Expanding Options for HIV Prevention Through Pre-exposure Prophylaxis in Hhohho Region, Swaziland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 517
- 试验地点
- 6
- 主要终点
- Uptake
研究概览
简要总结
This stepped-wedge cluster-randomized trial is embedded in an 18-month observational cohort study that has the aim to assess the operationalization of oral Pre-Exposure Prophylaxis (PrEP) in Swaziland as an additional HIV combination prevention method among individuals at high risk of HIV infection. The trial aims to determine the effect of a healthcare facility-based PrEP promotion package on the number of clients who take up PrEP.
详细描述
The study will assess who will be reached with an introduction to and an offer of PrEP - and who will take up PrEP - when PrEP becomes available through different delivery points in the public-sector health system, including outpatient department (OPD), antenatal care (ANC), postnatal care (PNC) , family planning (FP) , and following HIV counseling and testing (VCT).
In addition to PrEP reach and PrEP uptake, the study aims to establish PrEP retention and average costs per client, by different health systems delivery points and to assess the effectiveness of a feasible and low-cost PrEP Promotion Package (PPP). The exact composition of PPP will be informed by findings from in-depth- interviews with clients, providers, and PrEP stakeholders. The effect of the PPP on the monthly number of clients who are initiated on PrEP will be studied using a stepped-wedge cluster-randomized design. Specifically, the trial will have two sequences with three healthcare facilities in each sequence, and three periods. In the first period, all healthcare facilities will be in the control phase; in the second period three healthcare facilities will implement the PPP; and in the third period all six healthcare facilities will implement the PPP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Healthcare facilities will not be informed as to when they are expected to start implementing the intervention (the PrEP Promotion Package) until two weeks prior to the start of the intervention phase.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed HIV negative by rapid antibody test following the National HIV testing services (HTS) algorithm on the day of PrEP initiation
- •> 16 years of age
- •Willing and able to provide written informed consent
- •Identified at substantial risk of acquiring HIV infection
- •No current or recent illness (within past month) consistent with acute HIV infection in combination with a preceding high risk exposure for HIV
- •No contraindications to the use of Tenofovir(TDF)/Lamivudine (3TC)
- •Ready to adhere to PrEP and willing to attend the follow up evaluations including repeat HIV testing and monitoring for side-effects
排除标准
- •Younger than 16 years of age
- •Currently having symptoms of acute HIV infection
- •Suspicion of window period following a potential exposure to HIV
- •Body weight < 40 kg
- •Creatinine clearance <60 ml/min
- •Using other nephrotoxic drugs (e.g. aminoglycosides)
- •Not willing to come for follow up visits every 3 months which will include HIV testing and counselling and monitoring for side-effects.
研究组 & 干预措施
Control phase
This is the provision of PrEP without the use of the PrEP Promotion Package. PrEP promotion in the control phase consists of each clinic displaying posters that advertise PrEP, pamphlets, and palm cards that patients can take home from the clinic.
Intervention phase
This is the provision of PrEP as in the control phase plus the addition of five PrEP promotion components, which constitute the PrEP Promotion Package (PPP). These five additions are: 1) a PrEP promotion video to be played in the waiting room, 2) T-shirts advertising PrEP to be worn by healthcare workers, iii) a flipchart to support healthcare workers' PrEP counseling, iv) an informational booklet for clients to take home, and v) self-risk assessment forms to be displayed in the waiting room.
干预措施: PrEP Promotion Package (Other)
结局指标
主要结局
Uptake
时间窗: 18 months
The monthly number of clients who was initiated on PrEP
次要结局
- Substantial risk(18 months)
- Risk assessment(18 months)
- Acceptance conditional on risk(18 months)
- Linkage(12 months)
- HIV incidence(18 month)
- Retention at 6 months(6 months)