Aim 1. Accelerated antiretroviral therapy (ART) initiation, including starting ART on the day of HIV diagnosis, has emerged to be one of the approaches to improve ART uptake by shortening or removing some preparatory steps before ART initiation. By doing so, accelerated ART initiation is thought to remove some structural barriers associated with ART initiation process.
However, several concerns still need to be addressed, such as whether the expedited process would lead to adverse treatment outcomes after ART initiation. Searched strategy was developed using both MeSH and free text terms relevant to accelerated ART initiation (same-day, immediate, rapid). Exclusion criteria were studies that did not focus on HIV, did not involve HIV treatment, included individuals with HIV aged lower than 12, and contained non-human subjects. Additionally, we excluded articles that were case-reports, qualitative studies, systematic reviews, commentary, points of view, and conference presentations.
Four electronic databases (PubMed, Embase, Web of Science, MEDLINE) were used to identify relevant studies published in English between January 2015 and December 2023. Outcomes were retention, viral suppression, pre-ART screening procedures, preferred baseline antiretroviral regimens, additional baseline medications, and adverse events after ART initiation. Two independent researchers were involved in the study selection process. Of 5,455 studies retrieved, 25 studies were included in the review (Cohen’s kappa: 0.88). Six studies reported findings from randomized controlled trials conducted in Lesotho (n=2), Haiti (n=1), South Africa (n=3), and Kenya (n=1), with one study conducted in both South Africa and Keya; 19 studies were observational cohort study from Ethiopia (n=4), West Africa (n=1), Italy (n=2), the United States (n=3), South Africa (n=3), Kenya (n=1), Rwanda (n=1), Sub-Saharan African region (n=1), the United Kingdom (n=1), Turkey (n=1), and China (n=1).
The majority of the studies were conducted in urban areas (n=19). Of the 25 included studies, 19 had same-day ART initiation as the intervention or the exposure (three studies measured the time to ART initiation from the day of care engagement, and 16 studies measured it from the day of HIV diagnosis). There was heterogeneity in the pre-ART screening procedures, from relying on symptomatic screening and history assessment to using non-molecular rapid tests to help identify individuals with increased risk of clinical contraindications. Despite this, individuals with symptoms consistent with WHO stage 4 neurological diseases were not eligible for ART. Efavirenz-based ARV was the most regimen reported. The majority of PWH preferred to start ART within 7 days of HIV diagnosis or care engagement (range: 56.5%-86%). Our review suggested mixed results on retention in care and viral suppression after ART initiation, although many studies indicated potential benefits. Despite this, no study reported an association between clinical adverse events, including deaths, and accelerated ART initiation. Our review suggested that accelerated ART initiation can potentially increase ART uptake while not negatively impacting treatment outcomes in some settings. New tools in HIV treatment, such as safer drug regimens and injectable ART, may help improve PWH’s experience and reduce the burden associated with pill burden and frequent clinic visits.
Aim 2. Accelerated antiretroviral therapy (ART) initiation has been proposed to address some structural barriers associated with the ART initiation process and improve ART uptake. Despite this, there has yet to be a consensus on how this approach should be implemented, especially concerning the clinical readiness screening procedures. While emerging literature has reported the clinical safety of accelerated ART, limited data are reported from Thailand. Given the heterogeneity of clinical profiles of people with HIV (PWH) in different regions, past studies may not be generalizable to Thailand.
Additionally, as different screening procedures affect the time to ART initiation, we need to learn how these procedures impact treatment outcomes. Data were obtained from PWH from 10 ART facilities in six provinces (Chiang Rai, Chiang Mai, Chonburi, Ubon Ratchathani, Songkhla, and Bangkok) in Thailand between July 2017 and July 2019 and followed up until January 2021. All PWH registered in HIV care were included in the analysis, regardless of baseline clinical status. ART facilities were categorized into three models according to the hospital policy on pre-ART laboratory screening procedures: Model A did not consider any lab results at the initiation, Model B considered only CD4 count, and Model C considered other non-CD4 baseline laboratory results.
Log-Poisson regression was used to assess the impact of hospital policies on adverse outcomes (deaths, ART discontinuation, loss to follow-up) at months three, six, 12, 18, and 24 after care engagement. Logistic regression was used to examine the impact of hospital policies on viral non-suppression (VNS, HIV-1 RNA>50 copies/mL) at months six, 12, and 18 after ART initiation. Multilevel mixed model was used to account for potential clustering within each hospital policy. Of 10,926 PWH in the dataset, 9,695 (88.7%) were included in this study. Among these, 68% (6,571/9,695), 13% (1,236/9,695), and 19% (1,888/9,695) were in Models A, B, and C, respectively.
Both Models A and B had 2 ART facilities each, while Model C had 6 ART facilities. 54.2% (5,257/9,695) self-reported to be men who have sex with men, and the overall baseline median CD4 (IQR) was 168 (129-404) cells/mm3. Compared to Model A, the average risk ratio (95%CI) of adverse events at months three, six, 12, 18, and 24 for Model B was 1.14(1.08-1.20), 1.40(1.31-1.49), 1.19(1.10-1.27), 1.11(1.02-1.21), and 1.32(1.21-1.44), respectively, while it was 1.21(1.16-1.27), 1.76(1.67-1.85), 1.59(1.50-1.67), 1.81(1.71-1.90), and 1.98(1.88-2.10) for Model C, respectively. Of 9,695 PWH, 6,785 (70%) had a confirmed date of ART initiation; 37% (2,513/6,785), 34% (2,332/6,785), and 13% (851/6,785) PWH had information on viral load status at months six, 12, and 24 after ART initiation, respectively. Among these samples, compared to Model A, the average odds ratio (95%CI) of VNS for Model B at months six, 12, and 18 was 0.79(0.59-1.06), 1.06(0.71-1.55), and 1.47(0.49-3.58), respectively, while it was 1.01(0.77-1.32), 0.68(0.40-1.09), and 0.93(0.31-2.22) for Model C, respectively. ART facilities that considered CD4 or any other non-CD4 baseline laboratory results before starting ART had, on average, a higher likelihood of adverse outcomes after the initial care engagement visit and viral non-suppression after ART initiation than ART facilities that did not consider any baseline laboratory result.
Aim 3. Clinical screening and psychosocial readiness assessments prior to antiretroviral therapy (ART) initiation are imperative to ensure clinical safety and ART adherence among people with HIV (PWH). However, multiple preparation steps and long wait times associated with ART initiation can contribute to HIV care disengagement and low ART uptake. To address some of the barriers associated with lengthy assessment process, accelerated ART initiation, an approach to start ART on or near the day of HIV diagnosis, has been proposed. Despite this, concerns with the expedited preparation process remain, especially with the PWH’s readiness to have optimal HIV care adherence.
This study examined the impact of time to ART initiation on adverse outcomes after care engagement and viral non-suppression (VNS) after ART initiation among PWH in Thailand. Data were obtained from PWH from 10 ART facilities in 6 provinces (Chiang Rai, Chiang Mai, Chonburi, Ubon Ratchathani, Songkhla, and Bangkok) in Thailand between July 2017 and July 2019 and followed up until January 2021. PWH who tested negative for cryptococcal antigen test at baseline and had a confirmed date of ART initiation were included in the analysis and were categorized into three groups based on the time interval between care engagement (defined as the day that PWH first registered at an ART facility) and ART initiation: (1) same day (ART initiation upon the day of care engagement or same day), (2) 1-7 days, and (3) more than 7 days.
Log-Poisson regression was used to assess the impact of time to ART initiation on adverse outcomes (deaths, ART discontinuation, and loss to follow-up) at months three, six, 12, 18, and 14 after care engagement. Logistic regression was used to examine the impact of time to ART initiation on VNS (HIV-1 RNA>50 copies/mL) after ART initiation at months six, 12, and 18 after ART initiation. Age, population, hospital policy on pre-ART screening procedures, and baseline CD4 were adjusted in the final models. Of 10,926 PWH in the dataset, 5,528 (50.6%) had complete information on the date of care engagement, negative results for the cryptococcal antigen test, and the date of ART initiation. Among these, 44.23% (2,445/5,528), 38.69% (2,139/5,528), and 17.08% (944/5,528) started ART on the day of, 1-7 days from, and more than 7 days from HIV care engagement visit, respectively.
The median age (IQR) was 29 (24-36) and 61% (3,387/5,528) identified themselves as men who have sex with men. The baseline median CD4 (IQR) was 283 (162-412) cells/mm3. Compared to PWH who started ART on the day of HIV care engagement visit, the average risk ratio (RR) of adverse outcomes for those who started ART between 1-7 days at months three, six, 12, 18, and 24 was 0.73(0.60-0.89), 0.66(0.55-0.79), 0.74(0.63-0.86), 0.83(0.71-0.98), and 0.84(0.70-1.01), respectively, while it was 2.27(1.91-2.71), 2.16(1.85-2.52), 1.70(1.46-1.98), 1.93(1.65-2.25), and 2.83(2.44-3.30) for those who started ART more than 7 days, respectively. In the adjusted models, the associations from both groups became statistically non-significant, except for the more than 7 days at month 24 (adjusted RR:1.08; 95%CI:1.04-1.12). Of 5,528 PWH, 29% (1,616/55,28), 36% (1,967/5,528), and 14% (795/5,528) had information on viral load status at months six, 12, and 18 after ART initiation, respectively.
Among these individuals, time to ART initiation was determined to have no impact on VNS in both crude and adjusted models. Accelerated ART initiation has the potential to improve ART uptake while maintaining optimal adherence to HIV care. However, HIV programs should recognize and respond to the diversity of needs among PWH to minimize adverse outcomes following ART initiation.
| Identifer | oai:union.ndltd.org:columbia.edu/oai:academiccommons.columbia.edu:10.7916/k7zt-qe51 |
| Date | January 2024 |
| Creators | Seekaew, Pich |
| Source Sets | Columbia University |
| Language | English |
| Detected Language | English |
| Type | Theses |
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