Hiv
Conditions
Keywords
pre-exposure prophylaxis, PrEP, pregnancy, prevention of mother to child transmission, PMTCT
Brief summary
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.
Interventions
DRUGTDF-FTC
We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.
BEHAVIORALCounselling on PrEP in antenatal and postnatal care
Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.
Sponsors
University of Cape Town
Desmond Tutu HIV Foundation
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Open label cohort study
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Documented HIV-negative according to two fingerpick rapid tests (per routine antenatal care protocol in this setting), confirmed with a 4th generation antigen HIV test at study enrollment 2. No previous exposure triple-drug antiretroviral therapy 3. Age 18 years or older 4. Lives within 20 kilometers of a clinic 5. Without psychiatric or medical contraindications to PrEP use 6. Able to provide informed consent for research
Exclusion criteria
Failure to meet any of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Retention | 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 |
| PrEP Adherence | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Initiation | 18 months | number of women who initiate PrEP over time/ total number of women in active cohort |
| PrEP Adherence (Peri-sexual) | 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) |
| PrEP Adherence (Subjective, Self-reported) | 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) |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregnant Women Offered PrEP Pregnant women in antenatal care (16+ years) were offered oral TDF/FTC as PrEP in a cohort study | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | Pregnant Women Offered PrEP |
|---|---|
| Age, Categorical <=18 years | 10 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 190 Participants |
| Age, Continuous | 25 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 200 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment South Africa | 200 Participants |
| Sex: Female, Male Female | 200 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 200 |
| other Total, other adverse events | 0 / 200 |
| serious Total, serious adverse events | 10 / 200 |
Outcome results
Primary
PrEP Adherence
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)
Time frame: 3 months
Population: Women who were adherent on PrEP at 3 months per DBS measure of TFV-DP (equivalent to 2+ days/week by pregnant or postpartum)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Women Offered PrEP | PrEP Adherence | 25 participants |
Primary
PrEP Retention
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
Time frame: 18 months
Population: Participants who were retained on PrEP study and were on PrEP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Women Offered PrEP | PrEP Retention | 100 participants |
Secondary
PrEP Adherence (Peri-sexual)
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)
Time frame: 3 months
Population: 78 DBS drawn from participants on PrEP at 3m visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Offered PrEP | PrEP Adherence (Peri-sexual) | 25 Participants |
Secondary
PrEP Adherence (Subjective, Self-reported)
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)
Time frame: 3 months
Population: Participants who started PrEP at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Offered PrEP | PrEP Adherence (Subjective, Self-reported) | 118 Participants |
Secondary
PrEP Initiation
number of women who initiate PrEP over time/ total number of women in active cohort
Time frame: 18 months
Population: Pregnant women who enrolled in study and were offered PrEP
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Offered PrEP | PrEP Initiation | 180 Participants |