Mobile Health Supported Self-care Among Tertiary Education Students in Zimbabwe

NCT07403318 | Not Yet Recruiting DMC

• 2 other identifiers: MASCOT studyNIHR
• Study Type: interventional
• Target: 16,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unmet Need for Contraception; Uptake of HIV Prevention; Healthy Participants

Keywords

contraception; decision aid; young people; community-led; mHealth; adolescent girls and young women; adolescent boys and young men; HIV prevention; HIV post-exposure prophylaxis; HIV PEP; Emergency Contraception; peer-led interventions; student-led interventions

Outcome Measures

Primary Outcomes (2)

• 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.

  At the end of implementation of MASCOT, at 6 months

• 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.

  At the end of implementation of MASCOT, at 6 months

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

Other: MASCOT

Standard of Care

NO INTERVENTION

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

Interventions

MASCOT OTHER

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

MASCOT intervention

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• \- 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.
• \- None stated
• Work package 3: Adaptation of the parent mHealth tool
• \. Hackathon
• a. Students
• Enrolled in the specific institutions; in these disciplines: public health, information technology and computer science; and
• Willing to take part in the hackathon
• None stated
• b. Multi-disciplinary experts
• 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.

Sponsors & Collaborators

• Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe): collaborator
• Liverpool School of Tropical Medicine: lead

Study Sites (1)

Centre for Sexual Health and HIV/AIDS Research Zimbabwe

Harare, 0000, Zimbabwe

Location

Central Study Contacts

Oppah Kuguyo, PhD

CONTACT

+263775282460; oppah.kuguyo@ceshhar.org

Itai Kabonga, PhD

CONTACT

+263774765461; itai.kabonga@ceshhar.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: MASCOT is a suite of services that promote self-care among young people \- using a peer-led model, supported by mobile health and decision aids to improve the uptake of HIV and contraception services. This multifaceted implementation strategy combines all three components of self-care in the following strategies: i) education - through peer distributors and through the mHealth tool. ii) decision support for a) HIV prevention, b) contraception - offered through decision aids, addressing self-awareness, potentially leading to self- management. iii) 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 refer students 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.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 19, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ZI (1)