Brief Report: Context Matters: PrEP Adherence is Associated With Sexual Behavior Among HIV Serodiscordant Couples in East Africa

Haberer, Jessica; Ngure, Kenneth; Muwonge, Timothy; Mugo, Nelly; Katabira, Elly; Heffron, Renee; Musinguzi, Nicholas; Bangsberg, David R.; Celum, Connie; Baeten, Jared M.; Team, Partners Mobile Adherence to PrEP

doi:10.1097/qai.0000000000001548

Cited by 15 publications

(9 citation statements)

References 20 publications

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“…Our analysis identified several participant characteristics that are associated with non-adherence to PrEP in a Markov mixed-effects model framework. The covariate effects found to be significant are in general agreement with prior reports (Haberer et al 2013; Koenig et al, 2013; Amico and Stirratt, 2014; Corneli et al, 2014; Gengiah et al, 2014; Psaros et al, 2014; Kebaabetswe et al, 2015; Haberer et al, 2017a; Haberer et al, 2017b). The distinction of our approach was to utilize a parametric Markov model that provided insights into mechanisms of non-adherence (correlation to either P01 or P10) and predictive capabilities of adherence patterns in addition to the inferential analysis compared to the primary statistical analysis (Haberer et al, 2017a).…”

Section: Discussionsupporting

confidence: 90%

Assessment of Demographic and Socio-Behavioral Factors on Adherence to HIV Pre-Exposure Prophylaxis Using a Markov Modeling Approach

et al. 2019

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Purpose: Adherence is important for the effectiveness of human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP). The objective of the current work is to assess the impact of multiple demographic and socio-behavioral factors on the adherence to tenofovir-based PrEP among HIV serodiscordant couples in East Africa using Markov mixed-effects modeling approach. Methods: The Partners Demonstration Project was a prospective, open-label, implementation science-driven study of HIV PrEP among heterosexual HIV serodiscordant couples in Kenya and Uganda. The uninfected partner received oral PrEP according to the “bridge to antiretroviral therapy [ART]” strategy (i.e., until the infected partner had been on ART for ≥6 months). Adherence was monitored electronically; demographic and socio-behavioral data were collected during study visits. Analyzed data reflect 12 months of follow-up per participant. A two-state, first-order, discrete time Markov model was developed with longitudinal adherence data characterized by “dose taking (1)” and “dose missing (0).” Covariate effects were linearly added in the logit domain of transition probability parameters (P01 and P10) in the model. The full covariate model was initially developed, followed by backward elimination process to reduce the model. All significant covariates reported by a prior primary statistical analysis of the same data were included in the full covariate model. Results: The model included data from 920 participants, who were predominantly male (65%). Significant covariates associated with higher adherence were 25 years or older [odds ratio (OR) for P10, 0.61], female sex (OR for P10, 0.67), participant wanting the relationship with the partner to succeed (OR for P10, 0.79; OR for P01, 1.45), and sex with partner either with 100% or <100% condom use compared to those reported no sex (OR for P10, 0.84; OR for P01, 1.21). Significant covariates associated with lower adherence were partner on ART >6 months (OR for P01, 0.86; OR for P10, 1.34), subject in the study for >6 months (OR for P01, 0.8; OR for P10, 1.25), and problematic alcohol use (OR for P01, 0.63; OR for P10, 1.16). Conclusion: The developed Markov model provides a mechanistic understanding of relationship between demographic, socio-behavioral covariates, and PrEP adherence, by indicating the pattern of adherence influenced by each factor over time. Such data can be used for further intervention development to promote PrEP adherence.

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Section: Discussionsupporting

confidence: 90%

Assessment of Demographic and Socio-Behavioral Factors on Adherence to HIV Pre-Exposure Prophylaxis Using a Markov Modeling Approach

et al. 2019

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“…PrEP has been shown to be efficacious and safe for reducing HIV-1 risk among men who have sex with men [3, 4], heterosexual men and women [5–7], pregnant women [8], and injection drug users [9] in diverse geographic settings. As with ART, adherence is essential for PrEP efficacy.…”

Section: Introductionmentioning

confidence: 99%

HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya

Ortblad

Kearney

Mugwanya

et al. 2019

Trials

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Background The introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing and PrEP refills. HIV-1 self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits. Here, we describe the rationale and design of a randomized, noninferiority trial designed to test the effectiveness and safety of using HIVST to support PrEP delivery in Kenya. Methods The JiPime-JiPrEP (Kiswahili for ‘Test Yourself, PrEP Yourself’) study is a three-arm randomized trial taking place in Thika, Kenya. Participants ( n = 495) are eligible for enrollment if they are at least 18 years old, HIV-1 seronegative, and have been taking PrEP for 1 month. Three distinct participant types will be enrolled: men ( n = 165) and women ( n = 165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women ( n = 165) who are at HIV-1 risk and not in a known serodiscordant relationship. Participants in each of these subpopulations will be 1:1:1 randomized to: 1) the standard of care, with quarterly clinic visits; 2) oral HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs. All participants will complete quantitative surveys and provide blood samples for the objective measurement of PrEP adherence at baseline, 6 months, and 12 months. The primary outcomes are PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6 months and secondarily at 12 months. Discussion The findings from this trial can help to understand how HIVST—a new HIV-1 testing technology—can support health systems in sub-Saharan Africa. Additionally, the findings can inform policy aimed at improving the efficiency of PrEP implementation and scale-up in Kenya. Trial registration ClinicalTrials.gov, NCT03593629 . Retrospectively registered on 20 July 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3521-2) contains supplementary material, which is available to authorized users.

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“…Within this project, a substudy assessed PrEP adherence and sexual behavior with mobile phonebased short message service (SMS) surveys (30). Participants consisted of a convenience sample who owned mobile phones and were able to charge them reliably.…”

Section: Methodsmentioning

confidence: 99%

Tenofovir Plasma Concentration from Preexposure Prophylaxis at the Time of Potential HIV Exposure: a Population Pharmacokinetic Modeling and Simulation Study Involving Serodiscordant Couples in East Africa

Mallayasamy

Chaturvedula

Fossler

et al. 2019

Antimicrob Agents Chemother

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The Partners Demonstration Project was a prospective, open-label, implementation science-driven study of preexposure prophylaxis (PrEP) among heterosexual HIV serodiscordant couples in Kenya and Uganda. Adherence data were collected using the Medication Event Monitoring System (MEMS), and time of sexual activity was collected using the mobile phone short message service (SMS). Two plasma samples were collected at a single study visit. We integrated adherence, pharmacokinetics, and SMS data using a population pharmacokinetic (PopPK) model to simulate tenofovir plasma concentrations from PrEP at the time of sexual activity. In the first stage of this analysis, we used data from the current study to update a prior PopPK model of tenofovir (TFV) developed with data from the Partners PrEP Study (a phase III clinical trial). The second stage involved simulating plasma concentrations at the time of sexual activity using empirical Bayes estimates (EBEs) derived from the final model. In addition, EBEs from a previously published parent metabolite model of TFV (MTN-001, an open-label 3-way crossover study in healthy women) was used to simulate tenofovir diphosphate (TFV-DP) concentrations. We estimated percent PrEP "coverage" as the number of reported sexual events during which simulated concentrations were above an a priori threshold concentrations associated with a high degree of protection from HIV infection: plasma TFV of Ͼ40 ng/ml and peripheral blood mononuclear cell (PBMC) TFV-DP concentration of Ͼ36 fmol/million cells. The levels of coverage were 72% for TFV and 81% for TFV-DP. These levels are consistent with a high degree of protection against HIV acquisition in this study of a pragmatic delivery model for antiretroviral-based HIV prevention.

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Brief Report: Context Matters: PrEP Adherence is Associated With Sexual Behavior Among HIV Serodiscordant Couples in East Africa

Cited by 15 publications

References 20 publications

Assessment of Demographic and Socio-Behavioral Factors on Adherence to HIV Pre-Exposure Prophylaxis Using a Markov Modeling Approach

Assessment of Demographic and Socio-Behavioral Factors on Adherence to HIV Pre-Exposure Prophylaxis Using a Markov Modeling Approach

HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya

Tenofovir Plasma Concentration from Preexposure Prophylaxis at the Time of Potential HIV Exposure: a Population Pharmacokinetic Modeling and Simulation Study Involving Serodiscordant Couples in East Africa

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