TelePharm PrEP/PEP
2026년 5월 7일 업데이트: Katrina Ortblad, Fred Hutchinson Cancer Center
Leveraging Telehealth to Optimize PrEP and PEP Delivery at Pharmacies in Kenya
In this study, the investigators will evaluate whether introducing a remote nurse to screen, counsel, and guide clients through HIV self-testing (via a telehealth platform) and support interested clients (via SMS) between pharmacy visits increases PrEP/PEP initiations and continuation compared to standard PrEP/PEP delivery by pharmacy providers.
The investigators hypothesize that pharmacy PrEP/PEP services delivered with telehealth support will result in better service utilization and implementation outcomes compared to standard delivery and be cost-effective to implement.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
Participating study pharmacies will be 1:1 randomized 24 pharmacies (n=1,580 clients ≥15 years) to either: 1) telehealth support, where a remote nurse screens, counsels, and guides clients through HIV self-testing (HIVST) and, between visits, communicates with interested clients via 2-way SMS, or 2) standard delivery, where the pharmacy provider performs all delivery tasks and clients are not given additional support.
The primary outcomes are PrEP/PEP initiation and continuation, assessed 180 days following clients' first pharmacy PrEP/PEP visit.
연구 유형
중재적
등록 (추정된)
1580
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Katrina F Ortblad
- 전화번호: 206-667-7267
- 이메일: kortblad@fredhutch.org
연구 장소
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Kisumu, 케냐
- Kenya Medical Research Institute
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연락하다:
- Elizabeth A Bukusi
- 전화번호: +254-572021036
- 이메일: ebukusi@rctp.or.ke
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수석 연구원:
- Elizabeth A Bukusi
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
Pharmacies
- Registered with the Pharmacy and Poisons Board (PPB)
- Must have at least one full-time licensed pharmacist or pharmaceutical technologist on staff
- Must have a private room where HIV testing and PrEP/PEP counseling can occur
- >3 km from other study pharmacies
- Willing to participate in research activities, including 2-day training for pharmacy providers
- Willing to share pharmacy records with us
- Sells HIVST kits that are WHO certified.
Pharmacists/remote nurses
- ≥ 18 years old
- Licensed pharmacist, pharmaceutical technologist, or nurse
- Willing to provide PrEP and PEP services, including HIV testing and associated counseling services
- Willing to complete training on PEP/PrEP service delivery at pharmacies, including certification for rapid diagnostic testing
- Able and willing to provide informed consent
Clients
- ≥ 15 years old
- Interested in being screened for PrEP or PEP
- Meets all criteria to be eligible for pharmacy-delivered PrEP or PEP on the Prescribing Checklist, including being at risk for HIV and not having any medical conditions that might contraindicate PrEP/PEP safety
- Able and willing to provide informed consent
Exclusion Criteria:
Clients
- Unwilling to provide a phone number at which an RA can reach them for completing surveys and communicate important study-related information
- Currently enrolled in any other HIV vaccine or prevention trial
- Have a condition that would preclude provision of informed consent, make study participation unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving study objectives
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Telehealth support
Pharmacy provider-led PrEP/PEP delivery, with telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing and optional 2-way SMS with remote nurses).
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Remote nurses screen, counsel, and guide HIV self-testing for pharmacy clients; pharmacy providers dispense PrEP or PEP.
SMS support from remote nurses available between pharmacy visits.
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활성 비교기: Standard delivery
Pharmacy provider-led PrEP/PEP delivery, without telehealth support from remote nurses for counseling and testing at or between pharmacy visits (includes guided HIV self-testing).
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Pharmacy provider screen, counsel, and guide HIV self-testing for pharmacy clients, and dispense PrEP or PEP.
SMS support not available between pharmacy visits.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PrEP/PEP initiation
기간: 18 months post implementation
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Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP or PEP over the implementation period
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18 months post implementation
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PrEP/PEP continuation
기간: 18 months post implementation
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Pharmacy-level; count outcome: # of unique clients that refilled PrEP, transitioned from PEP-to-PrEP, or were dispensed PEP or on-demand PrEP 1+ times over the implementation period
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18 months post implementation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PrEP initiation
기간: 18 months post implementation
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Pharmacy-level; count outcome: # of unique clients dispensed any form of PrEP over the implementation period
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18 months post implementation
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PEP initiation
기간: 18 months post implementation
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Pharmacy-level; count outcome: # unique clients dispensed any form of PEP over the implementation period
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18 months post implementation
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PrEP/PEP use
기간: 1.5 and 6 months from initiation
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Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP or PEP during the implementation period
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1.5 and 6 months from initiation
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PrEP use
기간: 1.5 and 6 months from initiation
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Pharmacy-level; count outcome: # of unique clients who swallowed any PrEP during the implementation period
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1.5 and 6 months from initiation
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PEP use
기간: 1.5 and 6 months from initiation
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Pharmacy-level; count outcome: # of unique clients who swallowed any PEP during the implementation period
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1.5 and 6 months from initiation
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PrEP refill
기간: 18 months post implementation
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Pharmacy-level; count outcome: # of unique clients who refilled PrEP after initiating PrEP
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18 months post implementation
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Repeat PEP
기간: 18 months post implementation
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Pharmacy-level; count outcome: # unique clients who were dispensed PEP or PEP-in-pocket after initiating PEP
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18 months post implementation
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PEP-to-PrEP
기간: 18 months post implementation
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Pharmacy-level; count outcome: # unique clients who were dispensed PrEP after initiating PEP (any form) over the implementation period
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18 months post implementation
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Engaged with 1+ product
기간: 18 months post implementation
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Pharmacy-level; count outcome: # of unique clients that were dispensed more than one HIV prevention product (oral PrEP, injectable PrEP, PEP, etc) over the implementation period
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18 months post implementation
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On-demand PrEP use
기간: 6 months from initiation
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Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any on-demand PrEP over the implementation period
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6 months from initiation
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PEP-in-Pocket use
기간: 6 months from initiation
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Pharmacy-level; count outcome: # of unique clients who were dispensed and swallowed any PEP-in-Pocket over the implementation period
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6 months from initiation
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Product choice
기간: 18 months post implementation
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Individual-level; binary outcome: % of total PrEP/PEP clients that were dispensed each type of product (e.g., oral PrEP, on- demand PrEP, PEP, DVR, etc).
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18 months post implementation
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PrEP adherence
기간: 1.5 months from initiation
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Individual-level; binary outcome: % PrEP initiators (excluding on-demand) with optimal TFV-DP concentration in DBS
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1.5 months from initiation
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Reach
기간: 18 months post implementation
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Individual-level; binary outcome: % of PrEP/PEP clients in different populations of interest (e.g., men; youth <25 years); with separate evaluations by product type
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18 months post implementation
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Efficiency
기간: 18 months post implementation
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Pharmacy-level; continuous outcome: Avg.
duration (per visit & annually) of pharmacy providers' encounter per PrEP/PEP client, and clients' PrEP/PEP visit duration
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18 months post implementation
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Fidelity
기간: 1.5 months post initiation
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Individual-level; binary outcome: % of clients that received PrEP/PEP services as intended (e.g., correct quantity of drugs)
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1.5 months post initiation
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Sustainment
기간: 24 months post implementation
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Pharmacy-level; count outcome: Volume of unique PrEP/PEP clients served in the past 6 months, assessed at 24 months
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24 months post implementation
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Acceptability
기간: 24 months post implementation
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Individual-level; cont, binary outcome: # of unique client who find the study components acceptable; % of providers, including remote nurses, indicating acceptability; Also assessed in Aim 2 (described below)
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24 months post implementation
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to use (for on-demand PrEP) at 1.5 months
기간: 1.5 months
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Pharmacy-level; continuous outcome: Avg.
duration (in days) from on-demand PrEP dispensing to use, among on-demand clients
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1.5 months
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Time to use (for on-demand PrEP) at 6 months
기간: 6 months
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Pharmacy-level; continuous outcome: Avg.
duration (in days) from on-demand PrEP dispensing to use, among on-demand clients
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6 months
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STI diagnosis
기간: 18 months post implementation
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Individual-level; binary outcome: % of PrEP/PEP clients with a syndromic STI diagnosis (at any pharmacy PrEP/PEP visit)
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18 months post implementation
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Other drugs dispensed
기간: 18 months post implementation
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Pharmacy-level; binary outcome: % of PrEP/PEP clients dispensed other drugs (e.g., hypertension, contraception) at their visit
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18 months post implementation
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HIV incidence
기간: 18 months
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Pharmacy-level; binary outcome: % of PrEP/PEP clients who tested positive
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18 months
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HIV risk
기간: 18 months post implementation
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Inidiviudal-level; binary outcome: % of PrEP/PEP clients reporting specific behaviors (i.e., multiple sex partners)
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18 months post implementation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Kendall V Harkey, Fred Hutch Cancer Center
- 연구 의자: Rachel C Malen, Fred Hutch Cancer Center
- 수석 연구원: Katrina F Ortblad, Fred Hutch Cancer Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2028년 3월 31일
연구 완료 (추정된)
2028년 9월 30일
연구 등록 날짜
최초 제출
2026년 4월 24일
QC 기준을 충족하는 최초 제출
2026년 4월 24일
처음 게시됨 (실제)
2026년 5월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 7일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RG1125680
- R01MH140465 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Participant-level pharmacy record and research data will be shared through deposition of the data in an open-access public repository (Dryad).
In addition to sharing the study data publicly, data dictionaries and other tools supporting use of the data will be shared.
IPD 공유 기간
De-identified pharmacy record and research data from this study will be deposited in the Dryad data repository within 12 months of publication.
IPD 공유 액세스 기준
The study data will be accessible through the Dryad data repository. For all publications, a dataset will be created that is assigned a digital object identifier (DOI), which will be referenced in the publication so the research community can easily find and access the data, if interested. The Dryad repository can also be searched by topic, institution, and investigator name, which should make it easy for other interested parties to find and access the study data.
Any study data that cannot be shared via Dryad, will be made available through a formal request to the PIs. We will share data and supporting documentation upon request to outside investigators, after scientific review, IRB approval, and obtaining relevant Data Use Agreements.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .