PrEP for Prevention of HIV Transmission Among People Who Inject Drugs in Nairobi, Kenya (NCT05465265) | Clinical Trial Compass
CompletedNot Applicable
PrEP for Prevention of HIV Transmission Among People Who Inject Drugs in Nairobi, Kenya
Kenya256 participantsStarted 2021-09-01
Plain-language summary
The investigators broadly aim at determining barriers and facilitators to PrEP uptake and adherence and retention among the study participants. The investigators have the following specific objectives of determining: (1) the PrEP knowledge levels, attitudes, practices, and user experiences among injecting and sexual partners of PWID in Nairobi County (2) the socio-demographic, behavioural, and structural factors hindering the uptake of PrEP among PWID's sexual and injecting partners in Nairobi County; and (3) the effect of a theory-guided behavioural intervention (PrEP-UP) utilizing peer outreach and navigation on the uptake of PrEP by the study participants.
The investigators hypothesize that: PWID's injecting and sexual partners in Nairobi City lack PrEP knowledge, and have poor attitudes practices, and user experiences about PrEP; less than 50.0% of the PWID's sexual and injecting partners in Nairobi County have socio-demographic, behavioural and structural factors hindering their uptake of PrEP; and a theory-guided behavioural intervention (PrEP-UP) utilizing peer outreach and navigation has no effect on the uptake of PrEP by the study participants.
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.
The inclusion criteria for the study includes:
Being age 18 years and above.
Being HIV negative on a rapid HIV test conducted prior to interviews.
No pregnancy for females at the time of recruitment.
Active injection of illicit drugs in the six months preceding the study.
High multiple HIV risk and high HIV through sexual activities and sharing of injection equipment or syringes (the high multiple-risk group mixed unsafe drug use with unsafe sexual practices; the second group practiced high-risk sex with non-consistent condom combined with drug use; the moderate-risk group had limited unsafe sexual practices; and the "low-risk" group never had unprotected sex and never shared needles and other injection equipment).
Informed consent to participate inti the study.
The exclusion criteria includes:
Being a minor (below 18 years).
Those not actively injecting drugs.
Acute or chronic HIV infection
Those not consenting to participation into the study.
Pregnancy.
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.
1This trial tested two approaches — peer navigation versus pamphlets — to help people who inject drugs start and stay on PrEP in Nairobi; can you help me understand which of those approaches might work better for my situation and how I could access similar support locally?
2Since this trial is now completed, have the results been published yet, and if so, what did they show about how well people were able to stick with PrEP over the 18-week period?
3The trial relied on self-reported data for PrEP uptake, retention, and adherence — can you explain how that might affect how confident we should be in the findings, and whether it changes how you'd apply them to my care?
4This study was conducted specifically among people who inject drugs in Nairobi — how relevant do you think the findings are to my own circumstances, and are there similar programs or navigation services available where I live?
5Given that this trial focused on getting people started and retained on PrEP rather than testing PrEP itself, what do you think is the most evidence-based way for me to access and stay consistent with PrEP based on everything that's known so far?
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
PrEP uptake following either navigation or provision of pamphlets (Self-reported uptake reported through quantitative interviews)
Timeframe: 12 weeks
2
Retention into PrEP after uptake following either navigation or provision of pamphlets (Self-reported retention)
Timeframe: 18 weeks
3
Adherence to PrEP for 18 weeks (self reported through interviews conducted by investigators)