STI Testing to Enhance PrEP Use in Pregnancy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorBotswana Harvard AIDS Institute Partnership
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant and seeking antenatal care
Self-identifying as a cis-gender woman
Living without HIV
Not currently using PrEP
Disqualifiers
Male gender
Not pregnant
Living with HIV
Currently using PrEP
Trial design
Design model
Parallel
Treatments tested in this trial
Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
Diagnostic testXpert® CT/NG and TV testing
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Intervention armExperimental treatment 1 intervention
Group B: Standard-of-care armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 enrolment2
PrEP persistence
Evidence of PrEP persistence at 9 months postpartum among women who initiated PrEP.
Time frame
Enrolment to 9 months postpartum3
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 postpartumSecondary outcomes
1
PrEP Choice
Secondary outcomes are PrEP choice (pills vs. DPV-VR)
Time frame
Enrolment to 9 months postpartum2
STI rates
Prevalence of chlamydia, gonorrhoea and trichomonas at enrolment, third trimester and 9 months postpartum
Time frame
Enrolment to 9 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Botswana Harvard AIDS Institute Partnership
Lead sponsor
University of Washington
Collaborator
University of Botswana
Collaborator
Source ClinicalTrials.gov