Forecasted Pregnancy Outcomes and 48 Week Evaluations
Note: All mentions of ‘site’ refer to the study site where a participant enrolled in the OLE.
Parameters of Analysis:
This document was last updated on January 29, 2026.
Pregnancies were grouped based on the following scenarios:
- Pregnancy Occurred Prior to Week 96 if the pregnancy report date was less than or equal to 700 days after their OLE enrollment date.
- Pregnancy Occurred After Week 96 if the pregnancy report date was greater than 700 days after their OLE enrollment date.
Prenatal Pregnancies are defined as pregnancies where:
- No outcome date has been recorded.
- Fewer than 40 weeks has passed since the pregnancy was reported.
- Pregnancy has been confirmed.
- Participant is currently enrolled in the study.
- Trimesters are defined as:
- First: 0 to 14 Weeks since report date
- Second: 14 to 27 Weeks since report date
- Third: 27+ Weeks since report date
Postpartum Pregnancies are defined as pregnancies where:
- Participant is currently enrolled in the study or the pregnancy is a post week 96 pregnancy, the participant has terminated due to scheduled study exit, and the participant’s termination date is after the pregnancy outcome date.
- Non missing pregnancy report date and outcome date.
- Fewer than 50 weeks have passed since the pregnancy outcome date.
- Pregnancy resulted in a live birth outcome.
Outputs
Table 1: Pregnancy Counts by Group, Pregnancy Status, and Estimated Trimester.
| Group | Postpartum | Prenatal |
|---|---|---|
| Pregnancy Occurred After Week 96 | 63 | 0 |
| Total | 63 | 0 |
Table 2: Estimated Final Dates of Pregnancy Outcomes and Infant Assessments.
| Group | n | Sites |
Final Pregnancy Outcome
|
Final Infant Assessment
|
||
|---|---|---|---|---|---|---|
| Estimated Date | Days until Outcome | Estimated Date | Days until Assessment | |||
| Pregnancy Occurred After Week 96 | 63 | 17 | 2025-10-28 | -93 | 2026-09-29 | 243 |
Plot 1: Number of Remaining Expected Pregnancy Outcomes by Group and Pregnancy Status.
Plot 2: Number of Remaining Expected Week 48 Assessments by Group and Pregnancy Status.
Table 3: Estimated Final Dates of Pregnancy Outcomes and Infant Assessments by Site.
| Group | n |
Final Pregnancy Outcome
|
Final Infant Assessment
|
|||
|---|---|---|---|---|---|---|
| Estimated Date | Days until Outcome | Estimated Date | Days until Assessment | |||
| Kenya: Kisumu: Kisumu CRS (792) | Pregnancy Occurred After Week 96 | 1 | 2025-02-26 | -337 | 2026-01-28 | -1 |
| Malawi: Blantyre: Blantyre CRS (760) | Pregnancy Occurred After Week 96 | 2 | 2025-09-07 | -144 | 2026-08-09 | 192 |
| Malawi: Lilongwe: Malawi CRS (720) | Pregnancy Occurred After Week 96 | 2 | 2025-06-12 | -231 | 2026-05-14 | 105 |
| South Africa: Botha's Hill: Botha's Hill CRS (789) | Pregnancy Occurred After Week 96 | 2 | 2025-04-24 | -280 | 2026-03-26 | 56 |
| South Africa: Cape Town: Emavundleni CRS (779) | Pregnancy Occurred After Week 96 | 1 | 2025-05-13 | -261 | 2026-04-14 | 75 |
| South Africa: Cape Town: Stellenbosch University (DTTC-SU) CRS (818) | Pregnancy Occurred After Week 96 | 4 | 2025-07-07 | -206 | 2026-06-08 | 130 |
| South Africa: Johannesburg: Ward 21 (837) | Pregnancy Occurred After Week 96 | 2 | 2025-04-29 | -275 | 2026-03-31 | 61 |
| South Africa: Kwa Zulu Natal: Isipingo CRS (803) | Pregnancy Occurred After Week 96 | 2 | 2025-06-11 | -232 | 2026-05-13 | 104 |
| Swaziland: Siteki: Swaziland Prevention Center (871) | Pregnancy Occurred After Week 96 | 6 | 2025-10-16 | -105 | 2026-09-17 | 231 |
| Uganda: Entebbe: UVRI-IAVI (873) | Pregnancy Occurred After Week 96 | 2 | 2025-09-04 | -147 | 2026-08-06 | 189 |
| Uganda: Kampala: Baylor-Uganda CRS (872) | Pregnancy Occurred After Week 96 | 4 | 2025-10-27 | -94 | 2026-09-28 | 242 |
| Uganda: Kampala: MU-JHU Research Collaboration CRS (753) | Pregnancy Occurred After Week 96 | 10 | 2025-08-21 | -161 | 2026-07-23 | 175 |
| Zimbabwe: Chitungwiza: Seke South CRS (754) | Pregnancy Occurred After Week 96 | 4 | 2025-06-10 | -233 | 2026-05-12 | 103 |
| Zimbabwe: Chitungwiza: St.Mary's CRS (762) | Pregnancy Occurred After Week 96 | 5 | 2025-06-11 | -232 | 2026-05-13 | 104 |
| Zimbabwe: Chitungwiza: Zengeza CRS (774) | Pregnancy Occurred After Week 96 | 6 | 2025-10-18 | -103 | 2026-09-19 | 233 |
| Zimbabwe: Harare: Parirenyatwa CRS (770) | Pregnancy Occurred After Week 96 | 5 | 2025-10-28 | -93 | 2026-09-29 | 243 |
| Zimbabwe: Harare: Spilhaus CRS (771) | Pregnancy Occurred After Week 96 | 5 | 2025-07-03 | -210 | 2026-06-04 | 126 |
Plot 3: Number of Remaining Expected Week 48 Assessments by Site, Group, and Pregnancy Status.
