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临床试验/NCT07403318
NCT07403318尚未招募不适用

mHealth Supported Self-care Among Tertiary Education Students in Zimbabwe

Liverpool School of Tropical Medicine1 个研究点 分布在 1 个国家目标入组 16,000 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
16,000
试验地点
1
主要终点
Proportion of students at risk of HIV acquisition

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • - 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.
  • Exclusion Criteria:
  • - None stated
  • Work package 3: Adaptation of the parent mHealth tool
  • 1. Hackathon
  • 1a. Students
  • Inclusion criteria:
  • Enrolled in the specific institutions; in these disciplines: public health, information technology and computer science; and
  • Willing to take part in the hackathon
  • Exclusion criteria:
  • None stated
  • 1b. Multi-disciplinary experts
  • Inclusion criteria:
  • 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.
  • Exclusion criteria:
  • None stated
  • 2. Alpha testing
  • 2a. Students
  • Inclusion criteria:
  • Recruited from the same colleges/universities that participated in formative research
  • Willing and able to provide written informed consent.
  • Exclusion criteria:
  • None stated
  • 2b. Health workers
  • Inclusion criteria:
  • 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.
  • Exclusion criteria:
  • None stated
  • 3. Beta testing
  • 3a. Students
  • Inclusion criteria:
  • Students who have used the mHealth tool and decision aids
  • Willing and able to provide written informed consent.
  • Exclusion Criteria:
  • - None stated
  • 4. Pilot of mHealth supported self-care in two colleges/universities
  • 4a. Institutions
  • Inclusion criteria:
  • Less than 3500 students
  • Comparable male and female ratio
  • Participated in formative research
  • Exclusion criteria:
  • Institutions that participated in the formative research
  • 4b. Peer distributors
  • 另有 56 项未显示

研究组 & 干预措施

MASCOT intervention

Experimental

The MASCOT intervention is a suite of services that promotes self-care, using a peer-led model to distribute HIV and contraception services that is supported by a mobile health tool with decision aids. Students in the institutions where the MASCOT intervention is implemented will receive:

  1. education - through peer distributors and through the mHealth tool.
  2. decision support for a) HIV prevention, b) contraception - offered through decision aids, addressing self-awareness, potentially leading to self-management.
  3. peer-led implementation - peers distributing self-care commodities (HIV self-test kits and condoms), and promoting self-care, addressing self-awareness, self-testing and self-management. Peer distributors will also promote and/or referrals for additional HIV prevention services such as PEP, PrEP and voluntary medical male circumcision; and contraception services such as emergency contraceptive and other long acting contraceptive methods.

干预措施: MASCOT (Other)

Standard of Care

No Intervention

Students in the standard of care arm will receive normal HIV prevention and contraception services.

结局指标

主要结局

Proportion of students at risk of HIV acquisition

时间窗: At the end of implementation of MASCOT, at 6 months

In work package 5, a cluster randomised control trial will be conducted at colleges/universities to compare the effectiveness of MASCOT in promoting uptake of HIV and sexual and reproductive health services among young people in colleges/universities. After six months of implementing MASCOT, a population representative survey will be conducted among 15% of randomly selected students attending participating colleges/universities, regardless of interacting with MASCOT. This survey will include collection of dried blood spots from participants, for HIV testing and in HIV-positive samples, viral load testing. The numerator for this outcome is: total number of students at risk of acquiring HIV, defined as: HIV negative students (obtained from HIV negative result from blood spot testing) that are engaging in risky sex and not using HIV prevention methods (self-reported based on survey response). The denominator for this outcome is: the total number of surveyed students.

Proportion of students using effective contraception

时间窗: At the end of implementation of MASCOT, at 6 months

In work package 5, a cluster randomised control trial will be conducted at colleges/universities to compare the effectiveness of MASCOT in promoting uptake of HIV and sexual and reproductive health services among young people in colleges/universities. After six months of implementing MASCOT, a population representative survey will be conducted among 15% of randomly selected students attending participating colleges/universities, regardless of interacting with MASCOT. This survey will include questions on contraception use. The numerator for this outcome is: total number of students using effective contraception when having sex with a partner measured (self-reported based on survey responses). The denominator for this outcome is: total number of surveyed students.

次要结局

  • Provider and societal cost per contraceptive/HIV service taken up(From study inception to the end of implementation of intervention at 6 months)
  • Proportion of students at risk of HIV transmission(At the end of study implementation, at 6 months)
  • Quantitative implementation outcomes(From enrollment to the end of implementation at 6 months)
  • Qualitative implementation outcomes - Feasibility, acceptability, fidelity and impact of the study.(From enrollment to the end of implementation at 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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