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Despite considerable discussion and debate about adherence to preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV), scant data are available that characterize patterns of adherence to open-label PrEP. The current evidence base is instead dominated by research on adherence to placebo-controlled investigational drug by way of drug detection in active-arm participants of large randomized controlled trials (RCTs). Important differences between the context of blinded RCTs and open-label use suggest caution when generalizing from study product adherence to real-world PrEP use. Evidence specific to open-label PrEP adherence is presently sparse but will expand rapidly over the next few years as roll-out, demonstration projects, and more rigorous research collect and present findings. The current evidence bases established cannot yet predict uptake, adherence, or persistence with open-label effective PrEP. Emerging evidence suggests that some cohorts could execute better adherence in open-label use vs placebo-controlled research. Uptake of PrEP is presently slow in the United States; whether this changes as grassroots and community efforts increase awareness of PrEP as an effective HIV prevention option remains to be determined. As recommended by multiple guidelines for PrEP use, all current demonstration projects offer PrEP education and/or counseling. PrEP support approaches generally fall into community-based, technology, monitoring, and integrated sexual health promotion approaches. Developing and implementing research that moves beyond simple correlates of either study product use or open-label PrEP adherence toward more comprehensive models of sociobehavioral and socioecological adherence determinants would greatly accelerate progress. Intervention research is needed to identify effective models of support for open-label PrEP adherence.

The effect of HIV pre-exposure prophylaxis (PrEP) depends on uptake, adherence, and sexual practices. We aimed to assess these factors in a cohort of HIV-negative people at risk of infection. In our cohort study, men and transgender women who have sex with men previously enrolled in PrEP trials (ATN 082, iPrEx, and US Safety Study) were enrolled in a 72 week open-label extension. We measured drug concentrations in plasma and dried blood spots in seroconverters and a random sample of seronegative participants. We assessed PrEP uptake, adherence, sexual practices, and HIV incidence. Statistical methods included Poisson models, comparison of proportions, and generalised estimating equations. We enrolled 1603 HIV-negative people, of whom 1225 (76%) received PrEP. Uptake was higher among those reporting condomless receptive anal intercourse (416/519 [81%] vs 809/1084 [75%], p=0·003) and having serological evidence of herpes (612/791 [77%] vs 613/812 [75%] p=0·03). Of those receiving PrEP, HIV incidence was 1·8 infections per 100 person-years, compared with 2·6 infections per 100 person-years in those who concurrently did not choose PrEP (HR 0·51, 95% CI 0·26–1·01, adjusted for sexual behaviours), and 3·9 infections per 100 person-years in the placebo group of the previous randomised phase (HR 0·49, 95% CI 0·31–0·77). Among those receiving PrEP, HIV incidence was 4·7 infections per 100 person-years if drug was not detected in dried blood spots, 2·3 infections per 100 person-years if drug concentrations suggested use of fewer than two tablets per week, 0·6 per 100 person-years for use of two to three tablets per week, and 0·0 per 100 person-years for use of four or more tablets per week (p<0·0001). PrEP drug concentrations were higher among people of older age, with more schooling, who reported non-condom receptive anal intercourse, who had more sexual partners, and who had a history of syphilis or herpes. PrEP uptake was high when made available free of charge by experienced providers. The effect of PrEP is increased by greater uptake and adherence during periods of higher risk. Drug concentrations in dried blood spots are strongly correlated with protective benefit. US National Institutes of Health.

Medication adherence is an important but highly complex set of behaviors, which for life-threatening and infectious diseases such as HIV carry critical consequences for individual and public health. There is growing evidence that mobile phone text messaging interventions (mHealth) connecting providers with patients positively impact medication adherence, particularly two-way engagement platforms that require bidirectional communication versus one-way in which responses are not mandatory. However, mechanisms of action have not been well defined. The Behavior Change Wheel is a comprehensive framework for behavior change that includes an all-encompassing model of behavior known as Capability Opportunity Motivation-Behavior and is complemented by a taxonomy of behavior change techniques. Evaluating mHealth interventions for medication adherence using these tools could provide useful insights that may contribute to optimizing their integration into the healthcare system and successful scaling-up. This study aimed to help address the current knowledge gap regarding how two-way mHealth interventions for medication adherence may work by applying the Behavior Change Wheel to characterize WelTel: an interactive digital health outreach platform with robust evidence for improving adherence to antiretroviral therapy. To characterize how WelTel may promote medication adherence, we applied the Behavior Change Wheel to systematically (1) generate a behavioral diagnosis through mapping known antiretroviral therapy adherence barriers onto the Capability Opportunity Motivation-Behavior model of behavior, (2) specify the behavior change techniques that WelTel delivers, (3) link identified behavior change techniques to corresponding intervention functions of the Behavior Change Wheel, and (4) connect these behavior change techniques and intervention functions to respective Capability Opportunity Motivation-Behavior influences on behavior to determine potential mechanisms of action. Our evaluation of WelTel using the Behavior Change Wheel suggests that most of its impact is delivered primarily through its personalized communication component, in which 8 different behavior change techniques were identified and linked with 5 intervention functions (environmental restructuring, enablement, education, persuasion, and training). Its mechanisms of action in promoting antiretroviral therapy adherence may involve addressing all Capability Opportunity Motivation-Behavior influences on behavior (physical and psychological capability, physical and social opportunity, reflective and automatic motivation). Systematically unpacking the potential active ingredients of effective interventions facilitates the creation and implementation of more parsimonious, tailored, and targeted approaches. Evaluating WelTel using the Behavior Change Wheel has provided valuable insights into how and why such interactive two-way mHealth interventions may produce greater impact than one-way in addressing both nonintentional and intentional forms of nonadherence. The application of the Behavior Change Wheel for evidence synthesis across mHealth interventions targeting various conditions would contribute to strengthening the knowledge base regarding how they may work to impact medication adherence behavior.

Abstract Background Young men who have sex with men are among the most vulnerable to human immunodeficiency virus (HIV) infection. Although preexposure prophylaxis (PrEP) has demonstrated effectiveness, adherence and retention have been low among youth. Methods We conducted a randomized controlled trial to evaluate the impact of a youth-tailored, bidirectional text-messaging intervention (PrEPmate) on study retention and PrEP adherence. Young individuals at risk for HIV initiating PrEP within Chicago’s safety-net system were randomized 2:1 to receive PrEPmate or standard of care (SoC) for 36 weeks. The primary retention outcome was study-visit completion, and the primary adherence outcome was tenofovir diphosphate (TFV-DP) concentrations ≥700 fmol/punch (consistent with ≥4 doses/week) assessed at 4, 12, 24, and 36 weeks. The impact of PrEPmate on retention and adherence was evaluated using generalized estimating equation logistic models with robust standard errors. Results From April 2015 to March 2016, 121 participants enrolled (mean age 24; 27% black, 36% Latino). Participants who received PrEPmate were more likely to attend study visits (86% PrEPmate vs. 71% SoC, odds ratio [OR] = 2.62, 95% confidence interval [CI] 1.24–5.54) and have TFV-DP levels consistent with ≥4 doses/week (72% PrEPmate vs. 57% SoC, OR = 2.05, 95% CI 1.06–3.94). PrEPmate efficacy did not differ significantly by age, race/ethnicity, education, or insurance. Overall, 88% reported PrEPmate to be very/somewhat helpful, and 92% would recommend PrEPmate to others. Conclusions An interactive text-messaging intervention had high acceptability and significantly increased study-visit retention and PrEP adherence among young individuals at risk for HIV acquisition. Clinical Trials Registration NCT02371525. This study evaluated the impact of a text-messaging preexposure prophylaxis-support intervention among young men who have sex with men at risk for human immunodeficiency virus. Participants who received the intervention had higher study retention and PrEP adherence as measured by blood drug levels.

Antiretroviral therapy (ART) during pregnancy is important for both maternal health and prevention of perinatal HIV-1 transmission; however adequate data on the safety and efficacy of different ART regimens that are likely to be used by pregnant women are scarce. In this trial we compared the safety and efficacy of three antiretroviral regimens started in pregnancy: dolutegravir, emtricitabine, and tenofovir alafenamide fumarate; dolutegravir, emtricitabine, and tenofovir disoproxil fumarate; and efavirenz, emtricitabine, and tenofovir disoproxil fumarate. This multicentre, open-label, randomised controlled, phase 3 trial was done at 22 clinical research sites in nine countries (Botswana, Brazil, India, South Africa, Tanzania, Thailand, Uganda, the USA, and Zimbabwe). Pregnant women (aged ≥18 years) with confirmed HIV-1 infection and at 14–28 weeks' gestation were eligible. Women who had previously taken antiretrovirals in the past were excluded (up to 14 days of ART during the current pregnancy was permitted), as were women known to be pregnant with multiple fetuses, or those with known fetal anomaly or a history of psychiatric illness. Participants were randomly assigned (1:1:1) using a central computerised randomisation system. Randomisation was done using permuted blocks (size six) stratified by gestational age (14–18, 19–23, and 24–28 weeks' gestation) and country. Participants were randomly assigned to receive either once-daily oral dolutegravir 50 mg, and once-daily oral fixed-dose combination emtricitabine 200 mg and tenofovir alafenamide fumarate 25 mg; once-daily oral dolutegravir 50 mg, and once-daily oral fixed-dose combination emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; or once-daily oral fixed-dose combination of efavirenz 600 mg, emtricitabine 200 mg, and tenofovir disoproxil fumarate 300 mg. The primary efficacy outcome was the proportion of participants with viral suppression, defined as an HIV-1 RNA concentration of less than 200 copies per mL, at or within 14 days of delivery, assessed in all participants with an HIV-1 RNA result available from the delivery visit, with a prespecified non-inferiority margin of −10% in the combined dolutegravir-containing groups versus the efavirenz-containing group (superiority was tested in a pre-planned secondary analysis). Primary safety outcomes, compared pairwise among treatment groups, were the occurrence of a composite adverse pregnancy outcome (ie, either preterm delivery, the infant being born small for gestational age, stillbirth, or spontaneous abortion) in all participants with a pregnancy outcome, and the occurrence of grade 3 or higher maternal and infant adverse events in all randomised participants. This trial was registered with ClinicalTrials.gov, NCT03048422. Between Jan 19, 2018, and Feb 8, 2019, we enrolled and randomly assigned 643 pregnant women: 217 to the dolutegravir, emtricitabine, and tenofovir alafenamide fumarate group, 215 to the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group, and 211 to the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group. At enrolment, median gestational age was 21·9 weeks (IQR 18·3–25·3), the median HIV-1 RNA concentration among participants was 902·5 copies per mL (152·0–5182·5; 181 [28%] of 643 participants had HIV-1 RNA concentrations of <200 copies per mL), and the median CD4 count was 466 cells per μL (308–624). HIV-1 RNA concentrations at delivery were available for 605 (94%) participants. Of these, 395 (98%) of 405 participants in the combined dolutegravir-containing groups had viral suppression at delivery compared with 182 (91%) of 200 participants in the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group (estimated difference 6·5% [95% CI 2·0 to 10·7], p=0·0052; excluding the non-inferiority margin of −10%). Significantly fewer participants in the dolutegravir, emtricitabine, and tenofovir alafenamide fumarate group (52 [24%] of 216) had a composite adverse pregnancy outcome than those in the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group (70 [33%] of 213; estimated difference −8·8% [95% CI −17·3 to −0·3], p=0·043) or the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group (69 [33%] of 211; −8·6% [–17·1 to −0·1], p=0·047). The proportion of participants or infants with grade 3 or higher adverse events did not differ among the three groups. The proportion of participants who had a preterm delivery was significantly lower in the dolutegravir, emtricitabine, and tenofovir alafenamide fumarate group (12 [6%] of 208) than in the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group (25 [12%] of 207; −6·3% [–11·8 to −0·9], p=0·023). Neonatal mortality was significantly higher in the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group (ten [5%] of 207 infants) than in the dolutegravir, emtricitabine, and tenofovir alafenamide fumarate group (two [1%] of 208; p=0·019) or the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group (three [2%] of 202; p=0·050). When started in pregnancy, dolutegravir-containing regimens had superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen. The dolutegravir, emtricitabine, and tenofovir alafenamide fumarate regimen had the lowest frequency of composite adverse pregnancy outcomes and of neonatal deaths. National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health.

Young, Black Gay, and Bisexual men who have sex with men (YBGBM) are disproportionately impacted by HIV, especially in Southern United States. We conducted a cross-sectional survey (Feb19-Mar20). Eligibility criteria were self-reported age 16–29 years, HIV-negative, Black race, and cis-gender male. We assessed associations between demographics, religiosity, intersectional stigma, and pre-exposure prophylaxis (PrEP) use (never, previous or current) among YBGBM in Alabama. Univariate and multivariable multinomial logistic regression models were fit with factors selected a priori, guided by a conceptual framework including individual-, interpersonal- and structural-level barriers to PrEP. 305 participants completed surveys (median age 24, 75% employed, 32% lacked personal transportation, and 41% reported annual incomes < $15,000). Compared to never PrEP use (n = 219), factors associated with current PrEP use (n = 51) included: ≥ college degree [AOR (95% CI): 5.48 (2.05, 14.62)], friends’ social support [AOR (95% CI): 1.33 (1.00, 1.52)], perceived HIV risk [AOR (95% CI): 1.27 (1.14, 1.42)], and PrEP knowledge [AOR (95% CI): 1.42 (1.23, 1.65)] AND factors associated with previous PrEP use (n = 35) included: depression [AOR (95% CI): 3.08 (1.34, 7.09)], condom use less than all the time [AOR (95% CI): 11.98 (1.52, 94.41)], intrinsic religiosity [AOR (95% CI): 0.77 (0.68, 0.88)], stable housing [AOR (95% CI): 0.30 (0.11, 0.81)], perceived sexual stigma [AOR (95% CI): 0.84 (0.75, 0.94)], and perceived HIV risk [AOR (95% CI): 1.18 (1.05, 1.33)]. YBGBM face distinct challenges with engagement in HIV prevention services and further investigation is needed to understand individual, interpersonal as well as structural-level factors that may mediate the ability to utilize PrEP services. Tailored multilevel strategies are urgently needed to improve PrEP uptake and persistence in YBGBM.

Background As the crisis-based approach to HIV care evolves to chronic disease management, supporting ongoing engagement with HIV care is increasingly important to achieve long-term treatment success. However, ‘engagement’ is a complex concept and ambiguous definitions limit its evaluation. To guide engagement evaluation and development of interventions to improve HIV outcomes, we sought to identify critical, measurable dimensions of engagement with HIV care for people on treatment from a health service-delivery perspective. Methods We used a pragmatic, iterative approach to develop a framework, combining insights from researcher experience, a narrative literature review, framework mapping, expert stakeholder input and a formal scoping review of engagement measures. These inputs helped to refine the inclusion and definition of important elements of engagement behaviour that could be evaluated by the health system. Results The final framework presents engagement with HIV care as a dynamic behaviour that people practice rather than an individual characteristic or permanent state, so that people can be variably engaged at different points in their treatment journey. Engagement with HIV care for those on treatment is represented by three measurable dimensions: ‘retention’ (interaction with health services), ‘adherence’ (pill-taking behaviour), and ‘active self-management’ (ownership and self-management of care). Engagement is the product of wider contextual, health system and personal factors, and engagement in all dimensions facilitates successful treatment outcomes, such as virologic suppression and good health. While retention and adherence together may lead to treatment success at a particular point, this framework hypothesises that active self-management sustains treatment success over time. Thus, evaluation of all three core dimensions is crucial to realise the individual, societal and public health benefits of antiretroviral treatment programmes. Conclusions This framework distils a complex concept into three core, measurable dimensions critical for the maintenance of engagement. It characterises elements that the system might assess to evaluate engagement more comprehensively at individual and programmatic levels, and suggests that active self-management is an important consideration to support lifelong optimal engagement. This framework could be helpful in practice to guide the development of more nuanced interventions that improve long-term treatment success and help maintain momentum in controlling a changing epidemic.

In this study, 2499 HIV-seronegative men or transgender women who were at high risk for HIV acquisition were enrolled in a trial of daily emtricitabine plus tenofovir versus placebo. Those receiving the antiretroviral medication had a 44% reduction in HIV incidence. A total of 2.7 million new infections with the human immunodeficiency virus (HIV) were diagnosed worldwide in 2008, according to the Joint United Nations Program on HIV/AIDS (UNAIDS). Combination antiretroviral therapy for patients with HIV infection restores health and may decrease the transmission of the virus to uninfected partners. 1 Therapy also decreases mother-to-child transmission. 2 Postexposure chemoprophylaxis is recommended after occupational or nonoccupational exposure to HIV-infected fluids. 3 The use of such chemoprophylaxis requires that people recognize when they might have been exposed to HIV and that they start therapy within 72 hours. Both challenges are substantial limitations to the use of . . .

There has been tremendous progress in reducing vertical transmission of HIV in the past two decades due to the broad availability of antiretroviral therapy (ART) globally. Despite this progress, new paediatric infections are still occurring. In a pilot study, we evaluated a combination adherence support package, which included an adapted motivational interviewing-informed counselling approach (Integrated Next Step Counselling, iNSC) and an optional adherence supporter, for pregnant and breastfeeding women living with HIV. Participants were recruited from the antenatal clinic in Lilongwe, Malawi. Eligible participants were randomly allocated 1:1 to receive either the combination adherence package (intervention) or standard care (control) at the health facility. Our clinical outcome, measured at three- and six-month follow-up, was a composite endpoint of study retention with HIV viral suppression (HIV RNA <40 copies per mL). We screened 106 women living with HIV between March and July 2020. Of these, 100 women enrolled and were randomly assigned to intervention (n=51) or control (n=49). The majority of participants (94 of 100; 94%) were newly diagnosed with HIV. Retention in care was 92% at three months and 84% at six months. Three-quarters of women retained in care were virally suppressed at the three- and six-month study visits. At three months, our composite outcome (retention & viral suppression) was achieved by 70.6% (36/51) and 69.4% (34/49) of women in the intervention and control groups, respectively. At six months, this composite outcome was achieved by 68.6% (35/51) of the intervention group and 61.2% (30/49) of the control group (probability difference: 7.4%, 95% CI: -11.3%, 26.1%). These encouraging pilot findings suggest that this combination adherence package could be used to support ART adherence among pregnant and breastfeeding women living with HIV. We demonstrate feasibility of using a combined measure of adherence and viral suppression as an outcome measure. ClinicalTrials.gov (NCT04330989).

Qualitative studies suggest that social relationships play an important role in HIV pre-exposure prophylaxis (PrEP) use, but there have been few quantitative assessments of the role of social relationships in PrEP uptake or adherence. We examined the association between disclosure of study participation or LGBT identity and PrEP use in the 1603 HIV-negative participants enrolled in the iPrEx OLE study. We also evaluated the association between LGBT social group involvement and PrEP use. Study participation disclosure to parents and LGBT identity disclosure to anyone in a participant’s social network were associated with greater PrEP uptake. Study participation disclosure to partners was associated with higher probability of having protective PrEP drug concentrations compared [risk difference 0.15 95% CI (0.01, 0.30)]. For each additional type of LGBT organization a participant was involved in, the probability of PrEP uptake and having protective drug concentrations increased by 0.04 [95% CI (0.03, 0.06)] and 0.04 (95% CI (0.02, 0.07)] respectively. Overall, social context was associated with PrEP use in iPrEx OLE, and should be taken into consideration when designing future PrEP implementation programs.