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Can a phone app boost HIV prevention and contraception among students?

NCT ID NCT07403318

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to see if a mobile health (mHealth) tool, combined with decision aids, can help college students in Zimbabwe better access HIV prevention and contraception services. Researchers will work with 16,000 students to develop and test the tool over several stages, including a pilot and a large trial. The goal is to reduce new HIV infections and unintended pregnancies by making it easier for young people to make informed health choices.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 16,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Work package 1: Formative research 1. 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. Exclusion Criteria: \- None stated 2. 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 Inclusion criteria: * 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. Exclusion criteria: \- Students who were away from college for industrial attachment during intervention implementation 4c. Pilot survey Inclusion criteria: * Students enrolled at the colleges/universities for at least 6 months. * Willing to provide written informed consent for the survey. Exclusion criteria: \- Students who were away from college for industrial attachment during intervention implementation 4d. In-depth interviews with students Inclusion criteria: * Students enrolled at the colleges/universities for at least 6 months. * Willing to provide written informed consent for the in-depth interviews Exclusion criteria: None defined 4e. In depth interviews with Peer Distributors Inclusion Criteria: * 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. Exclusion criteria: None defined 4f. FGDs with students Inclusion criteria: * Enrolled at the colleges/universities for at least 6 months. * Willing to provide informed consent for the FGD. Exclusion criteria: 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. Exclusion criteria: None defined 5\. Cluster Randomised trial 5a. Institutions Inclusion criteria: * Located in 10 provinces: Harare, Mashonaland Central, West and East, Masvingo, Manicaland, Midlands Bulawayo and Matabeleland North and South * Maximum enrolment of 3500 students Exclusion criteria: 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 Inclusion criteria: * 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. Exclusion criteria: None defined 5d. Costing - Valuing distributor time Inclusion criteria: * Student peer distributor at a tertiary institution where the research is being done. * Willing and able to provide written consent Exclusion criteria: None defined

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As listed by the trial registrant

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How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Centre for Sexual Health and HIV/AIDS Research Zimbabwe

    Harare, 0000, Zimbabwe

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