Provider-led community antiretroviral therapy distribution in Malawi: Retrospective cohort study of retention, viral load suppression and costs.

BACKGROUND: Outcomes of community antiretroviral therapy (ART) distribution (CAD), in which provider-led ART teams deliver integrated HIV services at health posts in communities, have been mixed in sub-Saharan African countries. CAD outcomes and costs relative to facility-based care have not been reported from Malawi. METHODS: We performed a retrospective cohort study in two Malawian districts (Lilongwe and Chikwawa districts), comparing CAD with facility-based ART care. We selected an equal number of clients in CAD and facility-based care who were aged >13 years, had an undetectable viral load (VL) result in the last year and were stable on first-line ART for ≥1 year. We compared retention in care (alive and no period of ≥60 days without ART) using Kaplan-Meier survival analysis and Cox regression and maintenance of VL suppression (<1,000 copies/mL) during follow-up using logistic regression. We also compared costs (in US$) from the health system and client perspectives for the two models of care. Data were collected in October and November 2020. RESULTS: 700 ART clients (350 CAD, 350 facility-based) were included. The median age was 43 years (IQR 36-51), median duration on ART was 7 years (IQR 4-9), and 75% were female. Retention in care did not differ significantly between clients in CAD (89.4% retained) and facility-based care (89.3%), p = 0.95. No significant difference in maintenance of VL suppression were observed between CAD and facility-based care (aOR: 1.24, 95% CI: 0.47-3.20, p = 0.70). CAD resulted in slightly higher health system costs than facility-based care: $118/year vs. $108/year per person accessing care; and $133/year vs. $122/year per person retained in care. CAD decreased individual client costs compared to facility-based care: $3.20/year vs. $11.40/year per person accessing care; and $3.60/year vs. $12.90/year per person retained in care. CONCLUSION: Clients in provider-led CAD care in Malawi had very good retention in care and VL suppression outcomes, similar to clients receiving facility-based care. While health system costs were somewhat higher with CAD, costs for clients were reduced substantially. More research is needed to understand the impact of other differentiated service delivery models on costs for the health system and clients.

Burnout and depression: A cross sectional study among health care workers providing HIV care during the COVID-19 pandemic in Malawi.

Health care workers (HCWs) in eastern Africa experience high levels of burnout and depression, and this may be exacerbated during the COVID-19 pandemic due to anxiety and increased work pressure. We assessed the prevalence of burnout, depression and associated factors among Malawian HCWs who provided HIV care during the COVID-19 pandemic. From April-May 2021, between the second and third COVID-19 waves in Malawi, we randomly selected HCWs from 32 purposively selected PEPFAR/USAID-supported health facilities for a cross-sectional survey. We screened for depression using the World Health Organization Self Report Questionnaire (positive screen: score≥8) and for burnout using the Maslach Burnout Inventory tool, (positive screen: moderate-high Emotional Exhaustion and/or moderate-high Depersonalization, and/or low-moderate Personal Accomplishment scores). Logistic regression models were used to evaluate factors associated with depression and burnout. We enrolled 435 HCWs, median age 32 years (IQR 28-38), 54% male, 34% were clinical cadres and 66% lay cadres. Of those surveyed, 28% screened positive for depression, 29% for burnout and 13% for both. In analyses that controlled for age, district, and residence (rural/urban), we found that screening positive for depression was associated with expecting to be infected with COVID-19 in the next 12 months (aOR 2.7, 95%CI 1.3-5.5), and previously having a COVID-19 infection (aOR 2.58, 95CI 1.4-5.0). Screening positive for burnout was associated with being in the clinical cadre (aOR 1.86; 95% CI: 1.2-3.0) and having a positive depression screen (aOR 3.2; 95% CI: 1.9-5.4). Reports of symptoms consistent with burnout and depression were common among Malawian HCWs providing HIV care but prevalence was not higher than in surveys before the COVID-19 pandemic. Regular screening for burnout and depression should be encouraged, given the potential for adverse HCW health outcomes and reduced work performance. Feasible interventions for burnout and depression among HCWs in our setting need to be introduced urgently.

Correlates of uptake of COVID-19 vaccines and motivation to vaccinate among Malawian adults.

COVID-19 vaccine coverage in most countries in Africa remains low. Determinants of uptake need to be better understood to improve vaccination campaigns. Few studies from Africa have identified correlates of COVID-19 vaccination in the general population. We surveyed adults at 32 healthcare facilities across Malawi, purposively sampled to ensure balanced representation of adults with and without HIV. The survey, informed by the World Health Organization's Behavioural and Social Drivers of Vaccination Framework, asked about people's thoughts and feelings about the vaccine, social processes, motivation to vaccinate, and access issues. We classified respondents' COVID-19 vaccination status and willingness to vaccinate, and used multivariable logistic regression to assess correlates of these. Among 837 surveyed individuals (median age was 39 years (IQR 30-49) and 56% were female), 33% were up-to-date on COVID-19 vaccination, 61% were unvaccinated, and 6% were overdue for a second dose. Those up-to-date were more likely to know someone who had died from COVID-19, feel the vaccine is important and safe, and perceive pro-vaccination social norms. Despite prevalent concerns about vaccine side effects, 54% of unvaccinated respondents were willing to vaccinate. Access issues were reported by 28% of unvaccinated but willing respondents. Up-to-date COVID-19 vaccination status was associated with positive attitudes about the vaccine and with perceiving pro-vaccination social norms. Over half of unvaccinated respondents were willing to get vaccinated. Disseminating vaccine safety messages from trusted sources and ensuring local vaccine availability may ultimately increase vaccine uptake.

Malawian caregivers' experiences with HPV vaccination for preadolescent girls: A qualitative study.

Introduction: Many low- and middle-income countries have introduced the human papillomavirus (HPV) vaccine, but uptake remains extremely low. Malawi has the second-highest incidence of cervical cancer globally, and launched a national HPV vaccination program in 2019. We sought to understand attitudes about, and experiences with, the HPV vaccine among caregivers of eligible girls in Malawi. Methods: We conducted qualitative interviews with 40 caregivers (parents or guardians) of preadolescent girls in Malawi to understand their experiences with HPV vaccination. We coded the data informed by the Behavioural and Social Drivers of vaccine uptake model and recommendations from WHO's Strategic Advisory Group of Experts Working Group on Vaccine Hesitancy. Results: In this sample, 37% of age-eligible daughters had not received any HPV vaccine doses, 35% had received 1 dose, 19% had received 2 doses, and 10% had an unknown vaccination status. Caregivers were aware of the dangers of cervical cancer, and understood that HPV vaccine is an effective prevention tool. However, many caregivers had heard rumors about the vaccine, particularly its alleged harmful effect on girls' future fertility. Many caregivers, especially mothers, felt that school-based vaccination was efficient; but some caregivers expressed disappointment that they had not been more engaged in the school-based delivery of HPV vaccine. Caregivers also reported that the COVID-19 pandemic has been disruptive to vaccination. Conclusions: There are complex and intersecting factors that affect caregivers' motivation to vaccinate their daughters against HPV, and the practical challenges that caregivers may encounter. We identify areas for future research and intervention that could contribute to cervical cancer elimination: better communicating about vaccine safety (particularly to address concerns about loss of fertility), leveraging the unique advantages of school-based vaccination while ensuring parental engagement, and understanding the complex effects of the COVID-19 pandemic (and vaccination program).

Uptake of the COVID-19 vaccine among healthcare workers in Malawi.

BACKGROUND: Little is known about coronavirus disease 2019 (COVID-19) vaccination in Africa. We sought to understand Malawian healthcare workers' (HCWs') COVID-19 vaccination and its hypothesized determinants. METHODS: In March 2021, as the COVID-19 vaccine roll-out commenced in Malawi, we surveyed clinical and lay cadre HCWs (n=400) about their uptake of the vaccine and potential correlates (informed by the WHO Behavioral and Social Drivers of COVID-19 Vaccination framework). We analyzed uptake and used adjusted multivariable logistic regression models to explore how 'what people think and feel' constructs were associated with HCWs' motivation to be vaccinated. RESULTS: Of the surveyed HCWs, 82.5% had received the first COVID-19 vaccine dose. Motivation (eagerness to be vaccinated) was strongly associated with confidence in vaccine benefits (adjusted OR [aOR] 9.85, 95% CI 5.50 to 17.61) and with vaccine safety (aOR 4.60, 95% CI 2.92 to 7.23), but not with perceived COVID-19 infection risk (aOR 1.38, 95% CI 0.88 to 2.16). Of all the information sources about COVID-19 vaccination, 37.5% were reportedly negative in tone. CONCLUSIONS: HCWs in Malawi have a high motivation to be vaccinated and a high COVID-19 vaccine uptake. Disseminating vaccine benefits and safety messages via social media and social networks may be persuasive for individuals who are unmotivated to be vaccinated and less likely to accept the COVID-19 vaccine.

Virological Findings and Treatment Outcomes of Cases That Developed Dolutegravir Resistance in Malawi's National HIV Treatment Program.

Millions of Africans are on dolutegravir-based antiretroviral therapy (ART), but few detailed descriptions of dolutegravir resistance and its clinical management exist. We reviewed HIV drug resistance (HIVDR) testing application forms submitted between June 2019 and October 2022, data from the national HIVDR database, and genotypic test results. We obtained standardized ART outcomes and virological results of cases with dolutegravir resistance, and explored associations with dolutegravir resistance among individuals with successful integrase sequencing. All cases were on two nucleoside reverse transcriptase inhibitors (NRTIs)/dolutegravir, and had confirmed virological failure, generally with prolonged viremia. Among 89 samples with successful integrase sequencing, 24 showed dolutegravir resistance. Dolutegravir resistance-associated mutations included R263K (16/24), E138K (7/24), and G118R (6/24). In multivariable logistic regression analysis, older age and the presence of high-level NRTI resistance were significantly associated with dolutegravir resistance. After treatment modification recommendations, four individuals (17%) with dolutegravir resistance died, one self-discontinued ART, one defaulted, and one transferred out. Of the 17 remaining individuals, 12 had follow-up VL results, and 11 (92%) were <1000 copies/mL. Twenty-four cases with dolutegravir resistance among 89 individuals with confirmed virological failure suggests a considerable prevalence in the Malawi HIV program. Successful management of dolutegravir resistance was possible, but early mortality was high. More research on the management of treatment-experienced individuals with dolutegravir resistance is needed.

Investigating the implementation of differentiated HIV services and implications for pregnant and postpartum women: A mixed methods multi-country study.

Universal antiretroviral therapy (ART) for pregnant and postpartum women in sub-Saharan Africa has required adaptations to service delivery. We compared national policies on differentiated HIV service delivery with facility-level implementation, and explored provider and user experiences in rural Malawi, Tanzania and South Africa. Four national policies and two World Health Organization guidelines on HIV treatment for pregnant and postpartum women published between 2013 and 2017 were reviewed and summarised. Results were compared with implementation data from surveys undertaken in 34 health facilities. Eighty-seven in-depth interviews were conducted with pregnant and post-partum women living with HIV, their partners and providers. In 2018, differentiated service policies varied across countries. None specifically accounted for pregnant or postpartum women. Malawian policies endorsed facility-based multi-month scripting for clinically-stable adult ART patients, excluding pregnant or breastfeeding women. In Tanzania and South Africa, national policies proposed community-based and facility-based approaches, for which pregnant women were not eligible. Interview data suggested some implementation of differentiated services for pregnant and postpartum women beyond stipulated policies in all settings. Although these adaptations were appreciated by pregnant and postpartum women, they could lead to frustrations among other users when criteria for fast-track services or multi-month prescriptions were not clear.

Influence of evolving HIV treatment guidance on CD4 counts and viral load monitoring: A mixed-methods study in three African countries.

Little is known about how CD4 and viral load testing have evolved following implementation of universal test and treat (UTT) in African settings. We reviewed World Health Organization (WHO) guidance from 2013 to 2018, and compared it against national HIV policies in Malawi, Tanzania and South Africa. Three surveys rounds were conducted in 2013, 2016 and 2017-2018 in 33 health facilities across the three settings to assess implementation of national policies on the use of biological markers. Qualitative interviews were conducted with 26 HIV policymakers or programme managers, 21 providers and 66 people living with HIV to explore understandings and experiences of these tests. Various factors influenced adoption and implementation of WHO guidance, including historical policies on CD4 counts, governance issues, supply chain challenges and funding mechanisms. Facility-level practices relating to the use of these tests often diverged from national policies. Patients and providers valued both tests, but did not always understand their roles. In addition to continued support for scaling-up viral load testing, renewed focus should be placed on the ongoing value of point-of-care CD4 tests in the UTT era, including its role in assessing disease progression and informing clinical management of cases to reduce HIV-related mortality.

Consequences of male partner engagement policies on HIV care-seeking in three African countries: Findings from the SHAPE UTT study.

We explored how strategies to promote male partner engagement influenced HIV care-seeking among men and women living with HIV. In-depth interviews were conducted with 25 health workers, 66 female service users and 10 male partners in Ifakara (Tanzania), Karonga (Malawi) and uMkhanyakude (South Africa) to elicit experiences of offering, providing or receiving HIV care in the context of antenatal care. Data were coded inductively and analysed thematically. Participants reported benefits of couple testing during antenatal care, including facilitated HIV status disclosure and mutual support for HIV care-seeking. However, unintended consequences included women attending without partners, being refused or delayed access to antenatal services. Some women were required to obtain letters from village leaders to justify the absence of their partners, again to delaying or disrupting care-seeking. When partners attended antenatal care, consultations were reportedly more likely to focus on HIV testing, and less on antenatal or neonatal care. Strategies to increase men's attendance at HIV clinics with their partners can promote mutual support within couples for HIV care engagement, but may risk undermining engagement in pregnancy and HIV care for some women if over-stringently applied. Efforts are needed to address the underlying pervasive stigma associated with HIV care, both alone and as a couple.

Implications of HIV treatment policies on the health workforce in rural Malawi and Tanzania between 2013 and 2017: Evidence from the SHAPE-UTT study.

Effective implementation of policies for expanding antiretroviral therapy (ART) requires a well-trained and adequately staffed workforce. Changes in national HIV workforce policies, health facility practices, and provider experiences were examined in rural Malawi and Tanzania between 2013 and 2017. In both countries, task-shifting and task-sharing policies were explicit by 2013. In facilities, the cadre mix of providers varied by site and changed over time, with a higher and growing proportion of lower cadre staff in the Malawi site. In Malawi, the introduction of lay counsellors was perceived to have eased the workload of other providers, but lay counsellors reported inadequate support. Both countries had guidance on the minimum numbers of personnel required to deliver HIV services. However, patient loads per provider increased in both settings for HIV tests and visits by ART patients and were not met with corresponding increases in provider capacity in either setting. Providers reported this as a challenge. Although increasing patient numbers bodes well for achieving universal antiretroviral therapy coverage, the quality of care may be undermined by increased workloads and insufficient provider training. Task-shifting strategies may help address workload concerns, but require careful monitoring, supervision and mentoring to ensure effective implementation.

Assessing the implementation of facility-based HIV testing policies in Malawi, South Africa and Tanzania from 2013-2018: Findings from SHAPE-UTT study.

National HIV testing policies aim to increase the proportion of people living with HIV who know their status. National HIV testing policies were reviewed for each country from 2013 to 2018, and compared with WHO guidance. Three rounds of health facility surveys were conducted to assess facility level policy implementation in Karonga (Malawi), uMkhanyakude (South Africa), and Ifakara (Tanzania). A policy 'implementation' score was developed and applied to each facility by site for each round. Most HIV testing policies were explicit and aligned with WHO recommendations. Policies about service coverage, access, and quality of care were implemented in >80% of facilities per site and per round. However, linkage to care and the provision of outreach HIV testing for key populations were poorly implemented. The proportion of facilities reporting HIV test kit stock-outs in the past year reduced over the study period in all sites, but still occurred in ≥17% of facilities per site by 2017. The implementation score improved over time in Karonga and Ifakara and declined slightly in uMkhanyakude. Efforts are needed to address HIV test kit stock-outs and to improve linkage to care among people testing positive in order to reach the 90-90-90 targets.

Exploring the evolution of policies for universal antiretroviral therapy and their implementation across three sub-Saharan African countries: Findings from the SHAPE study.

Universal antiretroviral therapy (ART) strategies have dramatically changed HIV programming across sub-Saharan Africa. We explored factors that influenced the development, adoption and implementation of universal ART policies in Tanzania, South Africa and Malawi. We conducted 26 key informant interviews and applied Kingdon's 'streams' model to explore how problems, policies and politics converged to provide a window of opportunity for universal ART roll-out. Weak health systems and sub-optimal care retention were raised as problems during Option B+ implementation, which preceded universal ART , and persisted after its implementation. The adoption and implementation of Option B+ policy facilitated the uptake of universal ART. Politics played out through pressures from different stakeholders to accelerate or slow down implementation, from governments, civil society groups, researchers and donors. Policy processes leading to universal ART were open to pressures and influence. The extraordinary financial support which enabled the widespread and rapid implementation of universal ART skewed the power balance and sometimes left little space for locally-derived solutions to respond to specific health system abilities and epidemiological contexts. Donors may be more effective if they ensure a greater focus on strengthening the whole health system as well as accounting for local contextual factors and recent policy development histories when funding policy implementation.

Implementation and experiences of integrated prevention of mother-to-child transmission services in Tanzania, Malawi and South Africa: A mixed methods study.

Although integration of HIV and maternal health services is recommended by the World Health Organization, evidence to guide implementation is limited. We describe facility-level implementation of policies for integrating HIV care within maternal health services and explore experiences of service users and providers in rural Tanzania (Ifakara), South Africa (uMkhanyakude) and Malawi (Karonga). Policy in all countries included HIV testing during antenatal care (ANC), same-day antiretroviral therapy (ART) initiation for HIV-positive pregnant women, and postpartum referral to ART clinics, between six weeks (Malawi, South Africa) and two years after delivery (Tanzania). All facilities offered HIV testing within ANC, most commonly during the first visit. Although most women were comfortable with HIV testing, some felt that opting out would lead to sub-standard services. Some facilities conducted group post-test counselling for HIV-negative women, raising concerns of unintended HIV status disclosure. ART initiation was offered on the same day, the same room as an HIV diagnosis in >90% of facilities. Women's worries around postpartum referral included having unknown providers, insufficient privacy and queues. Adoption and implementation of policies on integrated HIV and maternal health services varied across settings. Patients' experiences of these policies may influence uptake and retention in care.

Assessing the costs and efficiency of HIV testing and treatment services in rural Malawi: implications for future "test and start" strategies.

BACKGROUND: Reaching the 90-90-90 targets requires efficient resource use to deliver HIV testing and treatment services. We investigated the costs and efficiency of HIV services in relation to HIV testing yield in rural Karonga District, Malawi. METHODS: Costs of HIV services were measured over 12 months to September 2017 in five health facilities, drawing on recognised health costing principles. Financial and economic costs were collected in Malawi Kwacha and United States Dollars (US$). Costs were calculated using a provider perspective to estimate average annual costs (2017 US$) per HIV testing episode, per HIV-positive case diagnosed, and per patient-year on antiretroviral therapy (ART), by facility. Costs were assessed in relation to scale of operation and facility-level annual HIV positivity rate. A one-way sensitivity analysis was undertaken to understand how staffing levels and the HIV positivity rate affected HIV testing costs. RESULTS: HIV testing episodes per day and per full-time equivalent HIV health worker averaged 3.3 (range 2.0 to 5.7). The HIV positivity rate averaged 2.4% (range 1.9 to 3.7%). The average cost per testing episode was US$2.85 (range US$1.95 to US$8.55), and the average cost per HIV diagnosis was US$116.35 (range US$77.42 to US$234.11), with the highest costs found in facilities with the lowest daily number of tests and lowest HIV yield respectively. The mean facility-level cost per patient-year on ART was approximately US$100 (range US$90.67 to US$115.42). ART drugs were the largest cost component averaging 71% (range 55 to 76%). The cost per patient-year of viral load tests averaged US$4.50 (range US$0.52 to US$7.00) with cost variation reflecting differences in the tests to ART patient ratio across facilities. CONCLUSION: Greater efficiencies in HIV service delivery are possible in Karonga through increasing daily testing episodes among existing health workers or allocating health workers to tasks in addition to testing. Costs per diagnosis will increase as yields decline, and therefore, encouraging targeted testing strategies that increase yield will be more efficient. Given the contribution of drug costs to per patient-year treatment costs, it is critical to preserve the life-span of first-line ART regimens, underlining the need for continuing adherence support and regular viral load monitoring.

Implementing prevention policies for mother-to-child transmission of HIV in rural Malawi, South Africa and United Republic of Tanzania, 2013-2016.

OBJECTIVE: To assess adoption of World Health Organization (WHO) guidance into national policies for prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV) and to monitor implementation of guidelines at facility level in rural Malawi, South Africa and the United Republic of Tanzania. METHODS: We summarized national PMTCT policies and WHO guidance for 15 indicators across the cascades of maternal and infant care over 2013-2016. Two survey rounds were conducted (2013-2015 and 2015-2016) in 46 health facilities serving five health and demographic surveillance system populations. We administered structured questionnaires to facility managers to describe service delivery. We report the proportions of facilities implementing each indicator and the frequency and durations of stock-outs of supplies, by site and survey round. FINDINGS: In all countries, national policies influencing the maternal and infant PMTCT cascade of care aligned with WHO guidelines by 2016; most inter-country policy variations concerned linkage to routine HIV care. The proportion of facilities delivering post-test counselling, same-day antiretroviral therapy (ART) initiation, antenatal care and ART provision in the same building, and Option B+ increased or remained at 100% in all sites. Progress in implementing policies on infant diagnosis and treatment varied across sites. Stock-outs of HIV test kits or antiretroviral drugs in the past year declined overall, but were reported by at least one facility per site in both rounds. CONCLUSION: Progress has been made in implementing PMTCT policy in these settings. However, persistent gaps across the infant cascade of care and supply-chain challenges, risk undermining infant HIV elimination goals.

Implementing prevention policies for mother-to-child transmission of HIV in rural Malawi, South Africa and United Republic of Tanzania, 2013­2016

Objective To assess adoption of World Health Organization (WHO) guidance into national policies for prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV) and to monitor implementation of guidelines at facility level in rural Malawi, South Africa and the United Republic of Tanzania. Methods : We summarized national PMTCT policies and WHO guidance for 15 indicators across the cascades of maternal and infant care over 2013­2016. Two survey rounds were conducted (2013­2015 and 2015­2016) in 46 health facilities serving five health and demographic surveillance system populations. We administered structured questionnaires to facility managers to describe service delivery. We report the proportions of facilities implementing each indicator and the frequency and durations of stock-outs of supplies, by site and survey round.Findings In all countries, national policies influencing the maternal and infant PMTCT cascade of care aligned with WHO guidelines by 2016; most inter-country policy variations concerned linkage to routine HIV care. The proportion of facilities delivering post-test counselling, same-day antiretroviral therapy (ART) initiation, antenatal care and ART provision in the same building, and Option B+ increased or remained at 100% in all sites. Progress in implementing policies on infant diagnosis and treatment varied across sites. Stock-outs of HIV test kits or antiretroviral drugs in the past year declined overall, but were reported by at least one facility per site in both rounds. Conclusion Progress has been made in implementing PMTCT policy in these settings. However, persistent gaps across the infant cascade of care and supply-chain challenges, risk undermining infant HIV elimination goals