PrEP AdherencePhase 3STEP-UPNCT06919614
STI Testing to Enhance PrEP Use in Pregnancy
A Phase 3 study testing Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing in people with PrEP Adherence and Sexually Transmitted Infections (STIs), run by Botswana Harvard AIDS Institute Partnership at 1 site in Botswana.
Trial summary
The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- PrEP Adherence, Sexually Transmitted Infections (STIs), Pregnancy
- What is being tested?
- Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBotswana
- Study dates
- 18 Jun 2025to 31 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant and seeking antenatal care
- Self-identifying as a cis-gender woman
- Living without HIV
- Not currently using PrEP
- Planning to remain in the city/town of enrolment until 9 months post-delivery.
- Planning to receive antenatal and postnatal care in the city/town of enrolment.
- Willing and able to provide informed consent
Who cannot join
- Male gender
- Not pregnant
- Living with HIV
- Currently using PrEP
- Not planning to remain in the city/town of enrolment until 9 months post-delivery
- Not planning to receive antenatal and postnatal care in the city/town to enrolment
- Not able or willing to provide informed consent for participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Botswana1 site, 1 recruiting
- Recruiting
DHMT Clinics
Gaborone
District Health Management Team, Greater Gaborone, +2673905792, researchreview.ggdhmt@gmail.com
About this study
Official title: Improving PrEP Outcomes Among Pregnant Women in Botswana With an Integrated STI Testing and PrEP Delivery Model
The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy. Pregnant women (n=600) seeking antenatal care in Botswana will be enrolled and randomly assigned to receive the standard of care (standard STI assessment with no STI testing) versus STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis during pregnancy and postpartum. The investigators' hypothesis is that providing STI testing alongside PrEP offer will encourage more women to start and continue using PrEP.
Read the detailed description
The investigators are conducting a 2-arm 1:1 randomized trial to compare PrEP delivery with co-offer of STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis (using Xpert CT/NG and TV assays) vs. standard-of-care (SOC, syndromic management) among pregnant women without HIV (n=600) in Botswana. Antenatal care clients will be offered PrEP (self-select oral pills or DPV-VR).
Participants will be followed up to 9 months postpartum. Women will be able to switch PrEP methods and start, stop, or restart PrEP at any time.
Primary outcomes are the proportion of clients who initiate PrEP, persist with use at 9 months postpartum, and adhere (quantified by hair drug levels). Secondary outcomes are PrEP choice (pills vs. DPV-VR), STI rates, and birth outcomes by randomization arm. Exploratory outcomes are HIV incidence, quality of care, adherence cofactors, and antimicrobial resistance.
- Being tested
- Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
- Keywords
- Pregancy, PrEP, HIV, STIs, Chlamydia, Gonorrhoea, Gonorrhea, Trichomonas, Dapivirine, Truvada, Oral PrEP
- Medical subject headings
- Sexually Transmitted Diseases, Chlamydia Infections, Gonorrhea, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testingDiagnostic test
Xpert® CT/NG and TV testing
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants randomized to the intervention arm will be offered Xpert® CT/NG and TV testing and treatment (in addition to syndromic STI assessment) at three time points (enrolment, at the 32 weeks' gestation visit and 9-month post-delivery visit) or two time points for participants enrolled in their third trimester. If a client accepts Xpert® testing, they will be instructed by the study clinician/research assistant on how to self-collect a vaginal swab. Receives: Diagnostic Test: Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing |
| Standard-of-care arm | No intervention | Participants in the standard-of-care arm will receive syndromic STI assessment per Botswana national guidelines. They will be offered Xpert® CT/NG and TV testing at the 9-month post-delivery visit only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP initiation among pregnant women seeking antenatal care
PrEP initiation among pregnant women seeking antenatal care defined as accepting either daily oral PrEP pills or the DPV-VR when offered at enrolment and evidence of self-reported use at 1-month.
Measured: Enrolment to 1 month post enrolment
PrEP persistence
Evidence of PrEP persistence at 9 months postpartum among women who initiated PrEP.
Measured: Enrolment to 9 months postpartum
PrEP adherence
PrEP adherence defined as either TFV or DPV hair levels (depending on PrEP method) at 9 months postpartum.
Measured: Enrolment to 9 months postpartum
Secondary outcomes (2)
PrEP Choice
Secondary outcomes are PrEP choice (pills vs. DPV-VR)
Measured: Enrolment to 9 months postpartum
STI rates
Prevalence of chlamydia, gonorrhoea and trichomonas at enrolment, third trimester and 9 months postpartum
Measured: Enrolment to 9 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start18 Jun 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEP AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Botswana Harvard AIDS Institute Partnership
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of Botswana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919614
- Sponsor's protocol ID
- BHP180
- Acronym
- STEP-UP
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving PrEP Outcomes Among Pregnant Women in Botswana With an Integrated STI Testing and PrEP Delivery Model
- ClinicalTrials.gov ID
- NCT06919614
- Acronym / sponsor ID
- STEP-UP / BHP180
- Keywords
- Pregancy, PrEP, HIV, STIs, Chlamydia, Gonorrhoea, Gonorrhea, Trichomonas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Botswana Harvard AIDS Institute PartnershipUniversity, hospital or other
- Collaborators
- University of Washington, University of Botswana
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are conducting a study in Botswana to see if offering STI testing along with expanded HIV prevention options (PrEP) helps more pregnant women start and continue using PrEP during and after pregnancy. Pregnant women (n=600) seeking antenatal care in Botswana will be enrolled and randomly assigned to receive the standard of care (standard STI assessment with no STI testing) versus STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis during pregnancy and postpartum. The investigators' hypothesis is that providing STI testing alongside PrEP offer will encourage more women to start and continue using PrEP.
Detailed description
The investigators are conducting a 2-arm 1:1 randomized trial to compare PrEP delivery with co-offer of STI testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis (using Xpert CT/NG and TV assays) vs. standard-of-care (SOC, syndromic management) among pregnant women without HIV (n=600) in Botswana. Antenatal care clients will be offered PrEP (self-select oral pills or DPV-VR).
Participants will be followed up to 9 months postpartum. Women will be able to switch PrEP methods and start, stop, or restart PrEP at any time.
Primary outcomes are the proportion of clients who initiate PrEP, persist with use at 9 months postpartum, and adhere (quantified by hair drug levels). Secondary outcomes are PrEP choice (pills vs. DPV-VR), STI rates, and birth outcomes by randomization arm. Exploratory outcomes are HIV incidence, quality of care, adherence cofactors, and antimicrobial resistance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Diagnostic Test: Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testingParticipants randomized to the intervention arm will be offered Xpert® CT/NG and TV testing and treatment (in addition to syndromic STI assessment) at three time points (enrolment, at the 32 weeks' gestation visit and 9-month post-delivery visit) or two time points for participants enrolled in their third trimester. If a client accepts Xpert® testing, they will be instructed by the study clinician/research assistant on how to self-collect a vaginal swab. |
| Standard-of-care arm | No intervention | –Participants in the standard-of-care arm will receive syndromic STI assessment per Botswana national guidelines. They will be offered Xpert® CT/NG and TV testing at the 9-month post-delivery visit only. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant and seeking antenatal care
- Self-identifying as a cis-gender woman
- Living without HIV
- Not currently using PrEP
- Planning to remain in the city/town of enrolment until 9 months post-delivery.
Key exclusion criteria (7 listed)
- Male gender
- Not pregnant
- Living with HIV
- Currently using PrEP
- Not planning to remain in the city/town of enrolment until 9 months post-delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testingXpert® CT/NG and TV testing | Diagnostic test | Intervention arm |
Primary outcome
PrEP initiation among pregnant women seeking antenatal care
Time frame: Enrolment to 1 month post enrolment
PrEP initiation among pregnant women seeking antenatal care defined as accepting either daily oral PrEP pills or the DPV-VR when offered at enrolment and evidence of self-reported use at 1-month.
PrEP persistence
Time frame: Enrolment to 9 months postpartum
Evidence of PrEP persistence at 9 months postpartum among women who initiated PrEP.
PrEP adherence
Time frame: Enrolment to 9 months postpartum
PrEP adherence defined as either TFV or DPV hair levels (depending on PrEP method) at 9 months postpartum.
2 secondary outcomes
PrEP Choice
Time frame: Enrolment to 9 months postpartum
STI rates
Time frame: Enrolment to 9 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing in people with PrEP Adherence and Sexually Transmitted Infections (STIs), run by Botswana Harvard AIDS Institute Partnership at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chelsea Morroni, MBChB, DFSRH, MPH, PhD (+267 316 6657, chelseaamorroni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP initiation among pregnant women seeking antenatal care (time frame: Enrolment to 1 month post enrolment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.