A Phase 3 interventional study of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing in PrEP Adherence, Sexually Transmitted Infections (STIs) and Pregnancy, sponsored by Botswana Harvard AIDS Institute Partnership. Recruiting at 1 site in Botswana. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Botswana Harvard AIDS Institute Partnership · Phase 3, Interventional, and Prevention
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.
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.
523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.
This study's planned enrollment of 600 is above the median of 449 across 425 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →Botswana Harvard AIDS Institute Partnership is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
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.
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.
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.
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.
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.
Diagnostic Test: Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
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.
Xpert® CT/NG and TV testing
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.
Time frame: Enrolment to 1 month post enrolment
PrEP persistence
Evidence of PrEP persistence at 9 months postpartum among women who initiated PrEP.
Time frame: 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.
Time frame: Enrolment to 9 months postpartum
PrEP Choice
Secondary outcomes are PrEP choice (pills vs. DPV-VR)
Time frame: Enrolment to 9 months postpartum
STI rates
Prevalence of chlamydia, gonorrhoea and trichomonas at enrolment, third trimester and 9 months postpartum
Time frame: Enrolment to 9 months postpartum
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Aug 2027, 26 months after the start.
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Sexually Transmitted Diseases →
Botswana Harvard AIDS Institute Partnership