion of participants experiencing adverse events, graded using the Division of AIDS (DAIDS) Adverse Event Grading Table.
Time frame: 12 and 24 weeks after contraceptive method initiation
Participant satisfaction with CAB-LA and hormonal contraceptive method measured by questionnaire (Aim 2a2)
Participant-reported satisfaction scores assessed using a questionnaire.
Time frame: 12 and 24 weeks after contraceptive method initiation
Continuation rates of CAB-LA and hormonal contraceptive method (Aim 2a3)
Proportion of participants continuing use of CAB-LA and the contraceptive method at each time point.
Time frame: 12 and 24 weeks after contraceptive method initiation
Participants' experiences and decision-making regarding CAB-LA and contraceptive method options assessed by semi-structured interviews (Aim 2b)
Qualitative assessment of participants' experiences, preferences, and decision-making processes regarding CAB-LA and contraceptive method use or switching, collected through semi-structured interviews conducted by trained study staff and audio-recorded, transcribed, and analyzed using thematic analysis.
Time frame: At the end of study participation or up to 12 months after study participation
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
Of 187 non-industry observational studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 23 months is below that.
Counting every sponsor, half of 201 studies reached it within 38 months; a quarter within 16 and three quarters within 69.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Jan 2025, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Alabama at Birmingham →