NCT04982250Befejeződött
Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation in Kenya
Peer PrEP Referral + HIV Self-test Delivery for PrEP Initiation Among Young Kenyan Women: Pilot Study & Randomized Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 3.
Rövid összefoglaló (regiszter, angolul)
Few young women at risk of HIV infection are initiating pre-exposure prophylaxis (PrEP) for HIV prevention in Kenya, thus we propose refining and testing a new model to increase PrEP initiation among young women at high HIV risk that has never been explored: enhanced peer PrEP referral with HIV self-test (HIVST) delivery. We conducted formative research to design of a model that is acceptable to young women and feasible to implement in Kenya. In this study, we will refine this model where young (≥16 to 24 years) female PrEP users refer their peers to PrEP and deliver HIVSTs in a pilot study and then test the refined model in a hybrid effectiveness-implementation trial. We hypothesize that relative to standard informal word-of-month peer PrEP referral (currently ongoing in Kenya), enhanced peer PrEP referral with HIVST delivery will increase PrEP initiation, continuation, and adherence among peers; have high fidelity; and be low cost.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 211 (tényleges)
- Első benyújtás
- 2021. júl. 23.
- Kezdés
- 2022. febr. 24.
- Elsődleges befejezés
- 2024. jún. 5.
- Fő szponzor
- Fred Hutchinson Cancer Center
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT04982250
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 211
- 2022. febr. 24. és az elsődleges befejezés (2024. jún. 5.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- Not able to identify up to 4 peers at risk of HIV infection
- Currently enrolled in an HIV study
- Not able to identify up to 4 peers at risk of HIV infection
Életkor
- Age ≥16 or >24 years
- Age ≥16 or >24 years
- Age ≥16 or >24 years
Egyéb
- For peer providers (qualitative data, pilot):
- Male
- Have not used PrEP for a minimum of three months
- Not willing to disclose PrEP use to their peers
- Not willing to participate in training with study counselors on PrEP referral and HIVST use
- Not willing to refer peers to PrEP and deliver HIVSTs
- Not able and willing to provide written informed consent
- For peer providers (cRCT):
- Male
- Have not used PrEP
- Illiterate
- Not willing to participate in training with study counselors on PrEP referral and HIVST use
- Not willing to refer peers to PrEP and deliver HIVSTs
- Not able and willing to provide written informed consent
- For peer clients (pilot, cRCT):
- Male
- Not referred by peer (i.e., a PrEP users) to initiate PrEP
- Not able and willing to provide written informed consent
Kiket keres a vizsgálat
- For peer providers (qualitative data, pilot):
- Age ≥16 to 24 years*
- Female
- Have been on PrEP for a minimum of three months
- Good adherence to PrEP (i.e., self-report take PrEP all the time)
- Willing to disclose PrEP use to their peers
- Able to identify up to 4 peers at risk of HIV infection
- Willing to participate in training with study counselors on PrEP referral and HIVST use
- Willing to refer peers to PrEP and deliver HIVSTs
- Able and willing to provide written informed consent
- Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery
- For peer providers (cRCT):
- Age ≥16 to 24 years*
- Female
- Must have refilled or initiated PrEP (i.e., been dispensed PrEP)
- Not currently enrolled in an HIV study
- Able to identify up to 4 peers with recent self-reported behaviors associated with risk of HIV acquisition
- Willing to participate in training with study counselors on PrEP referral and HIVST use
- Willing to refer peers to PrEP and deliver HIVSTs
- Able and willing to provide written informed consent
- Willing to provide contact information for follow-up
- Willing to engage in all research activities including completion of questionnaires
- Per the discretion of the site investigator, no clear risks of social harm or inability otherwise to reasonably conduct HIVST at home in the context of PrEP delivery
- For peer clients (pilot, RCT):
- Age ≥16 to 24 years*
- Female
- Referred by peer (i.e., a PrEP users) to initiate PrEP
- Able and willing to provide informed consent
- NOTE: We will only enroll young women ≥16 to 17 years into the study if they are emancipated minors and thus able to legally provide consent for participation in research. Kenyan law acknowledges women ages 14 to 17 who have become pregnant as emancipated minors. The PHRD site/UW collaboration has successfully enrolled emancipated minors into a number of prior studies, including PrEP clinical trials. In addition, Kenya's national policy guidelines explicitly permit PrEP use in this age group.
Életkor a regiszterben: 16 év – 24 év · Nem: csak nők · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Partners in Health and Research Development | Thika | Kenya | Ismeretlen állapot |
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