Development of a pharmacovigilance safety monitoring tool for the rollout of single low-dose primaquine and artemether-lumefantrine to treat Plasmodium falciparum infections in Swaziland: a pilot study.

BACKGROUND Countries remain reluctant to adopt the 2012 World Health Organization recommendation for single low-dose (0.25 mg/kg) primaquine (SLD PQ) for Plasmodium falciparum transmission-blocking due to concerns over drug-related haemolysis risk, especially among glucose-6-phosphate dehydrogenase-deficient (G6PDd) people, without evidence demonstrating that it can be safely deployed in their settings. Pharmacovigilance methods provide a systematic way of collecting safety data and supporting the rollout of SLD PQ. METHODS The Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT), comprising: (1) a standardized form to support the surveillance of possible adverse events following SLD PQ treatment; (2) a patient information card to enhance awareness of known adverse drug reactions of SLD PQ use; and (3) a database compiling recorded information, was developed and piloted. Data on patient characteristics, malaria diagnosis and treatment are collected. Blood samples are taken to measure haemoglobin (Hb) and test for G6PD deficiency. Active follow-up includes a repeat Hb measurement and adverse event monitoring on or near day 7. A 13-month prospective pilot study in two hospital facilities in Swaziland alongside the introduction of SLD PQ generated preliminary evidence on the feasibility and acceptability of PROMPT. RESULTS PROMPT was well received by nurses as a simple, pragmatic approach to active surveillance of SLD PQ safety data. Of the 102 patients enrolled and administered SLD PQ, none were G6PDd. 93 (91.2 %) returned on or near day 7 for follow-up. Four (4.6 %) patients had falls in Hb ≥25 % from baseline, none of whom presented with signs or symptoms of anaemia. No patient's Hb fell below 7 g/dL and none required a blood transfusion. Of the 11 (11 %) patients who reported an adverse event over the study period, three were considered serious and included two deaths and one hospitalization; none were causally related to SLD PQ. Four non-serious adverse events were considered definitely, probably, or possibly related to SLD PQ. CONCLUSION Improved pharmacovigilance to monitor and promote the safety of the WHO recommendation is needed. The successful application of PROMPT demonstrates its potential as an important tool to rapidly generate locally acquired safety data and support pharmacovigilance in resource-limited settings

An intervention to reduce sexual violence on university campus in Ghana: a pilot test of Relationship Tidbits at the University of Cape Coast

Background: Sexual assault is a significant challenge for universities worldwide, affecting the health and academic success of students. Although sexual violence prevention programmes are common at universities in the USA, they are non-existent in Ghana. In this study, we tested an adapted sexual violence prevention programme in students at the University of Cape Coast (UCC), Ghana. Methods: We adapted a sexual violence prevention programme created at the University of Michigan, USA, for use at UCC, Ghana. In February, 2016, we ran focus-group discussions that contributed to the initial adaptation to create a programmed called Relationship Tidbits. In April, 2016, we tested the adapted programme with UCC students. We recruited participants for the beta testing from their halls of residence and via snowball sampling. Students interacted with the programme in small groups of six participants and were encouraged to think aloud and ask questions. Participants completed a pre-programme and post-programme survey that included demographic information and measures of attitudes towards sexual violence and gender equity that had been previously validated for UCC using cognitive interview techniques. These measures are the Illinois Rape Myth Acceptance (IRMA) scale, the Gender Equitable Men (GEM) scale, and the Sexual Relationship Power Scale [SRPS]. We used paired samples t-tests to compare pre-programme and post-programme results. Findings: 71 students—36 men and 35 women with a mean age of 22·9 years (SD 4·7 years)—participated in the programme and testing. Male participants showed improvements in several measures including an increase in the overall mean IRMA scale score (from 60·1 (SD 13·1) to 73·4 (18·3); p<0·0001) as well as the “she asked for it” (p<0·0001), “he didn't mean to” (p=0·004), and “she lied” (p=0·001) subscales. Men also showed an increase in mean GEM score (from 54·5 to 59·5; p=0·011), suggesting more gender equitable attitudes after the training, as well as increases in the violence and reproductive health and disease prevention domains of the GEM (p=0·004 and p=0·021, respectively). Scores for female participants did not change significantly after the programme. Interpretation: Our preliminary findings suggest that the adapted programme for university students could change attitudes that are known to be associated with the perpetration of sexual violence. Because rape myth acceptance is common in this setting, the reduction in rape myth acceptance in men is important. Future work will include a more rigorous evaluation of the outcomes of this programme with respect to sexual violence attitudes and behaviours. Funding: None

Danger and sexuality: exploring negotiations in romantic and sexual relationships among university students in Ghana

Gender inequalities and social mores normalise gender-based violence in many settings. The goal of this study was to gain a more in-depth understanding of romantic and sexual relationships, consent, and gender-based violence among university students in Ghana. We used focus group discussions to explore individual factors influencing romantic and sexual relationships among students enrolled at a university in the Central Region of the country to inform the development and tailoring of future interventions. During a series of four focus group discussions comprising students recruited via convenience and snowball sampling, participants were asked to reflect on the nature of their romantic and sexual relationships. Demographic data and experiences of gender-based violence were also collected. The focus groups discussions were recorded and transcribed verbatim and analysed thematically. Five themes were developed from the data: (1) traditional gender roles; (2) self-control; (3) relationship-based consent; (4) cheating; and (5) non-verbal communication. This study suggests negative health and social ramifications of violence will continue until there is a resolution of conflicting social norms that result in different expectations about how men and women can address their sexual needs. Future programming and interventions for gender-based violence prevention should reflect on their impact across all ecological levels

Limitations of Rapid Diagnostic Testing in Patients with Suspected Malaria: A Diagnostic Accuracy Evaluation from Swaziland, a Low-Endemicity Country Aiming for Malaria Elimination.

BACKGROUND: The performance of Plasmodium falciparum-specific histidine-rich protein 2-based rapid diagnostic tests (RDTs) to evaluate suspected malaria in low-endemicity settings has not been well characterized. METHODS: Using dried blood spot samples from patients with suspected malaria at 37 health facilities from 2012 to 2014 in the low-endemicity country of Swaziland, we investigated the diagnostic accuracy of histidine-rich protein 2-based RDTs using qualitative polymerase chain reaction (PCR) (nested PCR targeting the cytochrome b gene) and quantitative PCR as reference standards. To explore reasons for false-negative and/or false-positive results, we used pfhrp2/3-specific PCR and logistic regression analyses of potentially associated epidemiological factors. RESULTS: From 1353 patients, 93.0% of RDT-positive (n = 185) and 31.2% of RDT-negative samples (n = 340) were available and selected for testing. Compared with nested PCR, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of RDTs were 51.7%, 94.1%, 67.3%, and 89.1%, respectively. After exclusion of samples with parasite densities &lt;100/μL, which accounted for 75.7% of false-negative results and 33.3% of PCR-detectable infections, the sensitivity, specificity, PPV, and NPV were 78.8%, 93.7%, 62.3%, and 97.1%. Deletions of pfhrp2 were not detected. False-positivity was more likely during the second year and was not associated with demographics, recent malaria, health facility testing characteristics, or potential DNA degradation. CONCLUSIONS: In the low-transmission setting of Swaziland, we demonstrated low sensitivity of RDT for malaria diagnosis, owing to an unexpectedly high proportion of low-density infection among symptomatic subjects. The PPV was also low, requiring further investigation. A more accurate point-of-care diagnostic may be needed to support malaria elimination efforts

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Additional file 3. Sample size guide