Mobile Health Supported Self-care Among Tertiary Education Students in Zimbabwe
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-60
SponsorLiverpool School of Tropical Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MASCOT
Other interventionA 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
Treatment groups
16,000 Participants
are divided into 2 treatment groupsGroup A: MASCOT interventionExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion of students at risk of HIV acquisition
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.
Time frame
At the end of implementation of MASCOT, at 6 months2
Proportion of students using effective contraception
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.
Time frame
At the end of implementation of MASCOT, at 6 monthsSecondary outcomes
1
Provider and societal cost per contraceptive/HIV service taken up
Trained economics data collectors including peer distributors will use a specially designed costing tool to collect information on activities contributing to program roll-out. The tool will record data on preparatory activities such as community entry and engagement workshops with key relevant stakeholders, value program and distributor (personnel) time, MASCOT commodities, vehicle and travel and other recurrent costs. For students, accessing HIV prevention and contraception services may involve travel (e.g., to collect EC or get confirmatory testing) and other costs in addition to productivity losses, which may potentially deter uptake. We will therefore aim to characterize these costs of accessing services in work package 5 post-intervention representative in-person surveys which will be conducted among 15% randomly selected students in each trial college. Only selected students who answer yes to accessing all or any MASCOT commodities will be included.
Time frame
From study inception to the end of implementation of intervention at 6 months2
Proportion of students at risk of HIV transmission
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 viral loading. The numerator for this outcome is: total number of students at risk of transmitting HIV, defined as: HIV positive students who are not virally suppressed (obtained from blood testing). The denominator for this outcome is: total number of surveyed students.
Time frame
At the end of study implementation, at 6 months3
Quantitative implementation outcomes
Based on program data: 1) numbers taking up each of the self-care services 2) numbers interacting with the decision aids. These data will be collected through the mHealth tool.
Time frame
From enrollment to the end of implementation at 6 months4
Qualitative implementation outcomes - Feasibility, acceptability, fidelity and impact of the study.
Feasibility- Qualitative studies will be used to assess whether MASCOT can be effectively implemented in practice. Feasibility will also be measured by analysing program data on: uptake of commodities (through mHealth tool), and use of decision aids (through mHealth tool). Acceptability- Qualitative interviews will be used to assess how well MASCOT was received by the target population and stakeholders. Program data (from mHealth tool) will be collected to determine acceptability of MASCOT. Fidelity- Qualitative interviews will be used to assess the degree to which the MASCOT intervention was implemented as intended or designed. Fidelity will be assessed on adherence to the peer-led model and mHealth use to promote uptake of HIV/SRH services. Impact- We will also use qualitative interviews to assess broader changes that may occur because of MASCOT over time. Data will be collected on potential contribution of MASCOT to improve uptake of HIV and contraception services.
Time frame
From enrollment to the end of implementation at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Liverpool School of Tropical Medicine
Lead sponsor
Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe)
Collaborator
Source ClinicalTrials.gov
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