Authentic participatory research with older adults for cognitive health (APROACH) in rural Botswana and urban Montreal: protocol for a pilot randomised controlled trial

Abstract

Introduction

Increasing numbers of older adults live with dementia especially in low- and middle-income countries. Most prevention relies on controlling conditions that increase the risk of dementia, such as hypertension, diabetes and sight and hearing loss. Recent pharmacological treatments have limited efficacy and are prohibitively expensive. Social isolation increases the risk of dementia and evidence suggests interventions to increase social engagement can reduce the risk possibly by supporting executive function. Three key features of authentic participatory research – shared governance, use of evidence and innovation – align with elements of executive function. Our pilot tests the feasibility and acceptability of participatory dementia prevention in Montreal, Canada and rural Botswana.

Methods and analysis

This pilot randomised controlled trial will recruit women and men aged 65 years and older who are socially isolated (not in paid or voluntary employment, not married) in urban Montreal and two rural communities in Botswana. In Botswana, we will randomly allocate participants in one community to receive the intervention immediately while the control community will receive the intervention after 18 months. In Montreal, individual participants will be randomly allocated to immediate or delayed intervention groups before or after their grouping by shared concern. We aim to recruit at least 100 participants in Botswana and 100 in Montreal. The intervention has six steps: individuals identify priority concerns; participants join groups with shared concerns; groups discuss the concern and potential solutions; groups share the concern and possible solutions with other stakeholders; implementation of solutions; and self-evaluation of the process. We will measure executive function using the Frontal Assessment Battery, and apply a questionnaire to measure integral brain health, physical health and social isolation at baseline, at 18 months and at 33 months. We will analyse narratives of change at the end of the intervention periods to understand participants’ experience of the intervention.

Ethics and dissemination

The McGill University Faculty of Medicine and Health Sciences Institutional Review Board approved the entire project on 18 September 2024, Study number: A06-M27-24A. The Psychosocial Research Committee (REC) of CIUSSS West-Central Montreal Research Ethics Board (REB) approved recruitment of clinic-related participants in Montreal on 3 March 2025, Project 2025-4112. The Health Research and Development Division of the Ministry of Health, Botswana, approved the study in Botswana on 24 June 2024, Reference number: HPRD 6/14/1.

In Botswana, we will disseminate the findings in community meetings in the two pilot communities and with government and non-government stakeholders convened by the Ministry of Health and the Social Development Department of the Ministry of Local Government and Traditional Affairs. In Montreal, we will disseminate the findings in research meetings and in other relevant fora. We will give oral and poster presentations about the study in relevant local, national and international academic conferences and meetings and publish papers about the findings in peer-reviewed, indexed academic journals.

Trial registration number

ISRCTN14273485.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This is the first study assessing the feasibility and acceptability of participatory dementia prevention.

• The participatory intervention leverages what is known about the neurobiology of executive function.

• Piloting in two very different settings (Montreal and rural Botswana) provides information about cultural relevance and adaptations of the intervention.

• The time available for the intervention might be insufficient for a meaningful effect on executive function.

• The pilot is not powered to detect moderate effects of the intervention with statistical significance.

Introduction

Research problem and justification for the project

Burden of dementia: Most people living with dementia do so in low- and middle-income countries (LMICs).^{1 2} The projected surge in dementia to affect 152 million by 2050 will happen mostly through increases in LMICs. This proposal engages older adults in dementia prevention that emphasises participant-designed interventions with community resources and capacity building of the next generation of dementia prevention researchers.

Limits of pharmacology: Pharmaceutical solutions to cognitive deterioration draw massive investment and great expectations. A 2025 systematic umbrella review,³ however, concluded there is insufficient evidence for repurposing any systemic drugs to reduce dementia risk. New candidate drugs either showed no effect on cognitive function⁴ or a statistical effect with controversial clinical significance.⁵

Social engagement can affect cognition:⁶ Observational studies report people who live alone without wanting to do so have a higher risk of dementia.^7–9 Several trials tested the effect of social interventions.^{10 11} The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability,¹² for example, involved researcher-defined lifestyle strategies (diet, exercise, cognitive training and vascular management).¹³ Promising results led to several multi-domain interventions, including Can-Thumbsup.¹⁴ The Dutch preDIVA trial¹⁵ provided researcher-designed advice and motivational interviews, showing no difference in dementia incidence between intervention and control.¹⁶ MAPT^{17 18} showed no difference between physical activity, cognitive training, nutrition advice and information sessions with placebo medication. HATICE^{19 20} showed older adults changed behaviours after e-health counselling; it did not show reduced dementia.

Physical activity adds little to dementia prevention: A meta-analysis²¹ reported 15 of 25 randomised controlled trials (RCTs) showed improvements for exercise on measures of executive function, memory or composite measures of cognition. In 14 studies reviewed by Gates et al,²² 92% of reported cognitive outcomes were not different with exercise. An aerobic exercise intervention did not affect cognitive outcomes compared with relaxation, balance and flexibility exercise controls.²³ The emerging consensus is that repetitive physical activity alone is not enough to prevent cognitive decline.^{24 25}

Dementia occurrence in sub-Saharan Africa: Although the number of scientific publications on dementia in Africa has increased steadily since the 1980s,²⁶ there is still no clear picture of how common the condition is. A systematic review reported a wide range of prevalence rates in variously constructed samples – from 6.3% to 25%.²⁷ Analysis of 10 studies between 1980 and 2011 estimated 2.4% of adults were affected over the age of 50 years.²⁸ A 2005 Botswana study of 372 participants aged ≥60 years tested with a non-validated version of the Mini-Mental State Examination (MMSE) reported a 9% prevalence of cognitive impairment.²⁹ A small Botswana study found 24 of a random sample of 265 older adults (9%) had cognitive impairment; they experienced a 3.6-fold higher 6-month mortality.³⁰ The dementia picture is complicated by HIV, itself associated with dementia.³¹ Lawler and colleagues³² reported 38% of randomly selected 120 HIV+ patients met the criteria for dementia using the International HIV Dementia Scale, which has been criticised for overdiagnosis.³³ A subsequent study found 42% with mild cognitive impairment and 25% with dementia in a similar population.³⁴

Mechanisms and measurement gaps: Preventing age-related cognitive decline has recently prompted investigation of lifestyle factors. It hinges on reducing the influence of concomitant conditions like hypertension and diabetes and contributing factors like hearing loss that might speed up cognitive decline.³⁵ We need new approaches to question and eventually reduce “potentially modifiable” risks, but also to question the larger hitherto “potentially unmodifiable” 60% of dementia.² Sandra Weintraub and colleagues provided a bird’s-eye view of neuropsychological changes in Alzheimer’s disease³⁶ and highlighted limitations of our measurement tools to detect and track early changes.³⁷ Dementia research lacks culturally/linguistically safe and appropriate measurement. Some assessment research focuses on real-world behaviours^{38 39} (tools to assess driving, financial decision-making, etc), but this is missing the whole-person approach it takes to recognise and to deal with the challenges of everyday life. An intervention to prevent dementia must take on that real-world whole person. And measurement of prevention efforts should similarly take account of the real-world whole person. The preventable fraction of dementia could be higher in LMICs than in rich countries, as nearly all risk factors are more common and less often mitigated by treatment.^40–42 Yet dementia prevention research addresses primarily, if not exclusively, older adults in richer countries.⁴³ Global prevention should be a priority, perhaps providing insights on the unmodifiable portion of dementia.

Rationale: There is a surge of interest in revitalising executive function⁴⁴ in dementia prevention. Looking beyond dementia and neurodegenerative diseases of ageing as narrow medical conditions, we revisit neurodegenerative diseases in a framework of agency and active engagement.⁴⁵ Going beyond token or procedural engagement, authentic participation implies genuine partnership and power sharing,⁴⁶ where participants use local evidence to innovate real-world solutions.

We treat older adults as authors and active decision-makers, not as patients who passively receive medication or who we urge to do exercises. Measured impacts of participatory research usually centre on the topic of research, like reducing risk of dengue fever⁴⁷ or increasing adherence to diabetes therapy.⁴⁸ Here we focus on the impact on participants themselves,^{49 50} their cognitive capacity, well-being, relationships and concomitant illnesses. We argue co-management of shared concerns, use of evidence and innovation (implementing new ideas) can be transformative,⁵¹ possibly through executive function.⁵² If these mechanisms use corresponding elements of executive function – the hypothesised combination of inhibition (effortful control), active memory and innovation⁵³ – this could revitalise cognitive capacity (figure 1).

Figure 1. Alignment of elements of authentic participatory research with elements of executive function.

Research goal and objectives

Goal

Pilot the concept, feasibility, acceptability, and tools to measure operationalising the hypothesised neurobiology of authentic participation, in preparation for a future multicentred RCT.

Objectives

1. Assess feasibility and resources needed for recruitment and intervention of participatory dementia prevention with at-risk older adults.

2. Assess indicative changes in the international context, including changes in cognitive, social and psychological health between and within intervention and control groups.

Methods and analysis

Study design

This pilot prepares for a multi-country RCT of participatory engagement of older adults for prevention of dementia. Simple randomisation of groups or communities to immediate or delayed intervention will rely on an online random number generator (https://www.random.org/). In both Montreal and Botswana, participants in the immediate intervention group or community will begin the participatory engagement intervention upon randomisation. After about 14 months, intervention resources will switch to the delayed intervention group or community. We propose this crossover design for reasons of equity and motivation for participants in the delayed intervention group; we also need to know how intervention dynamics persist after completion of the formal facilitated intervention period. At the crossover point, all participants will repeat the survey and cognitive testing, and those in the delayed intervention group will then receive the intervention. After another 14 months, all participants will repeat the survey and cognitive testing (in the initial intervention group to test sustainability). We can compare outcomes post-intervention with the baseline in the delayed intervention group, with before-after and difference-in-differences comparisons.⁵⁴ Figure 2 shows the design and timings.

Figure 2. Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram of the study. FAB, Frontal Assessment Battery.

Sample selection and recruitment

In southern Botswana, participants will be women and men aged 65 years or older recruited at the point of receiving their old-age pension in two rural communities. In Montreal, we will recruit older adults (65 years and above) among family members of residents with moderate to advanced dementia living in a long-term care home, or through community organisations focused on older adults.

Inclusion criteria

1. Age 65 years or older.

2. Non-dementia after cognitive test (Frontal Assessment Battery (FAB) and Montreal Cognitive Assessment (MoCA)/Mini Mental State Evaluation (MMSE).

3. Health exam addressing hypertension, diabetes, sight and hearing loss.

4. Complete baseline questionnaire.

Exclusion criteria

i. Cognitive disability including dementia

We will administer a short initial questionnaire to the older men and women to register address and contact details, also asking about marital status and social isolation. Based on responses to this initial questionnaire, the research team will identify eligible men and women, further giving preference to those who are more socially isolated (living alone and with few close friends). They will invite them to participate and, for those who agree, administer the baseline questionnaire and FAB. Pre-intervention health screening includes blood pressure measurement, blood sugar testing and testing of hearing and eyesight. We will exclude from participation any men and women who are unable to complete the baseline questionnaire and FAB, or who decline the health screening. The baseline health screening includes screening for cognitive impairment, in Botswana using the MMSE and in Montreal using the MoCA.

Recruitment started in April 2025 and will end in December 2026. The pilot will conclude in March 2028.

Intervention

The intervention is a six-step protocol to engage older adults in authentic participation, which we understand to include (1) active co-ownership and shared governance, (2) active use of (recent) evidence and (3) using space for innovation. This cycle will be repeated several times by each group, as they find solutions to initial concerns and move to tackle other concerns they identify as a group. We anticipate each group will deal with three to four issues during the intervention period, but the pace of dealing with each issue will be set by the participants. We will train facilitators in each of the steps of the implementation cycle. In Botswana, male facilitators will work with groups of older men and female facilitators with older women. Figure 3 depicts the intervention cycle.

Figure 3. Six steps in the participatory intervention.

1. Individual identification of priority issue: fieldworkers will ask each participant to describe (in words or in a sketch or painting) what they view as the most pressing issue related to their living conditions. This will confirm sufficient cognitive capacity to participate and identify themes for subsequent group work.

2. Groups with a shared interest: fieldworkers will create groups of participants with similar concerns. The groups will include from 3 to 10 participants depending on circumstances; we expect bigger groups in the Botswana community setting. We anticipate about 12 meetings of one to 2 hours weekly or fortnightly in each 6-step cycle; we expect the pilot to provide information about the best timing of meetings.

3. Collaborative analysis in groups: based on their individual concerns, the group will characterise or name an issue they want to deal with first. They will share what they know about the issue, through narratives or by fuzzy cognitive mapping (FCM),⁵⁵ mapping the causes and the potential resolutions of the issues. Our FCM approach derives from ecological⁵⁶ and health research⁵⁷ with adaptations by our research team.^58–60

4. Participant-led sharing of the issues and potential solutions: facilitators will support the groups to develop ways to share their concerns and to discuss possible solutions with relevant stakeholders, including oral presentations and participatory visual methods, including cellphilms,⁶¹ participatory video,⁶² photovoice.^{63 64}

5. Planning and implementing actions: the groups themselves might be able to resolve some issues, but often the solutions will require the engagement of others (family, service providers, etc). The groups will develop action strategies with short-term and longer-term fixes. The facilitators will record the plans and help the groups to achieve them, for example by brokering group interactions with relevant service providers.

6. Self-evaluation: the final step is group reflection and self-evaluation about how they addressed the issue, what changed and what that means to them.

Sample size considerations

We aim to include at least 50 older adults (30 women and 20 men) in Botswana in each of two communities: immediate intervention and delayed intervention (control). In Montreal, we aim to include 50 older adults in the immediate intervention group and a similar number in the delayed intervention (control) group. Thus, the minimum total sample size for the pilot is 200 in the two settings.

Pilot study size depends on the feasibility objectives,⁶⁵ in this case, recruitment and intervention dynamics: how many accept to participate in the two settings, if eligibility criteria are too open or too restrictive, participants’ ability to do screening exercises and to participate, retention in the intervention, acceptability of the assessment measures. For all these measures, we will adjust our approach until we recruit and keep people in the intervention in each country setting. The adjustments will inform the subsequent RCT. Our study will be clustered, as the intervention involves groups of older women and men.

Cited in Eldridge et al,⁶⁵ arguably a definitive authority on pilot studies, Whitehead et al suggest the size of a pilot trial should be related to the size of the future definitive RCT.⁶⁶ For such a trial designed with 90% power and two-sided 5% significance, they recommend pilot trial sample sizes for each treatment arm of 75, 25, 15 and 10 for standardised effect sizes that are very small (0.1), small (0.2), medium (0.5) or large (0.8), respectively. With at least 50 in each intervention arm, our pilot sample size is suitable for a larger trial with an effect size between 0.1 and 0.2.

If the participatory research intervention improves cognition or delays decline in cognition, we expect less attrition in the intervention group than in the control group. The pilot study will assess the feasibility of follow-up of the participants, documenting reasons and cognitive status of those who do drop out.

Outcomes to be measured

Primary outcome

The primary focus is to assess feasibility (Objective 1) in terms of recruitment, retention/adherence/engagement, data quality and intervention fidelity/adverse effects. For each recruitment channel, we will measure the number of participants contacted, screened, eligible, consented and enrolled; we will evaluate the inclusion and exclusion criteria for wider application. We will assess the retention, adherence and engagement and apply the most significant change technique to explore participant satisfaction with the intervention and to document unexpected effects. An economic evaluation will assess resources needed to run the intervention in relation to its health effectiveness. Concerned with sustainability beyond the initial intervention investment, we will revisit participants of the first intervention group 18 months after completion to assess sustainability of the intervention without research resources.

Secondary outcomes

A preliminary assessment of clinical effects (Objective 2) focuses first on sustained or improved executive function. We will administer the FAB⁶⁷ and Hachinski’s proposal of integral brain health⁶⁸ at three time points: at baseline, at 18 months (after the intervention in the immediate intervention group), and at 33 months (after the intervention in the delayed intervention group). FAB combines conceptualisation, lexical fluency, motor programming, sensitivity to interference, inhibitory control and environmental dependency, while the Integral Brain Health Index is a self-assessment of cognitive, psychological and social well-being. An administered questionnaire at baseline, 18 and 33 months will collate data on social isolation, health events and decisions, physical activity and personal goals.

At the beginning of their intervention period, each participant will identify personal goals they would like to achieve. At the end of the intervention period, they will reflect on the extent to which they have achieved their original goals or modified goals they formed during the intervention. The identification of personal goals and addressing challenges in the local ecology informs departure from one-size-fits-all interventions and impact measures to allow, at the beginning of the intervention, each participant in their ecosystem to define their own goals, physical and cognitive.⁶⁹

Especially in the LMIC context, dementia onset for older adults living alone might result in early death if they are unable to take care of food and water needs. The pilot is not powered to detect a difference in mortality, but a higher overall mortality in the delayed intervention group would be compatible with a protective effect of the intervention.

Data analysis plan

Following Samaan and colleagues,⁷⁰ table 1 summarises the data analysis plan in relation to the study objectives and expected outcomes.

Table 1. Summary of study objectives, outcomes and analysis plan.

AIM	Objective	Outcome	Hypothesis	Statistical analysis
Primary	Feasibility	Recruitment, retention	Participatory dementia prevention is feasible and acceptable	Descriptive
	Resources needed	Screening, session number/duration, facilitator training, transport, incentives		Economic analysis
	Acceptability and sustainability	Participants view intervention positively		Engagement index; Most significant change
Secondary	Cognitive, mental and social health	FAB and integral brain health index	The intervention will cause improvement	Between-group and within-group comparisons of FAB
	Survival	Participant tracing
	Personal achievement	Self-assessed improvement

FAB, Frontal Assessment Battery.

Pilot qualitative analysis

For each recruitment channel, we will measure the number of participants contacted, screened, eligible, consented and enrolled; we will evaluate the inclusion and exclusion criteria for wider application. We will use an existing instrument to assess the retention, adherence and engagement.^{71 72} We will introduce and test an index of authentic participation that includes facilitator assessments of individual participation and group dynamics and participant evaluation of their experience. We will use the most significant change technique to explore participant satisfaction with the intervention and to document unexpected effects.⁷³ An economic evaluation will cover set-up costs, training and maintaining the intervention. It will include likely savings and participant contingent valuation of dementia avoidance to inform cost implications of scale-up.⁷⁴

Using rapporteur notes or transcripts, we will conduct a hybrid thematic analysis⁷⁵ of narratives of change from participants at the end of their intervention period. A deductive analysis will be based on the three elements of authentic participation: co-ownership and shared governance, active use of evidence and innovation. We will supplement this with an inductive analysis, adding other themes emerging from the stories.⁷³

Participatory analysis of visual/arts-based media that participants may create during the intervention⁷⁶ will focus on naming themes and the resonance of themes to inform discussions among participants. One focus of participatory analysis will be the experiential aspects of engagement, attempting to understand the experience in relation to the shift in cognitive function.^{77 78}

Pilot quantitative analysis

The principal researcher (NA) and principal biostatistician (LT), who were not involved in fieldwork at either site, will conduct the analysis following the pre-specified plan and will be blinded to exposure identity. The FAB is a validated tool to evaluate executive function with a maximum score of 18.⁷⁹ In Botswana, local researchers will contextualise the FAB. Where the test refers to flowers or fruit that do not grow in the country, for example, these will be replaced by well-known trees or medicinal plants. We will add self-assessed integral brain health based on Hachinski’s proposal of integral brain health as “…cognitive, mental and social function”.^{68 80} We will compare the FAB and self-assessed integral brain health of intervention and control participants at three time points: at baseline, at 18 months (after the intervention in the immediate intervention group), and at 33 months (after the intervention in the delayed intervention group). Illustrative multivariate analysis,⁸¹ stratifying by gender, will examine associations between executive function outcomes and potential determinants. Blind to exposure identity, it will rely on Generalised Linear Mixed Models, using site as a random effect. Since we do not expect randomisation to be fully effective in dealing with potential confounders, we will address these in a secondary multivariate analysis.

Potential co-determinants will include exposure to the intervention as well as level of participation, family history, identity factors, personal health and co-morbidities. We will conduct before-after, difference-in-differences and parallel group comparisons to estimate the likely range of changes we should expect, the variances of the main outcome parameters and the intra-class correlation coefficients.

Ethics and dissemination

Ethical approval

The McGill University Faculty of Medicine and Health Sciences Institutional Review Board gave ethical approval for the entire project on 18 September 2024, Study number: A06-M27-24A. The Psychosocial Research Committee (REC) of CIUSSS West-Central Montreal Research Ethics Board (REB) gave ethical approval for the study in Montreal on 3 March 2025, Project 2025-4112. The Health Research and Development Division of the Ministry of Health, Botswana, gave ethical approval for the study in Botswana on 24 June 2024, Reference number: HPRD 6/14/1.

Confidentiality

Confidentiality during data collection

The questionnaires will include personal perspectives and health, identity, cultural and other confidential issues. The results of cognitive testing during the study are sensitive, given the stigma around cognitive loss and dementia. Local researchers will administer all questionnaires and cognitive testing with privacy to avoid any risk of personal information or information about functional loss becoming known to other people.

Health workers who undertake the initial health screening of participants (including blood pressure measurement, blood sugar testing, testing of hearing and eyesight) will do so following their usual protocols for patient confidentiality. They will release the results of these screening tests only to the participant and to the research team with the consent of the participants. They will not release the results of any of these screening tests to other study participants. Where the screening discovers health conditions, testers will refer participants in both intervention and control groups to a local health centre.

Participants in groups will likely know one another. Facilitators will ask participants to respect each other’s confidentiality. However, confidentiality cannot be guaranteed in the group setting, and facilitators will advise group participants not to share any identifiable personal experiences in the group.

Patient and public involvement

As a trial of a participatory intervention with older adults, the intervention was the result of participation of scores of community groups that over the years have made us aware of what works for them. This will be complemented with active involvement in the proposed intervention. We parsed the intervention into six steps to ensure its mapping to executive function, and five of those steps are participant-led. In this important sense, the proposed study pivots on public participation, with researchers providing the scientific framework and objective measurement to document how it works.

Data storage and retention

We will consider all questionnaire responses as confidential. Data on questionnaire responses, cognitive testing and clinical measurements sent to the secure cloud servers will not include any names or individual identifiers. Data on the cloud servers are password-protected; only designated research team members will have access. The McGill IT team has evaluated and approved the cloud server for safety to be used for data from Botswana. The data from Montreal will be stored in the cloud server of the Information Management System based at the Lady Davis Institute, approved by Quebec Health Authorities. We will store downloaded data on designated password-protected computers only. We will retain the data for 7 years.

Consent procedures

Local researchers recruiting study participants will use a consent script to explain the study, including the initial eligibility screening, the questionnaires to assess the impact of the intervention and the intervention itself. The consent script will also explain the voluntary nature of participation and the right of participants to withdraw from the study at any time. In Botswana, the researchers will record the informed oral consent of each participant, and a witness will sign to confirm the informed consent of the participant. In Montreal, participants will sign the informed consent form.

Protection of participants

This study presents minimal risk of harm to participants. The main potential risk could be from personal information (such as questionnaire responses or screening test results) becoming known to others. The arrangements for privacy during data collection and for maintaining confidentiality of all collected data mitigate this potential risk. It is possible that some participants may experience distress when recounting their narratives of their experience in the project. We will train interviewers to deal with any distress sensitively and to contact their supervisor to arrange for further help as necessary.

Particularly in Botswana, we will arrange for local health and social workers to provide support as necessary for older adults requiring additional advice or support to deal with health or social problems.

Time and compensation

Participants contribute time to respond to questionnaires, participate in collective analysis, create visual arts-based communications and participate in discussions. We will offer a small payment for group session participation, contributing to a sense of worth.

Dissemination

In Botswana, we will disseminate the findings in community meetings in the two pilot communities and in meetings of government and non-government stakeholders convened by the Ministry of Health and the Social Development Department of the Ministry of Local Government and Traditional Affairs. In Montreal, we will disseminate the findings in research meetings within McGill University, led by Participatory Research at McGill in the Department of Family Medicine, and in other relevant local stakeholder fora. We will give oral and poster presentations about the study in relevant local, national and international academic conferences and meetings and publish papers about the findings in peer-reviewed, indexed academic journals.

Data availability

Data for this pilot trial are not publicly available due to the sensitivity of personal health information and the privacy requirements of TCPS-2 and Quebec’s Law 25. Only de-identified datasets will be shared, and solely through a controlled-access process. Researchers may request access by submitting a proposal to the study’s Data Access Committee. Approved users must sign a data-use agreement prohibiting re-identification, unauthorised secondary use, or further transfer of data, including across borders. Any cross-jurisdictional data communication (eg, between Quebec and Botswana) will occur only following a Privacy Impact Assessment and verification of adequate protections.