Self-reported Antiretroviral Therapy Research Articles

Estimating the effect of COVID-19 pandemic restrictions on self-reported antiretroviral therapy use and late refill visits among people living with HIV in rural South Africa

Background: People living with HIV require reliable access to and adequate supply of antiretroviral therapy (ART) for viral suppression. The Deliver Health Study, a randomized trial conducted during the COVID-19 pandemic, found that home-delivered ART significantly increased viral suppression compared to clinic-based care. The effect of changing COVID-19 alert levels on self-reported ART use has not been quantified. Setting: KwaZulu-Natal, South Africa. Methods: Adults living with HIV were followed in the Deliver Health Study during October 2019-December 2020. We used difference-in-differences (DiD) to estimate the effect of changing COVID-19 alert levels during three distinct periods on self-reported missed ART doses (missed 0 vs. 1 doses in past week) for participants receiving home-delivered vs. clinic-based refills. We additionally estimated the effect of changing COVID-19 alert levels on late clinic ART refill visits (late vs. on-time). We used relative risk regression for both binary outcomes. Results: Of 155 participants, 46% were women and median age was 36 years. The mean number of missed weekly doses was 0.11, 0, and 0.12 in the home-delivery group and 0.09, 0.08, and 0.18 in the clinic group during periods 1, 2, and 3, respectively. There were no differences in relative risk (RR) of self-reported daily ART use between refill groups when comparing across periods (DiDperiod 2 vs. 1=1.05; 95% confidence interval [CI]: 0.97, 1.13 and DiDperiod 3 vs. 2=0.99; 95% CI: 0.91, 1.08). In the clinic group, the risk of late refill visits was significantly higher during COVID-19 restrictions (vs. before alert level 5 implementation) and even after the COVID-19 alert level was downgraded to level 1 (RRperiod 2 vs. 1=1.83, 95% CI: 1.34, 2.51 and RRperiod 3 vs. 2=1.71; 95% CI: 1.43, 2.04). Conclusion: The COVID-19 pandemic did not differentially impact self-reported ART adherence by method of ART refills, but the risk of late clinic refill visits was significantly higher during COVID-19 restrictions and sustained after restrictions were loosened.

Lower self-reported ART adherence among adolescents in boarding schools compared to day schools.

Adolescents living with HIV (ALH) have poorer adherence to antiretroviral therapy (ART) than adults. Many ALH in sub-Saharan Africa (SSA) are enrolled in boarding schools where stigma is pervasive and may impact adherence. We collected sociodemographic data, school information, medical history, and viral load (VL) data from ALH age 14-19 in 25 HIV clinics in 3 counties in Kenya. Using generalized estimating equations, we compared ART adherence in ALH attending day and boarding schools. Of 880 ALH, 798 (91%) were enrolled in school, of whom 189 (24%) were in boarding schools. Of those in school, median age was 16 (IQR: 15, 18), 55% were female, 78% had a parent as a primary caregiver, and 74% were on DTG-based ART. Median age at ART initiation was 6 years (IQR 3, 10).Overall, 227 (29%) ALH self-reported missing ART when school was in session (40% in boarding and 25% in day school). After adjusting for sociodemographic and HIV care characteristics, ALH in boarding schools were significantly more likely to self-report missing ART than those in day schools (adjusted Prevalence Ratio (aPR): 1.47, 95% CI 1.18, 1.83, p=0.001). Among 194 ALH, only 60% had undetectable (<20 copies/ml) HIV viral load (62% day schools and 51% boarding schools)(p=0.097). ALH had high self-reported non-adherence overall, with worse adherence among those in boarding schools. Schools remain a critical untapped resource for improving ALH outcomes.

Results from a pilot study of an automated directly observed therapy intervention using artificial intelligence with conditional economic incentives among young adults with HIV.

Despite improvements in antiretroviral therapy (ART) availability, suboptimal adherence is common among youth with HIV (YWH) and can increase drug resistance and poor clinical outcomes. Our study examined an innovative mobile app-based intervention that used automated directly observed therapy (aDOT) using artificial intelligence, along with conditional economic incentives (CEIs) to improve ART adherence and enhance viral suppression among YWH. We conducted a pilot study of the aDOT-CEI intervention, informed by the operant framework of Key Principles in Contingency Management Implementation, to improve ART adherence among YWH (18-29) in California and Florida who had an unsuppressed HIV viral load. We recruited 28 virally unsuppressed YWH from AIDS Healthcare Foundation (AHF) clinics, who used the aDOT platform for 3 months. Study outcomes included feasibility and acceptability, self-reported ART adherence, and HIV viral load. Participants reported high satisfaction with the app (91%), and 82% said that it helped them take their medication. Comfort with the security and privacy of the app was moderate (55%), and 59% indicated the incentives helped improve daily adherence. Acceptability and feasibility of the aDOT-CEI intervention were high with potential to improve viral suppression, although some a priori metrics were not met. Pilot results suggest refinements which may improve intervention outcomes, including increased incentive amounts, provision of additional information, and reassurance about app privacy and security. Additional research is recommended to test the efficacy of the aDOT-CEI intervention to improve viral suppression in a larger sample.

Association of tenofovir diphosphate and lamivudine triphosphate concentrations with HIV and hepatitis B virus viral suppression.

Concentrations of tenofovir diphosphate (TFV-DP) and lamivudine triphosphate (3TC-TP) in cells are correlates of medication adherence and antiviral activity. However, studies have yet to characterize the simultaneous relationship between TFV-DP and 3TC-TP concentrations with HIV and hepatitis B virus (HBV) suppression. Individuals with HIV/HBV coinfection on tenofovir disoproxil fumarate (TDF)-containing antiretroviral therapy (ART) were enrolled. Peripheral blood mononuclear cells (PBMCs) and dried blood spots (DBS) samples were collected and steady-state TFV-DP and 3TC-TP concentrations quantified using validated methods. The relationship between patient factors, TFV-DP, and 3TC-TP concentrations in PBMCs and DBS with HBV and HIV viral suppression were examined. Of 138 participants on TDF-containing ART for a median duration (range) of 6 (0.75-15) years, the median age was 43 years and 64% were women. Overall, 128 (92.8%) and 129 (93.5%) had suppressed HIV and HBV viral loads, respectively. Of the 128 participants with suppressed HIV, 122 (95.3%) had suppressed HBV. Self-reported ART adherence, recent change to dolutegravir-based ART, TFV-DP, and 3TC-TP concentrations in PBMCs and DBS were associated with HIV RNA suppression, while HBe antigen positivity, HIV suppression, and TFV-DP concentrations in DBS were associated with HBV DNA suppression (including six persons with HBV nonsuppression and HIV suppression). Long-term TDF/3TC-conatining ART was highly efficacious in individuals with HIV/HBV coinfection. Higher TFV-DP concentrations were predictive of suppression for both viruses. Persistent HBV viremia on TDF/3TC-containg ART requires additional research, but may represent poor adherence and the need for adherence interventions or novel antivirals.

Utility of self-report antiretroviral adherence for predicting HIV viral load among persons who inject drugs in Hai Phong Vietnam: assessing differences by methamphetamine use

ABSTRACT In resource-limited settings, alternatives to HIV viral load testing may be necessary to monitor the health of people living with HIV. We assessed the utility of self-report antiretroviral therapy (ART) to screen for HIV viral load among persons who inject drugs in Hai Phong Vietnam, and consider differences by recent methamphetamine use. From 2016 to 2018 we recruited PWID through cross sectional surveys and collected self-report ART adherence and HIV viral load to estimate sensitivity, specificity, positive and negative predictive values (PPV, NPV) and likelihood ratios (LR+, LR-) for self-reported ART adherence as a screening test for HIV viral load. We used three HIV viral load thresholds: < 1000, 500 and 250 copies/mL; laboratory-confirmed HIV viral load was the gold standard. Among 792 PWID recruited, PPV remained above 90% regardless of recent methamphetamine use with slightly higher PPV among those not reporting recent methamphetamine use. The results remained consistent across all three HIV viral load thresholds. Our findings suggest that when HIV viral load testing is not possible, self-reported ART adherence may inform decisions about how to prioritize HIV viral load testing among PWID. The high PPV values suggest self-reported high ART adherence indicates likely HIV viral suppression, irrespective of methamphetamine use.

Supportive couple relationships buffer against the harms of HIV stigma on HIV treatment adherence

IntroductionHIV stigma can impact couple relationships through stress or bring partners closer through shared experiences. Conversely, couple relationships may protect against the harms of stigma, including anticipated stigma on negative health outcomes. Yet few studies have assessed the potential link between HIV stigma, relationship dynamics, and antiretroviral therapy (ART) adherence. Using dyadic data from a cross-sectional study of Malawian couples living with HIV, we tested associations between anticipated stigma and: 1) relationship dynamics (e.g., trust, sexual satisfaction, communication) and partner support; and 2) self-reported ART adherence.MethodsHeterosexual couples (211 couples, 422 individuals) with at least one partner on ART were recruited from clinics in Zomba, Malawi. Partners completed separate surveys on anticipated stigma, relationship dynamics, and ART adherence. Linear mixed models evaluated associations between anticipated stigma and relationship dynamics, and whether associations varied by gender. Generalized estimating equation models tested for associations between anticipated stigma and high ART adherence (90–100% vs. < 90%) at the individual level, and whether they were moderated by relationship dynamics at the couple level.ResultsCouples' relationship length averaged 12.5 years, 66.8% were HIV sero-concordant, and 95.6% reported high ART adherence. In multivariable models, sexual satisfaction (β = -0.22, 95%CI = -0.41;-0.03, p = 0.020) and partner social support (β = -0.02, 95%CI = -0.04;-0.01, p < 0.01) were negatively associated with anticipated stigma. Significant interaction effects showed that adherence is moderated in couples with higher partner support and sexual satisfaction such that adherence is lowest when anticipated stigma is high and social support is low, and that adherence is lowest when anticipated stigma is high and sexual satisfaction is low.ConclusionsIncreased anticipated stigma is most associated with lower ART non-adherence at lower levels of social support and sexual satisfaction. Conversely, supportive and fulfilling relationships may buffer the negative association between stigma and ART adherence. Couples’ interventions that focus on improving communication and support systems within couples could reduce the negative impacts of anticipated stigma on couples living with HIV.

MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial.

Adolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for "Let's empower each other and improve our health") is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform. The aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support. We will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months. Study screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024. There is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country. ClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878. DERR1-10.2196/47137.

Achieving the third 95 in sub-Saharan Africa: application of machine learning approaches to predict viral failure.

Viral failure in people with HIV (PWH) may be influenced by multiple sociobehavioral, clinical, and context-specific factors, and supervised learning approaches may identify novel predictors. We compared the performance of two supervised learning algorithms to predict viral failure in four African countries. Cohort study. The African Cohort Study is an ongoing, longitudinal cohort enrolling PWH at 12 sites in Uganda, Kenya, Tanzania, and Nigeria. Participants underwent physical examination, medical history-taking, medical record extraction, sociobehavioral interviews, and laboratory testing. In cross-sectional analyses of enrollment data, viral failure was defined as a viral load at least 1000 copies/ml among participants on antiretroviral therapy (ART) for at least 6 months. We compared the performance of lasso-type regularized regression and random forests by calculating area under the curve (AUC) and used each to identify factors associated with viral failure; 94 explanatory variables were considered. Between January 2013 and December 2020, 2941 PWH were enrolled, 1602 had been on antiretroviral therapy (ART) for at least 6 months, and 1571 participants with complete case data were included. At enrollment, 190 (12.0%) had viral failure. The lasso regression model was slightly superior to the random forest in its ability to identify PWH with viral failure (AUC: 0.82 vs. 0.75). Both models identified CD4 + count, ART regimen, age, self-reported ART adherence and duration on ART as important factors associated with viral failure. These findings corroborate existing literature primarily based on hypothesis-testing statistical approaches and help to generate questions for future investigations that may impact viral failure.

Depression-Mediating Pathways From Household Adversity to Antiretroviral Therapy Nonadherence Among Children and Adolescents Living With HIV in Zambia: A Structural Equation Modeling Approach.

In Zambia, half of children and adolescents living with HIV (CALWH) on antiretroviral therapy (ART) are virologically unsuppressed. Depressive symptoms are associated with ART nonadherence but have received insufficient attention as mediating factors in the relationship between HIV self-management and household-level adversities. We aimed to quantify theorized pathways from indicators of household adversity to ART adherence, partially mediated by depressive symptoms, among CALWH in 2 Zambian provinces. In July-September 2017, we enrolled 544 CALWH aged 5-17 years and their adult caregivers into a year-long prospective cohort study. At baseline, CALWH-caregiver dyads completed an interviewer-administered questionnaire, which included validated measures of recent (past 6 months) depressive symptomatology and self-reported past-month ART adherence (never versus sometimes or often missing medication doses). We used structural equation modeling with theta parameterization to identify statistically significant ( P < 0.05) pathways from household adversities (past-month food insecurity and caregiver self-reported health) to depression (modeled latently), ART adherence, and poor physical health in the past 2 weeks. Most CALWH (mean age: 11 years, 59% female) exhibited depressive symptomatology (81%). In our structural equation model, food insecurity significantly predicted elevated depressive symptomatology ( ß = 0.128), which was associated inversely with daily ART adherence ( ß = -0.249) and positively with poor physical health ( ß = 0.359). Neither food insecurity nor poor caregiver health was directly associated with ART nonadherence or poor physical health. Using structural equation modeling, we found that depressive symptomatology fully mediated the relationship between food insecurity, ART nonadherence, and poor health among CALWH.

Discrimination and adherence in a cross-sectional study of Latino sexual minority men with HIV: Coping with discrimination as a mediator and coping self-efficacy as a moderator.

Discrimination is associated with antiretroviral therapy non-adherence and reduced well-being among people with HIV. We examined the potential for coping to mediate the associations between intersectional discrimination and non-adherence and coping self-efficacy (confidence in one's ability to cope with discrimination) as a moderator that may buffer the negative effects of discrimination on non-adherence in a cross-sectional convenience sample of 82 Latino sexual minority men with HIV. In bivariate linear regressions, discrimination targeting Latino ethnic origin, undocumented residency status, and sexual orientation were each significantly associated with lower self-reported antiretroviral therapy non-adherence (percentage of prescribed doses taken in the last month) and greater use of disengagement coping (denial, substance use, venting, self-blame, behavioral disengagement). Associations between discrimination targeting Latino ethnicity and non-adherence, and discrimination targeting undocumented residency status and non-adherence, were each mediated by disengagement coping responses. Moderation analyses highlighted significant discrimination by coping self-efficacy interaction effects-both coping self-efficacy for problem solving and stopping unpleasant emotions/thoughts each moderated the associations between Latino discrimination and adherence, between undocumented residency status discrimination and adherence, and between HIV discrimination and adherence. Coping self-efficacy for getting social support moderated the association between undocumented residency status discrimination and adherence. Further, the interaction coefficients across models indicated that the negative effects of discrimination on adherence were attenuated at higher levels of coping self-efficacy. Findings highlight the need for structural interventions that reduce-and ultimately eliminate-discrimination, and interventions that address the harmful effects of discrimination and adherence improvement interventions to enhance coping skills among people faced with intersectional discrimination.

Impact of weight gain with dolutegravir on antiretroviral adherence and viral suppression in four African countries.

We hypothesized that total body weight (TBW) gain after switching antiretroviral therapy (ART) regimen to tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) may negatively impact ART adherence and viral load (VL) and therefore sought to examine these associations. The ongoing African Cohort Study (AFRICOS) enrols people with HIV at 12 facilities in Kenya, Nigeria, Tanzania and Uganda supported by The US President's Emergency Plan for AIDS Relief. Among ART-experienced participants who switched to TLD, we used multivariable multinomial logistic regression to examine associations between pre-/post-TLD changes in percentage TBW (≥5% gain, <5% change, ≥5% loss) and changes in self-reported ART adherence (0, 1-2, ≥3 days missed doses in past 30 days) and VL [(<50 copies/mL (undetectable), 50-999 copies/mL (detectable, but suppressed), ≥1000 copies/mL (unsuppressed)]. Among 1508 participants, median time from starting TLD to follow-up was 9 months (interquartile range: 7-11). Overall, 438 (29.1%) participants experienced a TBW gain ≥5%, which was more common among females than among males (32.2% vs 25.2%, p = 0.005) and participants switching from efavirenz [32.0% vs nevirapine (19.9%) and boosted protease inhibitor (20.0%); p < 0.001]. Compared with a TBW change <5% [950 (63.0%) participants], TBW gain ≥5% was not significantly associated with more days with missed ART doses [adjusted odds ratio (aOR) = 0.77, 95% confidence interval (CI): 0.48-1.23] or VL becoming detectable and/or unsuppressed (aOR = 0.69, 95% CI: 0.41-1.16). Although a substantial proportion of participants experienced weight gain after switching to TLD, we did not identify a significant impact on adherence or virological outcomes.

People living with HIV who inject or have injected non-prescription drugs: Evidence of substantial differences in health inequalities and experiences of clinical care.

This study investigates differences in health and well-being associated with current, past or no injecting drug use (IDU) among people living with HIV (PLHIV) in Australia, identifying key health care considerations between injecting experiences. Data were extracted from the HIV Futures 9 study; a survey of PLHIV conducted in 2018-2019. Chi-square and analysis of variance analyses compared clinical and treatment characteristics, major physical and mental comorbidities, sexually transmitted infection diagnoses, and quality of life for those who reported current (last 12 months), past (12+ months ago) or no IDU. Current IDU (n = 106) was associated with higher rates of sexually transmitted infection testing and diagnoses, higher frequency of self-reported antiretroviral therapy non-adherence due to drug use and greater social quality of life than past (n = 126) or no IDU (n = 508; total N = 740). Past and current IDUs were associated with more mental illness diagnoses and self-reported concern about drug use. Past IDU was associated with more physical comorbidities, lower satisfaction with clinical care and greater difficulty in affording health care than current or no IDU. Past and current IDUs are associated with unique health concerns. However, past IDU appears to be related to greater dissatisfaction in navigating health care than individuals with current IDU experience. Higher social connection and the types of services being accessed by individuals who currently inject may play a role in shaping service satisfaction. Peer-based interventions to help support individuals in accessing services that are affirming of their needs is an ongoing priority.

Examining recruitment strategies in the enrollment cascade of youth living with HIV: Descriptive findings from a nationwide online adherence protocol.

Digital strategies and broadened eligibility criteria may optimize enrollment of youth living with HIV (YLH) in mobile health adaptive interventions. Prior research suggests that digital recruitment strategies are more efficient than traditional methods to overcome enrollment challenges among YLH in the United States. This paper highlights challenges and strategies that explain screening and enrollment milestones in a national online adherence protocol for YLH. Baseline data from a national online HIV adherence protocol of YLH collected from July 2018 through February 2021 were analyzed. A centralized recruitment procedure was developed which utilized (1) online recruitment via 'Online Master Screener', (2) paid online targeted advertisements on social media platforms (e.g., Facebook, Reddit) and geosocial networking dating applications (e.g., Grindr, Jack'd apps), and (3) site and provider referrals from Subject Recruitment Venues and other AIDS service organizations, website referrals, and text-in recruitment. Three distinct cohorts of YLH were identified, marked by changes in recruitment strategies. Overall, 3,270 individuals consented to screening, 2,721 completed screening, 581 were eligible, and 83 completed enrollment. We examined sociodemographic and behavioral differences in completing milestones from eligibility to full enrollment (i.e., submitting antiretroviral therapy and viral load data and completing baseline online survey). Those with most recent viral load tests more than 6 months ago were half as likely to enroll (OR 0.45, CI 0.21, 0.94). Moreover, eligible participants with self-reported antiretroviral therapy adherence (SRA) between 50% and 80% were significantly more likely to enroll than those with SRA greater than 80%. The findings add to our knowledge on the utility of digital technologies for YLH before and during the COVID-19 pandemic and provide insight into the impact of expanding eligibility criteria on enrollment. As the COVID-19 pandemic continues and usage of and engagement with social media and dating apps among YLH changes, these platforms should continue to be investigated as potential recruitment tools. Employing a wide variety of recruitment strategies such as using social media and dating apps as well as provider referral mechanisms, increasing compensation amounts, and including SRA in enrollment criteria should continue to be studied with respect to their ability to successfully recruit and enroll eligible participants. ClinicalTrials.gov (NIH U.S. National Library of Medicine) Identifier: NCT03535337; https://clinicaltrials.gov/ct2/show/NCT03535337. RR2-10.2196/11183.

Association between recent methamphetamine use, antiretroviral therapy and HIV viral load; a mediation analysis from a cohort of HIV positive persons who inject drugs in Hai Phong, Vietnam.

There has been a significant increase in methamphetamine use among persons who use drugs in Vietnam in the last 5-10years. We examined the degree to which adherence to antiretroviral therapy (ART) mediates the relationship between recent methamphetamine use and unsuppressed HIV viral load among people who inject drugs (PWID) in Hai Phong, Vietnam. We recruited PWID from October 2016-October 2018 and enrolled HIV positive PWID into a cohort, with up to three years of total follow-up. We assessed relationships among recent methamphetamine use frequency, ART adherence and unsuppressed HIV viral load. Mediation analysis was used to estimate the total and natural direct effects of recent methamphetamine use on unsuppressed HIV viral load and the indirect effect proportion. We enrolled 792 HIV seropositive PWID into the cohort; approximately 75.9% reported high/perfect ART adherence at baseline and 81.3% were virally suppressed. In mediation analysis, the total effect for the association between methamphetamine use and unsuppressed HIV viral load (1000 copies/mL) was 3.94 (95% CI: 1.95, 7.96); the natural direct effect was 2.14 (95% CI: 1.29, 3.55); the proportion mediated by self-reported ART adherence was 0.444. Similar results were found when examining lower unsuppressed HIV viral load cutpoints of 250copies/mL and 500copies/mL. Methamphetamine use is associated with unsuppressed HIV viral load among PWID despite high levels of ART adherence. Further research is needed to better understand these relationships, with emphasis on potential biological pathways that may interact with ART.

Feasibility and Acceptability of the Adherence Connection Counseling, Education, and Support (ACCESS) Proof of Concept: A Peer-Led, Mobile Health (mHealth) Cognitive Behavioral Antiretroviral Therapy (ART) Adherence Intervention for HIV-Infected (HIV+) Adolescents and Young Adults (AYA).

Effective antiretroviral therapy (ART) adherence strategies for HIV+ adolescents and young adults (AYA) are needed to prevent HIV-related morbidity, mortality, and onward transmission. In the Adherence Connection for Counseling, Education, and Support (ACCESS) pilot, an exploratory sequential mixed-methods design was used to develop and test a peer-led, mobile health (mHealth) cognitive behavioral ART adherence intervention. HIV+ AYA (ages 16-29years) with unsuppressed plasma HIV RNA (HIV viral load) were eligible for this five-session intervention directed to improving ART adherence and HIV viral load. A total of 78 peer-led remote videoconferencing sessions (via WebEx) were delivered to 16 participants. High completion rates (97.5%) and client satisfaction scores (mean = 29.13 of 32; SD = 2.45) were observed. Self-reported ART adherence improved (32% increase in doses taken; 95th CI 11.2-53.3) with an annualized average rate of 47.5% (0.28 log10) reduction in HIV viral load. We established proof of concept for the ACCESS peer-led, mHealth cognitive behavioral ART adherence intervention, with promising adherence and virologic outcome data.

1260. Comparing the impact of six-month antiretroviral therapy dispensing to three- to five-month dispensing on viral load suppression in Kenya and Nigeria.

Abstract Background Multi-month dispensing (MMD) of antiretroviral therapy (ART) decreases logistical burdens on HIV clinics and patients, which is especially important during the COVID-19 pandemic. HIV programs are scaling-up 6-month dispensing (6MD), but the impact on viral suppression (VS) has not been well-documented in programmatic settings. Methods The African Cohort Study (AFRICOS) is an international observational study of people living with HIV (PLWH) receiving HIV care. In Nigeria and Kenya, this includes 6MD. Participants undergo semiannual viral load quantification and were included in analysis if they had complete data, documentation of MMD (self-reported) and at least two follow-up visits after initiating MMD. In stratified analyses for each country, we used multivariable logistic regression with generalized estimating equations to estimate adjusted odds ratios (aOR) and 95% confidence intervals (95%CI) comparing VS &amp;lt; 50 copies/mL among those who received 6MD to those given 3-5 months dispensing (3-5MD) of ART. Analyses were adjusted for age, education, employment, distance to clinic, duration on ART, ART regimen (TLD vs other) and self-reported ART adherence (≥ 1 missed dose in past 30 days). Results Between January 30, 2020, when MMD data was first collected, and September 1, 2021, 1176 PLWH in Kenya and 272 in Nigeria had at least one visit; 285 participants from Kenya, totaling 442 visits, and 177 participants from Nigeria, totaling 382 visits, met criteria and were included in analysis. At most recent visit, VS &amp;lt; 50 copies/mL was documented in 266 (93.3%) participants from Kenya and 125 (70.6%) participants from Nigeria. Among the 35 participants given 6MD in Kenya, compared to 250 participants given 3-5MD, the aOR for VS was 0.42 (95%CI: 0.13-1.37); among the 91 participants given 6MD in Nigeria, compared to the 86 participants given 3-5MD, the aOR was 3.01 (95%CI: 1.70-5.31). Conclusion The positive association between 6MD and VLS in Nigeria, as compared to 3-5MD, should prompt more aggressive scale-up of 6MD. The lack of an association in Kenya merits further investigation, but likely relates to high overall VS and few participants on 6MD. Updated data from specific geographic and demographic sub-populations is needed to inform programming as 6MD is scaled. Disclosures All Authors: No reported disclosures.

Impacts of intimate partner violence and sexual abuse on antiretroviral adherence among adolescents living with HIV in South Africa.

We are failing to reach 95-95-95 for adolescents living with HIV (ALHIV). Sexual abuse and intimate partner violence (IPV) may impact antiretroviral therapy (ART) adherence, with high rates of 17.4 and 29.7%, respectively, across the southern sub-Saharan African region. However, evidence on their associations with adolescent ART adherence remains limited, with only three cross-sectional studies globally. A prospective cohort of ALHIV (sample N = 980, 55% female individuals, baseline mean age 13.6 years) were recruited from 53 health facilities in South Africa's Eastern Cape Province and responded to a structured questionnaire at 18-month and 36-month follow-up (2015-2016, 2017-2018). A repeated-measures random effects model assessed multivariable associations of self-reported sexual abuse and IPV with past-week ART adherence, controlling for individual, socioeconomic, and HIV-related factors. Past-week adherence was defined based on currently taking ART and not having missed any doses in the past 7 days (including weekends). We further fitted a moderation model by sex. Fifty-one percent of adolescents reported consistent ART adherence at both time points. Exposure to IPV was associated with lower odds of self-reported ART adherence (aOR 0.39, 95% CI 0.21-0.72, P = 0.003), as was sexual abuse (aOR 0.54, 95% CI 0.29-0.99, P = 0.048). The marginal predicted probability of ART adherence for adolescents with no exposure to either IPV or sexual abuse was 72% (95% CI 70-74%) compared with 38% (95% CI 20-56%) for adolescents with exposure to both IPV and sexual abuse. Moderation results showed similar associations between sexual violence and ART adherence by sex. Sexual violence prevention and postviolence care may be essential components of supporting adolescent ART adherence. Integration of HIV and violence prevention services will require accessible services and simple referral systems.

Viral suppression and self-reported ART adherence after 3 years of universal testing and treatment in the HPTN 071 (PopART) community-randomised trial in Zambia and South Africa: a cross-sectional analysis

In 2014, UNAIDS set the target that 90% of individuals on antiretroviral therapy (ART) be virally suppressed. Here, we use data from the HPTN 071 (PopART) trial to report whether the introduction of universal testing and treatment has affected viral suppression or treatment adherence among individuals who self-reported they were taking ART, and identify risk factors for these outcomes. This was a cross-sectional study nested within the randomly selected population cohort of the PopART trial. The trial took place in 21 communities in Zambia and South Africa. Analyses included 3570 HIV-positive participants who were seen at the second follow-up visit in 2016-17 and who self-reported that they were currently taking ART. Viral suppression was defined as HIV RNA of less than 400 copies per mL from a blood sample collected during the cohort visit, and ART adherence was measured using self-reporting (reported as no missed pills in last 7 days). Prevalences of these outcomes were compared across three trial arms using a two-stage approach suitable for clustered data. Each arm consisted of seven communities, with one arm receiving a combination HIV prevention package including immediate ART initiation, one receiving a combination HIV prevention package excluding immediate ART initiation and one arm receving standard of care. Risk factors for each of the outcomes were assessed using logistic regression. Among the 3570 participants who self-reported that they were currently on ART, 416 (11·7%) of 3554 were not virally suppressed (16 were missing viral suppression status) and 345 (9·7%) of 3566 reported being non-adherent to ART (four were missing adherence status). The proportion not virally suppressed was higher in communities in South Africa (195 [16·4%] of 1191) than in Zambia (221 [9·4%] of 2363). There was no evidence that the prevalence of the outcomes differed between trial arms. There was evidence that men, younger individuals, individuals who reported participating in harmful alcohol use, and those who reported internalised stigma were more likely to be non-adherent, and not virally suppressed. The results assuaged concerns that early ART initiation in a universal testing and treatment setting could lead to reduced adherence and viral suppression. US National Institute of Allergy and Infectious Diseases (which is a part of the National Institutes of Health), the International Initiative for Impact Evaluation with support from the Bill &amp; Melinda Gates Foundation, US President's Emergency Plan for AIDS Relief, and Medical Research Council UK.

Antiretroviral Drug Detection in a Community-Randomized Trial of Universal HIV Testing and Treatment: HPTN 071 (PopART).

Antiretroviral therapy (ART) reduces human immunodeficiency virus (HIV) transmission risk. The primary aim of this study was to evaluate ART uptake in a trial in Zambia and South Africa that implemented a community-wide universal testing and treatment package to reduce HIV incidence. Study communities were randomized to 3 arms: A, combination-prevention intervention with universal ART; B, combination-prevention intervention with ART according to local guidelines; and C, standard of care. Samples were collected from people with HIV (PWH) during a survey visit conducted 2 years after study implementation: these samples were tested for 22 antiretroviral (ARV) drugs. Antiretroviral therapy uptake was defined as detection of ≥1 ARV drug. Resistance was evaluated in 612 randomly selected viremic participants. A 2-stage, cluster-based approach was used to assess the impact of the study intervention on ART uptake. Antiretroviral drugs were detected in 4419 of 6207 (71%) samples (Arm A, 73%; Arm B, 70%; Arm C, 60%); 4140 (94%) of samples with ARV drugs had viral loads <400 copies/mL. Drug resistance was observed in 237 of 612 (39%) viremic participants (95 of 102 [93%] with ARV drugs; 142 of 510 [28%] without drugs). Antiretroviral therapy uptake was associated with older age, female sex, enrollment year, seroconverter status, and self-reported ART (all P < .001). The adjusted risk ratio for ART uptake was similar for Arm A versus C (1.21; 95% confidence interval [CI], .94-1.54; P = .12) and Arm B versus C (1.14; 95% CI, .89-1.46; P = .26). At the 2-year survey, 71% of PWH were on ART and 94% of those participants were virally suppressed. Universal testing and treatment was not significantly associated with increased ART uptake in this cohort.

Antiretroviral Drug Resistance in HIV Sequences From People Who Inject Drugs and Men Who Have Sex With Men Across 21 Cities in India.

BackgroundDrug resistance testing is limited in public-sector human immunodeficiency virus (HIV) care in India, and there are few systematic samplings for prevalent drug resistance mutations (DRMs), particularly among men who have sex with men (MSM) and people who inject drugs (PWID).MethodsWe conducted genotypic resistance testing on 915 HIV sequences sampled from viremic self-reported antiretroviral therapy (ART) experienced and naive PWID and MSM recruited from 21 cities across India in 2016–2017. We analyzed factors associated with resistance using logistic regression and evaluated evidence for transmitted resistance using phylogenetic analyses.ResultsOf the 915 participants sequenced, median age was 31, 436 were MSM, and 191 were ART experienced. Overall, 62.8% of ART-experienced participants and 14.4% of ART-naive participants were found to have low-level resistance or higher to 1 or more classes of drugs. Prevalence of tenofovir disoproxil fumarate resistance was 25.7% in ART-experienced participants and 1.11% in ART-naive participants. The highest proportion of drug resistance was seen across nucleoside reverse transcriptase inhibitors and nonnucleoside reverse transcriptase inhibitors, and resistance was significantly more common among MSM participants than PWID. Phylogenetic analyses revealed that 54.6% of ART-naive participants with resistance who clustered had shared DRMs, suggesting transmitted resistance may have occurred.ConclusionsPatients experiencing virologic failure on first-line therapy switched blindly to tenofovir/lamivudine/dolutegravir may effectively be receiving dolutegravir monotherapy due to resistance to tenofovir and lamivudine. While dolutegravir is expected to have full activity in the majority of patients in India, follow-up is needed to understand how resistance may affect long-term outcomes.