Table 4 Qualitative data collection schedule
Category | Case definition | Data collection method | Participant type | # of interviews |
|---|---|---|---|---|
Special circumstances among study participants | ||||
Seroconverts | Participant tests HIV positive during any follow visit. HIV test confirmed with ELISA test. | IDI | PrEP Participant | 3 IDIs |
Discontinued PrEP | Participants who decide to discontinue PrEP during any time of the study follow-up period. | IDI | PrEP Participant | 9 IDIs (3 per arm) |
Two or more consecutive missed visits | Participants who missed two or more consecutive adherence visits during follow-up period. | IDI | PrEP Participant | 12 IDIs |
Reported social harms | Participants who report any type of social harm due to study participation. i.e. participants treated unfairly and experiencing problems being accepted by their families, partners, and/or communities due to participation in the study | IDI | PrEP Participant | All Cases of Social Harms |
Unique pattern of medication use | Participants who have a unique pattern of medication use as identified by adherence counsellors or study nurses. i.e. Use over holidays and/or over weekends only | IDI | PrEP Participant | 9 IDIs (3 per arm) |
Never presented for medication refill following enrollment | Participants who never presented to study sites for adherence sessions/medication collection after initiating PrEP. | IDI | PrEP Participant | 15 IDIs |
PrEP uptake from community platforms | ||||
Immediate acceptors | Participants who consent to study and receive supply of PrEP the day of screening and study introduction. | IDI | Pop-up Site Testing Enrolment | 15 IDIs |
Immediate presenters | Participants who present to study sites for PrEP initiation within 0-3 days of completing baseline questionnaire. | IDI | Home-based Testing Enrolment | 15 IDIs |
Early presenters | Participants who present to study sites for PrEP initiation within 4-14 days of completing baseline questionnaire. | IDI | Home-based Testing Enrolment | 15 IDIs |
Late presenters | Participants who present to study sites for PrEP initiation within 15-30 days of completing baseline questionnaire. | IDI | Home-based Testing Enrolment | 15 IDIs |
Never presenters | Participants who never presented to study sites after completing baseline questionnaire. | IDI | Home-based Testing Enrolment | 15 IDIs |
Experiences with taking PrEP and engaging in adherence support activities | ||||
High adherence | Active participants who have attended more than one adherence session with DBS levels ≥ 700 fmol/punch. | IDI and CME | PrEP Participants | 20 IDIs (5 per intervention arm per site) |
Low adherence | Active participants who have attended more than one adherence session with DBS levels ≤ 699 fmol/punch. | IDI and CME | PrEP Participants | 20 IDIs (5 per intervention arm per site) |
Process evaluation and staff implementation experiences | ||||
PrEP field staff | Interviews with field staff, including research nurses, adherence counsellors, and field workers to understand their experiences with PrEP implementation at a community-based level. | IDI | Field Staff | 12 IDIs (6 per site) |
Observational exchange exercise | Exchange of one staff member per site to observe differences in staff interaction with PrEP participants that may influence participant adherence and attendance. | Staff Exchange | Field Staff | 1 day per site |
Community preparation and engagement | ||||
CAB members | Active community advisory members who advised study staff on study implementation, study progress, and community engagement. | FGD | CAB Members | 4 FGDs (2 per site) |