Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women (NCT05322629) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
South Africa650 participantsStarted 2022-09-07
Plain-language summary
To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily antiretroviral pill that is both safe and effective for preventing HIV in pregnant and breastfeeding mothers and 2)) enhanced adherence counseling combined with differentiated deliver of community PrEP delivery for women who have difficulties with regular PrEP use.
Our study will be among the first ever to evaluate the efficacy and cost-effectiveness of a PrEP intervention among pregnant and postpartum women and will play a key role in informing maternal PrEP interventions to eliminate HIV acquisition and transmission to partners and their infants.
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 16 years
. Plans to deliver at the study facility
. Documented HIV-negative according to two finger prick rapid tests (per national protocol for routine antenatal care) and confirmed with a 4th generation antigen HIV test
. Lives within 20 kilometers of the study facility
. Without psychiatric or medical contraindications to PrEP use
. \>20 weeks pregnant
. Able and willing to consent to study participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherence to PrEP at 6 months after PrEP initiation
Timeframe: 6 months following study enrollment
2
Adherence to PrEP at 15 months after PrEP initiation