Conducting Violence and Mental Health Research with Female Sex Workers during the COVID-19 Pandemic: Ethical Considerations, Challenges, and Lessons Learned from the Maisha Fiti Study in Nairobi, Kenya.

Conducting violence and mental health research during the COVID-19 pandemic with vulnerable groups such as female sex workers (FSWs) required care to ensure that participants and the research team were not harmed. Potential risks and harm avoidance needed to be considered as well as ensuring data reliability. In March 2020, COVID-19 restrictions were imposed in Kenya during follow-up data collection for the Maisha Fiti study (n = 1003); hence data collection was paused. In June 2020, the study clinic was re-opened after consultations with violence and mental health experts and the FSW community. Between June 2020 and January 2021, data were collected in person and remotely following ethical procedures. A total of 885/1003 (88.2%) FSWs participated in the follow-up behavioural-biological survey and 47/47 (100%) participated in the qualitative in-depth interviews. A total of 26/885 (2.9%) quantitative surveys and 3/47 (6.4%) qualitative interviews were conducted remotely. Researching sensitive topics like sex work, violence, and mental health must guarantee study participants' safety and privacy. Collecting data at the height of COVID-19 was crucial in understanding the relationships between the COVID-19 pandemic, violence against women, and mental health. Relationships established with study participants during the baseline survey-before the pandemic-enabled us to complete data collection. In this paper, we discuss key issues involved in undertaking violence and mental health research with a vulnerable population such as FSWs during a pandemic. Lessons learned could be useful to others researching sensitive topics such as violence and mental health with vulnerable populations.

A mixed-methods study measuring the effectiveness of a menstrual health intervention on menstrual health knowledge, perceptions and practices among young women in Zimbabwe.

OBJECTIVES: While integral to women's physical and mental well-being, achieving good menstrual health (MH) remains a challenge for many women. This study investigated the effectiveness of a comprehensive MH intervention on menstrual knowledge, perceptions and practices among women aged 16-24 years in Harare, Zimbabwe. DESIGN: A mixed-methods prospective cohort study with pre-post evaluation of an MH intervention. SETTING: Two intervention clusters in Harare, Zimbabwe. PARTICIPANTS: Overall, 303 female participants were recruited, of whom 189 (62.4%) were seen at midline (median follow-up 7.0; IQR 5.8-7.7 months) and 184 (60.7%) were seen at endline (median follow-up 12.4; IQR 11.9-13.8 months). Cohort follow-up was greatly affected by COVID-19 pandemic and associated restrictions. INTERVENTION: The MH intervention provided MH education and support, analgesics, and a choice of menstrual products in a community-based setting to improve MH outcomes among young women in Zimbabwe. PRIMARY AND SECONDARY OUTCOMES: Effectiveness of a comprehensive MH intervention on improving MH knowledge, perceptions, and practices among young women over time. Quantitative questionnaire data were collected at baseline, midline, and endline. At endline, thematic analysis of four focus group discussions was used to further explore participants' menstrual product use and experiences of the intervention. RESULTS: At midline, more participants had correct/positive responses for MH knowledge (adjusted OR (aOR)=12.14; 95% CI: 6.8 to 21.8), perceptions (aOR=2.85; 95% CI: 1.6 to 5.1) and practices for reusable pads (aOR=4.68; 95% CI: 2.3 to 9.6) than at baseline. Results were similar comparing endline with baseline for all MH outcomes. Qualitative findings showed that sociocultural norms, stigma and taboos around menstruation, and environmental factors such as limited access to water, sanitation and hygiene facilities affected the effect of the intervention on MH outcomes. CONCLUSIONS: The intervention improved MH knowledge, perceptions and practices among young women in Zimbabwe, and the comprehensive nature of the intervention was key to this. MH interventions should address interpersonal, environmental and societal factors. TRIAL REGISTRATION NUMBER: NCT03719521.

Pilot randomised controlled trial of a remotely delivered online intervention for adolescent mental health problems in India: lessons learned about low acceptability and feasibility during the COVID-19 pandemic.

BACKGROUND: 'POD Adventures' is a gamified problem-solving intervention delivered via smartphone app, and supported by non-specialist counsellors for a target population of secondary school students in India during the COVID-19 pandemic. AIMS: To evaluate the feasibility and acceptability of undertaking a randomised controlled trial of POD Adventures when delivered online with telephone support from counsellors. METHOD: We conducted a parallel, two-arm, individually randomised pilot-controlled trial with 11 secondary schools in Goa, India. Participants received either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes were assessed at two timepoints: baseline and 6 weeks post-randomisation. RESULTS: Seventy-nine classroom sensitisation sessions reaching a total of 1575 students were conducted. Ninety-two self-initiated study referrals (5.8%) were received, but only 11 participants enrolled in the study. No intervention arm participants completed the intervention. Outcomes at 6 weeks were not available for intervention arm participants (n = 5), and only four control arm participants completed outcomes. No qualitative interviews or participant satisfaction measures were completed because participants could not be reached by the study team. CONCLUSIONS: Despite modifications to address barriers arising from COVID-19 restrictions, online delivery was not feasible in the study context. Low recruitment and missing feasibility and acceptability data make it difficult to draw conclusions about intervention engagement and indicative clinical outcomes. Prior findings showing high uptake, adherence and engagement with POD Adventures when delivered in a school-based context suggest that an online study and delivery posed the biggest barriers to study participation and engagement.

A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: "POD Adventures" is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. OBJECTIVE: Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. METHODS: We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. RESULTS: The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. CONCLUSIONS: This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. TRIAL REGISTRATION: ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30339.

Community perspectives on the COVID-19 response, Zimbabwe.

OBJECTIVE: To investigate community and health-care workers' perspectives on the coronavirus disease 2019 (COVID-19) pandemic and on early pandemic responses during the first 2 weeks of national lockdown in Zimbabwe. METHODS: Rapid qualitative research was carried out between March and April 2020 via phone interviews with one representative from each of four community-based organizations and 16 health-care workers involved in a trial of community-based services for young people. In addition, information on COVID-19 was collected from social media platforms, news outlets and government announcements. Data were analysed thematically. FINDINGS: Four themes emerged: (i) individuals were overloaded with information but lacked trusted sources, which resulted in widespread fear and unanswered questions; (ii) communities had limited ability to comply with prevention measures, such as social distancing, because access to long-term food supplies and water at home was limited and because income had to be earned daily; (iii) health-care workers perceived themselves to be vulnerable and undervalued because of a shortage of personal protective equipment and inadequate pay; and (iv) other health conditions were sidelined because resources were redirected, with potentially wide-reaching implications. CONCLUSION: It is important that prevention measures against COVID-19 are appropriate for the local context. In Zimbabwe, communities require support with basic needs and access to reliable information to enable them to follow prevention measures. In addition, health-care workers urgently need personal protective equipment and adequate salaries. Essential health-care services and medications for conditions other than COVID-19 must also continue to be provided to help reduce excess mortality and morbidity.