HIV Pre-Exposure Prophylaxis for Conception Among HIV Serodiscordant Couples in the United States: A Cohort Study

Leech, Ashley A.; Biancarelli, Dea L.; Aaron, Erika; Coleman, Jenell S.; Anderson, Peter L.; Nkwihoreze, Hervette; Condron, Brianne; Sullivan, Meg

doi:10.1089/apc.2020.0005

Cited by 6 publications

(6 citation statements)

References 39 publications

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“…In the Kenyan pilot study, PrEP was initiated by 100% of the HIV-negative partners (including 40 couples in which the woman was HIV-negative) and 81% took at least 80% of PrEP doses one month prior to pregnancy based on electronic pill caps (27). Another recent periconception study in the U.S. observed that among 25 women taking PrEP while seeking conception with a male partner living with HIV, 87% had TFV-DP levels consistent with taking at least 4 doses/week (71). Indeed, our qualitative sub-study with participants and partners suggested that the motivation to have a safe option to fulfill the cultural expectations of having children while maintaining sero-different relationships encouraged PrEP adherence (72).…”

Section: Discussionmentioning

confidence: 99%

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High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda

Matthews

Atukunda

Owembabazi

et al. 2022

Preprint

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Background In Uganda, fertility rates and adult HIV prevalence are high, and many women conceive with partners living with HIV. Oral pre-exposure prophylaxis (PrEP) reduces HIV acquisition risk for women and, therefore, infants. We conducted a longitudinal cohort study in Uganda to evaluate oral PrEP uptake and adherence as part of HIV prevention in the context of reproductive goals for women (i.e., safer conception care). Methods We enrolled HIV-negative women with personal or partner plans for pregnancy with a partner living, or thought to be living, with HIV (2017-2020) to evaluate the impact of the Healthy Families intervention on PrEP use. Quarterly study visits through 9 months included HIV and pregnancy testing, and safer conception counseling. PrEP was provided to women in electronic pillboxes as the primary adherence measure (categorized as “high” with pillbox openings on > 80% of days). Enrollment questionnaires assessed factors associated with PrEP use. Plasma tenofovir (TFV) and intraerythrocytic TFV-diphosphate (TFV-DP) concentrations were determined at each visit for women who acquired HIV during follow-up and a randomly selected subset of those who did not. 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 of enrolled women who initiated PrEP) and (2) PrEP adherence (proportion of days with electronic pillbox openings during the first 3 months following PrEP initiation). We used univariable and multivariable-adjusted linear regression to evaluate baseline predictors of mean adherence over 3 months. We also assessed mean monthly adherence over 9 months of follow-up and during pregnancy. Results We enrolled 131 women with a mean age of 28.7 years (95% CI: 27.8-29.5). Ninety-seven (74%) reported a partner with HIV and 79 (60%) reported condomless sex at last encounter. Most women (N=118; 90%) initiated PrEP. Mean electronic adherence during the 3 months following initiation was 87% (95% CI: 83%, 90%); most (85%) had adherence >80%. No covariates were associated with 3-month pill-taking behavior. Plasma TFV concentrations were > 40ng/mL among 66%, 56%, and 45% at months 3, 6, and 9, respectively. TFV-DP concentrations were > 600 fmol/punch among 47%, 41%, and 45% of women at months 3, 6, and 9. We observed 53 pregnancies among 131 women with 848 person-months of follow-up (annualized incidence 75% [95% CI: 57%, 98%]) and one HIV-seroconversion in a non-pregnant woman accessing PrEP. Mean pillcap adherence for PrEP users with pregnancy follow-up (N=17) was 98% (95% CI: 97%, 99%). 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 and serial measures suggest 41-66% 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.

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Section: Discussionmentioning

confidence: 99%

“…TFV-DP was processed for all collected samples. TFV and TFV-DP levels were quantified using via liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis using previously described methods (64,(69)(70)(71).…”

Section: Assessment Of Prep Uptake and Adherencementioning

confidence: 99%

High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda

Matthews

Atukunda

Owembabazi

et al. 2022

Preprint

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“…Data were analyzed from prospective studies involving oral F/TDF for PrEP in cisgender women and adolescents conducted between 2012, the year F/TDF for PrEP was approved for use in the US, and 2020. These studies were performed as part of the postmarketing commitment to the FDA and were either demonstration projects (n = 7) or open-label studies (n = 4), with 7 conducted in sub-Saharan Africa, 2 in India, and 2 in the US (Table). Study populations varied, but all included individuals who could benefit from PrEP and persons in serodiscordant (1 partner living with HIV and 1 partner without HIV) relationships, adolescent females and young women, and female sex workers.…”

Section: Methodsmentioning

confidence: 99%

HIV Preexposure Prophylaxis With Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women

Marrazzo,

Tao,

Becker

et al. 2024

JAMA

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ImportanceEmtricitabine and tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP) is highly effective in cisgender men who have sex with men (MSM) when adherence is high (&gt;4 doses/week). Real-world effectiveness and adherence with F/TDF for PrEP in cisgender women is less well characterized.ObjectiveTo characterize the effectiveness of F/TDF for PrEP and its relationship with adherence in cisgender women.Design, Setting, and ParticipantsData were pooled from 11 F/TDF PrEP postapproval studies conducted in 6 countries that included 6296 cisgender women aged 15 to 69 years conducted from 2012 to 2020. HIV incidence was evaluated according to adherence level measured objectively (tenofovir diphosphate concentration in dried blood spots or tenofovir concentration in plasma; n = 288) and subjectively (electronic pill cap monitoring, pill counts, self-report, and study-reported adherence scale; n = 2954) using group-based trajectory modeling.ExposuresF/TDF prescribed orally once a day. HIV incidence was analyzed in subgroups based on adherence trajectory.Main Outcomes and MeasuresHIV incidence.ResultsOf the 6296 participants, 46% were from Kenya, 28% were from South Africa, 21% were from India, 2.9% were from Uganda, 1.6% were from Botswana, and 0.8% were from the US. The mean (SD) age at PrEP initiation across all studies was 25 (7) years, with 61% of participants being younger than 25 years. The overall HIV incidence was 0.72 per 100 person-years (95% CI, 0.51-1.01; 32 incident HIV diagnoses among 6296 participants). Four distinct groups of adherence trajectories were identified: consistently daily (7 doses/week), consistently high (4-6 doses/week), high but declining (from a mean of 4-6 doses/week and then declining), and consistently low (less than 2 doses/week). None of the 498 women with consistently daily adherence acquired HIV. Only 1 of the 658 women with consistently high adherence acquired HIV (incidence rate, 0.13/100 person-years [95% CI, 0.02-0.92]). The incidence rate was 0.49 per 100 person-years (95% CI, 0.22-1.08) in the high but declining adherence group (n = 1166) and 1.27 per 100 person-years (95% CI, 0.53-3.04) in the consistently low adherence group (n = 632).Conclusions and RelevanceIn a pooled analysis of 11 postapproval studies of F/TDF for PrEP among cisgender women, overall HIV incidence was 0.72 per 100 person-years; individuals with consistently daily or consistently high adherence (4-6 doses/week) to PrEP experienced very low HIV incidence.

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“…We used modified Poisson regression with generalized estimating equations to assess predictors of PrEP initiation and high adherence (defined as TFV ≥40 ng/ml) at the first quarterly visit following PrEP initiation. Baseline predictors identified based on our periconception HIV risk conceptual framework [ 35 ] included age, education, household income, number of prior pregnancies, number of sexual partners, condom use, tobacco and alcohol use, HIV stigma [ 16 ], perceived HIV risk [ 29 ], sexual relationship power [ 30 ], dyadic trust [ 31 ], social support [ 32 ], and depression [ 33 ]. Multivariable-adjusted risk ratios were constructed using a change-in-estimate approach [ 34 ] in which relative to a fully adjusted model (i.e., all known or hypothesized confounding factors identified by subject matter knowledge of the underlying causal structure included), we removed, one by one, each factor and recorded the estimated coefficient for the predictor-outcome association.…”

Section: Methodsmentioning

confidence: 99%

Oral preexposure prophylaxis uptake, adherence, and persistence during periconception periods among women in South Africa

Matthews,

Jaggernath,

Kriel

et al. 2024

Aids

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Objective: We developed the Healthy Families-PrEP intervention to support HIV-prevention during periconception and pregnancy. We evaluated preexposure prophylaxis (PrEP) use with three objective measures. Design: This single-arm intervention study enrolled women in KwaZulu-Natal, South Africa, who were HIV-uninfected, not pregnant, in a relationship with a partner with HIV or unknown-serostatus, and with pregnancy plans. PrEP was offered as part of a comprehensive HIV prevention intervention. Participants were followed for 12#$##x0200A;months. Methods: We evaluated periconception PrEP uptake and adherence using quarterly plasma tenofovir concentrations. We modeled factors associated with PrEP uptake and high plasma tenofovir (past day dosing). Patterns of use were analyzed using electronic pillcap data. Dried blood spots to measure intracellular tenofovir product (past 2#$##x0200A;months dosing) were analyzed for a subset of women. Results: Three hundred thirty women with median age 24 (IQR: 22#$#ndash;27) years enrolled. Partner HIV-serostatus was unknown by 96% (N#$##x0200A;#$#equals;#$##x0200A;316); 60% (195) initiated PrEP. High plasma tenofovir concentrations were seen in 35, 25, 22, and 20% of samples at 3, 6, 9, and 12#$##x0200A;months, respectively. Similar adherence was measured by pillcap and dried blood spots. In adjusted models, lower income, alcohol use, and higher HIV stigma were associated with high plasma tenofovir. Eleven HIV-seroconversions were observed (incidence rate: 4.04/100 person-years [95% confidence interval: 2.24#$#ndash;7.30]). None had detectable plasma tenofovir. Conclusion: The Healthy Families-PrEP intervention supported women in PrEP use. We observed high interest in periconception PrEP and over one-third adhered to PrEP in the first quarter; one-fifth were adherent over a year. High HIV incidence highlights the importance of strategies to reduce HIV incidence among periconception women. Clinical Trial Number: NCT03194308

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HIV Pre-Exposure Prophylaxis for Conception Among HIV Serodiscordant Couples in the United States: A Cohort Study

Cited by 6 publications

References 39 publications

High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda

High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda

HIV Preexposure Prophylaxis With Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women

Oral preexposure prophylaxis uptake, adherence, and persistence during periconception periods among women in South Africa

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