Streamlining the Efficiency of PrEP Implementation (NCT04424524) | Clinical Trial Compass
CompletedNot Applicable
Streamlining the Efficiency of PrEP Implementation
Kenya746 participantsStarted 2020-05-01
Plain-language summary
This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP users will be evaluated to understand delivery efficiency and in-depth interview with users and delivery key informants will be conducted to identify barriers and facilitators of implementation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For HIV-negative participants:
* Of legal age (≥18 years)
* Able and willing to provide written informed consent for research component of the project (blood draw for adherence, brief surveys and in-depth qualitative interviews)
* HIV uninfected based on negative HIV tests, per Kenya national guidelines
* Currently or previously accessed PrEP at participating HIV clinic
For Key delivery informants:
* Able willing and able to provide consent in order to participate in the survey and qualitative interviews.
* Works at any of the clinics implementing PrEP delivery. Key informants may include HIV testing service nurses, counselors, clinicians, social workers, or clinic managers.
Exclusion Criteria:
* Not meeting any of the inclusion criteria listed above.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient wait time
Timeframe: up to 6 months
2
PrEP continuation
Timeframe: up to 6 months
3
PrEP adherence
Timeframe: up to 6 months
4
Acceptability of direct-to-pharmacy PrEP care pathway
Timeframe: up to 6 months
5
Acceptability of user HIV self-testing for PrEP care pathway
Timeframe: up to 6 months
6
Feasibility of direct-to-pharmacy PrEP care pathway