NCT03902418: PrEP-PP

Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women

Completed Results posted Last updated 23 October 2024

What this trial tests

trial testing emtricitabine/tenofovir in HIV-I Infection in 1,195 participants. Completed in 30 September 2024.

Timeline

1 July 2019

Primary endpoint
30 June 2024

30 September 2024

Quick facts

Lead sponsor	University of California, Los Angeles
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,195
Start date	1 July 2019
Primary completion	30 June 2024
Estimated completion	30 September 2024
Sites	1 location across South Africa

Drugs / interventions tested

• emtricitabine/tenofovir

Conditions studied

• HIV-I Infection — all drugs for HIV-I Infection →

Sponsor

University of California, Los Angeles

Who can join

16 and older, female only, with HIV-I Infection. 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.

Participants Initiating Pre-exposure Prophylaxis During Pregnancy Primary · Percentage of participants initiating pre-exposure prophylaxis between first ante-natal clinic visit and birth of infant

Percentage of participants initiating pre-exposure prophylaxis during pregnancy

Group	Value	95% CI
Pregnant Women Initiating PrEP	1089

Adherence to TDF at 3-months on PrEP Primary · Measured at 3 month follow up visit

Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 3 months on PrEP

Group	Value	95% CI
Pregnant Women Initiating PrEP	256

Women Initiating Pre-exposure Prophylaxis Post-partum Primary · Percentage of participants initiating pre-exposure prophylaxis at first post-partum to final post-partum visit 12 months after birth

Percentage of women initiating pre-exposure prophylaxis

Group	Value	95% CI
Pregnant Women Initiating PrEP	1009

Adherence to TDF at 6 Months Post-partum Primary · Measured at 6-month post-partum visit

Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 6 month post-partum visit

Group	Value	95% CI
Women With Quantifiable Adherence to TFV-DP at 6-month Visit	51

Number of Participants With Adherence to TFV-DP at 6-month Visit Primary · Measured at 6-month study visit

Quantifiable TFV (versus none) using dried blood spots (DBS) taken at 6-month study visit among subset of women who reported taking PrEP in the last 30-days at 6-months

Group	Value	95% CI
Women With Quantifiable Adherence to TFV-DP at 6-month Visit	86

PrEP Initiation Among Those With STI POC Testing vs Syndromic Management Secondary · Measured at enrollment and 1 month follow up

Proportion of those with POC (point of care) STI vs syndromic management who initiate oral PrEP

Group	Value	95% CI
Women Receiving POC STI Testing	89
Women Receiving STI Syndromic Management	84

Adverse events — posted to ClinicalTrials.gov

Time frame: Between Aug 2019 and October 2021, we followed 1195 women and ascertained 1145 pregnancy outcomes, abstracted from maternal case files, infant road to health cards, and local obstetric records.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pregnant Women Offered PrEP

Serious: 67/1195 (6%)

Deaths: 0/1195

Serious adverse events (4 terms)

Reaction	System	Pregnant Women Offered PrEP
Pregnancy Loss, Miscarriage	Pregnancy, puerperium and perinatal conditions	—
Pregnancy Loss, Stillbirth	Pregnancy, puerperium and perinatal conditions	—
HIV sero-conversion	Infections and infestations	—
Live Birth Outcome, Neonatal Death	Pregnancy, puerperium and perinatal conditions	—

Other adverse events (2 terms — click to expand)

Reaction	System	Pregnant Women Offered PrEP
Live Birth Outcome, Low Birth Weight	Pregnancy, puerperium and perinatal conditions	—
Live Birth Outcome, Preterm Delivery	Pregnancy, puerperium and perinatal conditions	—

Most-reported serious reactions: Pregnancy Loss, Miscarriage, Pregnancy Loss, Stillbirth, HIV sero-conversion, Live Birth Outcome, Neonatal Death.

Data from ClinicalTrials.gov NCT03902418 adverse events section.

Sponsor's own description

The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain subdistrict of the Metro Region (to be identified in conjunction with provincial and local health authorities) Midwife Obstetric Units in Cape Town (n=600 pregnant women per site). The enrolled women will be followed through 12-months post-delivery.

Publications & conference data

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

1. Barriers to Oral HIV Pre-exposure Prophylaxis (PrEP) Adherence Among Pregnant and Post-partum Women from Cape Town, South Africa.
   Beesham I, Dovel K, Mashele N, Bekker LG, et al · · 2022 · cited 56× · PMID 35316471 · DOI 10.1007/s10461-022-03652-2
2. Maternal PrEP Use in HIV-Uninfected Pregnant Women in South Africa: Role of Stigma in PrEP Initiation, Retention and Adherence.
   Moran A, Mashele N, Mvududu R, Gorbach P, et al · · 2022 · cited 44× · PMID 34287756 · DOI 10.1007/s10461-021-03374-x
3. "I had Made the Decision, and No One was Going to Stop Me" -Facilitators of PrEP Adherence During Pregnancy and Postpartum in Cape Town, South Africa.
   Joseph Davey DL, Knight L, Markt-Maloney J, Tsawe N, et al · · 2021 · cited 41× · PMID 34085132 · DOI 10.1007/s10461-021-03320-x
4. Sexual Risk among Pregnant Women at Risk of HIV Infection in Cape Town, South Africa: What Does Alcohol Have to Do with It?
   Miller AP, Shoptaw S, Mvududu R, Mashele N, et al · · 2023 · cited 4× · PMID 35737280 · DOI 10.1007/s10461-022-03742-1
5. "So that's why I found PrEP to be safest way to protect yourself": exploring IPV experiences and impact on HIV prevention among pregnant and postpartum women in Cape Town, South Africa.
   Miller AP, Dean SS, Court L, Mvududu R, et al · · 2024 · cited 2× · PMID 38360616 · DOI 10.1186/s12889-024-17871-w
6. Point-of-care testing for sexually transmitted infections and HIV pre-exposure prophylaxis among pregnant women in South Africa, 2021-2022: randomised controlled trial.
   de Voux A, Nyemba DC, Silliman M, Mashele N, et al · · 2024 · cited 2× · PMID 38124133 · DOI 10.1136/sextrans-2023-055975