Mobile Health Supported Self-care Among Tertiary Education Students in Zimbabwe
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Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: MASCOT.
- Кому может быть актуально
- Состояния в реестре: Unmet Need for Contraception, Uptake of HIV Prevention, Healthy Participants. Базовые параметры: 16 лет — 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Zimbabwe
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Официальное название
mHealth Supported Self-care Among Tertiary Education Students in Zimbabwe
Обзор
Young people of ages 15-24 years, particularly those in Sub-Saharan Africa, do not optimally take up HIV services (HIV testing, HIV prevention and HIV treatment) and contraception. The number of new HIV infections in this group is disturbingly high and they suffer a lot of illness and death related to HIV. Research has found that four out of five sexually active adolescents in Africa are not using contraception. This means that millions of young people are exposed to unintended pregnancy and the associated negative effects such as unsafe abortions, school drop-out and reduced opportunities for both mother and baby. World Health Organisation have issued new guidelines for a new strategy, self-care, where an individual takes care of their own health and manages their illness with or without the support of a health worker. Self-care has potential to increase the number of young people who use HIV and contraception services. There is not enough information on how self-care can be done in a way that supports people to use services and maintain this use over time. Self-care can be made easier by mobile phone-based digital systems called mHealth, which may work by supporting access of services, for example where products are ordered online, or creating enabling conditions for self-care, for example through facilitating correct information-giving. With various options for HIV prevention and contraception available, young people may need support/guidance choosing options that suit them. Health workers in overburdened health systems may be too overwhelmed to clearly present all options to guide informed decisions. Decision aids (tools that support patients/users to make informed choices that suit their values and preferences) can enhance self-care by enabling informed decisions. Decision aids for HIV prevention and contraception need to be developed for use in self-care settings. Combining decision aids with mHealth tools can enhance self-care. This study will be co-developed with students enrolled in colleges/universities in Zimbabwe to develop a self-care strategy that includes mHealth together with decision aids and enables students to optimally use HIV and contraception services. The study is divided into five stages, and builds on another study where a self-care strategy supported by an mHealth tool (without decision aids) was developed. In the first stage of the current study, preferences for decision aids and attributes to include in the mHealth tool will be obtained using qualitative research and a scoping literature review. In the second stage, findings from the first stage will be used to develop blueprints for two decision aids: one for contraception and the other for HIV prevention. In the third stage, the decision aids will be integrated with the existing mHealth tool through a crowdsourcing activity including students, and experts in health and mHealth. In the fourth stage the self-care strategy supported by mHealth and decision aids will be tested in a pilot at 2 colleges/universities. Finally, the fifth stage be a randomised control trial, across college/universities in Zimbabwe, to see whether the self-care strategy supported by mHealth and decision aids will be effective to promote self-care, and therefore, results in an increase in the uptake of HIV and contraception services. This study will also be applied to make recommendations on how the strategy can be provided outside of college/university contexts.
Подробное описание
Young people aged 15-24 years have the worst HIV and sexual and reproductive health outcomes of all ages globally. Across sub-Saharan Africa, only 65% of people living with HIV aged 15-24 years know their HIV status, compared with 84% of older adults. There is suboptimum uptake of condoms and other HIV prevention interventions, pre-exposure prophylaxis and voluntary medical male circumcision. Every week, 7,800 15-24 year olds are infected with HIV globally, of whom 25% are African women. More than 80% of sexually active adolescents in sub-Saharan Africa do not use contraception; millions of young people face unintended pregnancy, unsafe abortions and school drop-out.
Self-care, where an individual maintains their own health and copes with illness with or without health worker support, is a novel World Health Organisation (WHO)-recommended intervention that could increase uptake of services and achieve health targets. WHO recommends use of mHealth (using mobile devices such as mobile phones or other wireless technologies in medicine/ public health) to support self-care. Knowledge on how to most effectively implement and sustain self-care to optimise health outcomes is lacking. Rigorous evidence is needed to guide policy and practice.
This study will co-develop an empowering self-care intervention for young people, together with intended users. The self-care intervention aims to promote young people to take care of their own sexual and reproductive health through increasing uptake of HIV testing, prevention and care, and of contraception, with the ultimate goal of reducing HIV incidence and unintended pregnancies. The intervention will comprise self-care supported by innovative mHealth tools incorporating decision aids (tools that support patients/ users to make informed choices that suit their values and preferences) and digital support for continued engagement. The intervention builds on previous research on HIV self-testing, self-care, young people and mHealth.
Poor engagement in care and prevention is a huge public health challenge particularly among young people for whom the negative health and socio-economic consequences may persist for decades. Among young Africans living with HIV only 65% know their HIV status. In Zimbabwe, 50% and 34% of young men and women living with HIV have unsuppressed virus and young people with HIV have the highest mortality of any age group. Targets for voluntary medical male circumcision and pre-exposure prophylaxis have been missed and condom use has declined. HIV incidence is high; globally 28% of new HIV infections are among people aged 15-24 years. Demographic health surveys from 18 African countries found that 82.6% of sexually active 15-19-year- olds were not using contraception, with high rates of unintended pregnancies reported,5 exposing them to unsafe abortions, school drop-out and reduced opportunities for both mother and child.
Young people face many barriers to the uptake of HIV and sexual and reproductive health services. In addition, health services fail to support them to make informed decisions about the range of available options. Barriers to service uptake among young people include: fear of disclosure of HIV status/sexual activity, negative attitudes of health workers towards sexual activity in young people and lack of proximity to services. Poor knowledge and poor risk perception are also important: less than 50% of young Africans have comprehensive knowledge of HIV and 48% of those at high risk of infection perceive themselves to be at risk.
Self-care could empower individuals to engage in activities that promote health, prevent disease and manage illness by increasing patient choice, autonomy and access to services. Self-care was first recommended by WHO in 2019, with guidelines revised on a rolling basis according to emerging evidence.
Self-care includes three components:
i) self-awareness e.g. self-help, self-education, self-efficacy; ii) self-testing e.g. self-sampling, self-screening and self-diagnosis; iii) self-management e.g. self-treatment, self-examination.
A conceptual framework for self-care developed by Narasimhan and WHO has four domains. Central to self-care is upholding human rights, gender equality and other ethical values while taking a holistic patient-centred approach. Self-care can be accessed in various sites (home, community, pharmacies, health services, digital technologies). An enabling environment is critical (education/information, commodity security and supportive laws/policies) as is health system accountability: self-care should enhance health system reach rather than shift burden from health workers to patients.
Enhancing sexual and reproductive health among young people will influence their health and socio-economic outcomes for the rest of their life. This study has potential to curtail health and socio-economic challenges faced by young people now and in the future while reducing burdens on the over-stretched health systems in sub-Saharan Africa. Our research will provide evidence of potential public health impact versus costs and inform future scale-up of mHealth-supported self-care. mHealth solutions can effect positive behaviour change and improve quality and coverage of care. WHO recognises mHealth as important for achieving universal health coverage and recommends mHealth for self-care. mHealth technologies can support access e.g. ordering self-testing products or receiving results from self-collected samples. They can promote an enabling self-care environment where accurate information/education is disseminated. mHealth tools that link to health information systems enable documentation of use of services.
The topical study will incorporate decision aids for HIV prevention and contraception to support patient informed choices tailored to their values and preferences. For a health intervention with a choice of options, decision aids provide information on each option, including effectiveness, advantages, disadvantages and match with specified personal values/preferences. Few decision aids have been evaluated for HIV prevention, yet the growing number of prevention options (different formulations of pre-exposure prophylaxis - tablets, vaginal ring, injectable, formulations with/without contraception, in addition to other prevention options) mean that young people need decision support. Decision aids for contraception have been developed and are widely used; however, they will need adapting for African self-care contexts.
Importance of peer-led interventions The current study builds on a previous study that employed mHealth supported, peer-led delivery of HIV and sexual and reproductive health services among students enrolled in colleges/universities. Peer distribution of HIV commodities was found to be highly acceptable; and feasibility work found near universal uptake of HIV self-tests by peers. Preliminary work in the pilot shows high acceptability of peer-led self-care among students and supporting programs. Other studies have also reported on effectiveness of peer-led approaches among young people.
Research questions and aims The intervention to be co-developed and evaluated is called mHealth supported self-care among tertiary education students in Zimbabwe (MASCOT).
Research questions
1. How can the existing mHealth supported self-care package for HIV and sexual and reproductive be enhanced? 2. What is the impact of mHealth supported self-care on uptake of sexual and reproductive health services among college/university students in Zimbabwe? 3. What are the societal costs of mHealth supported self-care in Zimbabwe? 4. How can an mHealth supported self-care intervention co-developed with college/university students in Zimbabwe be adapted for youth in other settings? Aim: To determine how self-care can address the protracted challenge of poor service engagement among young people, with the ultimate goal of reducing HIV incidence and unintended pregnancies.
Specific objectives
1. Explore preferences for decision aids for HIV prevention and contraception and how decision aids can be incorporated into the existing self-care model among college/university students. 2. Adapt decision aids for HIV prevention and contraception for young people according to context-specific values and preferences 3. Adapt the existing mHealth tool to include support for decisions on uptake of HIV prevention and contraception. 4. Determine the feasibility and acceptability of MASCOT in two colleges/ universities 5. Determine effectiveness of MASCOT in improving uptake of HIV and contraception services and its societal costs in a cluster randomised trial in colleges/universities in Zimbabwe 6. Explore how MASCOT might be adapted for other settings through a detailed process evaluation Setting/context: The study will be conducted in Zimbabwean colleges/universities including technical colleges, teachers' training colleges, and so will capture a wide range of education abilities.
Study overview
Five work packages will drive this research:
Work package 1 - Formative work to explore preferences for decision aids for HIV prevention and contraception and how to incorporate decision aids to the existing self-care intervention.
Work package 2 - Development of decision aids for HIV prevention and contraception.
Work package 3 - Using a hackathon to adapt the existing mHealth tool to include decision aids and a user interface Work package 4 - Pilot of mHealth supported self-care in two colleges/ universities.
Work package 5 - Cluster randomised trial to determine the effect of mHealth supported self-care on uptake of HIV and contraception services.
Description of the MASCOT intervention
MASCOT uses a multifaceted implementation strategy combining all three components of self-care in the following strategies:
i) Education or information-giving (addressing self-awareness) - through peer distributors and through the mHealth tool, overcoming poor knowledge.
ii) Decision support for a) HIV prevention, b) contraception - offered through decision aids, addressing self-awareness, potentially leading to self-management. Overcomes challenges with informed decision-making.
iii) Peer-led implementation - peers distributing self-care commodities and promoting self-care, addressing self-awareness, self-testing and self-management. Peers penetrate social circles, understand peer experiences and can package messages in understandable, acceptable ways.
iv) Consumer and stakeholder involvement to ensure the intervention is acceptable and appropriate - students, Ministry of Health and other stakeholders involved in intervention design, implementation and evaluation, addressing self-awareness, self-testing and self- management.
Conceptual Framework
Intervention development is informed by the Narasimhan/WHO self- care framework and COM-B framework. COM-B specifies that three conditions are essential for behaviour change: capability, opportunity and motivation. MASCOT will enhance psychological capability by providing information through peer distributors and the mHealth tool including the decision aid. Physical capability will be enhanced by training/information giving on practical aspects of self-care (e.g. how to conduct HIV self-tests).
MASCOT will address individual motivation to access contraception and/or HIV prevention/care by facilitating understanding of their risk through the decision aid. Self-care reduces the likelihood of deductive disclosure of sexual activity or HIV status by clinic staff or other clinic patrons - a major deterrent to service uptake. Widespread peer-driven implementation may also increase normalisation of self-care, potentially improving motivation.
MASCOT will improve the opportunity to access contraception and HIV prevention/care through peer distribution of technologies and assisted access to clinical services for those
Вмешательства
- Другое MASCOT
A suite of services comprised of a peer-led model to deliver HIV prevention and contraception services using mobile health with decision aids to support self-care among students
Первичные конечные точки
- Proportion of students at risk of HIV acquisition [Срок оценки: At the end of implementation of MASCOT, at 6 months]
- Proportion of students using effective contraception [Срок оценки: At the end of implementation of MASCOT, at 6 months]
Вторичные конечные точки (4)
- Provider and societal cost per contraceptive/HIV service taken up [Срок оценки: From study inception to the end of implementation of intervention at 6 months]
- Proportion of students at risk of HIV transmission [Срок оценки: At the end of study implementation, at 6 months]
- Quantitative implementation outcomes [Срок оценки: From enrollment to the end of implementation at 6 months]
- Qualitative implementation outcomes - Feasibility, acceptability, fidelity and impact of the study. [Срок оценки: From enrollment to the end of implementation at 6 months]
Критерии участия
Work package 1: Formative research
- Focus Group Discussions
- Aged 16 years old or over;
- Currently enrolled at a college/university where the research is being done;
- Willing and able to provide written informed consent.
Критерии исключения
\- None stated
- Key informant interviews
- Staff from MoHCC responsible for implementing or supervising implementation of HIV or sexual and reproductive health services, or for policy planning on the same topics,
- Staff from Ministry of Higher and Tertiary Education responsible for student health, staff from Ministry of Health implementing partners working on HIV and sexual and reproductive health services in Zimbabwe,
- Willing and able to provide written informed consent.
Критерии исключения
\- None stated
Work package 3: Adaptation of the parent mHealth tool
1\. Hackathon
1a. Students
Критерии включения
- Enrolled in the specific institutions; in these disciplines: public health, information technology and computer science; and
- Willing to take part in the hackathon
Критерии исключения
None stated
1b. Multi-disciplinary experts
Критерии включения
- Representatives in any of the following disciplines, Digital health experts, MoHCC, HIV and SRH services, other key stakeholders; and
- Willing to take part in the hackathon.
Критерии исключения
None stated
2\. Alpha testing
2a. Students
Критерии включения
- Recruited from the same colleges/universities that participated in formative research
- Willing and able to provide written informed consent.
Критерии исключения
None stated
2b. Health workers
Критерии включения
- Staff from MoHCC responsible for implementing or supervising the implementation of HIV and sexual and reproductive health services,
- Willing and able to provide written informed consent.
Критерии исключения
None stated
3\. Beta testing
3a. Students
Критерии включения
- Students who have used the mHealth tool and decision aids
- Willing and able to provide written informed consent.
Критерии исключения
\- None stated
4\. Pilot of mHealth supported self-care in two colleges/universities
4a. Institutions
Критерии включения
- Less than 3500 students
- Comparable male and female ratio
- Participated in formative research
Критерии исключения
Institutions that participated in the formative research
4b. Peer distributors
Критерии включения
- Aged >18 years;
- Currently enrolled at the participating colleges/universities
- Willing to be a peer distributor,
- Willing to conduct study activities according to the protocol.
Критерии исключения
\- Students who were away from college for industrial attachment during intervention implementation
4c. Pilot survey
Критерии включения
- Students enrolled at the colleges/universities for at least 6 months.
- Willing to provide written informed consent for the survey.
Критерии исключения
\- Students who were away from college for industrial attachment during intervention implementation
4d. In-depth interviews with students
Критерии включения
- Students enrolled at the colleges/universities for at least 6 months.
- Willing to provide written informed consent for the in-depth interviews
Критерии исключения
None defined
4e. In depth interviews with Peer Distributors
Критерии включения
- Student peer distributor at a tertiary education institution where the research is being done; and
- Willing and able to provide written consent for the interview.
Критерии исключения
None defined
4f. FGDs with students
Критерии включения
- Enrolled at the colleges/universities for at least 6 months.
- Willing to provide informed consent for the FGD.
Критерии исключения
None defined
4g. In depth interviews with health workers
- Health worker at participating college/university supporting the MASCOT intervention.
- Willing and able to provide written informed consent.
Критерии исключения
None defined
5\. Cluster Randomised trial
5a. Institutions
Критерии включения
- Located in 10 provinces: Harare, Mashonaland Central, West and East, Masvingo, Manicaland, Midlands Bulawayo and Matabeleland North and South
- Maximum enrolment of 3500 students
Критерии исключения
None defined
5b. Surveys, in-depth interviews with students, peer distributors and health workers and FDGs with students will be the same as for work package 4 above.
5c. Costing interviews with distributors
Критерии включения
- Student peer distributor at a tertiary education institution where the research is being done; and
- Willing and able to provide written consent for the costing interview.
Критерии исключения
None defined
5d. Costing - Valuing distributor time
Критерии включения
- Student peer distributor at a tertiary institution where the research is being done.
- Willing and able to provide written consent
Критерии исключения
None defined
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Zimbabwe · 1 центр
- Centre for Sexual Health and HIV/AIDS Research Zimbabwe — Harare
Идентификаторы
NCT: NCT07403318 · MASCOT study · NIHR