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Official title Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
ClinicalTrials.gov ID: NCT05624931
What this study is testing
- What it's testing
- Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- For participants across all three aims are:
- Female sex
- Aged 15+
- Pregnant and presenting antenatal care at the Gugulethu MOU
- HIV-negative
You likely can't join if
- There are no exclusion criteria with respect to parity or gravidity.
- Participants who are unable to provide informed consent or assent in English or Xhosa
- Have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will...
- Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.
See the full eligibility criteria
- For participants across all three aims are:
- Female sex
- Aged 15+
- Pregnant and presenting antenatal care at the Gugulethu MOU
- HIV-negative
- Recent PrEP initiation (\ 2 weeks late to pick up PrEP refill) or self-reported
- Moderate to severe symptoms of posttraumatic stress and/or depression (defined as a score of ≥31 on PTSD Checklist for DSM-5 (PCL-5) and/or a score of ≥13 on the Edinburgh Postnatal Depression Scale (EPDS). Cutoff...
- There are no exclusion criteria with respect to parity or gravidity.
- Participants who are unable to provide informed consent or assent in English or Xhosa
- Have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Positive symptoms of active psychosis or mania will be...
- Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Cape Town, Western Cape, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 15 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Cape Town, Western Cape, South Africa. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.