Thetha Nami Ngithethe Nawe ("Let's Talk"): A Step-wedge cRCT of Social Mobilisation by Peer-navigators Into Community-based Sexual Health and HIV Care (Incl. PrEP) to Reduce Sexually Transmissible HIV Amongst Youth in Rural KwaZulu-Natal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,716
- 试验地点
- 1
- 主要终点
- The uptake of risk informed biomedical HIV prevention
研究概览
简要总结
Study Hypothesis: Social mobilisation will attract and engage young people into decentralised sexual reproductive health (SRH) services where HIV prevention is tailored to need. Decentralised risk informed (differentiated) biosocial HIV prevention will reduce the overall prevalence of sexually transmissible HIV amongst young people aged 15-30.
Study aims:
- Measure the impact of social mobilisation into decentralised SRH services that provide tailored HIV prevention on the prevalence of transmissible HIV.
- Evaluate the acceptability, practicability, and reach of social mobilisation and decentralised SRH with tailored HIV prevention to deliver differentiated biosocial HIV prevention.
Study design: A step-wedge cluster randomised control trial comparing the effect of the Intervention (social mobilisation by peer navigators into mobile nurse-led SRH clinics) with Standard of Care (SoC) at Primary Health Care clinics, in reducing the proportion of 15-30 year olds with sexually transmissible HIV and increased uptake of risk-informed (differentiated) HIV prevention Intervention: Peer navigator social mobilisation intervention includes safe spaces, structured psychosocial and health needs assessment; Peer-mentorship with tailored health promotion, psychosocial support and lay-counselling; provision of condoms, HIV self-tests and pregnancy tests. The mobile SRH clinics provide sexually transmitted infection (STI) care, contraception, HIV testing and antiretroviral therapy (ART) if positive and Pre-Exposure Prophylaxis (PrEP) for those eligible (based on national guidelines) and negative.
SoC at Primary Health care clinics includes, contraception, HIV testing and ART if positive and PrEP for those eligible and negative.
Population: The eligible population are ~26,000 15-30-year-old residing in 40 administrative areas (clusters) of the uMkhanyakude district in rural KwaZulu Natal. The 40 clusters will undergo a stratified randomisation to early versus delayed intervention roll out.
Data collection: Research data will be collected from four sources: i) three random representative surveys of n= 2000, 15-30-year-olds; ii) programme, process, and clinical data; iii) qualitative data collected during the process evaluation iv) cost data using bottom-up ingredient-based costing and top-down costing using the budgets and expenditure reports.
Study Duration: 36 months.
详细描述
This implementation trial aims to measure the effect, of 'social mobilisation into decentralised SRH services that provide tailored HIV prevention' on the prevalence of transmissible HIV amongst young people aged 15-30, as well as cost-effectiveness, practicability and reach.
Trial design: investigators will use a cRCT and realist process evaluation with costings. The stepped wedge design consists of 40 clusters (administrative areas) randomised to two intervention steps (early and delayed), 15 months apart. The investigators compare prevalence of transmissible HIV and uptake of risk-informed HIV prevention in intervention areas with contemporaneous controls. The investigators will conduct a cost effectiveness analysis and use a realist process evaluation to interrogate the extent to which the intervention components deliver according to the theory of change and support demand, uptake and retention in risk-differentiated biomedical HIV prevention amongst young people. Investigators will use the process evaluation data to inform any modifications within the intervention arm and to inform stop/go decisions at the end of step1.
Study setting: The study is taking place in the uMkhanyakude district in rural KZN, which is mostly rural with over 85% youth unemployment and a high burden of HIV.
Study population and eligibility criteria: About 26,000 young people aged 15-30 residing in 40 administrative areas (clusters) of the uMkhanyakude district in rural KwaZulu Natal are eligible to receive the intervention and control services. Investigators use the AHRI health and demographic surveillance as a sampling frame to randomly select three separate cross-sectional samples of n=3600 (90 per cluster) 15-30-year-olds stratified by gender at baseline, midpoint (before the second step of scale up) and end-line to measure trial outcome. Based on previous studies in this setting, investigators anticipate that ~2800 will be contactable and eligible and that n=2000 (~50 per cluster) men and women aged 15-30, will be willing and able to provide consent to be included in the study.
Study interventions, eligibility criteria and outcomes are described below
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Restricted randomisation was used to randomly allocate administrative areas in equal measure (to early and delayed roll-out of the intervention steps (20:20). Restricted randomisation was used to ensure that the intervention steps are reasonably balanced with respect to key characteristics (obtained from the HDSS) specifically, adolescent and young adult population size and density, new versus old areas, and geographic location along the N2 road. Interventions were assigned during a public ceremony to ensure transparency and fairness in the randomisation and engagement of the community. Randomisation and allocation were kept separate throughout. The statistician and investigators did not participate in the public randomisation and will remain blinded until the analyses of primary and randomised secondary outcomes have been finalised. Investigators remain blinded to allocation throughout. The participants and intervention delivery teams are not blinded.
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resident in the cluster
- •Any gender
- •Aged 15-30
- •If aged 18-30 and able and willing to consent to participate
- •If aged 15-17, able and willing to assent and whose guardian or parent are able and willing to consent to their participation.
排除标准
- •Unable or unwilling to provide consent
- •Aged 14 or less
- •aged 31 or more
研究组 & 干预措施
community-based differentiated biosocial HIV prevention (incl. PrEP) with SRH
The intervention is available to all 15-30 year olds residing in the intervention cluster. Area based peer navigators mobilise all young people living in their cluster. They provide sexual health promotion, condoms, HIV self-tests, pregnancy test, and conduct structured psychosocial and health needs assessment with the young people they support. Based on the needs assessment they develop a tailored plan which includes, varying degrees of peer-mentorship and psychosocial support, lay-counselling and ART/PrEP adherence support. The peer navigators refer young people to mobile SRH services. The mobile SRH services provide gender and HIV status neutral nurse-led HIV testing, Individualised risk assessments for HIV care and PrEP, contraception and wider SRH services. The nurses liaise with the peer navigators to provide ongoing support for 3-monthly follow-ups with repeat HIV testing, adherence support and PrEP/ART/contraception refills.
干预措施: Community-based differentiated HIV prevention incl.PrEP with SRH (Combination Product)
Standard of Care
SOC is available to all young people in the delayed clusters. Care is provided in a nurse led Primary Health Clinics (PHC) to young people who attend the clinic. This includes HIV counselling and point of care testing, immediate initiation of ART if positive and PrEP if negative and eligible according to South African National PrEP guidelines. This is followed by a 3-monthly follow-up with repeat HIV testing, safety bloods, clinic-based counselling and adherence support and PrEP/ART refills. Clinic attendees are offered family planning support and syndromic management for STIs (as per South African National Department of Health Guideline).
干预措施: Primary Health Clinic based HIV prevention and care (Other)
结局指标
主要结局
The uptake of risk informed biomedical HIV prevention
时间窗: 36 months
The proportion of participants who are aware of HIV status; on treatment if positive; and have undergone risk assessment by peer navigators or SRH clinic if HIV negative (and taken up PrEP if HIV negative and eligible) in the intervention arm compared to control.
Prevalence of sexually transmitted HIV
时间窗: 36 months
The proportion of those aged 15-30 who are HIV positive and have a detectable HIV viral load defined as having an HIV viral load of \>= 400 copies per ml, in the intervention arm compared to control
The cost of transmissible HIV averted.
时间窗: 36 months
The cost per transmissible HIV case averted and the cost per case linked to risk differentiated biosocial HIV prevention.
次要结局
- Teenage pregnancy and fatherhood(36 months)
- Acceptability and reach of peer support(36 months)
- Uptake of contraception(36 months)
- Prevalence of Sexually Transmitted Infections(36 months)
- Uptake of PrEP(36 months)
- Cost per case linked to HIV care and Prevention(36 months)
- Proportion of men and women aged 15-30 at risk of acquiring HIV or transmitting HIV(36 months)
- Fidelity(36 months)
- Uptake of voluntary male medical circumcision(36 months)
- Acceptability and reach of mobile SRH clinics(36 months)