“…African women who initiated PrEP in pregnancy until 12 months postpartum found that 72% of all DBS samples had TFV-DP concentrations corresponding with <2 doses/week [45] and frequency of any quantifiable TFV-DP was higher in pregnancy than postpartum [38]. We similarly found high frequency of TFV-DP concentrations corresponding with <2 doses/week (64% overall) and lower adherence levels postpartum than pregnancy.…”
Section: Discussionsupporting
confidence: 55%
“…Data suggest that STIs are common among pregnant PrEP users in Kenya and South Africa [56][57][58] and STIs are facilitator of PrEP initiation. In a recent study, 93% of HIV-negative South African women with an STI diagnosed in pregnancy started taking PrEP [45]. Intervention studies that evaluate STI testing as a strategy to enhance PrEP initiation among women in HIV high-burden settings could be useful for informing PrEP decision-making and the burden of STIs in this population.…”
Objective: We evaluated pre-exposure prophylaxis (PrEP) initiation, persistence, and adherence measured via tenofovir-diphosphate (TFV-DP) concentrations in dried blood spots (DBS) among women offered PrEP during pregnancy.
Methods:We prospectively analyzed data from participants in the PrIMA Study (NCT03070600) who were offered PrEP during the second trimester and followed through 9 months postpartum. At follow-up visits (monthly in pregnancy; 6 weeks, 6 months, 9 months postpartum), self-reported PrEP use was assessed, and DBS were collected for quantifying TFV-DP concentrations.Results: In total, 2949 participants were included in the analysis. At enrollment, median age was 24 years [interquartile range IQR) 21-29], gestational age 24 weeks (IQR 20-28), and 4% had a known partner living with HIV. Overall, 405 (14%) participants initiated PrEP in pregnancy with higher frequency among those with risk factors for HIV acquisition, including >2 lifetime sexual partners, syphilis during pregnancy, forced sex, and intimate partner violence (P < 0.05). At 9 months postpartum, 58% of PrEP initiators persisted with PrEP use, of which 54% self-reported not missing any PrEP pills in the last 30 days. Among DBS randomly selected from visits where participants persisted with PrEP (n ¼ 427), 50% had quantifiable TFV-DP. Quantifiable TFV-DP was twice as likely in pregnancy than postpartum [adjusted risk ratio (aRR) ¼ 1.90, 95% confidence interval (CI) 1.40-2.57, P < 0.001]. Having a partner known to be living with HIV was the strongest predictor of PrEP initiation, persistence, and quantifiable TFV-DP (P < 0.001).Conclusions: PrEP persistence and adherence waned postpartum, though over half of PrEP initiators persisted through 9-months postpartum. Interventions should prioritize increasing knowledge of partner HIV status and sustaining adherence in the postpartum period.
“…African women who initiated PrEP in pregnancy until 12 months postpartum found that 72% of all DBS samples had TFV-DP concentrations corresponding with <2 doses/week [45] and frequency of any quantifiable TFV-DP was higher in pregnancy than postpartum [38]. We similarly found high frequency of TFV-DP concentrations corresponding with <2 doses/week (64% overall) and lower adherence levels postpartum than pregnancy.…”
Section: Discussionsupporting
confidence: 55%
“…Data suggest that STIs are common among pregnant PrEP users in Kenya and South Africa [56][57][58] and STIs are facilitator of PrEP initiation. In a recent study, 93% of HIV-negative South African women with an STI diagnosed in pregnancy started taking PrEP [45]. Intervention studies that evaluate STI testing as a strategy to enhance PrEP initiation among women in HIV high-burden settings could be useful for informing PrEP decision-making and the burden of STIs in this population.…”
Objective: We evaluated pre-exposure prophylaxis (PrEP) initiation, persistence, and adherence measured via tenofovir-diphosphate (TFV-DP) concentrations in dried blood spots (DBS) among women offered PrEP during pregnancy.
Methods:We prospectively analyzed data from participants in the PrIMA Study (NCT03070600) who were offered PrEP during the second trimester and followed through 9 months postpartum. At follow-up visits (monthly in pregnancy; 6 weeks, 6 months, 9 months postpartum), self-reported PrEP use was assessed, and DBS were collected for quantifying TFV-DP concentrations.Results: In total, 2949 participants were included in the analysis. At enrollment, median age was 24 years [interquartile range IQR) 21-29], gestational age 24 weeks (IQR 20-28), and 4% had a known partner living with HIV. Overall, 405 (14%) participants initiated PrEP in pregnancy with higher frequency among those with risk factors for HIV acquisition, including >2 lifetime sexual partners, syphilis during pregnancy, forced sex, and intimate partner violence (P < 0.05). At 9 months postpartum, 58% of PrEP initiators persisted with PrEP use, of which 54% self-reported not missing any PrEP pills in the last 30 days. Among DBS randomly selected from visits where participants persisted with PrEP (n ¼ 427), 50% had quantifiable TFV-DP. Quantifiable TFV-DP was twice as likely in pregnancy than postpartum [adjusted risk ratio (aRR) ¼ 1.90, 95% confidence interval (CI) 1.40-2.57, P < 0.001]. Having a partner known to be living with HIV was the strongest predictor of PrEP initiation, persistence, and quantifiable TFV-DP (P < 0.001).Conclusions: PrEP persistence and adherence waned postpartum, though over half of PrEP initiators persisted through 9-months postpartum. Interventions should prioritize increasing knowledge of partner HIV status and sustaining adherence in the postpartum period.
“… 23 , 24 , 25 , 26 , 27 Thirteen studies met the meta-analysis eligibility criteria. 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 Thirty-five potentially relevant studies were excluded because they are ongoing and did not have any data available at present. Fig.…”
“…In South Africa, in a cohort of 1,201 HIV-negative, pregnant women accessing care at a public sector clinic, 84% chose to use PrEP and 58% returned for 3-month follow-up [32]. Among those women, just 19% of pregnant women and 11% of postpartum women had drug concentrations consistent with taking 2 to 6 doses per week [86]. We observed ongoing high adherence, by pillcap, among women during pregnancy, suggesting that starting PrEP prior to pregnancy may provide an opportunity to overcome adherence barriers prior to onset of pregnancy symptoms or simply a selection bias that women who choose to use periconception PrEP are likely to have ongoing success.…”
Background
In Uganda, fertility rates and adult HIV prevalence are high, and many women conceive with partners living with HIV. Pre-exposure prophylaxis (PrEP) reduces HIV acquisition for women and, therefore, infants. We developed the Healthy Families-PrEP intervention to support PrEP use as part of HIV prevention during periconception and pregnancy periods. We conducted a longitudinal cohort study to evaluate oral PrEP use among women participating in the intervention.
Methods and findings
We enrolled HIV–negative women with plans for pregnancy with a partner living, or thought to be living, with HIV (2017 to 2020) to evaluate PrEP use among women participating in the Healthy Families-PrEP intervention. Quarterly study visits through 9 months included HIV and pregnancy testing and HIV prevention counseling. PrEP was provided in electronic pillboxes, providing the primary adherence measure (“high” adherence when pillbox was opened ≥80% of days). Enrollment questionnaires assessed factors associated with PrEP use. Plasma tenofovir (TFV) and intraerythrocytic TFV-diphosphate (TFV-DP) concentrations were determined quarterly for women who acquired HIV and a randomly selected subset of those who did not; concentrations TFV ≥40 ng/mL and TFV-DP ≥600 fmol/punch were categorized as “high.” Women who became pregnant were initially exited from the cohort by design; from April 2019, women with incident pregnancy remained in the study with quarterly follow-up until pregnancy outcome. Primary outcomes included (1) PrEP uptake (proportion who initiated PrEP); and (2) PrEP adherence (proportion of days with pillbox openings during the first 3 months following PrEP initiation). We used univariable and multivariable-adjusted linear regression to evaluate baseline predictors selected based on our conceptual framework of mean adherence over 3 months. We also assessed mean monthly adherence over 9 months of follow-up and during pregnancy.
We enrolled 131 women with mean age 28.7 years (95% CI: 27.8 to 29.5). Ninety-seven (74%) reported a partner with HIV and 79 (60%) reported condomless sex. Most women (N = 118; 90%) initiated PrEP. Mean electronic adherence during the 3 months following initiation was 87% (95% CI: 83%, 90%). No covariates were associated with 3-month pill-taking behavior. Concentrations of plasma TFV and TFV-DP were high among 66% and 47%, 56% and 41%, and 45% and 45% at months 3, 6, and 9, respectively. We observed 53 pregnancies among 131 women (1-year cumulative incidence 53% [95% CI: 43%, 62%]) and 1 HIV-seroconversion in a non-pregnant woman. Mean pillcap adherence for PrEP users with pregnancy follow-up (N = 17) was 98% (95% CI: 97%, 99%). Study design limitations include lack of a control group.
Conclusions
Women in Uganda with PrEP indications and planning for pregnancy chose to use PrEP. By electronic pillcap, most were able to sustain high adherence to daily oral PrEP prior to and during pregnancy. Differences in adherence measures highlight challenges with adherence assessment; serial measures of TFV-DP in whole blood suggest 41% to 47% of women took sufficient periconception PrEP to prevent HIV. These data suggest that women planning for and with pregnancy should be prioritized for PrEP implementation, particularly in settings with high fertility rates and generalized HIV epidemics. Future iterations of this work should compare the outcomes to current standard of care.
Trial registration
ClinicalTrials.gov Identifier: NCT03832530 https://clinicaltrials.gov/ct2/show/NCT03832530?term=lynn+matthews&cond=hiv&cntry=UG&draw=2&rank=1.
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