NCT03826199: PrEP-PP

Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)

Completed Phase 4 Results posted Last updated 1 December 2023

What this trial tests

Phase 4 trial testing TDF-FTC in Hiv in 200 participants. Completed in 30 September 2023.

Timeline

23 August 2019

Primary endpoint
1 December 2021

30 September 2023

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	200
Start date	23 August 2019
Primary completion	1 December 2021
Estimated completion	30 September 2023
Sites	1 location across South Africa

Drugs / interventions tested

• TDF-FTC — full drug profile →
• Counselling on PrEP in antenatal and postnatal care

Conditions studied

• Hiv — all drugs for Hiv →

Sponsor

University of California, Los Angeles

Who can join

16 and older, female only, with Hiv. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PrEP Retention Primary · 18 months

number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP

Group	Value	95% CI
Pregnant Women Offered PrEP	100

PrEP Adherence Primary · 3 months

number of women taking PrEP who have \>80 percent levels at \>40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)

Group	Value	95% CI
Pregnant Women Offered PrEP	25

PrEP Initiation Secondary · 18 months

number of women who initiate PrEP over time/ total number of women in active cohort

Group	Value	95% CI
Pregnant Women Offered PrEP	180

PrEP Adherence (Peri-sexual) Secondary · 3 months

number of women taking PrEP who have \>80 percent levels at \>40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time when women report condomless sex in past week= PrEP adherence rate (peri-sexual)

Group	Value	95% CI
Pregnant Women Offered PrEP	25

PrEP Adherence (Subjective, Self-reported) Secondary · 3 months

number of women taking PrEP, who self-report taking their medication daily (and pill count to confirm this) during periods of sexual risk over time / total woman time on PrEP in active cohort = PrEP adherence rate (subjective)

Group	Value	95% CI
Pregnant Women Offered PrEP	118

Adverse events — posted to ClinicalTrials.gov

Time frame: We collected data every study visit (quarterly) until 12 months postpartum (up to 18 months from baseline enrollment in study). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pregnant Women Offered PrEP

Serious: 10/200 (5%)

Deaths: 0/200

Serious adverse events (3 terms)

Reaction	System	Pregnant Women Offered PrEP
Miscarriage	Pregnancy, puerperium and perinatal conditions	—
Infant low birthweight or preterm	Pregnancy, puerperium and perinatal conditions	—
Stillbirth	Pregnancy, puerperium and perinatal conditions	—

Most-reported serious reactions: Miscarriage, Infant low birthweight or preterm, Stillbirth.

Data from ClinicalTrials.gov NCT03826199 adverse events section.

Sponsor's own description

The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1) Evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate attrition and associated factors across the PrEP cascade.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa.
   Joseph Davey DL, Mvududu R, Mashele N, Lesosky M, et al · · 2022 · cited 65× · PMID 35138678 · DOI 10.1002/jia2.25866
2. Defining gaps in pre-exposure prophylaxis delivery for pregnant and post-partum women in high-burden settings using an implementation science framework.
   Pintye J, Davey DLJ, Wagner AD, John-Stewart G, et al · · 2020 · cited 64× · PMID 32763221 · DOI 10.1016/s2352-3018(20)30102-8
3. Evaluating the use of oral pre-exposure prophylaxis among pregnant and postpartum adolescent girls and young women in Cape Town, South Africa.
   Khadka N, Gorbach PM, Nyemba DC, Mvududu R, et al · · 2023 · cited 13× · PMID 37795521 · DOI 10.3389/frph.2023.1224474
4. Early pre-exposure prophylaxis (PrEP) discontinuation among pregnant and postpartum women: Implications for maternal PrEP roll out in South Africa
   Joseph Davey DL, Mvududu R, Mashele N, Lesosky M, et al · · 2021 · DOI 10.1101/2021.05.04.21256514