Combatting HIV Or Other STIs Early (CHOOSE): An Integrated Strategy of Pre-Exposure Prophylaxis (PrEP) Mobile Health (mHealth) Support and Doxycycline Post-Exposure Prophylaxis (DoxyPEP)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- PrEP Uptake; proportion of participants receiving PrEP from the study site within 9 months of study follow-up
研究概览
简要总结
The overarching goal of this project is to optimize the PrEP Choice integrated mHealth package and assess the efficacy and cost of PrEP Choice on PrEP initiation and adherence among young people. It is hypothesized that PrEP Choice will improve HIV PrEP uptake and adherence among young people and will be cost-effective to deliver to young people in the United States (U.S.). This study will also assess the uptake, adherence, and acceptability of DoxyPEP among young people.
详细描述
This is an individual-level randomized trial with a wait-list control and provides PrEP and DoxyPEP for study participants at the Adolescent Medicine Trials Network for HIV Interventions (ATN) Site Consortiums (SCs). This study will be conducted to determine the efficacy and cost of the PrEP Choice package on initiation and long-term adherence (persistence) of PrEP use over 18 months among young people (n=200). All participants will receive brief, basic counseling about the different PrEP methods and a PrEP handout from the participating SC. They will also receive counseling and a handout about DoxyPEP. Participants in the intervention arm will receive the PrEP Choice package starting at enrollment. Participants in the control arm will receive the PrEP Choice package starting at 9 months after enrollment. Both intervention and control groups will be followed for a total of 18 months.
All PrEP drugs will be dispensed by the participating SCs. Participants can select from the following PrEP agents and regimens:
(1) daily oral tenofovir/emtricitabine (tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC]; (2) daily oral tenofovir alafenamide (TAF)/FTC; (3) 2-1-1 event-driven oral TDF/FTC; (4) bimonthly long-acting injectable cabotegravir (CAB-LA); or (5) twice yearly long-acting injectable lenacapavir (LEN). Participants can opt to start PrEP or change regimens at any time in the 18 months of follow-up. At 9 months, participants originally randomized to the control condition will begin to receive the PrEP Choice package in a wait-list control design. This addresses ethical concerns about withholding a potentially effective intervention from the control arm for an extended period. This design also allows for comparison both between arms (intervention versus control), as well as within arms (before versus after the PrEP Choice package in control arm) and allows measurement of extended outcomes and switching patterns for those initially randomized to the PrEP Choice package over 18 months. In addition, DoxyPEP will be offered to both study arms throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 24 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 13-24 years, inclusive;
- •Self-reports being at increased likelihood for HIV acquisition, defined as having anal sex with a male in their lifetime;
- •Owns an iOS or Android Smartphone and able to access all elements of the PrEP Choice package;
- •Not currently on PrEP and interested in learning more about PrEP;
- •Is not living with HIV;
- •Weighs at least 35 kg;
- •Willing to receive PrEP care from a provider at a participating ATN SC;
- •Able to understand, read, and speak English;
- •Able to participate at the study site; and
- •Willing and able to provide written informed consent.
- •If of legal age or otherwise able to provide independent informed consent as determined by local law and consistent with IRB policies: Willing and able to provide written informed consent for study participation.
- •If not of legal age or otherwise not able to provide independent informed consent as determined by local law and consistent with IRB policies: Parent or legal guardian is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for study participation.
排除标准
- •In a mutually monogamous sexual relationship with a partner not living with HIV for the past 12 months;
- •Currently participating in an interventional trial of PrEP agents, or prior enrollment in HPTN 083, HPTN 083-01, or any other study of long-acting PrEP (including PURPOSE- 2 lenacapavir study);
- •Plan to move within 18 months to an area inaccessible to a participating ATN SC;
- •An employee of the participating SC; or
- •Any concurrent participation in other clinical trials or behavioral intervention studies without prior approval from the protocol team.
- •Any other medical, behavioral, or other conditions that in the opinion of the SC Project Lead could interfere with adherence to study procedures or the individual's ability to remain in the study for an 18-month period or compromise interpretation of study results.
研究组 & 干预措施
Standard of Care and PrEP Choice at Enrollment
Participants randomized to the intervention arm will be onboarded PrEP Choice at their Enrollment Visit.
干预措施: Standard of care and PrEP Choice at Enrollment (Other)
Standard of care for the first 9 months followed by initiation of PrEP Choice at Month 9
Participants randomized to the delayed arm will be onboarded to PrEP Choice at their Month 9 study visit.
干预措施: Standard of care followed by PrEP Choice at Month 9 (Other)
结局指标
主要结局
PrEP Uptake; proportion of participants receiving PrEP from the study site within 9 months of study follow-up
时间窗: first 9 months of follow up
1\. PrEP uptake; the proportion of participants receiving PrEP from the study site within 9 months of study follow-up. PrEP uptake is binary, indicating whether the study participant has received PrEP from the study site. This endpoint compares the proportion of participants who receive PrEP from the study site within the first 9 months of study follow-up between the treatment arms.
PrEP Adherence; rate at which participants who received PrEP on study adhere to selected PrEP regimen as measured by dried blood spot for oral regimen and by the on-time CAB-LA and LEN injections for injectable PrEP
时间窗: first 9 months of follow-up
1\. PrEP adherence, the rate at which participants who received PrEP on study adhere to the selected PrEP regimen as measured by dried blood spot for participants selecting an oral regimen and by the on-time CAB-LA and LEN injections for participants opting for injectable PrEP through the first 9 months of study follow-up. PrEP adherence, as measured by dried blood stop for participants selecting an oral regimen and by the on-time CAB-LA and LEN injections for participants option for injectable PrEP, will be assessed every 3 months, and the rate at 9 months of study follow-up will be compared between arms.
DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site
时间窗: 18 months of follow up
1\. DoxyPEP uptake, the rate at which participants receive DoxyPEP from the study site within 18 months of study follow-up. DoxyPEP uptake is binary, indicating whether the study participant has received DoxyPEP from the study site. This endpoint compares the rates of participants who receive DoxyPEP from the study site, assessed every 3 months through the 18 months of study follow-up, between treatment conditions. Participants will be analyzed according to the treatment received, so participants on the delayed treatment arm will be considered on PrEP Choice once they cross over at 9 months.
DoxyPEP Adherence; the rate at which participants are adherent to DoxyPEP coverage of condomless sexual exposures as measured by self-report
时间窗: 18 months of follow up
1\. DoxyPEP adherence, the rate at which participants are adherent to DoxyPEP coverage of condomless sexual exposures as measured by self-report. DoxyPEP adherence is binary, indicated whether the study participant used DoxyPEP to cover their last condomless sexual exposure. This endpoint will be assessed every 3 months through 18 months of study follow-up and compared between treatment conditions. Participants will be analyzed according to the treatment received, so participants on the delayed treatment arm will be considered on PrEP Choice once they cross over at 9 months.
DoxyPEP Acceptability; assessed by Likert scale every 3 months of study follow-up
时间窗: 18 months of follow up
DoxyPEP acceptability, assessed by Likert scale every 3 months of study follow-up through 18 months of follow-up. DoxyPEP acceptability Likert scale results will be compared between the treatment conditions, assessed every 3 months through 18 months of study follow-up. Participants will be analyzed according to the treatment received, so participants on the delayed treatment arm will be considered on PrEP Choice once they cross over at 9 months. The Likert Scale is as follows: 1. Very acceptable 2. Somewhat acceptable 3. Neither acceptable nor unacceptable 4. Somewhat unacceptable 5. Very unacceptable
次要结局
- PrEP modality choice and switching(18 months of follow up)
- PrEP Adherence; rate at which participants who received PrEP on study adhere to selected PrEP regimen as measured by dried blood spot for oral regimen and by the on-time CAB-LA and LEN injections for injectable PrEP(18 months of follow up)
- STI Incidence; individual and combined rates of gonorrhea, chlamydia, and/or early syphilis infection compared between DoxyPEP users and non-users, assessed every 3 months(18 months of follow-up)
- DoxyPEP Uptake; the rate at which participants receive DoxyPEP from the study site(First 9 months of follow-up)