Baseline and primary data for the partner-provided HIV self-testing and linkage (PASTAL) adaptive multi-arm multi-stage cluster randomized trial in Blantyre, Malawi

Dataset containing details of 2,349 pregnant women accessing antenatal care in three primary health centres in urban Blantyre, Malawi who gave informed consent to participate in an adaptive multi-arm multi-stage cluster randomized trial. The unit of randomization was the antenatal care (ANC) clinic day. On a given ANC day, women could receive standard of care (SOC) of receiving just an invitation letter to deliver to their male partner who was absent at this ANC visit. Or, the women could receive SOC plus two oral self-test kits alone or in combination with a guaranteed financial incentive of $3 or$10 conditional on clinic attendance following self-testing for HIV care or prevention. Two other arms offered a lottery-based incentive with 10% chance of winning $30 to male partners achieving the primary outcome, or a phone call reminder to the male partner immediately following collection of kits by the woman repeated after five days. The dataset contains variables on baseline data for the women and their male partners as reported by the woman as well as data underlying the trial outcomes by arm. Recruitment and follow-up were completed between 8 August 2016 and 30 June 2017

Initial Accuracy of HIV Rapid Test Kits Stored in Suboptimal Conditions and Validity of Delayed Reading of Oral Fluid Tests

An anonymised dataset produced as part of a study on initial accuracy of commonly used HIV rapid diagnostic tests (RDT) when stored in suboptimal conditions and the validity of delayed reading of OraQuick oral fluid tests. It contains HIV results for each RDT, age, sex, previous testing data and an indication of whether or not there was a change in the reading of OraQuick oral RDT over the 12 month period of re-reading. It may be used to validate results related to analysis of sensitivity and specificity of each sub-optimally-stored test kit compared with optimally stored Determine and Uni-Gold conducted in parallel

Uptake, accuracy, safety and linkage into care over two years of promoting annual self-testing for HIV in Blantyre, Malawi: a community-based prospective study

A set of anonymised datasets produced in a community-based study to investigate self-testing for HIV in Blantyre, Malawi. Taken together the datasets enable replication of findings from the study including estimation of uptake of HIV self-testing (HIVST), analysis of sensitivity/specificity of self-reported self-test results compared to nurse-performed finger prick testing, and investigation of self-reported coercion to self-test

Analysis of maternal serum vitamin D concentrations at birth in women presenting with spontaneous preterm birth: A case-control study

Vitamin D is a potent immune system modulator; its deficiency correlates with increased susceptibility to infections. We evaluated the status of maternal serum vitamin D in women with spontaneous preterm birth. In this case-control study, the maternal serum concentration of vitamin D (25OH D) was measured in 95 women delivering preterm and 92 women having a term birth. Vitamin D sufficiency was found in 79% of the mothers who delivered preterm and 80.4% of the mothers who had term birth (p=0.822). There was a negative correlation between maternal serum concentration of 25 Hydroxyvitamin D and maternal age in the preterm birth group (p=0.043). In conclusion, there was no difference in maternal serum concentrations of 25 Hydroxyvitamin D between women delivering preterm compared to those having term birth. Maternal serum concentration of 25 Hydroxyvitamin D is not associated with occurrence of preterm birth. Keywords: Preterm birth, vitamin D, preterm delivery, 25 Hydroxyvitamin D, prematureLa vitamine D est un puissant modulateur du système immunitaire; sa carence est corrélée à une sensibilité accrue aux infections. Nous avons évalué le statut de la vitamine D sérique maternelle chez les femmes ayant une naissance prématurée spontanée. Dans cette étude cas-témoins, la concentration sérique maternelle de vitamine D (25OH D) a été mesurée chez 95 femmes ayant accouche avant terme et 92 femmes ayant une naissance à terme. Une suffisance en vitamine D a été trouvée chez 79% des mères qui ont accouché prématurément et 80,4% des mères qui ont eu un accouchement à terme (p = 0,822). Il y avait une corrélation négative entre la concentration sérique maternelle de 25 hydroxyvitamine D et l'âge maternel dans le groupe des naissances prématurées (p= 0,043). En conclusion, il n'y avait aucune différence dans les concentrations sériques maternelles de 25 Hydroxyvitamine D entre les femmes ayant accouché avant terme et celles ayant une naissance à terme. La concentration sérique maternelle de 25 hydroxyvitamine D n'est pas associée à la survenue d'un accouchement prématuré. Mots-clés: Naissance prématurée, vitamine D, accouchement prématuré, 25 hydroxyvitamine D, prématuré

Scaling up HIV self-testing in sub-Saharan Africa: a review of technology, policy and evidence.

PURPOSE OF REVIEW: HIV self-testing (HIVST) can provide complementary coverage to existing HIV testing services and improve knowledge of status among HIV-infected individuals. This review summarizes the current technology, policy and evidence landscape in sub-Saharan Africa and priorities within a rapidly evolving field. RECENT FINDINGS: HIVST is moving towards scaled implementation, with the release of WHO guidelines, WHO prequalification of the first HIVST product, price reductions of HIVST products and a growing product pipeline. Multicountry evidence from southern and eastern Africa confirms high feasibility, acceptability and accuracy across many delivery models and populations, with minimal harms. Evidence on the effectiveness of HIVST on increased testing coverage is strong, while evidence on demand generation for follow-on HIV prevention and treatment services and cost-effective delivery is emerging. Despite these developments, HIVST delivery remains limited outside of pilot implementation. SUMMARY: Important technology gaps include increasing availability of more sensitive HIVST products in low and middle-income countries. Regulatory and postmarket surveillance systems for HIVST also require further development. Randomized trials evaluating the effectiveness and cost-effectiveness under multiple distribution models, including unrestricted delivery and with a focus on linkage to HIV prevention and treatment, remain priorities. Diversification of studies from west and central Africa and around blood-based products should be addressed

Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: study protocol for a cluster randomised trial.

BACKGROUND: Despite large-scale efforts to diagnose people living with HIV, 54% remain undiagnosed in sub-Saharan Africa. The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women. Here, we design a study to investigate the effect on uptake of HIV testing and linkage into care or prevention of partner-delivered HIV self-testing alone or with an additional intervention among male partners of pregnant women. METHODS: A phase II, adaptive, multi-arm, multi-stage cluster randomised trial, randomising antenatal clinic (ANC) days to six different trial arms. Pregnant women accessing ANC in urban Malawi for the first time will be recruited into either the standard of care (SOC) arm (invitation letter to the male partner offering HIV testing) or one of five intervention arms offering oral HIV self-test kits. Three of the five intervention arms will additionally offer the male partner a financial incentive (fixed or lottery amount) conditional on linkage after self-testing with one arm testing phone call reminders. Assuming that 25% of male partners link to care or prevention in the SOC arm, six clinic days, with a harmonic mean of 21 eligible participants, per arm will provide 80% power to detect a 0.15 absolute difference in the primary outcome. Cluster proportions will be analysed by a cluster summaries approach with adjustment for clustering and multiplicity. DISCUSSION: This trial applies adaptive methods which are novel and efficient designs. The methodology and lessons learned here will be important as proof of concept of how to design and conduct similar studies in the future. Although small, this trial will potentially present good evidence on the type of effective interventions for improving linkage into ART or prevention. The trial results will also have important policy implications on how to implement HIVST targeting male partners of pregnant women who are accessing ANC for the first time while paying particular attention to safety concerns. Contamination may occur if women in the intervention arms share their self-test kits with women in the SOC arm. TRIAL REGISTRATION: ISRCTN, ID: 18421340 . Registered on 31 March 2016

Cost and quality of life analysis of HIV self-testing and facility-based HIV testing and counselling in Blantyre, Malawi.

BACKGROUND: HIV self-testing (HIVST) has been found to be highly effective, but no cost analysis has been undertaken to guide the design of affordable and scalable implementation strategies. METHODS: Consecutive HIV self-testers and facility-based testers were recruited from participants in a community cluster-randomised trial ( ISRCTN02004005 ) investigating the impact of offering HIVST in addition to facility-based HIV testing and counselling (HTC). Primary costing studies were undertaken of the HIVST service and of health facilities providing HTC to the trial population. Costs were adjusted to 2014 US$and INT$. Recruited participants were asked about direct non-medical and indirect costs associated with accessing either modality of HIV testing, and additionally their health-related quality of life was measured using the EuroQol EQ-5D. RESULTS: A total of 1,241 participants underwent either HIVST (n = 775) or facility-based HTC (n = 446). The mean societal cost per participant tested through HIVST (US$9.23; 95$9.14-US$9.32) was lower than through facility-based HTC (US$11.84; 95 % CI: US$10.81-12.86). Although the mean health provider cost per participant tested through HIVST (US$8.78) was comparable to facility-based HTC (range: US$7.53-US$10.57), the associated mean direct non-medical and indirect cost was lower (US$2.93; 95$1.90-US$3.96). The mean health provider cost per HIV positive participant identified through HIVST was higher (US$97.50) than for health facilities (range: US$25.18-US$76.14), as was the mean cost per HIV positive individual assessed for anti-retroviral treatment (ART) eligibility and the mean cost per HIV positive individual initiated onto ART. In comparison to the facility-testing group, the adjusted mean EQ-5D utility score was 0.046 (95 % CI: 0.022-0.070) higher in the HIVST group. CONCLUSIONS: HIVST reduces the economic burden on clients, but is a costlier strategy for the health provider aiming to identify HIV positive individuals for treatment. The provider cost of HIVST could be substantially lower under less restrictive distribution models, or if costs of oral fluid HIV test kits become comparable to finger-prick kits used in health facilities

'Whose failure counts?' A critical reflection on definitions of failure for community health volunteers providing HIV self-testing in a community-based HIV/TB intervention study in urban Malawi.

The category of community health worker applied within the context of health intervention trials has been promoted as a cost-effective approach to meeting study objectives across large populations, relying on the promotion of the concept of 'community belonging' to encourage altruistic volunteerism from community members to promote health. This community-based category of individuals is recruited to facilitate externally driven priorities defined by large research teams, outside of the target research environment. An externally defined intervention is then 'brought to' the community through locally recruited community volunteers who form a bridge between the researchers and participants. The specific role of these workers is context-driven and responsive to the needs of the intervention. This paper is based on the findings from an annual evaluation of community health worker performance employed as community counsellors to deliver semi-supervised HIV self-testing (HIVST) at community level of a large HIV/TB intervention trial conducted in urban Blantyre, Malawi. A performance evaluation was conducted to appraise individual service delivery and assess achievements in meeting pre-defined targets for uptake of HIVST with the aim of improving overall uptake of HIVST. Through an empirical 'evaluation of the evaluation' this paper critically reflects on the position of the community volunteer through the analytical lens of 'failure', exploring the tensions in communication and interpretation of intervention delivery between researchers and community volunteers and the differing perspectives on defining failure. It is concluded that community interventions should be developed in collaboration with the population and that information guiding success should be clearly defined

Treatment-seeking for tuberculosis-suggestive symptoms: a reflection on the role of human agency in the context of universal health coverage in Malawi

Tuberculosis (TB) is highly infectious and one of the leading killers globally. Several studies from sub-Saharan Africa highlight health systems challenges that affect ability to cope with existing disease burden, including TB, although most of these employ survey-type approaches. Consequently, few address community or patient perspectives and experiences. At the same time, understanding of the mechanisms by which the health systems challenges translate into seeking or avoidance of formal health care remains limited. This paper applies the notion of human agency to examine the ways people who have symptoms suggestive of TB respond to and deal with the symptoms vis-à-vis major challenges inherent within health delivery systems. Empirical data were drawn from a qualitative study exploring the ways in which notions of masculinity affect engagement with care, including men's well-documented tendency to delay in seeking care for TB symptoms. The study was carried out in three high-density locales of urban Blantyre, Malawi. Data were collected in March 2011 -March 2012 using focus group discussions, of which eight (mixed sex = two; female only = three; male only = three) were with 74 ordinary community members, and two (both mixed sex) were with 20 health workers; and in-depth interviews with 20 TB patients (female = 14) and 20 un-investigated chronic coughers (female = eight). The research process employed a modified version of grounded theory. Data were coded using a coding scheme that was initially generated from the study aims and subsequently progressively amended to incorporate concepts emerging during the analysis. Coded data were retrieved, re-read, and broken down and reconnected iteratively to generate themes. A myriad of problems were described for health systems at the primary health care level, centring largely on shortages of resources (human, equipment, and drugs) and unprofessional conduct by health care providers. Participants consistently pointed out how the problems could drive patients from promptly reporting symptoms at primary healthcare centres. The accounts suggest that in responding to illness symptoms including those suggestive of TB, patients navigate their options taking into cognisance past and current experiences with formal health systems. Understanding and factoring in the mediating role of such 'agency' is critical when implementing efforts to promote timely response to TB-suggestive symptoms

Reasons for disengagement from antiretroviral care in the era of “Treat All” in low‐ or middle‐income countries: a systematic review

Introduction: Disengagement from antiretroviral therapy (ART) care is an important reason why people living with HIV do not achieve viral load suppression become unwell. Methods: We searched two databases and conference abstracts from January 2015 to December 2022 for studies which reported reasons for disengagement from ART care. We included quantitative (mainly surveys) and qualitative (in‐depth interviews or focus groups) studies conducted after “treat all” or “Option B+” policy adoption. We used an inductive approach to categorize reasons: we report how often reasons were reported in studies and developed a conceptual framework for reasons. Results: We identified 21 studies which reported reasons for disengaging from ART care in the “Treat All” era, mostly in African countries: six studies in the general population of persons living with HIV, nine in pregnant or postpartum women and six in selected populations (one each in people who use drugs, isolated indigenous communities, men, women, adolescents and men who have sex with men). Reasons reported were: side effects or other antiretroviral tablet issues (15 studies); lack of perceived benefit of ART (13 studies); psychological, mental health or drug use (13 studies); concerns about stigma or confidentiality (14 studies); lack of social or family support (12 studies); socio‐economic reasons (16 studies); health facility‐related reasons (11 studies); and acute proximal events such as unexpected mobility (12 studies). The most common reasons for disengagement were unexpected events, socio‐economic reasons, ART side effects or lack of perceived benefit of ART. Conceptually, studies described underlying vulnerability factors (individual, interpersonal, structural and healthcare) but that often unexpected proximal events (e.g. unanticipated mobility) acted as the trigger for disengagement to occur. Discussion: People disengage from ART care for individual, interpersonal, structural and healthcare reasons, and these reasons overlap and interact with each other. While HIV programmes cannot predict and address all events that may lead to disengagement, an approach that recognizes that such shocks will happen could help. Conclusions: Health services should focus on ways to encourage clients to engage with care by making ART services welcoming, person‐centred and more flexible alongside offering adherence interventions, such as counselling and peer support