Clinical trial NCT05322629: Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
Official title: Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women (SCOPE-PP) in South Africa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Keywords: pregnant
postpartum
prevention of mother to child transmission
PrEP
pre-exposure prophylaxis
HIV prevention
breastfeeding
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Cape Town
First posted: 2022-04-12
Enrollment: 650
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In a randomized control trial of 750 women, the study team will evaluate: (1) PrEP continuation (missing \<1 PrEP collections) and (2) PrEP adherence per drug levels of TFV-DP at 6m follow up.

Pregnant women who are on PrEP or initiate PrEP at baseline visit will be recruited and screened for eligibility during their routine antenatal services at gestational \>25 weeks using a set script for screening and a brief description of the study. Study staff will obtain written informed consent immediately following screening.
Primary purpose: PREVENTION

Brief 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.

Detailed description: HIV incidence doubles during pregnancy and postpartum period compared with non-pregnant women, underscoring the urgent need for prevention interventions tailored to high-risk pregnant and breastfeeding women. Incident maternal HIV infections lead to an estimated one-third of all infant HIV infections. South Africa expects over 90,000 infant HIV cases in the next decade; one-third of those can be prevented by eliminating maternal HIV acquisition. Pre-exposure prophylaxis (PrEP) in pregnancy and breastfeeding is safe and effective at preventing HIV. However, PrEP use remains low in pregnancy, and drop precipitously in the postpartum period.

Researchers will test a novel strategy to optimize PrEP in pregnant and postpartum women in South Africa. Our randomized control trial (RCT) is designed to address key barriers to maternal PrEP use and evaluate cost-effectiveness to inform national policy. This trial builds on our earlier work demonstrating the acceptability, feasibility, safety and potential efficacy of a package of interventions including PrEP, enhanced adherence counseling combined with community, differentiated delivery of PrEP for women who want to take PrEP but have difficulties with adherence.

Our team developed and piloted a novel intervention entitled, Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP) that addresses barriers to taking daily PrEP by reducing clinic visit frequency and empowering women to adhere to PrEP. Our team will evaluate SCOPE-PP in a pragmatic RCT of pregnant and postpartum women at risk of HIV acquisition. The study will enroll 750 pregnant women in antenatal care and follow them through 12-months' postpartum. Women in the intervention will be offered rapid PrEP collection with enhanced adherence counseling. Women with poor PrEP continuation and/or adherence who want to continue on PrEP will be offered a differentiated care model of PrEP delivery to de-link PrEP from clinical visits. The primary outcome is PrEP continuation and adherence in postpartum women, measured through drug levels of tenofovir diphosphate. The study aims to: 1) Evaluate the efficacy of the SCOPE-PP intervention on PrEP adherence in pregnant and postpartum women in a RCT; 2) Assess the acceptability and feasibility of integrating SCOPE-PP into ante- and postnatal care using a consolidated framework for implementation research (CFIR); and 3) Estimate the incremental cost effectiveness of SCOPE-PP vs. standard of care per HIV infection and disability-adjusted life-year averted. This research is critical to inform maternal PrEP interventions to eliminate HIV acquisition and transmission.

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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Primary outcomes:
measure: Adherence to PrEP at 6 months after PrEP initiation
timeFrame: 6 months following study enrollment
measure: Adherence to PrEP at 15 months after PrEP initiation
timeFrame: 15 months following study enrollment
Secondary outcomes:
measure: HIV incidence (maternal and infant)
timeFrame: Any time during study follow up (through 15 months after enrollment)
measure: Adverse events
timeFrame: Any time during study follow up (through 15 months after enrollment)
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Gugulethu Midwife Obstetric Unit
Study officials:
References:
citation: Joseph Davey DL, Dovel K, Cleary S, Khadka N, Mashele N, Silliman M, Mvududu R, Nyemba DC, Coates TJ, Myer L. Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial. BMC Public Health. 2022 Jul 7;22(1):1306. doi: 10.1186/s12889-022-13652-5.