Pregnancy, PrEP Adherence, Sexually Transmitted Infections (STIs)
Conditions
Keywords
Pregancy, PrEP, HIV, STIs, Chlamydia, Gonorrhoea, Gonorrhea, Trichomonas, Dapivirine, Truvada, Oral PrEP
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTChlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis testing
Xpert® CT/NG and TV testing
Sponsors
Botswana Harvard AIDS Institute Partnership
University of Washington
University of Botswana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP initiation among pregnant women seeking antenatal care | 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 | Enrolment to 9 months postpartum | Evidence of PrEP persistence at 9 months postpartum among women who initiated PrEP. |
| PrEP adherence | Enrolment to 9 months postpartum | PrEP adherence defined as either TFV or DPV hair levels (depending on PrEP method) at 9 months postpartum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Choice | Enrolment to 9 months postpartum | Secondary outcomes are PrEP choice (pills vs. DPV-VR) |
| STI rates | Enrolment to 9 months postpartum | Prevalence of chlamydia, gonorrhoea and trichomonas at enrolment, third trimester and 9 months postpartum |
Countries
Botswana
Contacts
CONTACTChelsea Morroni, MBChB, DFSRH, MPH, PhD
Outcome results
None listed