Examining oral pre-exposure prophylaxis (PrEP) literacy among participants in an HIV vaccine trial preparedness cohort study.

BACKGROUND: PrEP literacy is influenced by many factors including the types of information available and how it is interpreted. The level of PrEP literacy may influence acceptability and uptake. METHODS: We conducted 25 in-depth interviews in a HIV vaccine trial preparedness cohort study. We explored what participants knew about PrEP, sources of PrEP knowledge and how much they know about PrEP. We used the framework approach to generate themes for analysis guided by the Social Ecological Model and examined levels of PrEP literacy using the individual and interpersonal constructs of the SEM. RESULTS: We found that PrEP awareness is strongly influenced by external factors such as social media and how much participants know about HIV treatment and prevention in the local community. However, while participants highlighted the importance of the internet/social media as a source of information about PrEP they talked of low PrEP literacy in their communities. Participants indicated that their own knowledge came as a result of joining the HIV vaccine trial preparedness study. However, some expressed doubts about the effectiveness of the drug and worried about side effects. Participants commented that at the community level PrEP was associated with being sexually active, because it was used to prevent the sexual transmission of HIV. As a result, some participants commented that one could feel judged by the health workers for asking for PrEP at health facilities in the community. CONCLUSION: The information collected in this study provided an understanding of the different layers of influence around individuals that are important to address to improve PrEP acceptability and uptake. Our findings can inform strategies to address the barriers to PrEP uptake, particularly at structural and community levels. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT04066881.

Optimised electronic patient records to improve clinical monitoring of HIV-positive patients in rural South Africa (MONART trial): study protocol for a cluster-randomised trial.

BACKGROUND: There is poor viral load monitoring (VLM) and inadequate management of virological failure in HIV-positive individuals on antiretroviral therapy in rural KwaZulu-Natal, South Africa. This could be contributing to increasing HIV drug resistance in the setting. This study aims to investigate the clinical and process impediments in VLM within the health system and to evaluate a quality improvement package (QIP) to address the identified gaps. The QIP comprises (i) a designated viral load champion responsible for administrative management and triaging of viral load results (ii) technological enhancement of the routine clinic-based Three Interlinked Electronic Register (TIER.Net) to facilitate daily automatic import of viral load results from the National Health Service Laboratory to TIER.Net (iii) development of a dashboard system to support VLM. METHODS/DESIGN: The study will evaluate the effectiveness of the QIP compared to current care for improving VLM and virological suppression using an effectiveness implementation hybrid type 3 design. This will use a cluster-randomised design with the primary healthcare clinics as the unit of randomisation with ten clinics randomised in a 1:1 ratio to either the intervention or control arm. We will enrol 150 HIV-positive individuals who had been on ART for ≥ 12 months from each of the ten clinics (750 in 5 intervention clinics vs. 750 in 5 control clinics) and follow them up for a period of 12 months. The primary outcome is the proportion of all patients who have a viral load (VL) measurement and are virally suppressed (composite outcome) after 12 months of follow up. Secondary outcomes during follow up include proportion of all patients with at least one documented VL in TIER.Net, proportion with VL ≥ 50 copies/mL, proportion with VL ≥ 1000 copies/mL (virological failure) and subsequent switch to second-line ART. DISCUSSION: We aim to provide evidence that a staff-centred quality improvement package, designated viral load monitoring champion, and augmentation of TIER.Net with a dashboard system will improve viral load monitoring and lead to improved virological suppression. TRIAL REGISTRATION: This trial is registered on ClinicalTrials.gov on 8 Oct 2021. Identifier: NCT05071573; https://clinicaltrials.gov/ct2/show/NCT05071573?term=NCT05071573&draw=2&rank=1.

Scoping review on lessons learnt on the promotion and use of drugs and traditional medicine in Africa during COVID-19.

ABSTRACTScientific evidence on the safety and efficacy of pharmaceutical drugs, substances and herbal medicines is important in medical advertising and promotion. Following guidelines for conducting a scoping review, we systematically searched PubMed, SCOPUS and Web of Science to identify in peer reviewed articles medications that were promoted and used widely in Africa during the COVID-19 pandemic. We also searched for information about how safety concerns about untested/or not properly tested drugs were communicated to the public during the pandemic. Of the 2043 articles identified, 41 papers were eligible for inclusion. Most studies were clinical trials (n = 11), systematic reviews (n = 9), quantitative studies (n = 9) the rest were qualitative studies, reviews and reports. We found that following global trends, several drugs, traditional and herbal treatments were used and repurposed for the treatment of respiratory symptoms of COVID-19 in Africa. The results highlighted the value of some herbal medicines for treatment during the COVID-19 pandemic, as well as the risks posed by the unregulated sharing of advice and recommendations on treatments in Africa, and globally.

Policy and Guideline Review of Vaccine Safety for COVID-19 in Pregnant Women in Southern Africa, with a Particular Focus on South Africa.

Pregnant and lactating mothers have historically been excluded from clinical trials. To understand the shift from excluding to including this population in COVID-19 vaccine trials, we conducted a review of guidance issued by countries in southern Africa over the last three years. We conducted a review of documents and official statements recorded on Ministries of Health websites, and social media platforms, the World Health Organisation website, the COVID-19 Maternal Immunisation tracker and the African Union official webpage. Search terms included COVID-19 vaccination policies, guidelines for pregnant and lactating women, COVID-19 vaccination trials and pregnant women. We retrieved and reviewed policies, guidelines, and official statements from 12 countries. We found inconsistencies and incomplete guidance in respect to the inclusion of pregnant and lactating mothers in COVID-19 vaccine trials from the selected countries. Of the twelve countries reviewed, Namibia and South Africa had clear guidance on vaccination plans and implementation for pregnant women, and their inclusion in COVID-19 vaccine trials. Explicit and clear guidelines are critical in communicating changes in policy towards those deemed vulnerable for them to participate in vaccine trials. This review provides lessons for future pandemics on managing changes in guidance towards those groups historically excluded from vaccine and clinical trials.

Assessing Community Acceptance of Maternal Immunisation in Rural KwaZulu-Natal, South Africa: A Qualitative Investigation.

Despite the significant benefits of maternal immunisation, uptake remains low in many parts of the world. In this qualitative study, we aimed to assess the factors that influence pregnant women's decision to engage with maternal immunisation in rural KwaZulu-Natal, South Africa. We conducted in-depth interviews with a total of 28 purposively sampled pregnant women and key informants using semi-structured topic guides. Data analysis was conducted using a modified Health Belief Model framework that included constructs of barriers to action, modifying factors of cue to action and perceived social norms. The findings show that traditional customs and institutional barriers such as low-quality health service delivery, long queues, and distance to the health facilities, immunisation vaccine stockouts and low levels of maternal knowledge influence the choice and decision to engage with maternal immunisation. Understanding health-related behaviours and addressing barriers to care is important in facilitating vaccination uptake. This study contributes to the understanding of maternal immunisation uptake in low-resource settings.

Knowledge, use (misuse) and perceptions of over-the-counter analgesics in sub-Saharan Africa: a scoping review.

BACKGROUND: Over-the-counter (OTC) analgesics are safe for pain-management when used as recommended. Misuse can increase the risk of hypertension and gastrointestinal problems. OBJECTIVE: To conduct a scoping review of the uses and misuses of OTC analgesics in sub-Saharan Africa, to inform strategies for correct use. METHOD: Following guidelines for conducting a scoping review, we systematically searched Pubmed, ResearchGate and Google Scholar databases for published articles on OTC analgesic drug use in sub-Saharan Africa, without restrictions on publication year or language. Search terms were 'analgesics', 'non-prescription drugs', 'use or dependence or patterns or misuse or abuse' and 'sub-Saharan Africa'. Articles focusing on prescription drugs were excluded. RESULTS: Of 1381 articles identified, 35 papers from 13 countries were eligible for inclusion. Most were quantitative cross-sectional studies, two were mixed-methods studies, and one used qualitative methods only. About half (n = 17) the studies recorded prevalence of OTC drug use above 70%, including non-analgesics. Headache and fever were the most common ailments for which OTC drugs were taken. Primary sources of OTC drugs were pharmacy and drug shops, and family, friends and relatives as well as leftover drugs from previous treatment. The main reasons for OTC drug use were challenges in health service access, perception of illness as minor, and knowledge gained from treating a previous illness. Information regarding self-medication came from family, friends and neighbours, pharmacies and reading leaflets either distributed in the community or at institutions of learning. OTC drug use tended to be more commonly reported among females, those with an education lower than secondary level, and participants aged ≥50 years. CONCLUSION: Self-medicating with OTC drugs including analgesics is prevalent in sub-Saharan Africa. However, literature on reasons for this, and misuse, is limited. Research is needed to educate providers and the public on safe use of OTC drugs.

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.

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.

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.

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.

Test but not treat: Community members' experiences with barriers and facilitators to universal antiretroviral therapy uptake in rural KwaZulu-Natal, South Africa.

INTRODUCTION: Antiretroviral therapy (ART) has revolutionised the care of HIV-positive individuals resulting in marked decreases in morbidity and mortality, and markedly reduced transmission to sexual partners. However, these benefits can only be realised if individuals are aware of their HIV-positive status, initiated and retained on suppressive lifelong ART. Framed using the socio-ecological model, the present study explores factors contributing to poor ART uptake among community members despite high acceptance of HIV-testing within a Treatment as Prevention (TasP) trial. In this paper we identify barriers and facilitators to treatment across different levels of the socio-ecological framework covering individual, community and health system components. METHODS: This research was embedded within a cluster-randomised trial (ClinicalTrials.gov, number NCT01509508) of HIV treatment as Prevention in rural KwaZulu-Natal, South Africa. Data were collected between January 2013 and July 2014 from resident community members. Ten participants contributed to repeat in-depth interviews whilst 42 participants took part in repeat focus group discussions. Data from individual interviews and focus group discussions were triangulated using community walks to give insights into community members' perception of the barriers and facilitators of ART uptake. We used thematic analysis guided by a socio-ecological framework to analyse participants' narratives from both individual interviews and focus group discussions. RESULTS: Barriers and facilitators operating at the individual, community and health system levels influence ART uptake. Stigma was an over-arching barrier, across all three levels and expressed variably as fear of HIV disclosure, concerns about segregated HIV clinical services and negative community religious perceptions. Other barriers were individual (substance misuse, fear of ART side effects), community (alternative health beliefs). Facilitators cited by participants included individual (expectations of improved health and longer life expectancy following ART, single tablet regimens), community (availability of ART in the community through mobile trial facilities) and health system factors (fast and efficient service provided by friendly staff). DISCUSSION: We identified multiple barriers to achieving universal ART uptake. To enhance uptake in HIV care services, and achieve the full benefits of ART requires interventions that tackle persistent HIV stigma, and offer people with HIV respectful, convenient and efficient services. These interventions require evaluation in appropriately designed studies.