Peer Delivery of HIV Self-Screening to Support Linkage to HIV Prevention in Rural KwaZulu-Natal, South Africa: A Cluster Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 主要终点
- The rate of linkage among women ages 18-24 years to HIV prevention services.
研究概览
简要总结
Hypothesis: HIV-Self-Test (HIV-ST) will allow peers or peer-networks to effectively and efficiently link older adolescent girls and young women into HIV prevention and care services.
Design: A cluster randomized control trial comparing two models of peer delivery of HIV-ST, through incentivized respondent driven peer networks and direct distribution by peer navigators compared to standard of care (referral to HIV testing, prevention and care services by peer navigators) in improving the uptake of HIV prevention and care amongst young women (18-24) living in the rural uMkhanyakude district of KwaZulu-Natal, South Africa.
Objectives:
- To increase the knowledge of HIV status among young women aged 18-24 years old through distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into HIV testing services.
- To determine an increase in the rate of linkage among young women aged 18-24 to HIV prevention and treatment services facilitated by distribution of HIV-ST through incentivized peer networks or direct distribution by peer navigators compared to peer navigators referring into services.
- To conduct a process evaluation of the acceptability, feasibility, and reach (out of school, recently migrant and living in remote areas) in linking 18-24-year-old women to HIV prevention and treatment services of HIV-ST distribution through incentivized peer networks, or direct distribution by peer navigators or peer navigators referring into services.
- To measure the cost per 18-24-year-old linked to prevention and care through peer-led incentivized HIV-ST delivery system or direct distribution of HIV-SS by peer navigators, compared to peer navigator referring into services.
Primary Outcomes:
The difference between the rate of linkage within three months of 18-24 years old women to HIV confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive. It will be between the two peer-delivery approaches to HIV-ST distribution (incentivized HIV-ST delivery through peer network and direct distribution of HIV-ST by peer navigators) compared to standard of care (peer navigator referral to HIV testing, treatment and prevention services). Rate is defined as the number of linkages per month of peer navigator outreach activity.
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)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18-24 years
- •Not currently on ART
- •Provide written informed consent
排除标准
- •Under 18 years or older than 24 years
- •Participants not willing to consent or unable to provide informed consent
- •Currently on ART
研究组 & 干预措施
Incentivised network delivery HIV-ST
Peer-navigators will use respondent-driven sampling to distribute HIV-ST kits through 'seeds'. Each 'seed' (female aged 18-24 years) will receive a session on HIV prevention, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV self-screening. Seeds will be asked to recruit females aged 18-24 years and given 5 uniquely numbered incentivized recruitment coupons with HIV-ST kits to pass on to their peers. Individual who return the coupons will undergo the same procedure as the seeds above and the individual who handed out the coupon will receive a sum of $1.5 in airtime per friend who returns the coupon. The packs include referral slips with information on how to link to HIV community-based confirmatory testing, HIV treatment and PrEP.
干预措施: Incentivised network delivery of HIV-ST (Other)
Peer Navigator distributed HIV-ST
Peer navigators will directly distribute HIV-ST kits to females aged 18-24 years over a period of six months. Each person recruited will receive a session from the peer-navigator on the HIV prevention services available, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV-ST. The packs include referral slips with information on how to link to community-based HIV confirmatory testing, HIV treatment and PrEP.
干预措施: Peer navigator delivery of HIV-ST (Other)
Standard of care
Peer navigators will encourage females aged 18-24 years to test for HIV at clinics, and link to services/care. Each female aged 18-24 approached by a peer navigator will receive a session from the peer-navigator on the HIV prevention services available, the importance of sexual health, the benefits of HIV testing PrEP and ART, and a demonstration of HIV self-screening. They will then be given a referral slip for HIV testing through the clinic. The referral slips include information on how to link to community-based HIV confirmatory testing, HIV treatment and PrEP.
干预措施: standard of care (Other)
结局指标
主要结局
The rate of linkage among women ages 18-24 years to HIV prevention services.
时间窗: within 3 months of receiving the intervention
The rate of linkage per month of peer navigator activity to a confirmatory testing and pre-exposure prophylaxis (PrEP) eligibility screening if HIV-negative and antiretroviral treatment (ART) starting if HIV-positive.
次要结局
- The number of linkages per 100 clinic referral slips distributed per arm;(within 3 months of receiving the intervention.)
- The change in proportion of all residents (men and women) aged 18-24 years who are aware of HIV-SS and who have used HIV-SS over time(12 months following intervention end date)
- Comparison of the difference per study area in the proportion of 18-24 year olds who report knowledge of HIV status and uptake of ART, PrEP and voluntary medical male circumcision (VMMC)(12 months following intervention end date)
- Comparison of the pattern of recruitment per arm of study(12 months following intervention end date)
- Comparison of costs per case linked to PrEP eligibility assessment (HIV-) and cost per case started on ART (HIV+) in intervention and control arms(6 months study implementation period)