Trial Outcomes & Findings for Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV (NCT NCT05845619)
NCT ID: NCT05845619
Last Updated: 2025-08-14
Results Overview
Plasma HIV RNA \>50 copies/mL. Data will be collected from clinical records only, no participant interaction. If \>1 viral load is collected during the time frame below, the first will be used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
550 participants
Primary outcome timeframe
Within 6 months after study engagement (i.e., after pilot study participation; after the enrollment visit for prospectively enrolled controls; after the date of eligibility for controls from records)
Results posted on
2025-08-14
Participant Flow
We enrolled 550 participants
There was no pre-assignment procedure
Participant milestones
| Measure |
Pilot
Enhanced virologic monitoring: The pilot intervention will include the following components:
1. More frequent viral load collection: Participants who enroll in the first 3 months of the pilot study period will be eligible for a 3-month follow-up visit and will have viral load assessed again at that time.
2. Rapid return of viral load results: Mentor mothers (peer counselors) will be trained to return viral load results to patients. Viral loads will will be processed with GeneXpert point of care technology.
3. Enhanced viral load counseling: Mentor mothers will reinforce adherence with all patients with undetectable levels via scripted messaging to reward and encourage healthy behavior. For those with any detectable levels, mentor mothers will be trained to provide targeted counseling with scripted messaging according to viral load level (undetectable, low-level viremia (50-1000), high viral load (\>1000)).
|
Controls - Prospectively Enrolled
routine care
|
Controls - Abstracted From Records
routine care
|
|---|---|---|---|
|
Overall Study
STARTED
|
275
|
125
|
150
|
|
Overall Study
COMPLETED
|
273
|
123
|
149
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Pilot
Enhanced virologic monitoring: The pilot intervention will include the following components:
1. More frequent viral load collection: Participants who enroll in the first 3 months of the pilot study period will be eligible for a 3-month follow-up visit and will have viral load assessed again at that time.
2. Rapid return of viral load results: Mentor mothers (peer counselors) will be trained to return viral load results to patients. Viral loads will will be processed with GeneXpert point of care technology.
3. Enhanced viral load counseling: Mentor mothers will reinforce adherence with all patients with undetectable levels via scripted messaging to reward and encourage healthy behavior. For those with any detectable levels, mentor mothers will be trained to provide targeted counseling with scripted messaging according to viral load level (undetectable, low-level viremia (50-1000), high viral load (\>1000)).
|
Controls - Prospectively Enrolled
routine care
|
Controls - Abstracted From Records
routine care
|
|---|---|---|---|
|
Overall Study
duplicate enrollment
|
2
|
2
|
1
|
Baseline Characteristics
Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV
Baseline characteristics by cohort
| Measure |
Pilot
n=273 Participants
Enhanced virologic monitoring: The pilot intervention will include the following components:
1. More frequent viral load collection: Participants who enroll in the first 3 months of the pilot study period will be eligible for a 3-month follow-up visit and will have viral load assessed again at that time.
2. Rapid return of viral load results: Mentor mothers (peer counselors) will be trained to return viral load results to patients. Viral loads will will be processed with GeneXpert point of care technology.
3. Enhanced viral load counseling: Mentor mothers will reinforce adherence with all patients with undetectable levels via scripted messaging to reward and encourage healthy behavior. For those with any detectable levels, mentor mothers will be trained to provide targeted counseling with scripted messaging according to viral load level (undetectable, low-level viremia (50-1000), high viral load (\>1000)).
|
Controls - Prospectively Enrolled
n=123 Participants
routine care
|
Controls - Abstracted From Records
n=149 Participants
routine care
|
Total
n=545 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30 years
n=5 Participants
|
30 years
n=7 Participants
|
31 years
n=5 Participants
|
30 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
273 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
545 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black African
|
273 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
545 Participants
n=4 Participants
|
|
Region of Enrollment
Kenya
|
273 participants
n=5 Participants
|
123 participants
n=7 Participants
|
149 participants
n=5 Participants
|
545 participants
n=4 Participants
|
|
Viral load in prior 12 months
Suppressed viral load (per clinical records)
|
175 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
351 Participants
n=4 Participants
|
|
Viral load in prior 12 months
Not suppressed viral load (per clinical records)
|
47 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Viral load in prior 12 months
No record (missing)
|
51 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 6 months after study engagement (i.e., after pilot study participation; after the enrollment visit for prospectively enrolled controls; after the date of eligibility for controls from records)Population: All participants
Plasma HIV RNA \>50 copies/mL. Data will be collected from clinical records only, no participant interaction. If \>1 viral load is collected during the time frame below, the first will be used.
Outcome measures
| Measure |
Pilot
n=273 Participants
Enhanced virologic monitoring
|
Controls - Prospectively Enrolled
n=123 Participants
routine care
|
Controls - Abstracted From Records
n=149 Participants
routine care
|
|---|---|---|---|
|
Plasma HIV RNA >50 Copies/mL
|
34 Participants
|
13 Participants
|
15 Participants
|
Adverse Events
Pilot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls - Prospectively Enrolled
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls - Abstracted From Records
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place