HIV Infections, Pregnancy Related, Viremia
Conditions
Brief summary
The goal of this study is to learn about supporting pregnant and postpartum women living with HIV with treatment adherence. The investigators will conduct a pilot study of an intervention that includes peer counseling about viral load levels and rapid delivery of viral load results. The investigators will evaluate the feasibility of the intervention, and will assess whether it improves viral suppression 6 months following the intervention, compared to historical controls.
Detailed description
The investigators will examine the use of more frequent virologic monitoring with enhanced communication around low-level viremia as a strategy to identify and support pregnant and postpartum women at risk of virologic failure. Virologic monitoring itself can reinforce adherence in stable patients, and more frequent monitoring can detect potential adherence challenges early. Notably, low-level viremia is a strong predictor of subsequent virologic failure, and the lowest level associated with perinatal transmission is not known. The pilot study will run for 6 months at 4 Ministry of Health facilities in Kisumu County, Kenya; 275 participants will be enrolled. Prior to the pilot study, 125 controls will be enrolled prospectively, and 150 controls will be abstracted from records from the prior year.
Interventions
BEHAVIORALEnhanced 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)).
Sponsors
Kenya Medical Research Institute
National Institute of Mental Health (NIMH)
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Pilot study participants will be compared to historical controls.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Women living with HIV * On antiretroviral treatment * Either pregnant in the 3rd trimester, OR, postpartum within 6 months of delivery
Exclusion criteria
* n/a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma HIV RNA >50 Copies/mL | 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) | 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. |
Countries
Kenya
Participant flow
Recruitment details
We enrolled 550 participants
Pre-assignment details
There was no pre-assignment procedure
Participants by arm
| Arm | Count |
|---|---|
| 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)). | 273 |
| Controls - Prospectively Enrolled routine care | 123 |
| Controls - Abstracted From Records routine care | 149 |
| Total | 545 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | duplicate enrollment | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Pilot | Controls - Prospectively Enrolled | Controls - Abstracted From Records | Total |
|---|---|---|---|---|
| Age, Continuous | 30 years | 30 years | 31 years | 30 years |
| Race/Ethnicity, Customized Black African | 273 Participants | 123 Participants | 149 Participants | 545 Participants |
| Region of Enrollment Kenya | 273 participants | 123 participants | 149 participants | 545 participants |
| Sex: Female, Male Female | 273 Participants | 123 Participants | 149 Participants | 545 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Viral load in prior 12 months No record (missing) | 51 Participants | 20 Participants | 37 Participants | 108 Participants |
| Viral load in prior 12 months Not suppressed viral load (per clinical records) | 47 Participants | 21 Participants | 18 Participants | 86 Participants |
| Viral load in prior 12 months Suppressed viral load (per clinical records) | 175 Participants | 82 Participants | 94 Participants | 351 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 273 | 0 / 123 | 0 / 149 |
| other Total, other adverse events | 0 / 273 | 0 / 123 | 0 / 149 |
| serious Total, serious adverse events | 0 / 273 | 0 / 123 | 0 / 149 |
Outcome results
Primary
Plasma HIV RNA >50 Copies/mL
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot | Plasma HIV RNA >50 Copies/mL | 34 Participants |
| Controls - Prospectively Enrolled | Plasma HIV RNA >50 Copies/mL | 13 Participants |
| Controls - Abstracted From Records | Plasma HIV RNA >50 Copies/mL | 15 Participants |
Comparison: In this pilot study, we hypothesized that pilot participants would have a reduced risk of viremia 6 months after the intervention compared to controls.p-value: 0.3395% CI: [0.83, 1.76]Regression, Logistic
p-value: 0.4195% CI: [0.73, 2.14]Regression, Logistic