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Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women

Active Not RecruitingNA

Sponsor: University of California, Los Angeles

Conditions: Hiv

Interventions: PrEP adherence biofeedback, Standard of care counseling

Countries: South Africa

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.

Eligibility overview

Sex: FEMALE

Age: 16 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 16 years
2. Plans to deliver at the study facility
3. 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
4. Lives within 20 kilometers of the study facility
5. Without psychiatric or medical contraindications to PrEP use
6. \>20 weeks pregnant
7. Able and willing to consent to study participation.

Exclusion Criteria:

Individuals not meeting the above criteria will be excluded.

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Locations (1)

Cape Town, South Africa, South Africa