Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07403318
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT07403318
Study Brief:
Protocol Section:
NCT07403318