Antiretroviral Therapy Refill 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.

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 with clinic-based care. The effect of changing COVID-19 alert levels on self-reported ART use has not been quantified. KwaZulu-Natal, South Africa. 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 3 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. Of 155 participants, 46% were women and the 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 of self-reported daily ART use between refill groups when comparing across periods [DiDperiod 2 vs. 1 = 1.05; 95% confidence interval: 0.97, 1.13 and DiDperiod 3 vs. 2 = 0.99; 95% confidence interval (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). The COVID-19 pandemic did not differentially impact self-reported ART adherence by the 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.

Costs of home-delivered antiretroviral therapy refills for persons living with HIV: evidence from a pilot randomized controlled trial in KwaZulu-Natal, South Africa.

Antiretroviral therapy (ART) is needed across the lifetime to maintain viral suppression for people living with HIV. In South Africa, obstacles to reliable access to ART persist and are magnified in rural areas, where HIV services are also typically costlier to deliver. A recent pilot randomized study (the Deliver Health Study) found that home-delivered ART refills, provided at a low user fee, effectively overcame logistical barriers to access and improved clinical outcomes in rural South Africa. In the present costing study using the payer perspective, we conducted retrospective activity-based micro-costing of home-delivered ART within the Deliver Health Study and when provided at-scale (in a rural setting), and compared to facility-based costs using provincial expenditure data (covering both rural and urban settings). Within the context of the pilot Deliver Health Study which had an average of three deliveries per day for three days a week, home-delivered ART cost (in 2022 USD) $794 in the first year and $714 for subsequent years per client after subtracting client fees, compared with $167 per client in provincial clinic-based care. We estimated that home-delivered ART can reasonably be scaled up to 12 home deliveries per day for five days per week in the rural setting. When delivered at scale, home-delivered ART cost $267 in the first year and $183 for subsequent years per client. Average costs of home delivery further decreased when increasing the duration of refills from three-months to six- and 12-month scripts (from $183 to $177 and $135 per client, respectively). Personnel costs were the largest cost for home-delivered refills while ART drug costs were the largest cost of clinic-based refills. When provided at scale, home-delivered ART in a rural setting not only offers clinical benefits for a hard-to-reach population but is also comparable in cost to the provincial standard of care.

HIV viral suppression and risk of viral rebound in patients on antiretroviral therapy: a two- year retrospective cohort study in Northern Tanzania

BackgroundThe world is moving towards the third target of the Joint United Nations Programme on HIV/AIDS to ensure most people receiving antiretroviral therapy (ART) are virologically suppressed. Little is known about viral suppression at an undetectable level and the risk of viral rebound phenomenon in sub-Saharan Africa which covers 67% of the global HIV burden.This study aimed to investigate the proportion of viral suppression at an undetectable level and the risk of viral rebound among people living with HIV receiving ART in northern Tanzania.MethodologyA hospital based-retrospective study recruited people living with HIV who were on ART for at least two years at Kibong’oto Infectious Disease Hospital and Mawenzi Regional Referral Hospital in Kilimanjaro Region, Tanzania. Participants’ two-year plasma HIV were captured at months 6, 12, and 24 of ART. Undetectable viral load was defined by plasma HIV of viral load (VL) less than 20copies/ml and viral rebound (VR) was considered to anyone having VL of more than 50 copies/ml after having history of undetectable level of the VL less than 20copies/ml. A multivariable log-binomial generalized linear model was used to determine factors for undetectable VL and viral VR.ResultsAmong 416 PLHIV recruited, 226 (54.3%) were female. The mean (standard deviation) age was 43.7 (13.3) years. The overall proportion of undetectable VL was 68% (95% CI: 63.3–72.3) and 40.0% had viral rebound (95% CI: 34.7–45.6). Participants who had at least 3 clinic visits were 1.3 times more likely to have undetectable VL compared to those who had 1 to 2 clinic visits in a year (p = 0.029). Similarly, participants with many clinical visits ( > = 3 visits) per year were less likely to have VR compared to those with fewer visits ( = 2 visits) [adjusted relative risk (aRR) = 0.64; 95% CI: 0.44–0.93].ConclusionParticipants who had fewer clinic visits per year(ART refills) were less likely to achieve viral suppression and more likely to experience viral rebound. Enhanced health education and close follow-up of PLHIV on antiretroviral therapy are crucial to reinforce adherence and maintain an undetectable viral load.

The impact of the COVID-19 pandemic on people living with HIV: a cross-sectional study in Caracas, Venezuela

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic has disrupted multiple health services, including human immunodeficiency virus (HIV) testing, care, and treatment services, jeopardizing the achievement of the Joint United Nations Programme on HIV/AIDS 90-90-90 global target. While there are limited studies assessing the impact of the COVID-19 pandemic on people living with HIV (PLHIV) in Latin America, there are none, to our knowledge, in Venezuela. This study aims to assess the impact of the COVID-19 pandemic among PLHIV seen at the outpatient clinic of a reference hospital in Venezuela.MethodsWe conducted a cross-sectional study among PLHIV aged 18 years and over seen at the Infectious Diseases Department of the University Hospital of Caracas, Venezuela between March 2021 and February 2022.ResultsA total of 238 PLHIV were included in the study. The median age was 43 (IQR 31–55) years, and the majority were male (68.9%). Most patients (88.2%, n = 210) came for routine check-ups, while 28 (11.3%) were newly diagnosed. The majority of patients (96.1%) were on antiretroviral therapy (ART), but only 67.8% had a viral load test, with almost all (95.6%) being undetectable. Among those who attended regular appointments, 11.9% reported missing at least one medical consultation, and 3.3% reported an interruption in their ART refill. More than half of the patients (55.5%) had received at least one dose of the COVID-19 vaccine, while the rest expressed hesitancy to get vaccinated. Most patients with COVID-19 vaccine hesitancy were male (65.1%), younger than 44 years (57.5%), employed (47.2%), and had been diagnosed with HIV for less than one year (33%). However, no statistically significant differences were found between vaccinated patients and those with COVID-19 vaccine hesitancy. Older age was a risk factor for missing consultations, while not having an alcoholic habit was identified as a protective factor against missing consultations.ConclusionThis study found that the COVID-19 pandemic had a limited impact on adherence to medical consultations and interruptions in ART among PLHIV seen at the University Hospital of Caracas, Venezuela.

Intersecting Epidemics: The Predictors of Continued Utilization of HIV Care and Treatment Services During the COVID-19 Outbreak Among People Living with HIV in ZIMBABWE.

Globally, there have been considerable achievements towards HIV care and treatment. AIDS-related deaths have been reduced by 60% since the peak in 2004. Potentially, the fight against the HIV epidemic was made more difficult with the outbreak of COVID-19. Thus, this study examined the implications of COVID-19 in the utilization of HIV care and treatment services among people living with HIV on antiretroviral therapy (ART) in Zimbabwe. The study aimed to identify the critical factors defining the utilization of HIV services at the advent of COVID-19 using the fifth revision of the Anderson Behavioral Model of Healthcare Utilization. The study utilized a concurrent triangulation design of which only one data collection phase was used. The quantitative data was collected from 2,157 people living with HIV on antiretroviral viral therapy through a structured interviewer-administered questionnaire. On the other hand, qualitative data was collected through in-depth interviews. Regarding accessing ART refills, the study findings revealed that adolescents aged 15-19 (aOR = 2.16; 95% CI: 1.18-3.96) had higher odds of utilizing ART refills compared to their counterparts who were aged 20-24. Living in arural area was associated with higher odds of utilizing the ART refill service (aOR = 2.20; 95% CI: 1.49-3.24). Regarding accessing viral load monitoring adults aged 25-39 (aOR = 0.41; 95% CI: 0.26-0.66) were less likely to utilize viral load monitoring compared to young people aged 20-24. Being vaccinated for COVID-19 was significantly associated with higher odds of utilizing the viral load monitoring service (aOR = 1.97; 95% CI: 1.36-2.87) than those not yet vaccinated. Living ina rural area was associated with higher odds of utilizing viral load monitoring (aOR = 1.50; 95% CI: 1.09-2.08). Regarding tuberculosis preventative therapy, adults aged 25-39 (aOR = 0.30; 95% CI: 0.20-0.47) were less likely to utilize tuberculosis preventative therapy compared to young people aged 20-24. Being vaccinated for COVID-19 was significantly associated with higher odds of utilizing tuberculosis preventative therapy (aOR = 1.59; 95% CI: 1.12-2.25) than those not yet vaccinated. Living ina rural area was associated with higher odds of utilizing tuberculosis preventive therapy (aOR = 1.58; 95% CI: 1.19-2.08). Regarding tuberculosis screening being vaccinated for COVID-19 was significantly associated with higher odds of utilizing tuberculosis screening services (aOR = 1.89; 95% CI: 1.41-2.54) than those not yet vaccinated. Although the severity of the COVID-19 pandemic has dwindled, COVID-19 appears to come and go in waves, and a few countries are still recording relatively high cases. It is therefore likely that the factors associated with utilization of HIV services identified by the study such as age, residence, type of health facility, vaccination of COVID-19 and fear of contracting COVID-19, among others, need to be included when planning to improve access to health utilization.

Person-centred, integrated non-communicable disease and HIV decentralized drug distribution in Eswatini and South Africa: outcomes and challenges.

Non-communicable diseases (NCDs) are highly prevalent in people living with HIV above 50 years of age and account for increasing mortality. There is little published evidence supporting person-centred, integrated models of HIV care, hypertension and diabetes treatment in southern Africa, and no data demonstrating mortality reduction. Where clinical visits for NCDs and HIV cannot be combined, integrated medication delivery presents an opportunity to streamline care and reduce patient costs. We present experiences of integrated HIV and NCD medication delivery in Eswatini and South Africa, focusing on programme successes and implementation challenges. Programmatic data from Eswatini's Community Health Commodities Distribution (CHCD) from April 2020 to December 2021 and South Africa's Central Chronic Medicines Dispensing and Distribution (CCMDD) from January 2016 to December 2021 were provided by programme managers and are summarized here. Launched in 2020, Eswatini's CHCD provides over 28,000 people with and without HIV with integrated services, including HIV testing, CD4 cell count testing, antiretroviral therapy refills, viral load monitoring and pre-exposure prophylaxis alongside NCD services, including blood pressure and glucose monitoring and hypertension and diabetes medication refills. Communities designate neighbourhood care points and central gathering places for person-centred medication dispensing. This programme reported fewer missed medication refill appointments among clients in community settings compared to facility-based settings. South Africa'sCCMDD utilizes decentralized drug distribution to provide medications for over 2.9 million people, including those living with HIV, hypertension and diabetes. CCMDD incorporates community-based pickup points, facility "fast lanes" and adherence clubs with public sector health facilities and private sector medication collection units. There are no out-of-pocket payments for medications or testing commodities. Wait-times for medication refills are lower at CCMDD sites than facility-based sites. Innovations to reduce stigma include uniformly labelled medication packages for NCD and HIV medications. Eswatini and South Africa demonstrate person-centred models for HIV and NCD integration through decentralized drug distribution. This approach adapts medication delivery to serve individual needs and decongest centralized health facilities while efficiently delivering NCD care. To bolster programme uptake, additional reporting of integrated decentralized drug distribution models should include HIV and NCD outcomes and mortality trends.

Retesting of Patients Receiving Antiretroviral Treatment at HIV Care and Treatment and Prevention of Mother-To-Child HIV Transmission Sites in Cameroon

The World Health Organization recommends retesting of newly diagnosed HIV cases for verification of results prior to antiretroviral therapy (ART) initiation. This study aimed at ascertaining the HIV status of clients on lifelong ART. We tested 25% of ART clients in 6 care and treatment (C&T) sites and all HIV-positive women receiving ART in 22 prevention of mother-to-child HIV transmission (PMTCT) sites in Northwest and Southwest regions. Testing was proposed consecutively to clients in group education sessions during ART refill visit until the sample size was achieved. Individual counselling was provided to clients who opted to be retested. Testing was with Determine HIV-1/2 and First Response rapid tests and further testing was with DNA-PCR. Clients with negative test results were counseled to discontinue ART. Results were analyzed comparing misdiagnosis at ART and PMTCT sites. A total of 4526 ART clients were retested for HIV; 3914(86.5%) from ART and 612(13.5%) from PMTCT sites. Female participants dominated (79%) and the median age was 39 years. Higher proportions of clients retested at PMTCT sites were negative with both tests (0.8% vs 0.1%) and had discordant results (1.1% vs 0.4%) than at ART sites. All 32 clients with negative or discordant results were tested with DNA-PCR and 22(0.5%) were negative; 11(0.3%) in ART and 11(1.8%) in PMTCT sites. HIV positive status was confirmed for 99.5% of clients retested, with a lower rate at PMTCT (98.2%) than C&T (99.7%) sites; meaning misdiagnosis and inappropriate ART treatment was more likely at PMTCT. Adherence to recommendation for HIV retesting for verification will reduce inappropriate treatment. Keywords: HIV, Retesting, Misdiagnosis, Care and Treatment Centre, PMTCT, Cameroon

Increasing multimonth dispensing of antiretrovirals and assessing the effect on viral load suppression among children and adolescents receiving HIV services in Nigeria.

Multimonth dispensing (MMD) enables less frequent clinic visits and improved outcomes for people living with HIV, but few children and adolescents living with HIV (CALHIV) are on MMD. At the end of the October-December 2019 quarter, only 23% of CALHIV receiving antiretroviral therapy (ART) through SIDHAS project sites in Akwa Ibom and Cross River states, Nigeria, were receiving MMD. In March 2020, during COVID-19, the government expanded MMD eligibility to include children and recommended rapid implementation to minimize clinic visits. SIDHAS provided technical assistance to 36 "high-volume" facilities-≥5 CALHIV on treatment-in Akwa Ibom and Cross River to increase MMD and viral load suppression (VLS) among CALHIV, toward PEPFAR's 80% benchmark for people currently on ART. We present change in MMD, viral load (VL) testing coverage, VLS, optimized regimen coverage, and community-based ART group enrollment among CALHIV from the October-December 2019 quarter (baseline) to January-March 2021 (endline) based on retrospective analysis of routinely collected program data. We compared MMD coverage (primary objective), and optimized regimen coverage, community-based ART group enrollment, VL testing coverage, and VLS (secondary objectives), among CALHIV 18 years and younger pre-/post-intervention (baseline/endline) at the 36 facilities. We excluded children younger than two years, who are not recommended for or routinely offered MMD. The extracted data included age, sex, ART regimen, months of ART dispensed at last refill, most recent VL test results, and community ART group enrollment. Data on MMD-three or more months of ARVs dispensed at one time-were disaggregated into three to five months (3-5-MMD) vs. six or more months (6-MMD). VLS was defined as ≤1,000 copies. We documented MMD coverage by site, optimized regimen, and VL testing and suppression. Using descriptive statistics, we summarized the characteristics of CALHIV on MMD and non-MMD, number of CALHIV on optimized regimens, and proportion enrolled in differentiated service delivery models and community-based ART refill groups. For the intervention, SIDHAS technical assistance was data driven: weekly data analysis/review, site-prioritization scoring, provider mentoring, line listing eligible CALHIV, pediatric regimen calculator, child-optimized regimen transitioning, and community ART models. The proportion of CALHIV ages 2-18 receiving MMD increased from 23% (620/2,647; baseline) to 88% (3,992/4,541; endline), while the proportion of sites reporting suboptimal MMD coverage among CALHIV (<80%) decreased (100% to 28%). In March 2021, 49% of CALHIV were receiving 3-5-MMD and 39% 6-MMD. In October-December 2019, 17%-28% of CALHIV were receiving MMD; by January-March 2021, 99% of those 15-18 years, 94% 10-14 years, 79% 5-9 years, and 71% 2-4 years were on MMD. VL testing coverage remained high (90%), while VLS increased (64% to 92%). The proportion on pediatric-optimized regimens increased (58% to 79%). MMD was feasible among CALHIV without compromising VLS. Expanded eligibility criteria, line listing eligible children, monitoring pediatric antiretroviral stock, and data use contributed to positive results. Future efforts should address low 6-MMD uptake related to stock limitations and synchronize antiretroviral refill pickup with VL sample collection.

RETRACTED ARTICLE: Development of attributes and attribute levels for a discrete choice experiment on patients’ and providers’ choice for antiretroviral therapy service in Northwest Ethiopia

BackgroundDiscrete choice experiments (DCEs) are used to assess the strength of preferences and value of interventions. However, researchers using this approach have been criticized for not conducting or publishing rigorous studies to select the required attributes and levels. Proper specification of attributes and their levels determines the validity of DCE. Hence, our study aimed to identify and define attributes and levels for the design of a DCE to elicit patients’ and providers’ preferences for ART service in Northwest Ethiopia.MethodsFour stages were followed to derive the final list of attributes and levels: (1) a literature review to derive conceptual attributes; (2) key informant interviews of 17 providers and in-depth interviews of 15 adult stable patients to identify context-specific attributes and attribute levels; (3) ranking survey among 31 HIV/AIDS program implementers and rating survey among 35 adult stable patients and 42 health workers providing antiretroviral therapy (ART) service to indicate participants’ preference of attributes; and (4) an expert opinion to reduce the list of attributes and levels.ResultsFirst, a literature review identified 23 candidate attributes. Second, individual-level analysis of the qualitative transcripts confirmed 15 of these 23 attributes. Third, the ranking and rating surveys put the importance of the 23 ART service attributes in order of preference. Fourth, through discussions with eight experts, 17 attributes were discarded based on multiple criteria. The six retained attributes were: the location of ART refills, the frequency of receiving ART refills, the person providing ART refills, the participants/others seen at the same ART refill visit, medication refill pick-up/delivery times, and the total cost of the visit during antiretroviral (ARV) medication refill. Finally, levels were assigned to these 6 attributes based on data from the literature, transcripts, and knowledge of the Ethiopian context.ConclusionsThis detailed description illuminates the attribute development process and provides the reader with a basis for evaluating the rigor of this phase of DCE construction. This paper contributes empirical evidence to the limited methodological literature on attributes and levels of development for DCE, thereby providing further empirical guidance on ART service preference, specifically among patients of low- and middle-income countries.

Retention in care among people living with HIV in the national antiretroviral therapy programme in Guinea: A retrospective cohort analysis.

Few studies have investigated retention in HIV care in West Africa. We measured retention in antiretroviral therapy (ART) programmes among people living with HIV and re-engagement in care among those lost to follow up (LTFU) in Guinea and identified associated risk factors using survival analysis. Patient-level data were analysed from 73 ART sites. Treatment interruptions and LTFU were defined as missing a ART refill appointment by over 30 days and by over 90 days respectively. A total of 26,290 patients initiating ART between January 2018 and September 2020 were included in the analysis. The mean age at ART initiation was of 36.2 years, with women accounting for 67% of the cohort. Retention 12 months after ART initiation was 48.7% (95%CI 48.1-49.4%). The LTFU rate was 54.5 per 1000 person-months (95% CI 53.6-55.4), with the peak hazards of LTFU occurring after the first visit and decreasing steadily over time. In an adjusted analysis, the hazards of LTFU were higher among men compared to women (aHR = 1.10; 95%CI 1.08-1.12), being aged 13-25 years old versus older patients (aHR = 1.07; 95%CI = 1.03-1.13), and among those initating ART in smaller health facilities (aHR = 1.52; 95%CI 1.45-1.60). Among 14,683 patients with an LTFU event, 4,896 (33.3%) re-engaged in care, of whom 76% did so within six months from LTFU. The re-engagement rate was 27.1 per 1000 person-months (95%CI 26.3-27.9). Treatment interruptions were correlated with rainfall patterns and end of year mobility patterns. Rates of retention and re-engagement in care are very low in Guinea, undermining the effectiveness and durability of first-line ART regimens. Tracing interventions and differentiated service delivery of ART, including multi-month dispensing may improve care engagement, especially in rural areas. Further research should investigate social and health systems barriers to retention in care.

HIV Care Preferences among Young People Living with HIV in Lesotho: A Secondary Data Analysis of the PEBRA Cluster Randomized Trial

Introduction. Sub-Saharan Africa is home to 89% of all young people living with HIV, a key population with specific challenges and needs. In-depth knowledge of service demands is needed to tailor and differentiate service delivery for this group. We evaluated HIV care preferences among young people living with HIV who were part of the PEBRA (Peer Educator Based Refill of ART) cluster-randomized trial. Methods. The PEBRA trial evaluated a novel model of care at 20 health facilities in Lesotho, Southern Africa. In the PEBRA model, a peer educator regularly assessed participant preferences regarding antiretroviral therapy (ART) refill location, SMS notifications (for adherence, drug refill, viral load), and general care support options and delivered services accordingly over a 12-month period. We present these preferences and their changes over time. Results. At enrolment, 41 of 123 (33.3%) chose ART refill outside the health facility, compared to 8 of 123 (6.5%) after 12 months. Among those selecting clinic-based ART refill, many preferred collecting ART during the peer educator led Saturday clinic club, 45 of 123 (36.5%) at the beginning and 55 of 123 (44.7%) at the end. SMS reminders for treatment adherence and ART refill visits were chosen by 51 of 123 (41.5%) at enrolment and 54 of 123 (44.7%) at the last assessment. Support by the peer educator was popular at the beginning (110 of 123 (89.4%)) and lower but still high at the end (85 of 123 (69.1%)). Thirteen of 123 (10.6%) participants chose support by the nurse, without the involvement of any peer educator, at the first and 21 of 123 (17.1%) at the last assessment. Conclusion. Our longitudinal preference assessment among young people living with HIV in Lesotho showed a sustained interest in SMS notifications for adherence and refill visits as well as in additional support by a peer educator. ART refill outside the health facility was not as popular as expected; instead, medication pick-up at the facility, especially during Saturday clinic clubs, was favoured. The PEBRA trial was registered with clinicaltrials.gov (NCT03969030. Registered on 31 May 2019)

Effect of Dolutegravir and multi-month dispensing on viral suppression among children with HIV.

Few studies in sub-Saharan Africa have assessed the impact of multi-month dispensing (MMD) of antiretroviral therapy (ART) and dolutegravir (DTG) beyond clinical trials among children with HIV (CWHIV). We assessed the effect of the two interventions on achieving undetectable viral load (VL) among CWHIV 0-15 years in Nigeria. We utilized longitudinal routine records, and cross-sectional survey data from caregivers of a sub-sample of children. VLs were considered suppressed at <1000 copies/ml and undetectable at <50 copies/ml. MMD was defined as ART refill for >84 days. The effect of MMD and DTG on VL levels, and associations between social factors and VL was estimated using generalized linear models, reporting adjusted relative risks (aRR)/prevalence ratios (aPR) and 95% confidence intervals (95%CI). Of 2,490 CWHIV, 52% were male, with a median age of 10 years (IQR: 6-13) and median duration on ART of 4.6 years (IQR: 2.8-7.1). Overall, 73% were on DTG and 55% received MMD. At baseline, 63% were suppressed, while 79% and 56% were suppressed and undetectable in their last VL respectively.We found no differences in undetectable VL between those on MMD and not on MMD (aRR: 1.05 [95%CI: 0.94-1.18]); and between those on DTG and not on DTG (1.07 [0.92-1.25]). In secondary analyses, poor adherence and being in a support group were associated with lower likelihood of undetectable VL (aPR: 0.85 [95%CI: 0.74-0.96], and 0.81 [0.68-0.96] respectively). MMD did not compromise treatment outcomes for CWHIV. Poor adherence however remains a barrier to achieving treatment targets.

Mobility and ART retention among men in Malawi: a mixed-methods study.

Mobility is associated with worse outcomes across the HIV treatment cascade, especially among men. However, little is known about the mechanisms that link mobility and poor HIV outcomes and what types of mobility most increase the risk of treatment interruption among men in southern Africa. From August 2021 to January 2022, we conducted a mixed-methods study with men living with HIV (MLHIV) but not currently receiving antiretroviral therapy (ART) in Malawi. Data collection was embedded within two larger trials (ENGAGE and IDEaL trials). We analysed baseline survey data of 223 men enrolled in the trials who reported being mobile (defined as spending ≥14 nights away from home in the past 12 months) using descriptive statistics and negative binomial regressions. We then recruited 32 men for in-depth interviews regarding their travel experiences and ART utilization. We analysed qualitative data using constant comparative methods. Survey data showed that 34% of men with treatment interruptions were mobile, with a median of 60 nights away from home in the past 12 months; 69% of trips were for income generation. More nights away from home in the past 12 months and having fewer household assets were associated with longer periods out of care. In interviews, men reported that travel was often unplanned, and men were highly vulnerable to exploitive employer demands, which led to missed appointments and ART interruption. Men made major efforts to stay in care but were often unable to access care on short notice, were denied ART refills at non-home facilities and/or were treated poorly by providers, creating substantial barriers to remaining in and returning to care. Men desired additional multi-month dispensing (MMD), the ability to refill treatment at any facility in Malawi, and streamlined pre-travel refills at home facilities. Men prioritize ART and struggle with the trade-offs between their own health and providing for their families. Mobility is an essential livelihood strategy for MLHIV in Malawi, but it creates conflict with ART retention, largely due to inflexible health systems. Targeted counselling and peer support, access to ART services anywhere in thecountry, and MMD may improve outcomes for mobile men.

A Sequential Multiple Assignment Randomized Trial of scalable interventions for ART delivery in South Africa: the SMART ART study

BackgroundOf the 8 million people in South Africa living with HIV, 74% of persons living with HIV are on antiretroviral therapy (ART) and 65% are virally suppressed. Detectable viral load results in HIV-associated morbidity and mortality and HIV transmission. Patient barriers to care, such as missed wages, transport costs, and long wait times for clinic visits and ART refills, are associated with detectable viral load. HIV differentiated service delivery (DSD) has simplified ART delivery for clients who achieve viral suppression and engage in care. However, DSD needs adaptation to serve clients who are not engaged in care.MethodsA Sequential Multiple Assignment Randomized Trial will be undertaken in KwaZulu-Natal, South Africa, to test adaptive ART delivery for persons with detectable viral load and/or who are not engaged in care. The types of differentiated service delivery (DSD) which will be examined in this study are clinic-based incentives, community-based smart lockers, and home delivery. The study plans to enroll up to 900 participants-people living with HIV, eligible for ART, and who are not engaged in care. The study aims to assess the proportion of ART-eligible persons living with HIV who achieve viral suppression at 18 months. The study will also evaluate the preferences of clients and providers for differentiated service delivery and evaluate the cost-effectiveness of adaptive HIV treatment for those who are not engaged in care.DiscussionTo increase population-level viral suppression, persons with detectable viral load need responsive DSD interventions. A Sequential Multiple Assignment Randomized Trial (SMART) design facilitates the evaluation of a stepped, adaptive approach to achieving viral suppression with “right-sized” interventions for patients most in need of effective and efficient HIV care delivery strategies.Trial registrationClinicalTrials.gov NCT05090150. Registered on October 22, 2021

Stakeholder Engagement to Drive Iterative Software Development of the ART-Access Web-Based Application for Community Pharmacy Dispensing of Anti-Retroviral Therapy

Introduction: Significant advances in combination anti-retroviral therapy have been instrumental in improving the quality of lives and life expectancy for people living with HIV. However, in the absence of a cure, sustained investment and innovation is required to improve adherence and quality of life for people living with HIV. We developed ARTAccess, a web-based application that links patient information on anti-retroviral therapy and viral load to an algorithm that guides a private community pharmacist on anti-retroviral therapy refills without the need for an additional nurse in the pharmacy. The aim of this paper is to describe the present the development process of the ARTAccess application and the exploration of the perceptions about its use by end users. Methods: Between October–December 2018, we conducted a qualitative observational study to document the processes of the ART-Access™ application development. Using theoretical frameworks of participatory action research and human-centred design, we undertook structured and unstructured observations of the application development review meetings. We observed and had interactions in 12 stakeholder meetings. Three observers attended each development meeting and independently drafted a reflective narration of the transcript and separately conducted their own analyses. ARTAccess was launched in January 2019 and in March 2019, three in-depth interviews were conducted with the nurse dispensers running the refill program at the three pharmacies where ARTAccess was piloted. Results: The ARTAccess application development meetings generated emerging themes. Introduction of a mHealth application for efficiency introduced job insecurity fears of health workers which needed to be addressed, to allow for increased engagement by health worker stakeholders. Stakeholder meetings provided important perceived gaps and needs for improvement at each stage of the ARTAccess application development. The user-centred design process led to five application versions; three more than the two originally planned; the feedback on the ARTAccess application became more positive as later versions were presented to stakeholders. Conclusions: The study provides evidence that participatory action research in a human-centred design approach enhanced the application development process of a new technology for health. In resource limited settings, where digital technologies may be used to support overstretched health systems, health workers need re-assurance that digital tools being developed will not threaten their employment.

Impact of COVID-19 on Adolescent HIV Prevention and Treatment Services in the AHISA Network

We investigated perceived impacts of COVID-19 on the delivery of adolescent HIV treatment and prevention services in sub-Saharan Africa (SSA) by administering a survey to members of the Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA) from February to April 2021. We organized COVID-19 impacts, as perceived by AHISA teams, under three themes: service interruptions, service adjustments, and perceived individual-level health impacts. AHISA teams commonly reported interruptions to prevention programs, diagnostic testing, and access to antiretroviral therapy (ART). Common service adjustments included decentralization of ART refills, expanded multi-month ART distribution, and digital technology use. Perceived individual-level impacts included social isolation, loss to follow-up, food insecurity, poverty, and increases in adolescent pregnancies and sexually transmitted infections. The need for collaboration among stakeholders were commonly cited as lessons learned by AHISA teams. Survey findings highlight the need for implementation science research to evaluate the effects of pandemic-related HIV service adaptations in SSA.

Barriers and Facilitators to Successful Intensive Adherence Counseling in Rural Northern Uganda: An Exploratory Interview with HIV-Positive Clients Using the COM-B Framework.

Intensive adherence counseling (IAC) was introduced as a strategy to enhance adherence to antiretroviral therapy (ART) among HIV clients with non-suppressed viral loads. There has been sub-optimal viral load suppression among HIV clients in Uganda enrolled in IAC. However, there is a scarcity of literature on the barriers and facilitators of successful IAC. We aim to explore the barriers and facilitators to successful IAC among HIV-positive clients seeking care in public health facilities in rural northern Uganda. This was an exploratory qualitative study conducted among 15 purposively sampled HIV-positive clients enrolled in IAC in public health facilities offering ART services in northern Uganda. We conducted in-depth interviews using semi-structured interview guides based on the capability, opportunity, motivation, and behavior (COM-B) framework for behaviour change. Data were analyzed using the deductive thematic approach of Braun and Clarke following the COM-B framework. The majority of the participants were females (60%), married (53%), and attained primary education (47%). Barriers to successful IAC were Capability - alcoholism and promiscuity, Opportunity - stigma and discrimination, delayed viral load result, shortage of food, and heavy workload; and Motivation - deteriorating health and lack of incentives. Facilitators to successful IAC were Capability - good knowledge of ART, good memory, and reminder alerts; Opportunity - availability of ART, social support, availability of ART, prolonged ART refill, and good counseling; and Motivation - desire to live longer and healthy and the desire to fulfill dreams and goals. Successful implementation of IAC needs to consider the context of the person in care thus the need to strengthen individualized IAC sessions. HIV care providers can adopt the COM-B framework to perform individualized IACs and use the information to strengthen the counseling sessions.

Stakeholders’ solutions to antiretroviral therapy interruption during the COVID-19 pandemic in China: a short report

ABSTRACT Obtaining antiretroviral therapy (ART) was a challenge for people living with HIV (PLHIV) in China during the COVID-19 outbreak. On 26 January 2020, the Chinese Center for AIDS/STD Control and Prevention issued a nationwide directive to relax restrictions on where and when PLHIV could refill ART. This qualitative study explored unexpected barriers under this directive and recommendations to improve future ART delivery. Between February 11 and February 15 2020, in-depth interviews of 4 groups of stake holders related to ART refilling (i.e., PLHIV, community-based organization employees, CDC staff, infectious disease physicians and nurses), were conducted via WeChat. Data were managed by NVivo 11.0 and transcripts were coded using thematic analysis. Sixty-two interviews were conducted. The main barriers to refilling ART included: (1) inconsistent documentation requirements to refill ART, (2) lack of specific protocols on ART refilling, (3) insufficient staffing, and (4) regimen verification and drug shortages. The most common recommendations to improve future ART delivery were: (1) to establish a nationwide system to distribute ART and (2) increase the number of pills delivered with each ART refill. Strengthening protocols and systems to refill ART and improving collaboration is key to preventing interruptions in ART among PLHIV during public health emergencies.

Self-transfers and factors associated with successful tracing among persons lost to follow-up from HIV care, Sheema District, Southwestern Uganda: retrospective medical records review, 2017–2021

BackgroundDue to improved coverage and scale-up of antiretroviral therapy (ART), patients are increasingly transferring between ART-providing sites. Self-transfers may constitute a high proportion of patients considered lost to follow-up (LTFU), and if overlooked when reporting patients who have dropped out of HIV care, may result in an incorrect estimation of retention. We determined the prevalence of self-transfers, and successful tracing, and identified associated factors among people living with HIV (PLHIV) LTFU from care at public health facilities in Sheema District, Southwestern Uganda.MethodsWe conducted a cross-sectional retrospective medical records review during February and March 2022. We included records of all PLHIV who were LTFU from 2017 to 2021, and who were registered at government-owned ART clinics in Sheema District. LTFU was considered for those who were not taking ART refills for a period of ≥ 3 months. We abstracted demographic and clinical data from medical records at the selected clinics. Participants were traced via phone calls or in-person to ascertain the outcomes of LTFU. We performed multivariate modified Poisson regression to identify factors associated with self-transfer, and successful tracing.ResultsOverall, 740 patients were identified as LTFU from three ART-providing clinics; of these, 560 (76%) were self-transfers. The mean age was 30 (SD ± 10) years, and most (69%, n = 514) were female; the majority (87%, 641/740) were successfully traced. Age (adjusted prevalence ratio [aPR] = 1.13, 95% CI 1.01–1.25, P = 0.026 for those aged 18–30 years compared to > 30 years), female sex (aPR = 1.18, 95% CI 1.11–1.25, P < 0.001), and having WHO clinical stage 1–2 (aPR = 2.34, 95% CI 1.89–3.91, P < 0.001) were significantly associated with self-transfer. Presence of a phone contact in the patient’s file (aPR = 1.10, 95% CI 1.01–1.90, P = 0.026) was associated with successful tracing of the patients considered LTFU.ConclusionSelf-transfers accounted for the majority of patients recorded as LTFU, highlighting the need to account for self-transfers among patients considered LTFU, to accurately estimate retention in care. ART-providing facilities should regularly update contact information for PLHIV to enable successful tracing, in the event that the patients are LTFU. This calls for a health-tracking system that easily identifies self-transfers across ART-providing clinics using unique patient identifiers.

Availability and experiences of differentiated antiretroviral therapy delivery at HIV care facilities in rural Zimbabwe: a mixed-method study.

IntroductionZimbabwe adopted differentiated HIV care policies in 2015 to promote client‐centred care and relieve strain on health facilities. We examined the availability, experiences and perceptions of differentiated antiretroviral therapy (ART) delivery in rural Zimbabwe following the policy adoption.MethodsWe undertook a cross‐sectional mixed methods study in all the 26 facilities providing HIV care in a rural district in Zimbabwe. We collected quantitative data about ART delivery and visit durations from 31 healthcare providers and a purposive stratified sample of 378 clients obtaining ART either through routine care or differentiated ART delivery models. We performed 26 semi‐structured interviews among healthcare providers and seven focus group discussions (FGDs) among clients to elicit their perceptions and experiences of ART delivery. Data were collected in 2019, with one follow‐up FGD in 2021. We analysed the transcripts thematically, with inductive coding, to identify emerging themes.ResultsTwenty facilities (77%) offered at least one differentiated ART delivery models, including community ART refill groups (CARGs; 13 facilities, 50%), fast‐track refill (8, 31%), family refill (6, 23%) or club refill (1, 4%). Thirteen facilities (50%) offered only one model. The median visit duration was 28 minutes (interquartile range [IQR]: 16–62). Participants in fast‐track had the shortest visit durations (18 minutes, IQR: 11–24). Confidentiality and disclosure of HIV status, travelling long distances, travel costs and waiting times were the main issues influencing clients’ views on differentiated ART delivery. Fast‐track refill was perceived as the preferred model of clients for its limited involuntary disclosure and efficiency. In contrast, group‐ and community‐based refill models reduced travel costs but were felt to be associated with involuntary disclosure of HIV status, which could discourage clients. Healthcare providers also experienced an additional workload when offering facility‐based group models, such as CARGs.ConclusionsDifferentiated ART delivery models were widely available in this rural setting, but most facilities did not offer a choice of models to address clients’ diverse preferences. A minority offered fast‐track refills, although this model was often mentioned as desirable. Confidentiality, travel expenses and client waiting times are key elements to consider when planning and rolling out differentiated HIV care.