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| Name | Class |
|---|---|
| University of Washington | OTHER |
| University of Botswana | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing | Diagnostic Test | Xpert® CT/NG and TV testing |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Enrolment to 1 month post enrolment |
| PrEP persistence | Evidence of PrEP persistence at 9 months postpartum among women who initiated PrEP. | 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. | Enrolment to 9 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Choice | Secondary outcomes are PrEP choice (pills vs. DPV-VR) | Enrolment to 9 months postpartum |
| STI rates | Prevalence of chlamydia, gonorrhoea and trichomonas at enrolment, third trimester and 9 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Morroni, MBChB, DFSRH, MPH, PhD | Contact | â€+267 316 6657‬ | chelseaamorroni@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DHMT Clinics | Recruiting | Gaborone | Botswana |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D002690 | Chlamydia Infections |
| D006069 | Gonorrhea |
| D014245 | Trichomonas Infections |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Enrolment to 9 months postpartum |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D016870 | Neisseriaceae Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |